Month: May 2018

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.

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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

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.