Category: Press Release

stem-cell-treatment-lymphoma

Stem Cell Treatment for Lymphoma: What You Should Know

If you or a loved one has been diagnosed with non-Hodgkin’s lymphoma and are embarking on treatment, it’s likely you’ve heard about stem cell transplants at some point. These transplants can be an important part of treatment for some patients, but they’re not appropriate for everyone who has lymphoma. Let’s take a look at the facts you should know.

These transplants work by improving function in the bone marrow

Stem cells are blood cells in their earliest stage of development, and they’re made in the body’s bone marrow. Think of bone marrow — the spongy substance inside our bones — as the immune system’s factory, churning out additional fighters every day.

The stem cells develop into mature blood cells within the bone marrow and then go into the bloodstream, where they serve a number of functions, including carrying oxygen to cells, helping blood to clot, and fighting infection. Normally, the bone marrow makes millions of new blood cells daily, to replenish the cells that are dying off naturally. For example, red blood cells live for only about four months.

In a stem cell transplant, bone marrow that’s been damaged — for those with non-Hodgkin’s lymphoma, that trauma comes from chemo — and unable to keep producing stem cells on its own gets a fresh infusion, so the factory can get back up and running.

Stem cell transplants are usually only used for recurring lymphoma

There are many forms of lymphoma, so when and how stem cell transplants are used will depend on what type of lymphoma is present, says Robert Dean, M.D., in the Department of Hematology and Medical Oncology at Cleveland Clinic. But, that said, these transplants are primarily used only when first-line treatments aren’t working, or if lymphoma has gone into remission and then recurred.

“When that happens, it tells us that some of the cancer cells were strong enough to resist the initial chemo, or that they managed to bypass the chemo in some way,” he says. “In that case, going back to using the same chemo as we did the first time wouldn’t be the best treatment, because it’s likely those cancer cells would be resistant. So, we need to consider adding a stem cell transplant into the mix for those patients.”

Stem cell transplants are not a treatment option on their own

Although they’re sometimes called “stem cell treatments,” this form of intervention is not a treatment by itself, the way that chemotherapy or radiation would be. Instead, it’s used as a way to help the immune system recover from stronger chemotherapy, says Jack F. Jacoub, M.D., medical oncologist and medical director of California-based MemorialCare Cancer Institute at Orange Coast Medical Center.

When lymphoma patients see their cancer come back, high-intensity chemo is the best option, Dr. Jacoub adds. But the major side effect of that is significantly reduced or even destroyed capability within the bone marrow.

“When you wipe out the bone marrow, essentially you no longer have immune system function,” he says. “You may have eliminated the cancer, but you can’t operate without an immune system.”

Stem cell treatments help the body start growing blood cells normally again, so that your immune system can get back to its normal functioning. “Think of a stem cell transplant as a parachute,” Dr. Dean says. “It’s a valuable safety mechanism, but chemo is the jump out of the airplane.”

Ideally, this combination provides a powerful way to treat recurrent lymphoma, because the stronger chemotherapy potentially clears the system of cancer cells, and the stem cell treatment helps the body get back to normal immune system function more quickly.

Dr. Dean adds that for many patients, higher dose chemo without a stem cell treatment isn’t recommended, because the body may not be able to get “back online” without one. After all, he adds, who would risk skydiving without a parachute?

You may get your own stem cells or donor cells

In some cancers, like leukemia, donor cells are preferred because they tend to be better at finding and attacking leftover cancer cells, Dr. Dean notes. But for lymphoma, using a patient’s own cells can often be just as effective. If that’s the approach an oncologist chooses, some of your stem cells will be harvested and stored before the stronger-chemo rounds, and then re-introduced to the body after the chemo has cleared from the system.

There are some cases where donor cells are more commonly used, mainly with certain forms of particularly aggressive lymphoma. For example, there’s a type of non-Hodgkin’s lymphoma called mantle cell lymphoma where the body makes abnormal B-cells (the white blood cells that fight infection). Dr. Dean notes that this type of cancer tends to be treated more effectively with high-dose chemo and donor stem cells.

But no matter where your stem cells might originate, the goal is the same. “Stem cell therapy is added on to treatment with the expectation of a longer remission,” he says.

Elizabeth Millard is a freelance journalist specializing in health, wellness, fitness, and nutrition. Her articles have appeared in SELF, Men’s Health, CNN, MyFitnessPal, and WebMD, and she has worked on patient education materials for Mayo Clinic and UnitedHealth Group. Find her on Instagram at @bossykind and on Twitter at @EMillard_Writer. Her online portfolio is at elizabethmillard.pressfolios.com. When not writing, she’s also a yoga teacher and organic farmer.

Article & Image Source: Stem Cell Treatment for Lymphoma: What You Should Know

how-lymph-nodes-work

How Your Lymph Nodes Protect You from Cancer — And What Happens When They Don’t

Unlike cancers related to an organ or a specific part of the body — such as lung cancer or breast cancer — lymphoma can develop at any point within the lymphatic system, and involve one of numerous types of cancers under the larger definitions of Hodgkin’s and non-Hodgkin’s lymphomas. To understand how this cancer can develop, let’s first take a look at the lymph system, how it works, and what happens when it can’t.

What is the lymph system?

Your lymphatic system is an important part of your immune system, and is represented by an extensive network of vessels passing through almost all of the body’s tissues, shuttling a clear liquid called lymph throughout the body.

On this network are around 500 to 700 “lymph nodes” that essentially act as manufacturing stations for lymph — a fluid that contains white blood cells used to defend the body against invaders like viruses and bacteria. One of the main types of these cells is called a lymphocyte, which include T cells and B cells, two of the strongest fighters in your immune system’s army of cells.

Lymph nodes also serve as filtering mechanisms; the lymph system regularly drains excess fluid from body tissues and then routes it though the lymph nodes for assessment by immune system cells.

“Think of it as a whole branching network that runs through your body and works to keep everything well regulated, and as part of that effort, to identify invaders,” says Catherine Diefenbach, M.D., clinical director of lymphoma at NYU Langone Perlumtter Cancer Center, New York.

Lymph nodes are small, bean-shaped structures that are grouped into clusters, particularly in the neck, armpits, groin, chest, and abdomen. Also considered part of the lymph system are bone marrow, the spleen, tonsils, and the thymus.

How does the lymph system work, and how does it fail?

When the lymph system shuttles fluid out of the tissues for examination and finds bacteria or viruses, it traps them and enlists immune cells to attack. This often creates an inflammatory response, causing the nodes in that area to swell, and if it’s in a part of the body where it can be felt externally, you might feel pain or tenderness there, Dr. Diefenbach says. The effect of “swollen glands” is actually enlarged lymph nodes.

You may also experience more aggressive symptoms like night sweats, fever, weight loss, adds Jack F. Jacoub, M.D., medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Memorial Medical Center, Fountain Valley, California.

When the system gets out of balance in some way, the process of keeping your body fluids in balance can get out of whack. That can lead to fluid building up in your tissues instead of being shuttled out by the lymph vessels. When that happens, you will likely have swelling — called lymphedema — that can cause issues like infections and blockages. Because your immune system won’t be operating efficiently, it can also leave you more susceptible to illness.

Cancer of the lymph system can arise either because of cells in the system that have turned malignant, or because a lowered immune system allowed cancer cells to go unchecked. In both cases, those cancer cells can spread throughout the body along the lymph system and then grow in lymph node clusters.

If you’re experiencing swelling that doesn’t go away, or having some of the more aggressive symptoms like fever, that should prompt a check with your doctor for possible lymphoma or other conditions that might be affecting the lymph system, advises Dr. Jacoub.

How is lymphoma diagnosed and treated?

Because the lymph system runs throughout the entire body, lymphoma is detected through whole-body imaging like a PET scan or a CAT scan, Dr. Jacoub says. It may also be diagnosed through a bone marrow biopsy. He adds that staging is still evolving, but in general, stage 1 involves a cancer that is in one lymph node region, such as contained in the neck or the groin. Stage 2 is in two or more lymph node regions and may involve one organ as well. Stages 3 and 4 represent a spread beyond the lymph node areas to organs like the liver or lungs.

Both Hodgkin’s and non-Hodgkin’s lymphoma involve the lymphocytes, but the former has the presence of a certain type of B cell — called a Reed-Sternberg type — that has become malignant. If you don’t have this abnormal cell, you have non-Hodgkin lymphoma.

Unlike some forms of cancer that benefit from tumor removal by surgery, it’s rare for lymphoma to be addressed that way, Dr. Jacoub notes. That’s because it’s considered a “total body illness” due to the way the lymphatic system operates. There are more than 30 types of non-Hodgkin’s lymphoma, so specific treatment will be based on what type is present. But in general, says Dr. Jacoub, chemotherapy and targeted radiation are considered the first-line treatments for most lymphomas.

Elizabeth Millard is a freelance journalist specializing in health, wellness, fitness, and nutrition. Her articles have appeared in SELF, Men’s Health, CNN, MyFitnessPal, and WebMD, and she has worked on patient education materials for Mayo Clinic and UnitedHealth Group. Find her on Instagram at @bossykind and on Twitter at @EMillard_Writer. Her online portfolio is at elizabethmillard.pressfolios.com. When not writing, she’s also a yoga teacher and organic farmer.

clinical-trials-lymphoma

What You Should Know About Clinical Trials If You Have Lymphoma

With both Hodgkin’s and non-Hodgkin’s lymphoma, there are numerous clinical trials in progress designed to test new protocols, different medication regimens, or pre-market drugs.

For those who have been diagnosed and are curious about whether a trial is a good fit, it’s worth doing some research and talking with your physician about the possibility. Here are some basics as a solid starting point.

What the ‘phases’ of a clinical trial mean

There are four phases of clinical trials. Phase one assesses the safety of a drug, device, or other intervention. It usually includes a small number of participants — often fewer than 100.

“Phase one trials used to have a negative connotation, because patients sometimes believed you would be ramping up dosage of a drug until they saw bad side effects,” says Jack F. Jacoub, M.D., medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Memorial Medical Center, Fountain Valley, California. “That’s simply not the case. You’re not seen as a lab rat in these trials, you’re viewed as a vital participant in a very important process toward improving medicine. That’s true at every phase.”

In phase two, with safety in place, the drug or device is evaluated for efficacy. This involves more participants, and may use a “control” group that receives a placebo or standard treatment. Most often, though, there is no placebo — simply different levels of medication dosages or the same dose applied to multiple types of conditions.

“There’s a common misconception that some people in the trial will get a placebo and therefore not be treated for their condition,” says Dr. Jacoub. “But there will always be a standard of care in place.”

Phase three brings in several hundred to several thousand participants and uses randomized and blind testing to determine whether the treatment works for a larger number of people. Phase three also looks more closely at potential adverse reactions, such as significant side effects.

At that point, the drug, device, or intervention can then be approved for use among a wider patient population, and may enter phase four, which looks at long-term effectiveness.

For every phase, there is an initial process called “informed consent.” During that period, you’ll have the chance to ask the researchers questions — although you can certainly do that during the trial as well. Informed consent is required by federal law for research institutions, to ensure that patients understand the requirements, risks, and benefits of participating in a specific trial.

No matter what phase you join, keep in mind that you can drop out anytime. Joining a trial doesn’t mean you’re automatically “locked in” until the end. Participation is always voluntary.

What to consider before joining a trial

Even if you’ve qualified for a trial based on the specific research criteria of that trial, there are still several factors to keep in mind before joining. For example, a major aspect is what type of support you have from caregivers, says Marlon Saria, Ph.D., R.N., advanced practice nurse researcher at the John Wayne Cancer Institute, Santa Monica, California.

Dr. Saria has been involved with clinical trials for eight years, with usually around 20 trials open simultaneously. Those who seem to do the best with trials, he notes, are people who have engaged and organized caregivers.

“If you have a diagnosis like cancer, you already have a complex medical issue,” he says. “You’re dealing with pain management, treatment, possible medication schedules, testing, and appointments. Adding a clinical trial into that gives you more to track and remember. It’s best to have support for that.”

Also, an active caregiver can be observant about potential side effects. Dr. Saria has seen patients leave clinical trials because they haven’t noticed problems until their side effects were quite advanced. But if those effects are caught early, they can be addressed and allow you to stay in the trial.

For those with lymphoma who don’t have an involved caregiver, help is available through the Leukemia & Lymphoma Society (LLS), says Alissa Gentile, R.N., director of the organization’s Clinical Trial Support Center. The LLS service has nurses who follow patients through clinical trials and help them through the process. Also useful, LLS maintains an online database of lymphoma-related trials on its website.

Keep financial aspects in mind

Another consideration when thinking about whether to join a trial may be the financial impact. In some cases, participants receive payment, but more often, the pharmaceutical or device company involved in the treatment only pays for the treatment used in the clinical trial.

That doesn’t cover expenses like hospital stays, doctor and nurse time, and other costs, including some drugs costs, according to Gentile.

“There is a large misconception that clinical trials will cover all expenses, and unfortunately, that’s rarely true,” she says. “That’s why it’s important to look at potential costs and insurance coverage when evaluating whether to join a trial. Otherwise, you may have an unpleasant surprise when you find that you have to cover costs that you didn’t expect.”

Knowing the aspects of a trial — how long the trial will be conducted, how current treatment will be affected, which out-of-pocket expenses will be involved, and what factors would cause you to be dropped from the trial — is a crucial part of making the decision about whether a trial seems like a good fit for you.

Elizabeth Millard is a freelance journalist specializing in health, wellness, fitness, and nutrition. Her articles have appeared in SELF, Men’s Health, CNN, MyFitnessPal, and WebMD, and she has worked on patient education materials for Mayo Clinic and UnitedHealth Group. Find her on Instagram at @bossykind and on Twitter at @EMillard_Writer. Her online portfolio is at elizabethmillard.pressfolios.com. When not writing, she’s also a yoga teacher and organic farmer.

Abby-Lee-Miller-Continues-To-Fight-Rare-Cancer

Abby Lee Miller Continues To Fight Rare Cancer

The Dance Moms star is starting her third round of chemo.

  • ‘Dance Moms’ star Abby Lee Miller has begun her third round of chemotherapy for her Burkitt lymphoma.
  • Abby Lee was first diagnosed with the rare form of cancer following a hospitalization in April for what doctors thought was a spinal infection.
  • Burkitt lymphoma is an aggressive type of non-Hodgkin’s lymphoma, a type of cancer that starts in the white blood cells, and can be lethal within weeks without treatment.

Dance Moms star Abby Lee Miller has had an intense past few months in the health department. First, she was hospitalized with severe neck pain and had to have emergency spinal surgery. Then, she learned she had a rare form of cancer known as Burkitt lymphoma (a type of non-Hodgkin’s lymphoma), according to ET Online. Now, she’s undergoing her third round of chemo to try to treat her cancer.

Abby (who has been in the hospital since mid-April, per Page Six) shared a closeup of her face bathed in sunlight on Instagram Sunday. “Going outside to feel the sun on my face was wonderful!!!” she wrote. “Kids, never take anything in this world for granted! It can all change so suddenly! The Brilliant Dr. B cleared me for sunning this afternoon! Woo Hoo! Thank you sir!”

Her sweet sunning shot comes just days after she revealed that she was about to start her third round of chemotherapy. “I should be planning a weekend of fun in the sun at the pool!,” she captioned a throwback photo on Instagram. “There’s nothing I enjoy more than swimming and a good tan! Instead, I start round 3 of chemo……… another battle that I must win!!!”

What is Burkitt lymphoma?

In case you’re not familiar with it, Burkitt lymphoma is an aggressive form of non-Hodgkin’s lymphoma, a type of cancer that affects white blood cells, according to the American Cancer Society (ACS).

With Burkitt lymphoma, the cancer usually starts in a person’s abdomen, where it forms a large tumor. It can spread rapidly to the brain and spinal fluid. It is very rare, according to the ACS-making up just 1 to 2 percent of all lymphomas.

“Burkitt lymphoma is very aggressive,” says Jack Jacoub, M.D., a medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Medical Center in Fountain Valley, Calif. “It can be lethal in a matter of weeks with no therapy.” Luckily, the ACS says that more than half of patients can be cured by “intensive chemotherapy.”

There’s no word on how much longer Abby’s treatment is expected to take, but for her specific type of cancer, treatment generally involves undergoing chemotherapy cycles for four to five months, Jacoub says. That can include chemotherapy injections into the spine as well as intravenous chemo.

Why did Abby have to avoid sun exposure during treatment?

Jacoub says people who undergo chemo can burn a lot easier and quicker than others. He adds that doctors usually advise patients not receive direct, prolonged sun exposure for several weeks after their last chemotherapy session. However, it’s probably okay to briefly grab a few rays here and there.

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 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.