Category: Press Release

BTK Inhibitor Offers Benefits of Ibrutinib Without Cardio Side Effects

The Bruton’s tyrosine kinase (BTK) inhibitor, ibrutinib, has been improving the survival rates of patients with leukemia and lymphoma since being FDA approved in 2013. Ongoing research and positive patient outcomes have reaffirmed the efficacy of the drug as a cancer treatment.

One major side effect of ibrutinib, however, is cardiovascular damage.

Now, some of the same researchers involved in creating ibrutinib have developed the second-generation cancer drug acalabrutinib. The new BTK inhibitor promises to deliver the same cancer-fighting benefits of its first-generation cousin, but with minimal treatment-limiting side effects.

Data has shown acalabrutinib improves survival rates in patients with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), according to the researchers who developed and tested both BTK inhibitors at The Ohio State University Comprehensive Cancer Center (OSUCCC)—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute in Columbus.

The OSUCCC—James researchers recently reported data from a clinical trial conducted at 15 cancer centers in the U.S., U.K., and Italy. A total of 134 patients received acalabrutinib, including 132 with CLL and two with small lymphocytic lymphoma. The overall response rate to the treatment was 85 percent and most patients (81%) continued treatment at 19.8 months.

Meanwhile, in a separate analysis led by OSUCCC—James researchers, 610 patients with various blood cancers were treated with acalabrutinib. The average median duration of treatment was 14.2 months. While adverse side effects led to discontinuation of treatment in only 6.1 percent of patients. That compares to 17.3 percent of patients receiving ibrutinib who required discontinuation of therapy due to adverse events.

“It’s very promising that acalabrutinib produces the same response rates that we saw with ibrutinib, but what’s really exciting is that those results seem to deepen with time and also reduce the likelihood of life-impacting side effects like atrial fibrillation,” lead researcher, John C. Byrd, MD, told Oncology Times.

The recently reported data also show the drug is safe and effective in treating multiple blood cancers, not just CLL, Byrd said. “Combined data from seven ongoing clinical trials testing acalabrutinib reported mostly low-grade side effects and excellent cancer control in patients with follicular lymphoma, mantle cell lymphoma, prolymphocytic leukemia, small lymphocytic lymphoma, and Waldenstrom macroglobulinemia.”

Rapid Response

FDA granted accelerated approval for acalabrutinib in October 2017 for the treatment of adult patients with MCL who have received one prior therapy. The accelerated approval was based in part on the overall response rate to acalabrutinib, which included 80 percent of patients achieving overall response with 40 percent achieving complete response and 40 percent achieving partial response. By comparison, ibrutinib produced overall response rates of 77 percent, with 33 percent of patients obtaining complete response.

Second-generation acalabrutinib was engineered to overcome the side effects and other treatment challenges identified with ibrutinib, said Byrd, the D. Warren Brown Designated Chair in Leukemia Research and a Distinguished University Professor at Ohio State.

“We found that most patients tolerate [ibrutinib] very well and that it improves survival rates in patients with CLL and MCL. But to understand any resistance to the treatment and overcome any challenges or side effects, we immediately began working on a second-generation drug, acalabrutinib,” he said.

Among the key takeaways from the recent studies of acalabrutinib, Byrd said, is that the results were “very positive in both patients with relapsed disease and patients who had never been treated for CLL, as well as when acalabrutinib was given alone or in combination with other drugs.”

“When acalabrutinib was given in combination with an engineered antibody drug, the response rate was 95 percent in those who had never received treatment, and overall survival in patients with relapsed CLL was 92 percent a year and a half to 2 years after treatment began,” Byrd continued. “When administered alone to CLL and SLL patients, acalabrutinib treatment resulted in an 85 percent response rate and more than 80 percent of patients remained on treatment after 20 months.”

Future research, Byrd said, needs to include finding more ways to treat patients with the new drug.

“The overall response rates to acalabrutinib in these trials begins to show us the potential impact this drug can have on the management of CLL, but there is an urgent need for additional research and to find additional treatment options,” he said.

“We know that this drug is well-tolerated and that its results are durable over time. Now we need to further investigate drug combinations that are going to work for different patients to provide the most effective treatment for their individual cancer.”

Immense Potential

Medical oncologists around the country said they are eager to prescribe acalabrutinib for their patients.

“As ibrutinib is currently indicated in five distinct hematology neoplasm scenarios, the potential for this agent is immense,” said Sean Fischer, MD, Medical Oncologist and Hematologist at Providence Saint John’s Health Center in Santa Monica, Calif.

“Acalabrutinib, in preclinical studies, showed not only higher degrees of selectivity and inhibition of BTK, but also decreased thrombotic risk compared to historical data with ibrutinib suggesting this agent could have best-in-class potential,” he added.

The increase in overall response rates and significant decrease in the number of patients who needed to discontinue treatment due to side effects with acalabrutinib compared to ibrutinib are reasons to consider using the younger BTK inhibitor, Fischer noted.

“Based on this indirect comparison, my bias would be to prescribe acalabrutinib in the appropriate patient population given its efficacy and tolerability compared to similar options for patients with relapsed MCL,” he said. “I have used the agent several times thus far, since its approval, and I hope to gain more experience as the drug’s indications improve, as it is in studies for other indications, such as CLL, SLL, and other low-grade lymphoproliferative disorders.”

Acalabrutinib adds to “an array of multiple, effective novel agents for this disease that have dramatically improved the outcomes of such patients,” said Jack Jacoub, MD, Medical Oncologist and Medical Director of MemorialCare Cancer Institute at Orange Coast Medical Center in Fountain Valley, Calif.

“Initially, I would reserve its use for those who I may be worried about using ibrutinib, the first available BTK inhibitor, such as those patients with a history of arrhythmias, concurrent anticoagulant use, and/or a bleeding diathesis, as preliminary data suggest a low rate of related side effects with acalabrutinib as opposed to ibrutinib,” Jacoub said.

“We have yet to use [acalabrutinib], but we are anticipating clinical trial availability for our patients with this agent that is being studied in many indications,” he added. “Honestly, I would hope it puts a pricing pressure on ibrutinib, proves safer to ibrutinib, and obviously more effective (yet to be determined).”

Chuck Holt is a contributing writer.

Looking for the latest research advances?

Interested in the most recent oncology research? Stay up-to-date with the “Journal Snapshot” column featuring the latest advances in the field. Visit http://bit.ly/2Ik7GbM now!

Shannen Doherty Is ‘Banking’ Her Own Blood Before Surgery

Shannen Doherty, who has spoken publicly about her breast cancer diagnosis and treatment over the past few years, recently revealed that she’s about to have surgery—and she’s “banking” her own blood for it.

“My doctor had me bank some blood for my upcoming surgery,” she captioned a photo on Instagram of herself and a phlebotomist from the American Red Cross. “Mars P was patient with me and didn’t even roll his eyes at my anxiety over the needle size. He was patient, kind and really good.”

“As I sat there banking blood for myself, I asked him about some of the people also donating…especially the ones with TVs,” she continued. “So two of them come every two weeks and donate platelets which takes two hours. Another girl comes as often as allowed to donate blood. To say I’m moved by the generosity of people is an understatement. I’m vowing that as long as I’m cleared in the future, I will start donating.”

Doherty didn’t provide any other details about her upcoming surgery, but she has been in remission since April 2017. In early April of this year, Doherty said on Instagram that she’s “staying positive” after a post-cancer tumor scan came back “elevated.” However, she stressed that she’s still in remission. “Just means I get monitored and another test,” she explained. “But even after that call, I’m staying positive and taking stock of my life.”
If you need blood as a result of surgery, you can get a transfusion from donated blood or “bank” your own ahead of time just in case.

When you undergo any surgery, your doctor will do what they can to limit your blood loss. But sometimes you may need a blood transfusion to make up what you’ve lost. Donated blood is thoroughly tested to make sure it’s as safe as possible for transfusion, but they still carry small risks for complications, such as transfusion reactions or infections. So, in some cases, patients prefer to use their own blood (aka autologous donation), should they need a transfusion.

This probably happens more often than you realize. It’s “fairly common for planned surgeries that are expected to be uncomplicated,” Jayesh Mehta, M.D., a hematologist and oncologist at the Robert H. Lurie Cancer of Northwestern University at Northwestern Memorial Hospital, tells SELF, such as hip replacement surgery and heart surgery.

A breast cancer patient may have breast surgery, but that doesn’t usually involve a large loss of blood, Jack Jacoub, M.D., a medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Medical Center in Fountain Valley, Calif., tells SELF. But, if someone had a genetic disposition linked with their breast cancer, doctors may recommend that they have additional risk reduction surgery, like removing the ovaries or uterus, which could involve more notable blood loss. “That may be significant enough to warrant a transfusion,” Dr. Jacoub says.
If you want to do analogous blood donation, you’ll need your doctor to write an order to have your blood drawn first, Ross Herron, M.D., chief medical officer of the Red Cross West Blood Services Division, tells SELF.

Then, you can take that order to a community blood center or the hospital where you’ll have your surgery and have your blood collected, David Oh, M.D., chief medical officer at Hoxworth Blood Center, University of Cincinnati, tells SELF.

Once you arrive, you’ll probably have your vital signs and temperature taken and have to provide a short medical history before you actually have your blood drawn, Dr. Herron says. If you go to a community organization like the Red Cross, your blood will be tested for markers of infectious diseases like hepatitis and HIV before it’s sent to the hospital where you may use it, he says. (If you do test positive for any of these, it doesn’t mean you can’t use your blood—it just needs to be quarantined from other blood that’s been drawn to prevent a potential contamination, Dr. Herron explains.)
You’ll have to carefully time your banking procedure so that your body has time to recover without letting your blood sit around too long before surgery.

“It takes some time for your body to make up for the cells that were collected, so donation is often discouraged with less than a week prior to the surgery date,” Dr. Oh says. But blood can only be stored for so long. Donated red blood cells can be stored for up to 42 days, Dr. Oh says. So you may be able to have your blood taken anywhere from six weeks to five days before your surgery, according to the U.S. National Library of Medicine.

It’s generally recommended that you donate between one to two units of blood, Dr. Mehta says. (One unit is 525 milliliters.) If you donate two, you’ll probably do the donation in two separate appointments spaced out by one to three weeks to allow the blood in your body to replenish itself, he says.

So, this isn’t something you can do for urgent, emergency surgeries. It also means that you can only use up to two of your own units of your own blood during a transfusion. “If it’s complex surgery that requires a lot of blood, this is not possible,” Dr. Mehta says.

The blood is then stored in a blood bank and kept handy while you undergo surgery. If you need the blood, you’ll receive it via transfusion, just like you would if you were having it from an outside source, Dr. Mehta says. But if your blood isn’t used during or after your surgery, it’ll be tossed. “It is estimated that only half of the blood collected as autologous is actually transfused to the patient because it may not be needed,” Dr. Oh says.

Although banking your own blood comes with a bit of extra hassle, it might make perfect sense for your specific situation. So, if you know you have an upcoming surgical procedure and you’re curious about banking your own blood, talk it over with your doctor.

8 Things Doctors Wish You Knew About Metastatic Breast Cancer

– For starters, don’t read about survival rates on the internet.

“Breast” and “cancer” are never two words you want to hear together, but discovering you have metastatic, or stage IV, breast cancer can make a bad situation feel impossibly worse. A lot of this fear stems from some common misunderstanding about what metastatic breast cancer is, how it spreads, what the prognosis is, and available treatments.

The word “metastatic” simply means that the cancer has spread to other parts of the body beyond the original location of the tumor. The cancer originates in the breast, but the cells can travel to any other part of your body, leading to tumors in your lymph nodes, lungs, liver, bones, brain, or other places. Nearly 30 percent of women who are diagnosed with early-stage breast cancer will ultimately develop metastatic disease, according to The National Breast Cancer Foundation.

Each year about 255,000 people are diagnosed with stage IV breast cancer. While the majority are women, men can get the disease too. Approximately 41,000 people die of breast cancer each year and metastatic breast cancer is responsible in the majority of the cases, according to NBCF. The five-year survival rate is about 25 percent for women and 20 percent for men.

That may sound grim, but it’s important to know the more positive side of a metastatic breast cancer diagnosis. The field is changing quickly with more and more treatment options, and many patients are living long, productive lives for longer and longer periods. Here’s what a leading group of oncologists wish everybody knew about metastatic breast cancer.

1. Metastatic breast cancer is not a death sentence

Hearing that your breast cancer has spread throughout your body is definitely not good news, but every doctor we spoke to was adamant that metastatic breast cancer is often no longer the death sentence it used to be. “Many of the available treatments are very effective and may extend life expectancy many years,” says Dennis Holmes MD, a breast cancer surgeon and researcher and interim director of the Margie Petersen Breast Center in Santa Monica, California. “Some women even live a normal life span.”

One of the best ways to navigate the stressful period right after diagnosis is to find a doctor you really trust (and don’t be afraid to seek second opinons) and surround yourself with a solid support group of family, friends, or other breast cancer patients or survivors, according to Mitch Golant, PhD, a psychologist with Breastcancer.org.

2. Metastatic breast cancer isn’t necessarily like other metastatic cancers

Any cancer diagnosis with the words “stage IV” or “metastatic” in front of it is terrifying, but when it comes to breast cancer you may have less to fear than you may think, says Jack Jacoub, MD, medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Medical Center. “Metastatic breast cancer is unlike other cancer types that spread—like lung or colon—and generally the prognosis is much better,” he says. “Women live longer and we have more therapies available; we routinely see women with metastatic breast cancer, especially that involving bone, living well over several years and feeling good.”

3. Metastatic breast cancer can’t turn into another cancer

Once your diagnosis of breast cancer is confirmed, it will always be breast cancer—even if it has metastasized, or spread, to other parts of your body. “Many patients think that cancer that has spread to the bone has then become ‘bone cancer’ or if it’s spread to the liver then it’s now ‘liver cancer,’ but breast cancer cells will remain breast cancer under the microscope and by every other characterization,” Dr. Jacoub explains.

4. A lot of factors go into cancer survival rates

In general, the five-year survival rate for stage IV metastatic breast cancer with metastases in other organs is a rather dismal 22 percent. But that number leaves out a lot of individual factors that can affect your prognosis, says Maxim Privalov, MD, oncologist and breast cancer specialist at Bookimed. These include the level of metastatic spread, the size of tumor(s), your age, your overall health, treatment options available, your doctor’s experience, and the clinic you’ve chosen.

This is why it’s so important to find a doctor you trust and then talk to them about your specific tumor biology, treatment options, and prognosis, rather than believing some number off the internet, he adds.

5. There are more treatment options than ever before

People hear breast cancer and automatically picture scorched-earth chemotherapy, but there are multiple other treatments available to women with metastatic breast cancer, Dr. Holmes explains. Hormone therapy is the first line of treatment for estrogen positive (ER+), the most common type of breast cancer, Dr. Jacoub says. These include hormone-blocking medications like tamoxifen and hormone-inhibiting drugs like aromatase inhibitors. These can be taken as pills or injections and may produce wonderful results, particularly when used at the beginning of treatment, he adds.

There’s also promising new classes of what are known as targeted medications, which block the growth of breast cancer cells in specific ways, according to the NBCF. The fact that they’re targeted to very specific pathways that allow cancer cells to divide and spread means they typically have fewer side effects compared with chemotherapy and radiation. These drugs can be used on their own, with anti-estrogen drugs, or in conjunction with chemo. More drugs in this category are being developed and FDA approved frequently.

For the most aggressive kind of metastatic breast cancer—triple negative—there are exciting clinical trials using a type of medication known as immunotherapy. This new therapy uses the patient’s own immune cells to attack and kill cancer cells.

6. You might not even need chemo for treatment

It’s normal to hear “cancer” and automatically jump to “chemo” but that’s not necessarily the case anymore, says Dr. Jacoub. “One myth we hear a lot is the assumption that metastatic disease requires chemotherapy, which isn’t true for the majority of breast cancer cases,” he says. “It really depends on cancer subtype. For triple negative or HER2 types of metastatic cancer, chemo is generally recommended but they only make up about 20 percent of cases,” he explains. “However, the most common subtype, making up 80 percent of cases, is estrogen receptor positive, which typically responds very well to hormone therapies.”

7. Mastectomies have gotten a lot better

Mastectomies aren’t necessary in all cases of metastatic breast cancer—whether or not you get one depends on the cancer subtype, the tumor, and several other factors—but they are a fairly common treatment for metastatic breast cancer, Dr. Privalov says. “It may help stop the metastatic spread and prolong your life expectancy,” he explains. If you end up in this situation, know that both the surgery to remove your breast(s) and the breast reconstruction after surgery have come a long way in the past few years. Losing your breasts may feel like a huge loss and understanding your surgical options—like using your own tissue instead of implants—may help you feel better about the process, he adds.

8. Palliative care may not be what you think

People hear the phrase “palliative care” and may assume it’s only for people who are dying but palliative care is really about increasing your quality of life, regardless of how advanced your disease is, Dr. Privalov says. For metastatic breast cancer, palliative care can mean everything from talking to a therapist who specializes in breast cancer patients to medications that alleviate side effects like nausea, fatigue, and pain.

“Even if the cancer cannot be cured completely, doctors have options in palliative therapy to reduce breast cancer symptoms, increase your comfort, and help prolong life expectancy,” he explains. While you’re focusing on getting the best treatment to kill your cancer, it’s important to take care of the rest of your body and life with mental and physical therapies, and that’s where palliative care may come in.

RAI Following Thyroid Cancer Surgery Increases Risk for AML & CML

In a recent study of the risk and outcomes of a second hematologic malignancy in a population-based cohort of patients with well-differentiated thyroid cancer (WDTC), researchers found an early increase in the risk of acute myeloid leukemia (AML) and chronic myeloid leukemia (CML), but no other malignancies, in patients treated with radioactive iodine (RAI) following surgery.

The increased risk of AML and CML was seen not only in patients with high-risk disease features, but also in those with low-risk and intermediate-risk tumors. The risk for AML and CML peaked during the first 2 years after RAI treatment. In addition, AML developing after RAI “trended toward inferior survival” compared to patients in whom AML was their first cancer (median overall survival, 1.2 years vs. 2.9 years; P=.06) (J Clin Oncol 2017; https://doi.org/10.1200/JCO.2017.75.0232).

Of 148,215 patients identified with WDTC from the 18 Surveillance, Epidemiology, and End Results (SEER) registries, 53 percent received surgery alone and 47 percent received RAI. In total, 783 patients developed a second hematological malignancy. Compared with thyroidectomy alone, RAI treatment was associated with an increased early risk of AML (HR, 1.79; 95% CI, 1.13 to 2.82; P=.01) and CML (HR, 3.44; 95% CI, 1.87 to 6.36; P=.001).

According to the researchers, patients were excluded from the study for the following:

  • their thyroid cancer was not follicular or papillary histology;
  • they received treatment with chemotherapy or tyrosine kinase inhibitors;
  • WDTC was not their first cancer;
  • their hematologic malignancy was a first, third, or higher order of primary cancer;
  • they received external beam radiotherapy; and
  • if radiation or survival status was unknown.

Competing risk regression analysis was used to calculate the risks of second hematologic malignancy treatment and outcomes in the study.

Because SEER does not report on the dose of RAI administered, it was not possible to directly determine dose-response relationship of radiation-induced leukemia. Consistent with RAI dosing recommendations that bases RAI dose on disease burden, investigators applied an interaction term based on tumor size and regional disease to assess dose-response. WDTC patients with tumor size ≥ 2 cm (vs. < 2 cm) and regional disease (vs. local) had higher risk of AML and CML, suggesting receipt of higher RAI dose.

Individualized Prognosis

In an interview with Oncology Times, the study’s corresponding author, Sudipto Mukherjee, MD, PhD, MPH, Associate Staff Member in the Department of Hematology and Medical Oncology at the Cleveland Clinic Taussig Cancer Institute, said the impetus for the study was to provide patients with WDTC a more complete picture of what to expect after diagnosis.

“Far too often in clinical practice we offer therapeutic options to cancer patients who need those treatments, but often fail to provide them with a comprehensive picture of benefits and risk of available therapies, particularly long-term risk of second cancers, which is a devastating complication of cancer treatment,” said Mukherjee, whose main focus of research is trying to quantify the risk for second cancers in patients who had their first cancer treated with chemotherapy, radiation, or both.

Several previous studies have examined the relationship between RAI and development of second cancers, both solid tumors as well as hematological malignancies. What separates this study from previous studies is that, in this study, the researchers quantified the risk of individual hematologic malignancies rather than using broad categories of leukemia and lymphoma and, secondly, showed dynamic changes in the risk of these cancers over time.

“Second cancer risk analysis done by grouping several different leukemic (acute and chronic) entities under the broad category of leukemia is an oversimplified analysis and findings using such an approach can be potentially misleading. This is because it does not account for the fact that leukemias are biologically heterogeneous with different prognosis and outcomes,” Mukherjee said.

“For example, if a patient presents with AML after RAI treatment, providing them with an AML-specific prognosis is more accurate rather than overall acute leukemia risk that groups AML as well as acute lymphoblastic leukemia (ALL). AML and ALL, as we know, are disparate leukemic entities with different treatment strategies and outcomes—they are apples and oranges,” he explained.

The study also reports on dynamic changes in the risk of developing a second hematologic malignancy by comparing it with the risk of such cancers in the general population, Mukherjee noted. “I think a much more meaningful way of explaining the risk to the patients is, ‘Well, you have an increased risk of developing leukemia following the treatment of thyroid cancer, your risk of leukemia peaks in the second year of completing your treatment and, after 5-6 years following RAI exposure, your risk drops to baseline population rates.’ Providing a sense of how the risk changes over time following treatment gives patients a better understanding of what to expect with increasing number of years survived.”

Clinical Implications

The study’s results support the most recent American Thyroid Association guidelines, which instruct physicians to use caution when treating WDTC patients with low- or intermediate-risk tumors with RAI. There were two surprising findings, however, Mukherjee said.

“One, I was not expecting the risk of AML would peak so early. We found that AML risk peaks after the second year following exposure to RAI, which is a very early rise, and by 6 years the risk declines and becomes comparable to what we would see in the general population.”

A second surprising finding was an extended risk for CML, he said. “We found that the risk for CML peaked in the second year, but the elevated risk persisted for up to 10 years [before] it starts declining, which is something we did not expect.”

A major finding of clinical concern in this study was increased risk of AML and CML with RAI treatment even in low- and intermediate-risk WDTC, which comprise 94 percent of all WDTC tumors, Mukherjee said.

“If you look at our study, which encapsulates 40 years, from 1973 to 2014, the use of RAI following surgery for WDTCs went up steadily from 3 percent to 4 percent in 1973 to 50 percent in 2006. A substantial majority of these tumors are small (< 2 cm), asymptomatic tumors classified as low-risk for which use of RAI following surgery has not been shown to improve survival. But, definitely, these patients are put at risk of having a second cancer, particularly AML and CML.”

Fortunately, the ATA guidelines calling for caution in using RAI in low-risk tumors appear to be increasingly recognized in real-world clinical practice. “Since the issuance of these guidelines, we have started to notice a decline in RAI use for these tumors, which dropped to about 46 percent by 2014,” Mukherjee said.

“The clinical implications of these findings really are that, for WDTC patients with high disease risk features, RAI is necessary because of survival benefit with this approach,” he added. “But our study clearly shows that the risk of AML and CML following RAI also increases in low- and intermediate-risk WDTC tumors treated with RAI. I think that is the key take-home message—that, if it is possible, RAI should be avoided in low- to intermediate-risk tumors, in light of data that has not shown any survival benefit in these disease categories to date.”

The second take-home message is that patients with WDTC exposed to RAI should be actively monitored for myeloid malignancies, particularly AML and CML, during their cancer surveillance, Mukherjee continued. “We did not delve into that, but it seems like regular monitoring of the peripheral blood counts is one of the simplest ways to monitor these patients, especially in those patients who do not recover their counts completely in a reasonable period of time following RAI treatment, at least for the first 2 years, because the risk peaks during the second year.”

Further Studies Needed

Although the number of patients with WDTC who develop second cancers following RAI treatment is small, and even though the absolute risk for developing AML and CML is low, the problem is real and potentially avoidable. Especially for AML, this is concerning as the prognosis is dismal, Mukherjee said.

“What I would be curious to know is: Are there any other factors in addition to having RAI that puts this select group of patients at risk of having AML?” he said. ”Do these patients who develop these cancers following RAI exposure have any kind of underlying genetic predisposition to develop these cancers? This is an area that needs further investigation, because now we have data from other diseases that supports this assertion.

“For example, several recent publications have shown that people with CHIP [clonal hematopoiesis of indeterminate potential] mutations are at increased risk of developing myeloid malignancies,” said Mukherjee, pointing to two studies published last year that showed patients with solid tumors who harbored CHIP mutations at the time of their diagnosis were at much higher risk of subsequently developing therapy-related myeloid malignancies (Lancet Oncol 2017;18(1):100-111, Lancet Oncol 2017;18(1):112-121). “This is something that has not really been explored in the thyroid area.”

Meanwhile, potential alternatives to RAI are on the horizon. “I think that a lot of these options will be targeted therapies driven by genomic discoveries. This together with increasing awareness of the risks of RAI will hopefully lead to decline in the use of RAI for low-risk WDTC tumors over the next decade with a concomitant decline in the risk of fatal second cancers like AML in long-term WDTC survivors.”

Commentary

Melanie Goldfarb, MD, Endocrine Surgeon and Director of the Endocrine Tumor Program at John Wayne Cancer Institute at Providence Saint John’s Health Center in Santa Monica, Calif., said the results of the study by Mukherjee, et al, re-enforce the position of many high-volume endocrine surgeons like herself who are confident they will not injure the recurrent laryngeal nerve, which controls the vocal cords, or harm the parathyroid gland, and thus are able to only use RAI in patients with a high risk of disease recurrence.

“There was definitely a time when every patient got RAI following surgery, but that has tapered off,” Goldfarb told Oncology Times. “If the thyroid cancer is growing into other tissues in the neck or into other parts of the body, if it is growing outside of the lymph nodes, or if they have really ugly histology, that’s really the only time we are going to say, ‘Hey, we should really use some RAI.”

“This is an important retrospective population-based study which adds growing evidence that adjuvant RAI therapy is a risk factor for therapy-associated AML and, interestingly, CML,” said Jack Jacoub, MD, Medical Oncologist, Hematologist, and Medical Director at MemorialCare Cancer Institute, Orange Coast Medical Center, Fountain Valley, Calif.

“[CML] is associated with a specific acquired genetic abnormality, and the association with environmental risk factors such as radiation is much weaker than for AML. Nonetheless, these findings should give pause to neck surgeons, nuclear medicine doctors, oncologists, and endocrinologists when evaluating patients with small [WDTC],” he said.

Chuck Holt is a contributing writer.

Cancer Tumors

Scientists Developing Nanorobots Whose Mission Is to Kill Cancer Tumors

Nanomedicine researchers have successfully programmed nanorobots to find tumors and cut off their blood supply while leaving healthy tissue unharmed.

They’re microscopic, autonomous, and on a mission.

They are nanorobots programmed to seek and destroy tumors. And it’s not science fiction.

Scientists from Arizona State University, with researchers from the National Center for Nanoscience and Technology of the Chinese Academy of Sciences, have successfully programmed nanorobots to shrink tumors in mice.

It’s a major breakthrough in the field of nanomedicine for cancer.

Radiation and chemotherapy are common cancer treatments. They’re often quite effective in destroying cancer cells.

They can also cause serious damage to healthy tissue, with long-term consequences.

In this first-of-a-kind study in mammals, the researchers developed a way to attack cancerous tumors while preserving healthy tissue.

They programmed the nanorobots to find these tumors and cut off their blood supply.

Details of the study are published in Nature Biotechnology.

How nanorobots kill tumors

The researchers in this study used a mouse tumor model.

Human breast, melanoma, ovarian, and lung cancer cells were injected into mice to spur tumor growth.

Once the tumors grew, the nanorobots were injected into the mice.

The nanorobots were made from flat, rectangular DNA origami sheets 90 nanometers by 60 nanometers. They were outfitted with an enzyme called thrombin, which helps blood to clot.

The nanorobots traveled the bloodstream carrying a DNA aptamer. The DNA aptamers targeted a protein called nucleolin, high amounts of which are found only on the surface of tumor endothelial cells. This particular protein is not found on the surface of healthy cells.

After locating and binding to the tumor blood vessel surface, the nanorobots opened up and delivered the thrombin. This caused clotting in blood vessels that feed tumor growth, cutting off the blood supply and killing tumor tissue.

And it happened quickly.

Within a few hours of injection, the nanorobots had gathered in large numbers around tumors.

Within 24 hours, tumor blood supply was blocked and tissue damage had begun.

Healthy tissues were not affected.

There was no evidence of the nanorobots entering the brain, where they might cause serious side effects.

The researchers found the nanorobots to be safe and effective in shrinking tumors in both mice and Bama miniature pigs.

Most nanorobots were cleared from the body after 24 hours.

In the mouse model, median survival time doubled from 20 days to 45 days.

Dr. Santosh Kesari is a neurologist and neuro-oncologist and chair of the Department of Translational Neurosciences and Neurotherapeutics at the John Wayne Cancer Institute at Providence Saint John’s Health Center in California.

Kesari told Healthline that there are currently many drugs that go to the tumor within a few hours of administration, but tumor shrinkage can take a long time.

“This approach seems a little faster than normal because it’s not attacking the tumor cell — it’s attacking by cutting off the blood supply and causing acute symptoms, similar to a stroke, in the tumor. Blood clots happen fast. We do see a similar effect with other angiogenesis drugs, like Avastin, that have a pretty quick effect relative to chemo for solid tumors,” he said.

Nanorobots can’t go it alone

In addition to targeting tumors, cancer treatment often requires a systemic approach.

That’s because cancer cells can break off the primary tumor and travel through the blood and lymphatic systems.

According to Kesari, the treatment used in the study will only work in the context of tumor blood vessels.

“It won’t target single cells. A group of tumor cells come together and start making new blood vessels. Only then can the drug be delivered to those sites,” he said.

In the study, the nanorobots did help prevent metastasis in the mice.

In an interview with Healthline, Dr. Jack Jacoub, medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Medical Center in California, also helped put this research in perspective.

“This mechanism of action targets blood vessel formation. So, highly vascular tumors will be sensitive to this treatment. There are other agents we use now in multiple cancers to target blood vessel formation,” he said.

Cutting off blood supply may have some effect on circulating tumor cells that are spreading in the body, said Jacoub.

But it may not be enough.

“Cancer cells set up a location to grow, but they need nutrients to allow them to join with other cancer cells to create a tumor. In theory, it would affect them [circulating tumor cells], but it’s unlikely to be clinically meaningful. They might have already escaped the impact of this application. But it’s still early in animal models,” he said.

Jacoub said patients would likely still need additional drug therapy.

“This application combined with drug therapy would be a fairly realistic strategy for treatment. Chemotherapy, targeted drugs, biologic drugs. We’re moving away from traditional types of chemotherapy. There are a lot better therapies we include in the chemotherapy umbrella and it’s becoming a lot more refined,” he continued.

Jacoub suggested this application might help some patients avoid surgery.

“Or you might need it to reduce the size of a tumor before surgery. Limiting the blood supply of tumors will cause them to necrose or die without an adequate nutrient and blood supply,” he said.

Significant hurdles

The treatment used in the study slowed tumor growth and improved survival.

But Kesari notes that the mice are still dying of tumor burden.

“It seems safe because it doesn’t cause the normal toxicity of chemotherapy and radiation. So, I can imagine the next step will be to see how it will work in combination with chemotherapy and radiation. It’s potentially synergistic. Or it could be antagonistic. You need blood vessels to deliver drugs, so if you cut off the blood vessels, you can’t deliver more drugs,” said Kesari.

“This problem may be fixed with timing. For chemotherapy, it’s an issue. So, you would have to plan it that you give chemotherapy first, then this drug,” he explained.

Kesari said these are issues that could be figured out at the next level of analysis.

Jacoub observed some other potential issues.

For one thing, it’s an expensive proposition.

“It will require enormous resources to bring this technology to patients. They’ve got to find a pharmaceutical partner or a very deep-pocketed venture capital group,” he said.

There’s also a big difference between animal trials and human trials.

“What happens in animals and humans isn’t always identical when it comes to toxicity, efficacy, and tolerability. You’ve seen some benefit, but how much does it impact patient survival or curability? There are natural hurdles you have to go through for the development of technology like this, which are appropriate for the safety of patients,” said Jacoub.

The future of nanorobots

Until human clinical trials can be conducted, many questions will remain.

In addition to delivery, Jacoub believes the payload concept is also important.

“That is really what is working and it’s the nanorobots that deliver it. They’re trying to get this payload delivered. We have biologic agents that engage only with cancer cells because something on the surface (of the cell) allows it to be recognized as a cancer cell, and then release a payload. In this case, the researchers chose a payload that affects blood vessel formation. There’s a conceivable scenario of using multiple agents affecting different functions in cancer cells,” he said.

Jacoub explained that there are other nanoparticle-based therapies in late-stage clinical trials.

“Of course, the holy grail is not having it affect healthy cells. This is a very important field in oncology when it comes to chemotherapy. Over the next few years, you’ll see a movement away from the term [chemotherapy] even. It has a lot of connotations for both physicians and patients. We’re entering a totally different era,” he said.

As important as this latest research is, Jacoub cautions that it’s still early in development.

“Readers should understand that this is perhaps the next frontier parallel to immunotherapy and other therapies in cancer care. There’s a whole host of companies with similar technologies. Some will ultimately reach patients,” he continued.

“Progressing from phase 1 trials through phase two and phase three takes years,” said Jacoub. “That’s a big leap. We’ll have to see how it goes.”

Image Credit: Health News

Breast Cancer Drug

Is New BRCA Breast Cancer Drug Worth the Price?

The first drug approved to treat BRCA-related breast cancer has limits, but it’s important for women with metastatic disease and BRCA mutation carriers.

There’s a new drug to treat one of the tougher types of breast cancer.

It’ll buy you about three extra months of what’s called progression-free survival.

And it’ll cost you, or your insurance company, $13,000 a month.

Is it worth it?

Experts interviewed by Healthline seem to think that for most people, it probably is. They also see a lot of potential for this kind of drug in the future.

Earlier this month, the Food and Drug Administration (FDA) approved the first treatment specifically for advanced breast cancer associated with BRCA gene mutations.

The drug, Lynparza, is already used to treat ovarian cancer.

Its expanded use now includes HER2-negative metastatic breast cancer in women who carry BRCA gene mutations.

Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor. It blocks an enzyme that helps repair damaged DNA, making cancerous cells with damaged BRCA genes less likely to be repaired.

This can slow or stop tumor growth.

The National Cancer Institute estimated there were 252,710 new cases of female breast cancer and 40,610 deaths from the disease in the United States last year.

BRCA1 and BRCA2 mutations make up about 5 to 10 percent of all breast cancers. BRCA mutations are also associated with ovarian, fallopian tube, peritoneal, prostate, and pancreatic cancers.

You can inherit BRCA gene mutations from either parent. If one parent carries the mutation, their children have a 50 percent chance of inheriting it.

Approval of Lynparza was granted to AstraZeneca Pharmaceuticals LP.

Who can take Lynparza

The new approval for Lynparza is for women who have already had some chemotherapy or hormone therapy.

Dr. Jack Jacoub is a medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Medical Center in California.

Jacoub told Healthline that the length of prior chemotherapy is variable.

“Someone could have been on chemotherapy a year or two, then progressed. Then the clinician tried something else they felt should be stopped. It could happen quickly or she could have been on chemo for some time. It depends on response to treatment,” he explained.

“Some women might continue to take hormone therapies,” continued Jacoub. “There are some nuances to that. BRCA1 is almost associated with triple-negative breast cancer. But in the BRCA2 group, the majority is estrogen receptor-positive and would continue on hormone therapy along with this drug. But with some patients on chemotherapy, when they’ve reached that point, clinicians often feel they’ve exhausted the benefits of hormone therapy drugs. Each patient is different,” said Jacoub.

FDA approval for a blood test called BRACAnalysis CDx has been granted to Myriad Genetic Laboratories, Inc. The test determines eligibility for the treatment.

Progression-free survival and quality of life

Progression-free survival is the length of time tumors don’t show significant growth after treatment.

In trials, median progression-free survival for patients taking Lynparza was seven months. For patients on chemotherapy alone, it was slightly more than four months.

For Josh Newby, Komen Advocate in Science for Susan G. Komen, it’s personal.

He lost his mother to metastatic breast cancer associated with the BRCA2 gene mutation.

“Progression-free survival is an interesting phrase,” Newby said in an interview with Healthline.

“As patients and advocates, we want to look at things other than that. My mother, who was not doing very well, got on a drug that extended her life by five months. But extension of life with quality of life is important. Before she passed away, my mother was able to travel and see and do things,” said Newby.

Jacoub agreed that length of survival isn’t the only thing to consider.

“Metastatic disease obviously implies that it’s incurable. So, a woman’s survival duration is important, but so is quality of life. If giving one therapy would make someone absolutely miserable, you’d have to really think hard about how much you’re helping. But if it’s tolerable, by all means. You build these blocks of time,” said Jacoub.

The FDA lists a variety of common side effects, including low red or white blood cell counts, nausea, and respiratory tract infections. Severe side effects include cancers of the blood or bone marrow, and inflammation in the lungs.

Jacoub said the discussion of side effects is important for many reasons.

They vary from person to person. And there’s a learning curve with its use.

“We see it in women with ovarian cancer. Side effects can become impressive in the first few weeks. Don’t trivialize them because it’s a pill and not an IV drug. This class of drugs carries its own set of side effects that can be fairly substantial and that one has to respect and be careful of. They can be similar or worse than IV chemo, depending on the agent used,” cautioned Jacoub.

“There are symptoms from the disease. Shrinking a tumor is important. There’s a meaningful benefit in the setting of metastatic disease,” he said.

About the seven-month progression-free survival in the trial, Jacoub pointed out that while half didn’t do as well, half did a whole lot better.

“There’s no exact mathematical model. So there are situations where you can have a fairly satisfying response. I wouldn’t cite long-lasting response as the reason to do it. Hope is important, but you have to frame it in realistic boundaries,” he continued.

Heavy price tag

Without insurance, Lynparza costs $13,886 per month.

Addressing the cost of the drug, Jacoub said, “Insurance is obligated to cover it. The cost, honestly, is overwhelming and there’s no question it’s a burden.”

He noted that the price is comparable to other special oral drugs in this area.

“Some oral targeted drugs can be taken for years in some diseases. It takes a lot of money and effort to develop these drugs, but if you see others coming out, there may be some cost competition. Often times the cost doesn’t really decrease until the drug is out of patent. We’re eager to have more tools to help patients and it’s a good discussion to have,” said Jacoub.

There are challenges for those who don’t have insurance.

“Reach out to organizations like Komen and others who provide support and guidance,” suggested Newby. “And I can’t stress enough how important it is to get a second opinion, even if you’re at one of the top cancer centers in the world. Different institutions have different abilities to navigate insurance or find compassionate use.”

AstraZeneca offers some assistance with copays and out-of-pocket costs.

Research moving into a new realm

Lynparza is the first PARP inhibitor approved for breast cancer.

It’s also the first time a drug has been approved to treat metastatic breast cancer associated with BRCA gene mutations.

Jacoub hopes it’s the first in a line of new PARP inhibitors for breast cancer treatment.

“This class of drugs is being studied across multiple phases of disease, including in a preoperative setting. The metastatic setting is the fertile soil from which we get these questions. We always want to take it into earlier-stage settings. It’s the first clear sign there is a benefit. I suspect it will be joined by others,” he said.

Jacoub said the field of BRCA cancers and other hereditary cancers is a fast-moving area. He expects things to be changing a lot.

“People were talking about this even before the application was submitted to the FDA,” said Newby.

“Not only because of the results, but because of the way researchers are looking at cancer. What we’ve learned is that we need to study each patient’s individual cancer based on genetic mutation, not just tumor type. What’s interesting is that since the approval there’s been a buzz. This is getting attention from the general public. We’re moving into a new realm,” he continued.

“The next step is to identify those patients who will be exceptional responders to new drugs being approved. Not only will you probably see this drug applied to other tumor types, but companies are working on similar drugs. Organizations like Komen and others want to fund the kind of research that gets the wheels spinning. This moves the research forward,” said Newby.

Awareness, advocacy, and hope

Jacoub encourages patients to keep up on developments and discuss them with their oncologists.

And Newby promotes self-advocacy.

“My mom passed away four years ago and about five drugs have since been approved for metastatic breast cancer. That’s pretty amazing,” said Newby.

“Each cancer is unique in its own way, not only from a scientific molecular level, but on a personal level,” he said.

Newby is a BRCA2 gene mutation carrier.

He hopes to have children someday. Those children would have a 50-50 chance of carrying the same mutation.

“Hopefully, that will change and my children won’t have to face this same kind of problem. The key is to create awareness about drugs being approved. It’s not a cure, but it’s moving in that direction with support from organizations like Komen that are working with patients. Again, I can’t stress enough: Be your own advocate, or advocate for a loved one. Get tested and seek out help and counseling. There are many resources out there,” said Newby.

Which Professions Do Americans Trust Most? (The Answer May Surprise You)

At a time when our faith in institutions—from banks to Congress to the media—is at nearly its lowest point in three decades, professionals in the most respected fields share what it is about them that earns people’s trust.

Trust is a rare commodity these days, which is all the more reason to celebrate it. Forty years ago, Gallup began asking Americans which professions they consider to be the most honest and ethical. Health-care workers dominated the 2016 list—nurses have been number one for the past 15 years—but the top eight (listed here in order) include some surprises. To get a sense of why these professions have retained the public’s confidence, we asked individuals in these top-rated fields what they do to establish trust with the people they serve. Maybe the rest of us can learn from their examples. Meet the heroes of the Trusted League, these are the most trusted brands in America.

Nurses

Rich Bluni

Rich Bluni

Age: 49

Orlando, Florida

I became a nurse because of my dad. He was diagnosed with cancer, and I just saw with my own eyes the people who made the most difference: They comforted him, caught mistakes, and helped ease his pain. I wanted to be a part of that.

Trust in nursing is almost on a spiritual level. The people we care for are the most frightened and most vulnerable. They trust that you will give everything you have and that you will be there for them physically, mentally, emotionally, and spiritually.

A parent of a child I was taking care of on and off for several months came up to me when I was clocking in one day. She said she had requested that I take care of her son that night. I said of course, and I looked at her and could tell something was wrong. When I asked her, she told me he was going to die that night and she wanted me to be present for them.

That night, she held his right hand and I held his left. She insisted I stay until he left. She told me he loved me. It was such a sacred moment, that this mother thought of me not only as a caregiver and a nurse but also as someone she trusted so much that she wanted me to be there with her and her son when he took his last breath. I don’t think you could feel more trusted than that. Meet 13 more unsung heroes who will restore your faith in our country.

Pharmacists

Sally Rafie

Sally Rafie

Age: 34

San Diego, California

Where else can you walk down the street and get health advice for free? No other health-care professionals are in a position to do that. We make ourselves available to people—both to our patients and to those who are not patients—and we do it right in their own community.

Every decision I make is about putting patients and their families first. For instance, as part of my training I had to work at a clinic that was held in a church that didn’t want us to discuss birth control because it was contrary to the church’s teachings. I chose not to take part because I was unable to fully give my professional opinion to the patients. (My professor arranged an assignment in a different location.) As professionals, we have so much pride in our knowledge and expertise on prescriptions, immunizations, and complicated health and medical information. Still, our patients don’t always need to hear that. Sometimes they just need a shoulder to cry on. I try to keep in mind that it’s not about me or proving I am knowledgeable but about meeting their needs. That’s true whether you’re helping a patient, a friend, a client, or a family member. This is how you can use body language to build trust.

Medical doctors

Jack Jacoub

Jack Jacoub

Age: 44

Fountain Valley, California

When I became a doctor, I wanted to make a difference. The people I most respected and was most impressed with were the oncologists in my program. The conditions I work with have scary and concerning issues. I try to introduce myself in a pleasant way. I sit down; I don’t stand. I make good eye contact with the patient and his or her family. I like to learn more about them before I get to the issue of why they are seeing me. Communication skills are key, as well as showing empathy, under­standing, and availability.

A week or so ago, a nurse that I’ve known for many years was diagnosed with breast cancer. She could have gone anywhere; she could have chosen not to be treated close to home with people she knew. She chose to come see me and is now in treatment. For a physician, the single most rewarding thing is when someone you work with—someone whom you’ve worked with for years and who has seen your body of work—chooses you. Here is how you can build trust with your co-workers.

Engineers

Chrissy Keane

Chrissy Keane

Age: 41

Crofton, Maryland

I don’t know that being an engineer means you are automatically trustworthy. However, I do think that most engineers like to follow rules and be organized. They tell you what they think, whether you want to hear it or not. Those are important elements in building trust.

I focus on electrical and civil engineering, generally overseeing water mains and building renovations. I deal with a lot of property owners, and it takes genuine concern and understanding to allow them to trust that I am not trying to inconvenience them or destroy any of their property. I first make sure that I take care in my work and that I have explanations and backup to validate it. But the biggest thing is follow-through, meaning if I say I will do something, I need to do it. I think you have to want to be trusted, to want to do a good job, and I think you have to genuinely care about your work. That is innate. But I do think you can learn how to get people to trust you. I think you can learn to be organized better, learn from experience that you need to be ­honest—even if it is not what your boss or client wants to hear.

Dentists

Joseph M. Vargas

Joseph M. Vargas

Age: 37

Baltimore, Maryland

I grew up in a household with healthcare providers (both of my parents were physicians), so I always knew I was going to be in some form of community service in the health fields. I want to help people through my work, and trust is the basis of my relationship with patients. They put their well-being in my hands, and I try to describe exactly what I am doing. For those who want an explanation as I work, I provide that. Some people want to know; some people don’t. I tell them they are in control. My goal is to keep them as comfortable as possible. I try to tailor my treatment to their specific needs. There is no better compliment than when patients recommend you to their friends and family—or when they send thank-you notes.

Police officers

G. M. Cox

G. M. Cox

Age: 64

Fort Worth, Texas

From my perspective as a police officer, trust means that I have the best interests of the people I serve in my heart and in my actions and that I’m going to treat everyone the same way. Some people mistrust police. I can understand that to some degree. I worked with several cops who had a different attitude—they saw their authority rather than their personality as their power base. But mostly they are good people. Trust can be taught, but you gotta want to learn it.

To me, being a public servant is a two-way street. I always want to go up to people and talk to them in a professional manner—be personable, empathetic, don’t talk down to them. It might be the only time that a person has been spoken to with respect. You have to establish and maintain that trust. Be equal. Transparent. Communicate fairly and honestly. Most of what we do is service. It’s not crook catching. Your job as a peace officer is to be neutral. Listen.

College teachers

Rebecca Bratten Weiss

Age: 43

Hopedale, Ohio

In my years of teaching, I have had so many students confide deeply personal matters that they had shared with no one else. This always feels like an honor, and it’s something with which I have to be cautious, because when a young person is depressed or traumatized, his or her sense of identity can be fragile.

So trust means something that goes beyond professional ethics. It has to do with how we relate to ­others. One has to work diligently to develop a moral code, an ethical character. The ideals of honor, magnanimity, and justice, which were valued by the ancients, have relevance today. If I behave unjustly toward someone, I am not trustworthy, even if I try to adorn myself in a disguise of trustworthiness.?I keep in mind that my students are the entire reason I am here. If I think they’re just wasting my time or forget that my responsibility is to their flourishing as individuals, I am not doing my job.

My advice: Do no harm. If more people took this simple mantra to heart, we might have a human community with greater bonds of trust.

Clergy

Rabbi Norman Patz

Rabbi Norman Patz

Age: 79

North Caldwell, New Jersey

In a professional sense, when people talk to me in confidence, no one finds out about it unless I get permission. That’s the very first thing I start with. On the broader end, trust is the basis of every civilized society. If we can’t trust the government or the people we deal with to carry through on their promises, then society is undermined from within. It is hollowed out. Trust explicitly includes dependability and predictability—­people come to rely on that, and on you.

Relationships that are built on trust have as their components honesty, tact, timing, and being as open, honest, and transparent as possible without unloading your own griefs and aggravations. Rabbis have an annual convention, and we save the complaining for those times!

You learn how to trust. You learn whom to not share with or collaborate with. An elderly man in my congregation was dying. I called his daughter. I’d done her wedding, and I’d named her baby when he was born. I knew the man’s doctors had recommended hospice. She said she would never have hospice for her father, that she would keep him alive no matter what. So I said, Listen. You have to balance and make a call between your personal feelings and your father’s physical condition. There’s going to be a time when you have to let him go. How are you going to let him go? She listened because of the many years built on trust.

cofee

Coffee Is Great, but That Alone Is Not Going to Extend Your Life

If you’re like most people, you probably reach for a cup of coffee (or several) every day. Maybe you even smugly share articles about the benefits of coffee while sipping out of your favorite “don’t talk to me until I’ve had my coffee” mug. If so, you’re probably thrilled about two new studies recently published in the Annals of Internal Medicine that suggest coffee may help you live longer. But…it’s a little more complicated than that, of course.

First, let’s dig into what these studies found out about your coffee habit.

One study examined more than 520,000 people in 10 European countries and found that people in the highest coffee-consumption group also had the lowest rate of mortality. When they dove a little deeper, the researchers also found that there was a statistically significant link between drinking coffee and a lowered risk of dying from heart disease or stroke in women. Both male and female coffee drinkers also had a decreased risk of dying from a digestive disease.

The other study looked at more than 185,000 African Americans, Native Americans, Hawaiians, Japanese-Americans, Latinos, and Caucasians, and found that, in most cases, drinking coffee was linked to a longer life (Hawaiians were the only outliers). Specifically, people who drank two to four cups a day had an 18 percent lower risk of death compared with people who did not drink coffee. They also had a lower risk of death from heart disease, cancer, respiratory disease, stroke, diabetes, and kidney disease.

Of course, correlation does not equal causation. Meaning, we can’t say that drinking coffee causes people to live longer—just that it’s associated with living longer.

In the European study, researchers point out that reverse causality could have come into play, meaning that it’s possible that people who live longer just happen to prefer coffee, versus coffee actually causing them to live longer. They also point out that the coffee-drinking habits of study participants were only taken once. So, it’s possible people could have just happened to have gone through a coffee-heavy phase during the study, only to change their habits later. In the second study, researchers say it’s possible that there were confounding variables (i.e. other factors that can impact the results) that they didn’t catch. For instance, maybe coffee drinkers are also more likely to exercise, which could also affect your mortality risk.

It’s worth pointing out that this isn’t the first time science has linked coffee with good health. A Harvard University study published in 2015 analyzed the coffee consumption of more than 208,000 people over 30 years, as well as their cause of death and discovered that people who drank one to five cups of decaf or regular coffee a day had a lower risk of mortality than those who didn’t. Those coffee drinkers were less likely to die from heart disease, neurological diseases, Type 2 diabetes, and suicide. A meta-analysis of 36 studies published in the journal Circulation in 2014 also found that people who drink three to five cups of coffee a day were at the lowest risk of developing heart disease. Still, we’re not able to say that coffee is what’s really causing people to live longer.

“The question that really remains is why? ”Anton Bilchik, M.D., Ph.D., professor of surgery and chief of gastrointestinal research at John Wayne Cancer Institute at Providence Saint John’s Health Center in Santa Monica, California, tells SELF. The researchers offer some explanations that drinking coffee may improve liver function and reduce inflammation, and Dr. Bilchik says these are important factors when it comes to reducing your risk of developing cancer as well as heart disease. “There is a large area of research right now regarding heart disease and cancer, and how they relate to inflammation—it’s certainly possible that drinking coffee may reduce inflammation that takes place in the body and it may be protective,” he says. However, this link hasn’t been proven yet.

So you can’t just rely on your three-cups-a-day to extend your life. But, sure, you might be able to count that as one of your daily habits that are associated with living a long and healthy life.

There are several factors that go into reducing your overall disease risk, including eating well, avoiding smoking, and exercising regularly, Jack Jacoub, M.D., an internist, medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Memorial Medical Center in Fountain Valley, California, tells SELF. “People reduce their mortality rate by doing various things—this could be one of them,” he says. “There has already been a pretty clear message that there might be some positive effects from drinking coffee. These very large studies provide even more supportive evidence.”

That said, drinking coffee has a few known side effects that are also important to factor in. Having too much caffeine, which is found in regular coffee and even decaf to some extent, can increase a person’s heart rate and possibly cause irregular heart activity that could be dangerous to those who already have heart problems, Morton Tavel, M.D., a clinical professor of medicine at the Indiana University School of Medicine, tells SELF. It can also cause hyperactivity, headaches, and agitation, Dr. Bilchik points out, as well as exacerbate acid reflux in people with digestive issues. The caffeine in coffee can also make some people feel lightheaded and dizzy, and drinking a lot of coffee could dehydrate you, Dr. Jacoub says. “But if you don’t have those issues, I think the data continues to build on itself that it’s good to drink coffee,” he says.

Ultimately, Dr. Bilchik says that drinking coffee in moderation is safe and even seems to have a beneficial effect. But, if it’s not your thing, that’s OK, too—it’s not the end-all, be-all to longevity.

Risk of Breast Cancer

15 Ways You Can Decrease Your Risk of Breast Cancer

Breast cancer affects us all

The numbers are staggering. One in 8 (12.4 percent) U.S. women will develop breast cancer during her lifetime, according to the National Cancer Institute. The Susan G. Komen Breast Cancer Foundation estimates that approximately 255,000 people will be diagnosed with breast cancer in the U.S. this year alone, and more than 40,000 lives will be lost to this disease. These are numbers we feel every day, as most people, regardless of who they are or where they live, are impacted by breast cancer in some way, whether it be a family member, friend, or colleague who has or knows someone who has this disease. While there’s much left out of a woman’s control when it comes to getting breast cancer, especially considering most cases appear randomly and do not always run in families, there are several important steps that can reduce this risk substantially. In honor of Breast Cancer Awareness Month, doctors share the steps you can take every day, week, month and year to put your best foot forward towards lowering your risk. Find out the breast cancer symptoms you might ignore.

First things first: Know your family history

It’s standard procedure nowadays for nearly every type of doctor you see to inquire about your family history, as genetics have been proven to be a key contributor to an individual’s cancer risk—and it’s especially important when it comes to breast cancer. “Some women (and men) have an especially high risk of developing breast cancer related to inherited predisposition, history of radiation treatments to the chest wall during adolescence or early adulthood, or because of ‘overactive’ breast tissue that is sometimes detected on breast biopsies,” explains Lisa Newman MD, MPH, a member of Komen’s Scientific Advisory Board and director of the Breast Oncology Program for the Henry Ford Cancer Institute. Red flags that she says suggest possible inherited predisposition include having multiple relatives with breast or ovarian cancer, male relative(s) with breast cancer and relatives that were diagnosed with breast cancer at young ages. “Patients who are found to have an increased risk of breast cancer should then discuss risk-reducing options (such as medication or surgery) or more aggressive breast cancer screening options (such as mammograms starting at younger ages or a special breast imaging test called an MRI),” adds Dr. Newman. Find out six simple changes you can make to lower your breast cancer risk.

Perform self breast exams monthly

While the American Cancer Society recently revised its guidelines on self breast exams, noting that there’s not enough research to support their clear benefits, experts agree that they’re still important—and there’s absolutely no downside. “Knowing what your baseline ‘lumps’ are so you’ll be able to immediately recognize when something feels new or different is key,” says Phoebe Harvey, MD, chief of hematology/oncology for Kaiser Permanente Northwest in Portland, Oregon. “Women who have naturally lumpy breasts often say they find it hard to know what’s ‘normal.'” Her best advice is to pay attention to lumps that feel unlike the rest of your breast tissue, for example, that are harder or just seem out of place. These should be checked out by your provider. “There can also be visual clues as well, like a change in the size or shape of your breast, or dimpling of the skin,” she adds. And if you do find a lump, don’t freak out. Here are seven things that lump could be beside breast cancer.

Schedule yearly mammograms

Women who have an average risk of breast cancer should begin having annual mammograms, basic x-rays of the breast, according to the American Cancer Society. However, there’s been a great deal of controversy in recent years with regard to the age and frequency. Experts recommend discussing your risk factors with your doctor to determine if a mammography before the age of 40 is right for you. “Although getting screened for breast cancer does not reduce your risk, it can help identify the proper screening methods you should be using based on your risk factors and can help to identify cancer early when it is easiest to treat,” explains Jane Kakkis, MD, medical director of breast surgery at MemorialCare Breast Center at Orange Coast Medical Center in Fountain Valley, California. If you are old enough to have a screening mammogram, Dr. Kakkis recommend also asking your doctor whether or not you have dense breast tissue. “If you have dense breast tissue, then your risk of breast cancer is increased and, depending on other risk factors that you might have, your doctor may recommend supplementing your mammogram screening with ultrasound or MRI.” Find out how dense breasts affect your breast cancer risk.

Maintain a normal body weight

Among the laundry list of reasons why a healthy BMI (body mass index) is beneficial is that it has been known to significantly reduce your risk of cancer, as well as several other diseases including heart disease and diabetes. “One reason for this is that body fat produces estrogen, which increases the risk of developing breast cancer,” explains Dennis Holmes, MD, breast cancer surgeon and researcher and interim director of the Margie Petersen Breast Center at John Wayne Cancer Institute at Providence Saint John’s Health Center in Santa Monica, California. This is even more important as we get older, as Dr. Newman notes that women who are overweight or obese after menopause have a 30 to 60 percent higher breast cancer risk compared to those who are lean. Aim for a BMI that is between 18.5 to 24.9, as anything above is considered overweight and anything above 30 is considered obese. Find out how else BMI may affect your health.

Exercise several times a week

According to Marc Hurlbert, Ph.D, breast cancer specialist and chief mission officer for the Breast Cancer Research Foundation, physical activity may be the most potent lifestyle factor in reducing the risk of breast cancer, especially after menopause. “It not only helps in achieving and maintaining a healthy weight, but exercise also reduces the levels of metabolic hormones including insulin and leptin, and it reduces levels of estrogen, all of which promote tumor growth,” he says. “Exercise may be most beneficial in overweight women who may have high levels of insulin and estrogen.” The American Cancer Society recommends that adults get at least 150 minutes of moderate intensity, or 75 minutes of vigorous intensity, activity each week, preferably spread throughout the week. Find out 15 breast cancer myths you can safely ignore.

Watch your diet

When it comes to maintaining a healthy weight, diet goes hand-in-hand with exercise. “Changes to your body as you age, and especially after menopause, make it necessary to change lifestyle and eating habits to maintain a healthy weight,” Dr. Kakkis explains. She recommends the Mediterranean diet, which incorporates a lot of fresh vegetables, healthy sources of fats, lean protein sources, and whole grains. “All of these, especially when coupled together, benefit your cardiovascular system and lead to a substantial amount of health benefits.” She does note, however, that even with a healthy diet, portion sizes should be appropriate, with the largest food group in each meal being vegetables. Also, do your best to eliminate preservative-laden foods, especially nitrates, as well as hormone and pesticide additives. “Soy concentrated products should be avoided by high-risk persons or breast cancer survivors, (soy supplements, soy milk, etc.) and natural food sources of soy, such as tofu should be limited to three small servings per day,” she says. “Using proper oils for deep frying is important, as oils that are heated past their optimal temperature develop chemicals known to cause cancer to enter the food.” Peanut oil is an example of an oil that can be used for deep frying. Find out more easy ways to make your diet more Mediterranean.

Cut down on the cocktails

While it’s not exactly clear why, there is a growing body of evidence that suggests as little as one alcoholic beverage a day is enough to increase an individual’s risk of breast cancer. “Among other things, alcohol is thought to raise estrogen levels and can also contribute to weight gain,” explains Dr. Harvey. This can be a tough pill to swallow for those who enjoy a nightly cocktail or glass of wine, but Dr. Harvey urges that the correlation is strong enough. She advises people to strongly consider reducing their intake, especially since alcohol is a known risk factor for a number of other cancer types as well. Are you drinking too much? Find out here.

Quit smoking, stat

“Recent studies show that smoking, especially heavy smoking, may increase the risk of certain breast cancers,” says Dr. Hurlbert. “The effect may be stronger when a woman starts smoking before her first child.” Second-hand smoke plays a role in increasing a person’s risk too. “In animal studies, chemicals from first or second-hand smoke caused breast tumors and was found in the milk of nursing rodents,” he says. Bottom line: Smoking is terrible for your health and may be a catalyst for increasing your breast cancer risk. Quitting is your only option to reduce this risk. Here are the 23 best ways to quit smoking.

Take aspirin or ibuprofen regularly

Seriously! Research has found that women who take two or more tablets of aspirin or ibuprofen each week for at least five years have a 20 percent lower risk of developing breast cancer. “Taking these medications for more than 10 years lowers the risk even further,” notes Dr. Holmes. “Either mediation is capable of reducing chronic inflammation within the body, which can predispose some women to develop cancer.” While the ideal dose and frequency of use of aspirin or ibuprofen have not been determined, Dr. Holmes recommends women to consider taking a low dose of aspirin (81 mg) or ibuprofen (200 mg) twice a week if they’re not already doing so for other reasons.

Have children earlier in life (if possible)

While the reasons aren’t totally clear, research suggests that women who conceive children earlier in life have a lower risk of breast cancer. The Nurses’ Health Study, for one, shows that women who give birth in their 20s compared to those who give birth in their 30s or later, have a reduced risk of breast cancer. “It is believed that the hormonal and other cellular effects of pregnancy influence the breast tissue positively and is protective against cancerous transformation,” explains Jack Jacoub, MD, medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Medical Center in Fountain Valley, California. Additionally, women who have multiple children see a decreased risk. One reason for this, notes Dr. Jacoub, is that pregnancy limits the periods of “incessant ovulation” over a woman’s lifetime. “This is when ovaries are functional and producing high levels of sex hormones, namely estrogen.”

Breastfeed your baby

While this isn’t always easy, or feasible, for all women, research shows that women who breastfeed, when compared to those who don’t, have a modestly decreased risk of breast cancer. “The effect is greatest in women who breastfeed for one and a half to two years,” notes Dr. Hurlbert. “Breastfeeding delays the return of menses after childbirth and this lowers the lifetime exposure to estrogen.” He also notes that total exposure to estrogen over a lifetime can increase the risk of breast cancer after menopause. “That’s one reason why having children is also protective, as a woman’s estrogen levels drop during pregnancy.”

Limit oral contraceptive use

“Following on the discussion about exposure to estrogen, oral contraceptives increase this exposure,” says Dr. Hurlbert. In other words, women who use oral contraceptive have a slightly higher risk of breast cancer compared to those that don’t. “The risk decreases over time after stopping contraceptive use and women who have not taken contraceptives for more than ten years are no longer at increased risk from contraceptive use.” He recommends that women discuss their use of hormone-based contraception with their doctors to determine what is best for their particular health concerns and situation.

Quit menopausal hormone use

The practice of using menopausal hormone therapy (MHT) to relieve symptoms of menopause, such as hot flashes and sleep disturbances, has been used for more than a century, but recently it’s been linked to an increase in breast cancer risk. “The combination of estrogen plus progestin for several years increases the likelihood of developing breast cancer and can make mammograms more difficult to interpret,” explains Dr. Newman. “You can reverse some of this risk by discontinuing these hormones.” She recommends talking with your doctor about safe alternatives to control menopausal symptoms. Try these natural remedies for menopause symptoms.

Preventative surgery

Although all women are at risk of developing breast cancer, some women are at particularly high risk because of personal health factors and family history. These “high risk” women, many of which are carriers of the BRCA 1 or BRCA 2 genetic mutations, should consider taking preventative action, which often involves surgery, to dramatically reduce their risk of breast cancer. “If you have a strong family history of breast cancer, genetic testing is highly recommended so you can better understand your options,” says Nikita Shah, MD, breast cancer specialist at the Breast Care Center at Orlando Health UF Health Cancer Center. If someone in your family has been diagnosed with breast cancer, especially before age 40, ask your doctor about getting tested for the BRCA gene. In some cases, your doctor may recommend you go ahead with a preventative surgery, such as removal of the breasts, ovaries, and Fallopian tubes, to reduce your risk of getting cancer.

Understand how your community and identity can affect your risk

Research suggests that those with certain ethnic and socioeconomic backgrounds may be at a predisposition to be diagnosed with breast cancer, for example, Ashkenazi Jewish families have a significantly higher risk of carrying mutations or abnormalities, Dr. Newman notes. “We also know that breast cancer mortality and death rates are significantly higher among African American compared to white American women.” She explains that this disparity is related to socioeconomic disadvantages and healthcare access barriers that are more prevalent in the African American community, but it has also been shown that a biologically more aggressive pattern of breast cancer (triple negative breast cancer) is twice as common among African American compared to White American women. Breast health awareness and early detection or screening programs, as well as research, are essential to address and eliminate these disparities, so use what is available to you and use it wisely. Find out 12 things your mom’s health may reveal about yours.

After Refusing to Vaccinate Her Son

A Mother Is Going to Jail After Refusing to Vaccinate Her Son

Michigan mom Rebecca Bredow has been ordered to spend seven days in jail after refusing to vaccinate her son. Bredow was sentenced on Wednesday nearly a year after a judge ordered her to have her 9-year-old vaccinated, the Associated Press reports.

Michigan allows parents to waive vaccination requirements for their children based on religious or personal beliefs. Before parents are allowed to fill out this waiver, parents or guardians of children who go to public or private school in Michigan are required to take an educational session to learn about the diseases that vaccines can prevent, according to the Michigan Department of Health and Human Services. Bredow says she did just that, and that she won’t vaccinate her son due to religious reasons.

But her ex-husband, James Horne, who shares custody of their son, wants to have their child vaccinated. Bredow says that she and Horne originally agreed to delay their son’s vaccines for three months after he was born in 2008 and two years later they agreed to stop all further vaccinations.

Watch This This Is What It’s Really Like to Live With Type 2 Diabetes

However, it appears Horne changed his mind. And, as part of the ongoing custody battle, the Washington Post reports that Bredow’s attorney signed a court order last November saying that her son had to be vaccinated (which means she had to get it done). But after almost a year, she has continued to refuse. “I’m a passionate mother who cares deeply about my children, their health and their well-being. … If my child was forced to be vaccinated, I couldn’t bring myself to do it,” she said during her hearing, per the AP.

“I understand you love your children. But what I don’t think you understand is that your son has two parents, and dad gets a say,” Judge Karen McDonald told Bredow in court, per the AP. The judge awarded Horne temporary custody of their son and ordered him to be vaccinated.

It’s important to note that Bredow is going to jail because she violated a November 2016 court order to vaccinate her son—not specifically because of her vaccination beliefs, Cason D. Schmidt, J.D., a research assistant professor at Texas A&M University, tells SELF. “Contempt of court is a punishment for violating a court’s order and is essential for preserving the authority of the justice system,” he explains. “Courts would be powerless if everyone could ignore decisions with impunity.”

Still, her vaccination beliefs are tightly wrapped up in the case. And the story showcases just how intense things can get when people decide not to vaccinate their children for nonmedical reasons.

Research overwhelmingly finds that vaccines are safe and crucial for children’s health, but many states still allow for some exemptions.

Vaccination laws are decided at the state level, and all 50 states require children to receive certain vaccinations before they go to public school, per the Centers for Disease Control and Prevention (CDC). However, there are some exceptions, which are broken into medical and nonmedical reasons. Medical reasons exempt children with certain severe allergies, those who have cancer, and those who have a blood disorder, per the CDC. (It’s worth noting that, because these individuals cannot get vaccinated, they depend on the herd immunity which happens when the majority of people around them are vaccinated). On the other hand, nonmedical exemptions include personal beliefs, religious reasons, or philosophical reasons for avoiding vaccines.

Michigan law is a little vague when it comes to nonmedical exemptions, stating that parents and guardians can opt out of immunization requirements for religious convictions or having an “obstruction” or “objection” to vaccination. “It doesn’t say what the nature of that [obstruction or objection] has to be, but it can’t be ‘because I’m not able to get off from work to vaccinate my child,'” says Denise Chrysler, director of Michigan’s The Network for Public Health Law. “There has to be an objection to the vaccine.” Parents are also asked to check off which specific vaccinations they’re opposed to when they fill out the waiver, she says.

Few states (California, Mississippi, and West Virginia) don’t allow for any nonmedical exemptions. The majority of states let parents cite religious exemptions, per the Pew Research Center, while 20 states allow parents to use a waiver for religious and personal reasons.

California used to allow parents to cite religious or personal beliefs but that changed in 2015 with the passage of SB 277, which came on the heels of a measles outbreak that was traced back to Disneyland.

“There was much [legislative] movement following the 2014–2015 measles outbreak,” Leila Barraza, J.D., M.P.H., an assistant professor at the Mel and Enid Zuckerman College of Public Health at the University of Arizona, tells SELF. “As more outbreaks keep happening, this may be a trend we see in the future—a trend of more states making it more difficult for parents to seek exemptions from vaccine requirements.”

Despite the amount of states currently allowing vaccination exemptions, the American Medical Association strongly urges parents to vaccinate their children.

“We know that vaccinations are safe and effective. We know their benefits far outweigh any risks. And we know that as physicians, we must encourage our patients to listen to the science and facts behind this issue,” former AMA president Robert M. Wah, M.D., said in a statement on the organization’s website in 2015.

Although California no longer allows for nonmedical exemptions to vaccines, Danelle Fisher, M.D., chairwoman of pediatrics at Providence Saint John’s Health Center in Santa Monica, California, tells SELF that she “absolutely” was asked about it in the past. “When there is not a true medical reason to postpone or delay vaccines, I’ve never felt comfortable refusing on the behalf of the child,” she says, adding that some parents ultimately decided to leave her practice because of it. Even now, she says she’s had a few patients whose parents have asked her to sign a medical exemption form when it wasn’t necessary (she said no). “The vast majority that ask for it really don’t have a good medical exemption,” Dr. Fisher says.

“I see people who want a vaccination exemption a lot,” nurse-practitioner Kara Schrader, an assistant professor of health programs at Michigan State University, tells SELF. “But education of the parents does seem to make a difference.”

Vaccination is a mutual decision between parents and practitioners, she says, adding, “I’m not going to kick someone out of my practice because they’re not vaccinating.” So, if a patient says they don’t want to vaccinate their child, Schrader says she’ll ask them why and talk to them about the importance of vaccination and the science behind it. She also hands them pamphlets from the CDC and Michigan Department of Health and Human Services.

In her 12 years of practice, Schrader says she’s only had two parents who have still declined to vaccinate their infants after learning the facts.