Category Archives: Treatment & Management

Testimony of Dr. Diana Zuckerman About PEPAXTO FDA Advisory Committee Meeting on September 22, 2022

Other Cancers, Testimony & Briefings, Treatment & Management

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.  Our largest program is focused on cancer.  My expertise is based on post-doc training in epidemiology and public health, and previous positions at HHS and faculty member and researcher at Yale and Harvard.

All of us want more treatment options for refractory cancers, but we want patients to be able to have confidence that FDA approval means a product is proven safe and effective.  The OCEAN study of 495 multiple myeloma patients has important information that was not available when the drug received accelerated approval. Even if some patients taking Pepaxto do well, it is only with a randomized controlled trial that we can determine if Pepaxto is helpful or if the patients would do better without it.

Our Center’s analyses support the FDA findings that the data do not confirm the indication.  In the randomized trial comparing Pepaxto to another treatment option, median survival was 5.3 months shorter, and the death rate was slightly higher.

The Sponsor says some patients do better but we agree with FDA that “Results from subgroup analyses cannot be used to conclude benefit in a subset of patients, when the overall patient population has shown a detrimental treatment effect.”

We also agree with the FDA that PFS is not improved and that “An anti-cancer therapy that prolongs PFS is not considered safe and effective if the therapy results in a detrimental effect on OS”

Public trust in the FDA has been weakened in recent years.  FDA standards matter to all of us.  Would you want your loved one to take Pepaxto rather than a superior treatment option?  Not all oncologists will be as knowledgeable about the data as those serving on this panel.

It concerns us that the sponsor continues to ignore FDA concerns, rely on shortcuts instead of better research, and that the company withdrew the drug in October but then rescinded the withdrawal.  Was this just a delaying tactic?  We agree with the FDA that the sponsor did not provide new data, and with Dr. Pazdur that FDA approval relies on solid information about appropriate dosage, which is lacking here.

Maybe Pepaxto would benefit some types of patients and better research is needed to prove that.  As FDA states, the preponderance of evidence from the prespecified analysis and in all other subgroups suggests an increased risk of death in patients and a potential for harm.”

We were pleased that the Committee voted 14-2 that the evidence does not support that the benefits outweigh the risks.

The FDA followed through and rescinded Pepaxto approval in December, 2022.

To Stay: Two More Cancer Indications With ‘Dangling Approvals’

In the News, News Stories & Editorials, Treatment & Management, We're In the News, , ,

Kerry Dooley Young, Medscape News: April 29, 2021

Two more cancer indications that had been granted accelerated approval by the US Food and Drug Administration (FDA) are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27–29) and follows a similar verdict from day one.

Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indications for a number of immunotherapy checkpoint inhibitors, despite poor results in studies that were meant to confirm the benefit of these medicines for certain patients.

On the second day (April 28) of the 3-day FDA meeting, the Oncologic Drugs Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases of what top agency staff call “dangling accelerated approvals.”

ODAC voted 10-1 in favor of maintaining the indication for atezolizumab (Tecentriq) for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining accelerated approval for pembrolizumab (Keytruda) for first-line cisplatin- and carboplatin-ineligible patients with advanced/metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but it is not bound to do so. If the FDA were to decide to strip the indications in question from these PD-1 medicines, such decisions would not remove these drugs from the market. The three drugs have already been approved for a number of other cancer indications.

Off-label prescribing is not uncommon in oncology, but a loss of an approved indication would affect reimbursement for these medicines, Scot Ebbinghaus, MD, vice president of oncology clinical research at Merck & Co (the manufacturer of pembrolizumab), told ODAC members during a discussion.

[….]

Another participant at the meeting asked the panel and the FDA to consider the burden on patients in paying for medicines that have not yet been proven to be beneficial.

Diana Zuckerman, PhD, of the nonprofit National Center for Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in hopes that something will work,” she said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that isn’t proven to work?”

[….]

To read the entire article, see https://www.medscape.com/viewarticle/950165

Dietary Supplements Before and During Chemotherapy

Diet, Habits, & Other Behaviors, General Treatment Issues, Treatment & Management, ,

Meg Seymour, PhD, National Center for Health Research

Many Americans, including those with cancer, take dietary supplements. People take supplements because they believe it will help them stay healthy and give them vitamins and minerals they may not get from their diet. Chemotherapy patients often take supplements because their nausea makes it difficult to eat, and they want to be sure to get enough nutrients. 

People think of dietary supplements as a no-risk insurance policy to improve nutrition, but a study published in 2020 shows that supplements can have risks if you are undergoing chemotherapy. More than 1,000 breast cancer patients were asked whether or not they took any supplements either before or during their chemotherapy.[1] The researchers then continued to evaluate any subsequent cancer or death for up to 15 years (almost all of the women were followed for at least 5 years).

  Results showed that patients who took vitamin B12 before and during their chemotherapy were more likely to die or have their cancer return. They were also more likely to die from any cause, not just from cancer. This increase in cancer recurrence or death was only for people who took the B12 supplements both before and during their chemotherapy. Patients who only took the B12 supplements before chemotherapy or only took supplements during chemotherapy were not more likely to have a recurrence of their cancer or die. Patients who took Iron supplements both before and during chemotherapy were also more likely to have their cancer return or to die of any cause. However, the same was also true for people who only took iron supplements during their chemotherapy.

The researchers also looked at antioxidant supplements, which include vitamins A, C, and E. They found that most patients did not take these supplements both before and during chemotherapy, but those who did were more likely to have cancer return after treatment. However, this finding was not “statistically significant,” which means that more research is needed to determine whether these worse outcomes occurred by chance.  In addition, the 44% of the patients in the study who were taking multivitamins did not have better or worse outcomes than people who were not taking them.

This is what scientists call an observational study rather than a clinical trial. In a clinical trial, some patients would be randomly assigned to take supplements and others would be assigned to take a placebo (with no active ingredients). In an observational study, people make their own decisions about what treatment (in this case supplements) to take. Those who chose to take supplements might have different health issues or health habits than those who did not. For example, it is possible that the people who were more likely to take supplements both before and during their chemotherapy were less healthy to begin with. For example, they could have been taking B12 or Iron supplements because they had anemia, and anemia may have increased the possibility of cancer recurrence or death. Also, because patients were asked whether or not they took supplements (instead of being given the supplements by researchers), it is impossible to know whether what patients said about supplements was completely accurate. For example, some patients could have said that they were regularly taking a supplement, but really they only took it occasionally.   

Dr. Christine Ambrosone, the lead researcher of the study, said in an interview that this is only one observational study, and doctors should not necessarily base their recommendations on this single study. Doctors need to consider the specific needs of each patient. For example, someone with anemia might need a dietary supplement, and the benefits of those supplements might outweigh the potential risks. 

If you are considering taking a dietary supplement, it is important to keep in mind that the Food and Drug Administration does not regulate dietary supplements for purity and quality. There is no guarantee that a supplement will work or even that it contains exactly what the bottle says it contains.[2] It is always important to talk with your doctor to help you decide if the benefits of any dietary supplement you are considering outweigh the potential risks. 

 

  1. Ambrosone, C. B., Zirpoli, G. R., Hutson, A. D., McCann, W. E., McCann, S. E., Barlow, W. E., … & Unger, J. M. (2019). Dietary Supplement Use During Chemotherapy and Survival Outcomes of Patients With Breast Cancer Enrolled in a Cooperative Group Clinical Trial (SWOG S0221). Journal of Clinical Oncology, JCO-19.
  2. Brooks, J, Mitchell, J., Nagelin-Anderson, E. , & Zuckerman, D. National Center for Health Research. How Safe are Natural Supplements? Center4research.org. http://www.center4research.org/examining-safety-natural-supplements/. 2019.

Insurance Coverage Information for Breast Implant Removal

Breast Cancer, Breast Cancer, Treatment & Management

The original reason for getting your breast implants matters to health insurance companies (as well as Medicare and Medicaid).  If your implants were put in after a mastectomy and your doctor believes that removing your implants is “medically necessary,” then your health insurance is legally obligated to cover your breast implant removal under the Women’s Health and Cancer Rights Act of 1998 (WHCRA).

If the original reason for getting breast implants was for augmentation of healthy breasts, then some health insurance companies will cover your explant surgery if they consider the services to be “medically necessary.”

What are “Medically Necessary” Services?

Insurance companies cover services that they determine to be “medically necessary” to treat a disease or illness. Although you or your doctor may believe a service is medically necessary, insurance companies don’t always agree.

Most insurance companies will not cover any cosmetic procedures and some will not cover complications from previous cosmetic procedures.  However, many companies consider removal of breast implants medically necessary for patients with any of these conditions:

Unfortunately, insurance companies usually won’t cover the cost of breast implant removal for autoimmune or connective tissue diseases or other systemic complications. If you have any of the conditions listed in the bullets above, you should focus on those in your insurance claim because insurance companies are more likely to cover these symptoms.

How do I know whether my insurance company will cover the cost of removal?

To find out if your insurance company is likely to cover removal, you will need to look at your specific policy language. You can usually find this language in a document called “Evidence of Coverage” (EOC), this is also sometimes called a “Benefits Booklet.” It is a document (typically about 100 pages) that describes in detail the healthcare benefits covered by your health plan, including procedures that your insurance company will and will not cover.

You can access an electronic copy of your EOC through your online account on your insurance company’s website. You can also call the member services number on the back of your insurance card and ask an insurance representative for a copy of this document.

What Do I Look For?

Once you have your policy, look for language about breast implant removal.  If you don’t see any language about breast implant removal, search for language on complications from cosmetic surgery. If you cannot find any specific language about breast implant removal, you should also look to see what your insurance company’s definition of “medically necessary” is. It is also important to check whether your insurance plan requires pre-authorization for any surgeries.

If you’re using an electronic copy, you don’t need to read the entire document. You can easily find terms using the “Control+F” keys on your keyboard. That will provide a “search box” that will search for any words you enter. Just enter the word “breast” or “cosmetic” or “medically” in the search box. If you are unable to find what you need in the lengthy document, call your member services line and ask for assistance to locate the correct pages.

File for Pre-Authorization

Most insurance companies will require that you get pre-authorization (also called prior approval or pre-certification) before the surgery. This means your insurance company reviews your relevant information and determines whether surgery is medically necessary. Then, the insurance company will let you know if it is likely to cover your surgery. However, that pre-authorization isn’t a promise that your surgery will be covered.

The easiest way to get pre-authorization is to have your plastic surgeon sign and submit a letter that lists your symptoms and explains why removal is medically necessary based on your insurance policy language. (Usually one or more of health problems listed on the bullets earlier in this article). Your surgeon should also enclose any medical documentation that provides proof of your symptoms.

It is best if your plastic surgeon signs this letter to send with your insurance claim. However, if your surgeon is unwilling to sign the letter, another doctor involved with your care, such as your primary care provider, can sign. You can find templates for these letters here. If your doctor agrees to sign the letter, but won’t submit it to your insurance company, you will need to submit the letter before your surgery to ensure you receive pre-authorization.

NOTE: If you don’t get pre-authorization when it was required, the insurance company isn’t required to cover the surgery, even if it considers the procedure to be medically necessary.

After Your Surgery: Filing a Reimbursement Claim

If your surgeon is in your insurance company network, he/she should file a claim on your behalf. If not, you will have to pay upfront for the surgery and file the reimbursement claim with your insurance company. Even if you see a surgeon who doesn’t take insurance, you should still file a pre-authorization claim with your insurance company. If you didn’t seek pre-authorization before your surgery, you can still file a reimbursement claim.

In your reimbursement claim, you will need to submit your pre- and post-operative reports, along with a letter from the surgeon stating that the procedure was medically necessary.

You can learn more about getting private insurance to cover your explant surgery, including how to appeal a denial, here on our breast implant information website. 

What if I have Medicare?

Medicare usually covers breast implant (saline or silicone) removal for any of these conditions:

  • Painful capsular contracture with disfigurement
  • Implant rupture
  • Infection
  • Implant extrusion (coming through the skin)
  • Interference with the diagnosis of breast cancer
  • Siliconoma or granuloma (silicone-filled lumps under the skin)
  • Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system)

Medicare coverage can differ depending on the state where you live. You can check the specific Medicare policies on breast implants removal in your state here.

You can learn more about getting Medicare to cover your explant surgery here on our breast implant information website. 

You can learn more about getting Medicaid to cover your explant surgery here on our breast implant information website. 

What do I Need to Know about Breast Implant Removal Surgery?

See our article here.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff

How to Report Problems With Medical Products to the FDA

General Treatment Issues, Quality Of LIfe, Treatment & Management

National Center for Health Research.

Every year, tens of thousands of consumers suspect that their medicines or medical devices might be causing unexpected side effects. Side effects – also called adverse reactions – can be quite minor, such as a rash or stomach upset, or very serious, such as mental confusion, heart damage or an autoimmune reaction. It is sometimes difficult to tell if the health problem is caused by the medical product or is merely a coincidence. That is why serious problems that are possibly related to a medical product should be reported to your physician and to the Food and Drug Administration (FDA). You do not have to be certain that the health problem is caused by the medical product – the purpose of a tracking program is to figure out if there is a problem by looking for a pattern in the reports. By tracking these reports, the FDA can determine if there is a pattern that may indicate the need to warn consumers or even to withdraw a product from the market.

The FDA has a program called MedWatch for reporting serious reactions and problems with medical products, including drugs and implanted devices.

The process is relatively simple and is outlined on the MedWatch website. You may ask your doctor to fill out a MedWatch form detailing the problem you have been experiencing. The MedWatch form is available online or you or your doctor can request a copy of the form by calling the FDA toll free at 1-888-INFO-FDA (1-888-463-6332).

If for some reason you do not wish to have the form filled out by your doctor or your doctor refuses to fill out the form (doctors are not required by law to complete a report to the FDA), then you can complete the form yourself. MedWatch provides a set of instructions for completing the form on their website, as well as an online form that you can submit on the website.

If you prefer to report your problem over the telephone, you can do that by calling the at 1-800-FDA-1088.

If you have questions or comments about a specific drug or medical device, you can call the FDA toll free information number at 1-888-INFO-FDA (1-888-463-6332), press 2, followed by 1 for information, then:

  • for dietary supplements, press 2
  • for drug products, press 3
  • for medical devices, press 4
  • for biologics, including human cells, tissues and cellular and tissue-based products, press 6

Reporting problems helps fix them and ensure that other patients do not experience the same unexpected side effects or reactions.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

Hormonal Therapy for Ductal Carcinoma In Situ (DCIS)

Breast Cancer, Treatment & Management
Diana Zuckerman, PhD and Danielle Shapiro, MD, MPH, Cancer Prevention and Treatment Fund

In recent years, ductal carcinoma in situ (DCIS) has become one of the most commonly diagnosed breast conditions. It is often referred to as “stage zero breast cancer” or a “pre-cancer.” It is a non-invasive breast condition that is usually diagnosed on a mammogram when it is so small that it has not formed a lump. In DCIS, some of the cells lining the ducts (the parts of the breast that secrete milk) have developed abnormally, but the abnormality has not spread to other breast cells.

DCIS is not painful or dangerous, but it sometimes develops into breast cancer in the future if it is not treated. If it develops into breast cancer, it can spread, at which point it is called invasive. The goal of treating invasive cancer is to prevent it from spreading to the lungs, bones, brain, or other parts of the body, where it can be fatal. Since DCIS is not an invasive cancer, it is even less of a threat than Stage 1 or Stage 2 breast cancer, which are the earliest types of invasive cancer.[1]  For more information, see our free DCIS booklet, and our other articles on DCIS.

Most women with DCIS will never develop invasive cancer whether they are treated or not, but it is impossible to predict which women with DCIS will develop cancer and which ones won’t. That’s why treatment is recommended. A woman with DCIS does not need all the same treatments as a woman diagnosed with invasive breast cancer, but surgery is almost always recommended. Most DCIS patients will choose a lumpectomy (which removes the DCIS but does not remove the entire breast), and radiation therapy is usually recommended for those women to destroy any stray abnormal cells in the same breast.[1]

Some women also try hormone therapy such as tamoxifen or aromatase inhibitors. That is the focus of this article.

DCIS does not need to be treated immediately. A woman can spend a few weeks after her diagnosis to talk with her doctors, learn the facts about her treatment choices, and think about what is important to her before she chooses which kind of treatment to have.

Hormonal Therapy

Hormonal therapy is recommended for some women with DCIS to help prevent breast cancer from developing and to prevent DCIS from returning after it has been surgically removed.  It is only effective for women whose DCIS is “estrogen receptor positive”, which DCIS usually is.

Hormonal therapy is taken as a pill every day for at least 5 years. Side effects include increased risk of endometrial cancer, severe circulatory problems, or stroke. In addition, hot flashes, vaginal dryness, abnormal vaginal bleeding, and a possibility of premature menopause are common for women who were not yet menopausal when they started treatment.[1]

What is the benefit of hormone therapy for women also undergoing radiation therapy?

Tamoxifen blocks the effects of estrogen on breast cells, which can stop the growth of cancer cells that are sensitive to estrogen. A study of more than 1,800 pre-menopausal and post-menopausal women with DCIS evaluated the benefits of tamoxifen for women who had lumpectomy and radiation treatment. These women were randomly assigned to take tamoxifen for 5 years or a placebo (sugar pill). The study found that after 5 years, women who took tamoxifen were about 5% less likely to develop either DCIS or cancer in the same breast, cancer in the opposite breast, or distant cancer spread (8.2% in women taking tamoxifen vs. 13.4% in placebo). However, the vast majority of women survived and they did not live any longer whether they took tamoxifen or not.[1]

For postmenopausal women, aromatase inhibitors may be used instead of tamoxifen. Aromatase inhibitors block the body’s ability to make estrogen. A study of more than 3,000 post-menopausal women with DCIS evaluated the benefits of hormone treatment for women who had lumpectomy and radiation treatment. These women were randomly assigned to take tamoxifen or anastrozole for 5 years. The study found that after 5 years, compared to women taking tamoxifen, the women taking anastrozole were 2% less likely to develop either DCIS or cancer in the same breast, cancer in the opposite breast, or distant cancer spread (from about 8% of women taking tamoxifen compared to 6% taking anastrozole).  As in the previous study, the vast majority of women survived and those taking anastrozole did not live any longer than women taking tamoxifen.[2]

That was a very small benefit for anastrozole compared to tamoxifen, and another study of post-menopausal women with DCIS found no difference between the two hormone treatments.[3]

What is the benefit of hormone therapy for lumpectomy patients who do not undergo radiation therapy?

Although radiation therapy is usually recommended for lumpectomy patients, it is inconvenient and many women prefer to avoid it.  In addition, radiation is only beneficial for preventing cancer in the one breast, while hormone therapy helps prevent cancer in both breasts. A study of more than 1,700 women with DCIS who underwent a lumpectomy evaluated radiation and/or tamoxifen.  The women were randomly assigned either to radiation, tamoxifen, radiation plus tamoxifen, or no treatment after surgery. For women who did not have radiation therapy, tamoxifen reduced the chances of developing DCIS within 10 years in the same breast by about 3% and the chances of developing DCIS in the other breast by about 1%. Interestingly, tamoxifen did not significantly decrease the chances of developing invasive breast cancer in the same breast, and only reduced the chances of developing invasive cancer in the opposite breast by about 1%.[4]

In women treated with radiation, about 10% developed DCIS or breast cancer within the next 10 years after surgery, and it made no difference whether these women took tamoxifen or not. And while the vast majority of women were alive 10 years later, their chances of survival were no different whether they were treated with radiation, tamoxifen, both, or neither.[4]

Side Effects

While there are benefits to using hormonal therapy, tamoxifen and aromatase inhibitors carry risks of serious harms. Because estrogen plays an important role in maintaining strong bones and healthy cholesterol, blocking estrogen can put healthy women at greater risk for heart disease and osteoporosis.

Tamoxifen:

  • endometrial (uterine) cancer- for every 1,000 women, 2 more will develop uterine cancer
  • blood clots- for every 1,000 women, 3 more will develop potentially dangerous blood clots
  • strokes-  for every 100 women, 1 will develop a stroke
  • cataracts
  • hot flashes
  • vaginal discharge
  • vaginal bleeding

source: Medscape

Aromatase Inhibitors:

  • uterine cancer-  for every 1000 women, 20 more will develop uterine cancer
  • blood clots- for every 1,000 women, 20 more will develop a blood clot
  • strokes- for every 100 women, 2 more will develop a stroke
  • Joint pain for every 1000 women, 20 to 100 more will develop joint pains
  • hot flashes
  • vaginal bleeding
  • vaginal discharge

source: Medscape

The Bottom Line

In women diagnosed with DCIS, hormonal therapy can help prevent DCIS from recurring.  If a woman doesn’t undergo radiation therapy, hormonal therapy can reduce her chances of  invasive cancer in the opposite breast, but not invasive cancer in the same breast. And, hormonal therapy used in addition to radiation treatment apparently has no benefit, but does have added risks.

Perhaps most important, women who take hormonal therapies do not live any longer than women who don’t.

Too often, women with DCIS are encouraged to undergo radiation as well as hormonal therapy, but as you can see, the benefits of doing both are not greater than the benefits of choosing one or the other. And, the benefits of either radiation or hormonal therapy are primarily for reducing the chances of recurrence, but there is no benefit in terms of living longer.  Fortunately, almost all women with DCIS will live regardless of which of these treatments they have.

Talk to your doctor about which treatment options may be right for you.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

Footnotes:

  1. National Cancer Institute. Breast Cancer Treatment PDQ. (Feb. 2018). Available online: https://www.cancer.gov/types/breast/hp/breast-treatment-pdq#link/_1576_toc
  2. Margolese, Richard G et al. Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial.The Lancet. 2016;387(10021): 849 – 856.
  3. Forbes, John F et al. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial. The Lancet.2016;387(10021): 866 – 873.
  4. Cuzick, Jack et al. Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma in situ: long-term results from the UK/ANZ DCIS trial. The Lancet Oncology. 2011; 12(1): 21 – 29
  5. Medscape. Drugs & Diseases. Available online: https://reference.medscape.com/drug/soltamox-tamoxifen-342183#4 and https://reference.medscape.com/drug/arimidex-anastrozole-342208#4

What are the Alternatives to Traditional Radiation Therapy for Breast Cancer?

Breast Cancer, Treatment & Management
Dana Casciotti, PhD, Anna E. Mazzucco, PhD, and Danielle Shapiro, MD, MPH, Cancer Prevention and Treatment Fund

Almost all women with early-stage breast cancer will live just as long if they choose lumpectomy (also called breast conserving surgery) instead of mastectomy. However, traditional radiation treatment is recommended for lumpectomy patients because it lowers their chances of the cancer returning.

Traditional radiation therapy is given on an outpatient basis 5 days each week for 6-8 weeks, and that is a difficult schedule for many patients. Many women living in rural areas or far from the hospital choose to get a mastectomy because daily radiation is so inconvenient.

For some women, radiation to a smaller area of the breast over a shorter period of time may be a useful alternative. These options are called partial breast irradiation (PBI).

PBI can be given with just 5-10 treatments over about a week’s time, and researchers are testing if treatments can be shortened to 2 days. According to experts, PBI can reduce the chances of a tumor coming back in the area around the lumpectomy from 10-25% to 3-4%.[1]

Based on a comprehensive 2016 research review, women who had PBI were more likely to have their tumor come back or to have a new tumor form in the same breast than women who had whole breast radiation treatment (WBRT). However, women who had PBI were not more likely to die any sooner or to later need a mastectomy.[2] 

PBI is not for everyone (see considerations below). Each type of PBI carries a different potential risk than the other types. For example, PBI with brachytherapy carries a higher risk of infection or seroma (fluid filled pocket in the breast tissue after surgery) than PBI with external beam radiation.[3] However, PBI with external beam radiation, increases risk for harmful effects to the lungs and heart. Three-dimensional models can reduce the radiation exposure to normal tissue, but do not completely eliminate risk.[4]

Across many studies, it is not clear whether PBI is more harmful to skin tissue than traditional radiation therapies.[5, 6,7] Harmful effects on the skin are rated on a scale of 1 to 4, with 4 being the worst. The changes in skin appearance include wrinkling, shrinkage, color change, red blotches, thickening, skin loss and destruction, etc.[8]  

PBI has been studied in clinical trials lasting no longer than 5 years, which isn’t really long enough to know if the therapy works the same or better than traditional radiation treatment. Traditional radiation therapy has been proven to be safe and effective for women for at least 15 years after treatment.

Who Should Consider PBI?

The American Society of Therapeutic Radiology and Oncology (ASTRO) provides the following recommendations: [9]

  1. Women aged 50 and over
  2. Early-stage breast cancer that is confined to one defined area of one breast only
  3. Estrogen receptor-positive breast cancer
  4. Women who had a breast lump removed with “clean margins” (no cancer cells were found in the area that was removed surrounding the lump)
  5. Women who did not have chemotherapy prior to surgery

Who should not be given PBI?

  1. Women aged 40 and younger
  2. Women who had the cancer removed but the margins contained cancer cells (“positive margins”)

What are the Types of PBI?

PBI can be given in the following ways:

  1. Intracavitary brachytherapy or MammoSite- A radiation bead is placed in the surgical cavity (the space left in the breast tissue after the breast lump is removed). This can be done at the time of surgery or later.
  2.  Interstitial brachytherapy- Several catheters are placed into the surgical cavity. Radioactive beads can be put in the breast through the catheters.
  3. Intra-operative technique- During the surgery, a machine is used that gives local radiation to the surgical cavity before the wound is closed.
  4. External beam radiotherapy using 3D modeling- Beams of radiation are given from different directions to match the 3D shape of the tumor. This focuses the rays on the tumor while reducing damage to the rest of the breast.

What are the Benefits and Harms of PBI?

Advantages of PBI:

  1. Smaller area of breast is given radiation, which reduces damage to normal breast tissue.
  2. Treatments can be given over days instead of weeks, making it more convenient and easier to schedule with other medical appointments.
  3. Because of the more convenient schedule, more women may be able to choose to get lumpectomy instead of mastectomy.

Disadvantages of PBI:

  1. Increased chances of tumor coming back or new tumor forming in the same breast compared to traditional radiation therapy.
  2. Because PBI can give a bigger dose of radiation, women may have later toxic effects, which affect the way the breast looks.
  3. Invasive approaches (placing beads in the surgical wound or catheters in the wound) can increase the chance of infection and can slow wound healing, which may affect the way the breast looks.

The Bottom Line

Radiation treatment can help women to conserve breast and prevent cancer spread after lumpectomy. PBI can be more convenient in the short run, but in the long run, we do not know if it is as safe or effective as traditional radiation treatment.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References:
1. Kuznar, W. ASCO Reading Room: APBI: A Compromise Solution Following BCT–In low-risk breast cancer patients, recurrence rates equivalent to those for WBI. Medpage Today. (July 26, 2016). Available Online: https://www.medpagetoday.com/reading-room/asco/breast-cancer/59322?pop=0&ba=1&xid=tmd-md&hr=trendMD

2. Hickey BE, Lehman M, Francis DP, See AM. Partial breast irradiation for early breast cancer. Cochrane Database of Systematic Reviews 2016, Issue 7. DOI: 10.1002/14651858.CD007077.pub3.

3. Lei RY, Leonard CE, Howell KT, et al. Four-year clinical update from a prospective trial of accelerated partial breast intensity-modulated radiotherapy (APBIMRT). Breast Cancer Research and Treatment. 2013;140(1):119-133. doi:10.1007/s10549-013-2623-x.

4. Jacobson GM, Siochi RA. Low-Energy Intraoperative Radiation Therapy and Competing Risks of Local Control and Normal Tissue Toxicity. Frontiers in Oncology. 2017;7:212. doi:10.3389/fonc.2017.00212.

5. Whelan TJ, Olivotto I, Parpia S, et al. Interim toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation (APBI) using 3D conformal external beam radiation therapy (3D CRT) Int J Radiat Oncol Biol Phys. 2013;85:21–22. DOI: 10.1200/JCO.2013.50.5511

6. Keshtgar MRS, Williams NR, Bulsara M, et al. Objective assessment of cosmetic outcome after targeted intraoperative radiotherapy in breast cancer: results from a randomized controlled trial. Breast Cancer Res Treat. 2013;140:519–525. DOI: 10.1007/s10549-013-2641-8.

7. Akhtari M, Abboud M, Szeja S, et al. Clinical outcomes, toxicity, and cosmesis in breast cancer patients with close skin spacing treated with accelerated partial breast irradiation (APBI) using multi-lumen/catheter applicators. Journal of Contemporary Brachytherapy. 2016;8(6):497-504. doi:10.5114/jcb.2016.64830.

8. RTOG Foundation. RTOG/EORTC Late Radiation Morbidity Scoring Schema. Available online: https://www.rtog.org/ResearchAssociates/AdverseEventReporting/RTOGEORTCLateRadiationMorbidityScoringSchema.aspx.

9. Correa C, et al. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-based Consensus Statement. Practical Radiation Oncology 2017, Issue 7. DOI: 10.1016/j.prro.2016.09.007.

Which Breast Implants are Safest for Mastectomy Patients?

General Treatment Issues, In the News, Treatment & Management
Diana Zuckerman, PhD, Madris Tomes, and Amelia Murphy, National Center for Health Research and Device Events
Based on the summary of book chapter in Breast Implants, Rene Simon (ed.), Nova Science Publishers, 2017.

Our new book chapter on breast implants explains that the 55-year history of breast implants reflects repeated efforts to improve their safety and effectiveness by reducing the cosmetic problems and health complications that develop during the years while they are in the human body. The most recent effort is the type of highly cohesive breast implants known as “gummy bear implants” because of the thick gel that is described as similar to gummy bear candies. The goal of the more cohesive gel is to make implants last longer and be less likely to leak. First approved in the United States in 2012, adverse event reports indicate that this newest generation of implants causes complications similar to older generations of silicone gel breast implants.

The first breast implants, made in the 1960’s, were for cosmetic enhancement. When women’s augmented breasts became hard over time, implant manufacturers responded by making the silicone gel thinner. One manufacturer, Surgitek, added polyurethane foam to the outside to make the breasts feel softer. Those design changes caused other problems, however: the thinner gel had a tendency to “bleed” through the silicone elastomer shell, which contributed to the most common complication, capsular contracture. Breast implants made with thinner gel also ruptured and leaked more easily, and the gel broke down into silicone oil which could migrate to other organs or cause silicone granulomas inside their bodies. The polyurethane foam caused other problems: implant removal was very difficult and women lost their breast tissue during explant surgery, and the foam was found to break down to a known carcinogen.

The Food and Drug Administration (FDA) did not require breast implant manufacturers to submit data to prove the implants were safe and effective until 1992. By that time, the manufacturers had developed implants with a thicker shell and a more cohesive silicone gel. However, the studies revealed that, like the earlier implants, the more cohesive implants did not “last a lifetime” as had been claimed. As a result, manufacturers continued to modify the silicone gel to make it less likely to rupture and leak.

Despite claims that gummy bear implants are safer than other breast implants, a 5-year study found that the rupture rate was more than 4% for first-time augmentation patients.  The percentage of women needing additional surgery within 5 years ranged from 17% to 48%, depending on whether the patients were augmentation patients or reconstruction patients, and whether the gummy bear implants replaced previous implants. Our analysis found that from January 1, 2008 through June 30, 2017, 1298 adverse event reports for silicone gel breast implants were made to the FDA, 252 (19%) of which were for gummy bear implants. This is very high when you keep in mind that gummy bear implants were relatively rare in the U.S. prior to FDA approval in 2012. This chapter puts these statistics in the context of what is known about the safety of silicone breast implants and how that has changed over time.

Copies of the entire book chapter are available upon request at info@center4research.org

Ovarian Cancer: What Are the Treatment Options?

Ovarian Cancer, Treatment & Management
By Lea Simms and Laura Gottschalk, PhD, Cancer Prevention & Treatment Fund

Ovarian cancer is the 5th leading cause of cancer death in women in the U.S. Approximately 21,000 women will receive a new diagnosis of ovarian cancer in 2015. [1]

Ovarian cancer begins in or near the ovaries, which is part of the female reproductive system. There are two ovaries, one on either side of the uterus, connected to the uterus by the fallopian tubes. Ovarian cancer is often undetected until it has spread to the uterus, pelvis, and abdomen.[2]

Like all cancers, treatment is much more successful in the early stages when the cancer has not yet spread.[3] Women over the age of 55, women who have a family history of breast or ovarian cancer, and women who have had trouble getting pregnant or have never been pregnant are all at increased risk for ovarian cancer.[4]

To find out more about who is at risk and what to do about it, see our article Ovarian Cancer: who should be concerned and what can they do?

Traditionally, there have been three different types of ovarian cancer described:[5]

  • Epithelial
  • Germ cell
  • Stromal

Epithelial tumors are the most common type: 85%-90% of all ovarian cancers are epithelial.[2]These tumors start from the layer of cells that cover the outside of the ovaries or line the inside of the fallopian tubes, and can then spread to other parts of the body. There are four different types of epithelial ovarian cancer: serous (the most common), mucinous, endometroid, and clear cell. These different types of epithelial cancer describe how the tissue looks under the microscope and also the behavior of the cancer.

Germ cell tumors are a rarer form of ovarian cancer, in which the tumor starts growing in the germ cells that produce the eggs. Germ cell tumors make up about 2% of ovarian cancer cases and have a very high survival rate of 90%.[2] This type of cancer is most commonly seen in women under 25 years old (ovarian cancer research fund). There are several types of germ cell tumors: teratomas, dysgerminomas, endodermal sinus tumors, and choriocarcinomas.

There are also stromal tumors which begin in the tissue cells that hold the ovary together. Stromal tumors are diagnosed in about 1% of women with ovarian cancer and have a high survival rate of 75%.[2]

Like most cancers, ovarian cancer is probably not a single disease, but is made up of several different types of cancer that start in different places in or near the ovaries. Each type of cancer has its own unique genetic make-up, place where it begins to grow, and way of spreading. For example, the most common form of ovarian cancer, high-grade serous carcinoma, is now thought to start in the fallopian tube instead of the ovary [6]. New treatments for ovarian cancer are in the early stages, but the goal is to develop treatment options for these specific types of ovarian cancer.

Benign ovarian tumors are not cancerous and can be treated by removal of all or a part of an ovary. Tumors that are cancerous can metastasize (spread) and can be fatal. The stage of the tumor is used to describe how much it has spread ranging from stage I (only within the ovary or fallopian tube and has not yet spread) to stage IV (has spread to outside organs like the liver or lungs). The grade classifies the tumor on how much it looks like normal tissue: 1 is the most like normal tissue and 3 is the least like normal tissue. These classifications are used to determine what treatment is recommended.[1]

Treatments

If you were diagnosed with ovarian cancer, your medical team will recommend one or more treatment options. The main treatments for ovarian cancer are:

The most common recommendation for all stages of ovarian cancer is surgery followed by chemotherapy.[1]

Surgery

Surgery for epithelial ovarian cancer has two main goals: to stage and debulk (remove) the tumor. Staging refers to the doctors looking to see how far the cancer has spread and then taking tissue samples to test in a lab. Usually this means the doctor will remove the ovaries, uterus, cervix, fallopian tubes and omentum (fatty tissue around these organs), and then remove tissue and fluid samples from the abdominal cavity and pelvis.[1] The surgeon will then remove as much of the tumor as possible, which is called debulking. If the disease seems to be limited to one or both ovaries, the surgeon will biopsy the pelvis and abdomen to find out if the cancer has spread. Sometimes debulking is not possible because the patient is not healthy enough or the tumor may be attached to other organs. In these cases, chemotherapy will be used to treat the cancer that can’t be surgically removed.[1]

Research has shown that if the cancer is caught early enough, a woman can be safely treated without removing her uterus (read more about it http://dev.stopcancerfund.org/p-ovarian-cancer/patients-under-50-with-early-stage-ovarian-cancer-safe-treatment-with-no-loss-of-fertility/).  Women with later stage ovarian cancer usually must undergo surgery that removes the uterus and thus causes infertility.[7]

For germ cell tumors and stromal tumors the main goal of surgery is to remove the cancer. Germ cell tumors are usually treated with a hysterectomy (removal of the uterus) and bilateral salpingo-oophorectomy (removal of ovaries and fallopian tubes). If the cancer is found in one ovary, then only one of the ovaries and a fallopian tube will be removed to preserve the woman’s fertility. Stromal tumors are treated by removing the cancerous ovary, unless the cancer has spread to other areas, in which case a hysterectomy or bilateral salpingo-oophorectomy will be performed.[1]

Chemotherapy

After surgery, patients with epithelial ovarian cancer are treated with chemotherapy. Typical chemotherapy is a combination of 2 or more drugs, every 3-4 weeks, with 3-6 cycles. A cycle is a schedule of regular doses of drugs followed by a rest period.[2]

The chemo drugs are given by mouth, injected into a vein (Intravenous chemotherapy also known as IV), or injected through a catheter directly into the abdomine (called intraperitoneal chemotherapy or IP). IP therapy works by bringing the toxic drugs in a concentrated form to exactly where the cancer is, while IV therapy aims to kill cancer cells wherever they might be located.[5] In 2006, researchers reported that on average, patients receiving IP chemotherapy lived 65 months, compared to 50 months for patients receiving IV chemo only [8]. That is why the National Cancer Institute currently recommends IP administration of chemo to treat ovarian cancer. However, this recommendation may soon change. In 2016, a study of 1,560 ovarian cancer patients surprisingly found no difference in survival for women receiving IP chemo compared to other traditional methods [9]. This is important because IP therapy tends to  cause worse side effects.[5]

Although IP and IP/IV administration has been shown to have benefits and has been recommended by the National Cancer Institute, the combination tends to have worse side effects.[5] That is probably why most eligible patients do not receive a combination of IP and IV chemotherapy.[7]

There are many different types of chemotherapy drugs and research has shown that giving a combination of drugs in the initial treatment of ovarian cancer is more effective.[10] Most doctors prescribe a platinum compound such as cisplatin or carboplatin and a taxane compound such as paclitaxel or docetaxel.[1] A very large study in 2006 compared 198 clinical trials of 48,440 women being treated for ovarian cancer and found that the regimen that best prolonged survival is a platinum and taxane combination with intraperitoneal administration.[8]

Hormone Therapy

Hormones or hormone-blocking drugs can stop the growth of tumors. Tamoxifen is an anti-estrogen drug that is common in the treatment of breast cancer and some ovarian stromal tumors.[1] There have been no large studies of Tamoxifen for ovarian cancer, however.  It is generally used as a second-line therapy for recurrent stromal tumors or tumors that do not respond to standard chemotherapy. Since side effects are generally mild, it is considered a less toxic choice for women who cannot tolerate the side effects of standard chemotherapy. However, tamoxifen can increase the risk of serious blood clots in the legs, so patients should be aware of this risk before considering it.[1]

Targeted Therapy

Targeted therapy uses genetically engineered drugs such as bevacizumab (Avastin) and olaparib (Lynparza) to attack the cancer cells. In several studies, Avastin has been shown to have some effectiveness in delaying the progression of ovarian cancer but it is not clear whether it helps patients live longer, and it has substantial side effects that can harm quality of life.[11][12]

Olaparib (Lynparza) is approved by the FDA for the treatment of ovarian cancer in women with BRCA1 or BRCA2 mutations as a last resort for women who have had three or more prior unsuccessful treatments of chemotherapy.[13]  It has not been proven safe or effective for other ovarian cancer patients, but two studies are underway to see if the drug can be a useful treatment for women with BRCA mutations who have previously tried at least one platinum-based chemotherapy treatment.[14][15]

Radiation Therapy

Radiation therapy is not common for ovarian cancer.  Radiation therapy uses high energy x-rays or particles to kill the cancer cells.  It is sometimes used for recurrent cases when the cancer is confined to a small area.[2]

Which types of treatment you and your doctor decide to go with depends on the type of ovarian cancer you have and how it has advanced.

Clinical Trials

Clinical trials are used to help find new treatments for cancer.[2] If more effective treatments are found through clinical trials, they may become the standard treatment. If the new treatment is found to be less effective or have worse side effects, it probably will not be approved by the FDA and will not be available in the future.  Patients can enter clinical trials at different stages of their cancer treatment, but some trials may only be open to patients who have not yet started treatment. Remember: the treatments tested in clinical trials are not proven to be effective and the side effects are often unknown.  The new treatment may be worse than standard treatments, better, or identical in terms of effectiveness or side effects.  For those reasons, clinical trials are usually chosen by patients who have no other good options for treatment.  See here for the National Cancer Institute’s list of clinical trials: http://www.cancer.gov/about-cancer/treatment/clinical-trials.

The Latest Research

New research suggests that the most common route of treatment (first surgery, then chemo) might not be the most effective route of treatment. There is now evidence that having chemotherapy first, then followed by surgery, may be more effective for women with ovarian cancer, especially with epithelial ovarian tumors.[16]  Research has shown that chemotherapy prior to surgery improved the debulking of the tumor[17][18] and that patients also had fewer surgical complications and better post-operative recovery.[19]

The latest research, by Dr. Sean Kehoe and his team of doctors, took place in 87 hospitals in the UK and New Zealand.[18] The study randomly assigned 552 women with stage III or IV ovarian cancer to either the “Primary Surgery Group” (surgery followed by 6 cycles of chemotherapy) or to the “Primary Chemotherapy Group” (3 cycles of chemotherapy, then surgery followed by 3 more cycles of chemotherapy). The study measured overall survival rate as well as progression free survival (delaying the spread of cancer) and quality of life. At the conclusion of the study, 231 patients in the primary surgery group had died as had 220 in the primary chemotherapy group. Although the number of patients that died was similar, the Primary Chemotherapy group lived 1.5 months longer on average and had fewer adverse side effects and fewer toxic effects than the Primary Surgery group. The median survival rate (how long they lived after treatment) for the Primary Surgery group was 22.6 months compared to 24.1 months for the Primary Chemotherapy group. These results are also consistent with observational studies that showed similar results in survival rates.[20]

Although the differences in survival rate and duration of survival were similar, the chemotherapy group did have marginally better outcomes. This new finding may change the way doctors treat ovarian cancer and gives women another option rather than immediate surgery.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

  1. How is ovarian cancer treated? (2015, March 12). Retrieved June 8, 2015, from http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-treating-general-info
  2. Ovarian, Fallopian Tube, and Primary Peritoneal Cancer. (n.d.). Retrieved June 8, 2015, from http://www.cancer.gov/types/ovarian
  3. Ovarian cancer. (n.d.). Retrieved June 16, 2015, from http://www.mayoclinic.org/diseases-conditions/ovarian-cancer/basics/definition/con-20028096
  4. Waghray, P. (n.d.). Ovarian cancer: Who should be concerned and what can they do? Retrieved August 12, 2015, from http://dev.stopcancerfund.org/uncategorized/ovarian-cancer-who-should-be-concerned-and-what-can-they-do/
  5. Types of Ovarian Cancer. (n.d.). Retrieved June 16, 2015, from http://www.ocrf.org/about-ovarian-cancer/what-is-ovarian-cancer/types-of-ovarian-cancer
  6. Perets  R, Drapkin  R.  It’s totally tubular… riding the new wave of ovarian cancer research. Cancer Res. 2016;76(1):10-17.
  7. Bromberg, J. (n.d.). Patients under 50 with early-stage ovarian cancer: Safe treatment with no loss of fertility. Retrieved August 12, 2015, from http://dev.stopcancerfund.org/p-ovarian-cancer/patients-under-50-with-early-stage-ovarian-cancer-safe-treatment-with-no-loss-of-fertility/
  8. Armstrong DK, Bundy B, Wenzel L, et al. Intraperitoneal Cisplatin and Paclitaxel in Ovarian Cancer. N Engl J Med. 2006; 354:34-43.
  9. Walker JL, Brady, MF, Wenzel L. A phase III trial of bevacizumab with IV versus IP chemotherapy for ovarian, fallopian tube, and peritoneal carcinoma: An NRG Oncology Study. Annual Meeting on Women’s Cancer. March 19-22, 2016. San Diego, CA. Presentation.
  10. Kyrgiou, M, G Salanti, N Pavlidis, E Paraskevaidis, and JPA Ioannidis. n.d. “Survival benefits with diverse chemotherapy regimens for ovarian cancer: Meta-analysis of multiple treatments.” Jnci-Journal Of The National Cancer Institute 98, no. 22: 1655-1663. Science Citation Index, EBSCOhost (accessed August 12, 2015).
  11. Garcia A, Singh H. Bevacizumab and ovarian cancer. Ther Adv Med Oncol. 2013; 5(2): 133–141. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3556875/
  12. Li, J., Zhou, L., Chen, X., & Ba, Y. (2015). Addition of bevacizumab to chemotherapy in patients with ovarian cancer: a systematic review and meta-analysis of randomized trials. Clinical & Translational Oncology: Official Publication of The Federation of Spanish Oncology Societies And of The National Cancer Institute of Mexico.
  13. Lynparza (Olaparib) label. (2014, December 1). Retrieved August 13, 2015, from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162
  14. Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (SOLO-1). (2013, April 30). Retrieved August 13, 2015, from https://www.clinicaltrials.gov/ct2/show/NCT01844986
  15. Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy. (2013, June 7). Retrieved August 13, 2015.
  16. Bristow RE, Chi DS. Platinum-based neoadjuvant chemotherapy and interval surgical cytoreduction for advanced ovarian cancer: a meta-analysis. Gynecol Oncol 2006; 103: 1070–76.
  17. Vergote I, De Wever I, Tjalma W, Van Gramberen M, Decloedt J, van Dam P. Neoadjuvant chemotherapy or primary debulking surgery in advanced ovarian carcinoma: a retrospective analysis of 285 patients. Gynecol Oncol 1998; 71: 431–36.
  18. Kang S, Nam BH. Does neoadjuvant chemotherapy increase optimal cytoreduction rate in advanced ovarian cancer? Meta-analysis of 21 studies. Ann Surg Oncol 2009; 16: 2315–20.
  19. Hou JY, Kelly MG, Yu H, et al. Neoadjuvant chemotherapy lessens surgical morbidity in advanced ovarian cancer and leads to improved survival in stage IV disease. GynecolOncol 2007; 105: 211–17.
  20. Kehoe, S., Hook, J., Nankivell, M., Jayson, G., Kitchener, H., Lopes, T., . . . Swart, A. (n.d.). Primary chemotherapy versus primary surgery for newly diagnosed advanced ovarian cancer (CHORUS): An open-label, randomised, controlled, non-inferiority trial. The Lancet.

The Benefits of Exercise After Getting Diagnosed with Cancer

Breast Cancer, Colon Cancer, Diet, Habits, & Other Behaviors, General Treatment Issues, Prevention, Quality Of LIfe, Treatment & Management

Morgan Wharton and Annika Schmid, Cancer Prevention and Treatment Fund

You may have heard that regular exercise can reduce your risk of developing cancer, but did you know it’s also good for cancer patients who are undergoing or have completed treatment?

Is Exercise Good for Everyone Diagnosed with Cancer?

Exercise has proven benefits for cancer patients, ranging from improved fitness and higher quality of life to reduced rates of recurrence and a longer life.[1-9] What we know about exercise and cancer mostly comes from studying patients with breast or colon cancer, but there’s reason to believe that there are benefits of exercise for men and women suffering from all types of cancer, even cancer as advanced as Stage III.[3, 7]

The best news of all: It doesn’t matter if you were fit before you got diagnosed. Whether or not you exercised before has no bearing on what exercise can do for you during and after treatment.[3, 4, 6] So, it’s never too late to use exercise to fight cancer. If you’re coping with cancer or its aftermath, now is the time.

What Does the Science Show about Exercise for Cancer Patients?

Many studies have shown that exercise is beneficial to cancer patients, but no one is sure exactly why. Earlier studies suggested that exercise may help women avoid breast cancer or a recurrence of it by decreasing female hormones that feed cancer in the breast,[10-11] or by lowering inflammation in the body,[12] a suspected contributor to many diseases. In 2014, a study was published that provides a new possible explanation for how exercise helps the body fight cancer.[13] Researchers looked at irisin, a protein released from muscles after exercise, to see how it would affect breast cancer cells and healthy breast cells in test tubes. What they found was that when breast cancer cells came into contact with irisin, they started to self-destruct in a programmed way. While the exercise protein reduced the number of malignant cells and their ability to move around, it left the healthy cells unharmed! The researchers also found that irisin made Doxorubicin, a chemotherapy drug commonly given to breast cancer patients, more effective at killing cancer cells. Though this study did not look at what happens to cancer cells in actual patients after they exercise, it could help explain why other studies have found that cancer patients who are physically active feel better during treatment and are less likely to have their cancer come back.

A study from 2020 found that exercise is beneficial for preventing cancer deaths. It examined how active people were per day, and found that people who were more active were less likely to die from cancer by a follow-up 6 years later.[14] However, the study did not include people who were undergoing cancer treatment when the study was measuring physical activity, which makes sense since cancer treatment can drastically reduce the ability to exercise. This means that the results of the study are not specifically about people undergoing cancer treatment.

Studies that did look at patients focused on those beginning exercise (such as walking or aerobic exercise with weight training) somewhere between 2 weeks and 1 year after completing cancer treatment. In these studies, treatment could include surgery, chemotherapy, radiation, or a combination of these therapies.[1, 2, 3, 4, 6, 7, 8] Some studies also examined the effects of exercise during cancer treatment.[5, 9]

Less Body Fat and Better Immune System:

Studies have shown that in cancer patients, exercise during or after treatment reduces fat and improves body mass index (BMI).[2, 6, 9] Exercise lowers blood pressure, boosts the immune system, and increases bone mineral density.[6, 8, 9] Denser bones means fewer fractures.

Improved Fitness:

As expected, cancer patients who exercise regularly during and after treatment reported increases in strength, walking ability, aerobic capacity, and flexibility.[2, 6, 9]

Less Fatigue and Fewer Side Effects from Treatment:

Cancer patients who had completed treatment reported fewer negative side effects from treatment once they began to exercise regularly.[7] Patients who exercised during treatment reported less nausea and less difficulty sleeping.[9] The most commonly reported improvement was reduced fatigue. [6, 8, 9] In addition, a study published in 2021 indicates that exercise may also help relieve “chemo brain” (also known as chemo fog), which is a common side effect for cancer patients undergoing chemotherapy.[15] Common symptoms of chemo brain are having trouble with learning new tasks, remembering names, paying attention, and concentrating. The study found that patients who did either 2.5-5 hours of moderate intensity exercise (like brisk walking) per week or who did 1.5-2.5 hours of high intensity exercise (such as running) per week in the week before starting chemotherapy, within 1 month of completing chemotherapy, and 6 months after completing chemotherapy were less likely to report “chemo brain” symptoms than patients who did not exercise. Chemo brain can be upsetting and debilitating, affecting more than 75% of breast cancer patients undergoing chemotherapy, for example. 

Better Quality of Life:

In addition to the physical health benefits of exercise, cancer patients who exercised also reported improved mental and emotional well-being.[2] Patients who exercised during treatment and those who began to exercise afterwards frequently reported an increase in quality of life.[9] Patients who began to exercise regularly after treatment experienced less anxiety and a renewed “fighting spirit.”[9] Cancer patients over the age of 80 who exercised regularly during their weeks or months of treatment reported less loss of memory.[5]

Reducing Cancer Recurrence and Other Benefits for Survivors:

Because exercise improves the immune system, cancer patients who exercise regularly lower their risk of the cancer returning.[1, 2, 3, 8] Patients who exercise are less likely to die from cancer and are more likely to live longer than patients who don’t exercise.[14]

A 2022 study found that cancer survivors who exercise and do not sit 8 or more hours a day live longer than less active cancer survivors.[16] The study followed over 1,500 cancer survivors ages 40 and over for an average of 4.5 years.  The researchers found that those who exercised at least 150 minutes per week were less likely to die (of cancer or anything else) than people who did not report exercising. Survivors who reported sitting for more than 8 hours a day were also more likely to die than those who reported sitting less than 4 hours per day, and survivors who reported both a lack of exercise and sitting more than 8 hours per day were the most likely to die of all the survivors studied. The researchers recommend that cancer survivors stay active, by exercising 150-300 minutes per week and by standing and moving as much as possible, rather than sitting.

What Kind of Exercise Should I Do?

Aerobic activity of light to moderate intensity was the most common type of exercise in the studies of cancer patients.[2, 3, 6, 8, 9] Combining aerobic exercise with walking and resistance training (such as weight lifting or using resistance bands) led to greater health benefits than aerobic activity alone.[2, 6, 8] 

Most studies used Metabolic Equivalent (MET) hours to measure physical activity by level of intensity. MET hours measure the energy output of various activities compared to the energy used by the body when at rest. Activities that require more effort have a higher MET score than activities with lower intensities. One study suggested that 18-27 MET hours per week represents the ideal rate of exercise, because that group showed the lowest rate of recurrence and more activity did not lead to increased benefits.[7] Having a MET score comparable to 6 or more hours of walking in a week showed a 47% higher chance of survival without recurrence.[3] Click here for a chart of various activities and their MET hour equivalent, so you can calculate your weekly exercise in MET hours and maximize your benefits from exercise.

Walking can improve the health of cancer patients. Studies estimate that the greatest benefit from walking is seen in patients who walk at an average speed(a 20 minute mile) for 3-5 hours weekly.[7] Patients who walked just 1 hour per week, regardless of walking speed, showed improvements over the group of patients who reported no physical activity in a week.[7]

To get the most out of exercise, you need to make it a habit—something you commit to for the long-term. That’s why it is better to start small, with easily achievable changes like using the stairs regularly instead of the elevator or walking each evening after dinner. Remember not to set unrealistic goals, because it is better to start small and keep it up than to try to do too much and give up. Don’t miss the chance to get at least some benefit from this easy, free strategy to fight cancer.

The Bottom Line

Exercise helps individuals who are undergoing cancer treatment and those who have completed cancer treatment. Cancer patients who exercise regularly during and after treatment can expect fewer side-effects from treatment, including less fatigue, fewer problems with concentration and memory, and better overall fitness and health. Patients who exercise are less likely to experience a return of cancer in the future and are more likely to live longer, healthier lives.

You should try to walk at least six hours a week at an average pace (about 1 mile per 20 minutes).

Even minimum exercise, like walking one hour per week, can improve the health of cancer patients who have completed treatment, compared to cancer patients who do not exercise at all. The benefits from exercise can be seen in all cancer patients, regardless of whether or not they exercised regularly before they were diagnosed with cancer. It’s never too late to begin to exercise and improve your health!

References

  1. Barbara Sternfeld, E.W., Charles P. Quesenberry, Jr., Adrienne L. Castillo, Marilyn Kwan, Martha L. Slattery, and Bette J. Caan, Physical activity and risk of recurrence and mortality in breast cancer survivors: Findings from the LACE study. Cancer Epidemiology, Biomarkers & Prevention, 2009. 18(1): p. 87-95.
  2. Daniel Y T Fong, J.W.C.H., Bryant P H Hui, Antoinette M Lee, Duncan J Macfarlane, Sharron S K Leung, Ester Cerin, Wynnie Y Y Chan, Ivy P F Leung, Sharon H S Lam, Aliki J Taylor, Kar-keung Cheng, Physical activity for cancer survivors: Meta analysis of randomised controlled trials. British Medical Journal, 2012. 344(70).
  3. Jeffrey A. Meyerhardt, D.H., Donna Niedzwiecki, Donna Hollis, Leonard B. Satz, Robert J. Mayer, James Thomas, Heidi Nelson, Renaud Whittom, Alexander Hantel, Richard L. Schilsky, and Charles S. Fuchs, Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: Findings from CALGB 89803. Journal of Clinical Oncology, 2006. 24(22): p. 3635-3541.
  4. Jeffrey A. Meyerhardt, E.L.G., Michelle D. Holmes, Andrew T. Chan, Jennifer A. Chan, Graham A. Colditz, and Charles S. Fuchs, Physical activity and survival after colorectal cancer diagnosis. Journal of Clinical Oncology, 2006. 24(22): p. 3527-3534.
  5. LK Sprod, S.M., W Demark-Wahnefried, MC Janelsins, LJ Peppone, GR Morrow, R Lord, H Gross, KM Mustian, Exercise and cancer treatment symptoms in 408 newly diagnosed older cancer patients. Journal of Geriatric Oncology, 2012. 3(2): p. 90-97.
  6. Margaret L. McNeely, K.L.C., Brian H. Rowe, Terry P. Klassen, John R. Mackey, Kerry S. Courneya, Effects of exercise on breast cancer patients and survivors: A systematic review and meta analysis. Canadian Medical Association Journal, 2006. 175(1): p. 34-41.
  7. Michelle D. Holmes, W.Y.C., Diane Fesknich, Candyce H. Kroenke, Graham A. Colditz, Physical activity and survival after breast cancer diagnosis. Journal of the American Medical Association, 2005. 293(20): p. 2479-2486.
  8. Rosalind R. Spence, K.C.H., Wendy J. Brown, Exercise and cancer rehabilitation: A systematic review. Cancer Treatment Reviews, 2009. 36: p. 185-194.
  9. Ruud Knols, N.K.A., Daniel Uebelhart, Jaap Fransen, and Geert Aufdemkampe, Physical exercise in cancer patients during and after medical treatment: A systematic review of randomized and controlled clinical trials. Journal of Clinical Oncology, 2005. 23(16): p. 3830-3842.
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