Category Archives: Treatment & Management

Exercise, Reducing Your Likelihood of Cancer, and Life After Treatment

Diet, Habits, & Other Behaviors, Quality Of LIfe, Treatment & Management

Farmin Shahabuddin, MPH, Cancer Prevention and Treatment Fund

Most people know that exercise is good for your heart and overall health. What many people do not know is that exercise may also reduce the likelihood of developing cancer and help cancer survivors live longer after treatment ends. Whether you have never had cancer or finished treatment and want to lower your chances of it coming back, physical activity is one of the most important things you can do.

Can Exercise Reduce Your Likelihood of Getting Cancer?

Research shows that people who are physically active are less likely to develop many types of cancer. A study of 1.4 million people found that those who exercised regularly were less likely to develop 13 types of cancer, including breast, colon, liver, kidney, stomach, and bladder cancer.1

A 2025 study tracked activity of more than 85,000 adults using wearable devices. The most active people were about 26% less likely to develop cancer than the least active.2 Even light activities such as errands and household chores made a difference. Taking more steps each day also helped. For example, people who took 9,000 steps a day were about 16% less likely to develop cancer than those who took 5,000.

Cancer usually is growing before it is diagnosed, and being active in the year before a diagnosis is also beneficial according to a 2025 study of more than 28,000 people with stage 1 cancers who had activity records for the year before their diagnosis.3 Those who exercised as little as 60 minutes per week were 27% less likely to have their cancer progress to a more advanced stage  and were 47% less likely to die, compared to those who were not active.3 Five years after diagnosis, about 91% of the most active people were still alive, compared to about 84% of those who had not been active.3

Why Does Exercise Lower the Likelihood of Cancer?

Exercise may lower the likelihood of cancer in several ways. It lowers hormones such as estrogen and insulin that can encourage cancer cells to grow.4,5,6 It helps the immune system spot and destroy abnormal cells.6 It also helps people maintain a healthy weight, which matters because being overweight contributes to an estimated 14% to 20% of cancer deaths in the U.S.6 Exercise also helps move food through the digestive system faster, which reduces the time that the lining of the intestines is exposed to potentially harmful substances.

Scientists are still learning more about why exercise can prevent cancer. A 2026 lab study found that even 10 minutes of exercise changed the blood in ways that helped colon cancer cells repair damaged DNA.7 While more research is needed, this adds to the evidence that exercise sends signals throughout the body that may help fight cancer.

How Much Exercise Do You Need?

The U.S Department of Health and Human Services physical activity guidelines recommend that all adults get 150 to 300 minutes per week of moderate activity such as brisk walking, or 75 to 150 minutes of vigorous activity such as running. Adults should also do muscle strengthening exercises at least 2 days per week.6 These guidelines are not specific to cancer prevention. Of course, any amount of physical activity is better than none. The key is to start where you are and gradually build up.

Exercise for Cancer Survivors After Treatment

Exercise does not just matter before a cancer diagnosis. It can also be helpful during cancer treatment (see this link for our article on that). Regular exercise after you have finished cancer treatment, can also help you live longer and feel better, with fewer side effects from treatment, including less fatigue.8,9 Survivors who exercise regularly are less likely to die from cancer and are more likely to live longer than those who do not exercise.[10-14] It does not matter if you were fit before you got diagnosed. What matters is that you start exercising now.

Since exercise improves the immune system, cancer survivors who exercise regularly lower their chances of the cancer returning. A large 2026 study followed more than 17,000 cancer survivors for an average of about 11 years. 15 The survivors had bladder, endometrial, lung, oral cavity, ovarian, or rectal cancer. The activities studied included brisk walking, cycling, and swimming.      The study compared survivors at different activity levels to those who did no physical activity at all. It found that even small amounts of exercise that were considerably less than the recommended physical activity guidelines, were linked to longer survival. Bladder cancer survivors who did relatively low levels of exercise were 33% less likely to die from their cancer, endometrial cancer survivors were 38% less likely, and lung cancer survivors were 44% less likely, compared to those who did no physical activity.

Survivors who met or exceeded the recommended guidelines saw even greater benefits. Endometrial cancer survivors who met the guidelines were 60% less likely to die from their cancer, and lung cancer survivors were 62% less likely, compared to those who did no exercise. Oral and rectal cancer survivors who doubled the recommended amount of activity were 61% less likely to die of oral cancer and 43% less likely to die of rectal cancer.

Sitting Less Matters Too

Along with exercising more, sitting less can also make a difference. A 2022 study followed over 1,500 cancer survivors ages 40 and over for an average of 4.5 years. Survivors who exercised at least 150 minutes per week were less likely to die than those who did not exercise. 16  Survivors who sat for more than 8 hours a day were also more likely to die than those who sat less than 4 hours per day. Those who both did not exercise and sat more than 8 hours per day had the worst outcomes of all.”

A 2020 study followed 8,000 adults aged 45 and older for about 5 years. People who sat the most were more likely to die from cancer than those who sat the least.17 Replacing just 30 minutes of sitting per day with moderate to vigorous activity was linked to a 31% lower chance of dying from cancer. Even replacing that sitting time with light activity like standing or gentle walking was linked to an 8% lower chance of dying.

What Kind of Exercise Should I Do?

Aerobic activity of light to moderate intensity was the most common type of exercise studied in cancer patients. Combining aerobic exercise with walking and resistance training, such as lifting weights or resistance bands, led to greater health benefits than aerobic activity alone.11,13 Lifting weights refers to any weights, even just a few pounds. Do not assume you need barbells and large muscles.

Walking is the easiest way to start. The greatest benefit comes from walking at an average speed, about a 20-minute mile, for 3 to 5 hours per week.8 Even walking just 1 hour per week showed improvements over no physical activity at all.

The most important thing is to make it a habit. Start small by taking the stairs instead of the elevator or walking after dinner each evening. It is better to start small and keep it up than to try to do too much and give up. Do not miss the chance to get at least some benefit from this easy, free way to fight cancer.

The Bottom Line

Exercise is a powerful, free tool. For people who have never had cancer, regular physical activity is linked to a lower likelihood of developing many types of cancer. For survivors who have finished treatment, exercise lowers the chances of cancer coming back and helps people live longer. Being active before a diagnosis also improves outcomes if cancer does occur. Even if you were not active before, starting to exercise afterward still helps. Try to walk 3 to 5 hours a week at an average pace, about 1 mile per 20 minutes. Try to sit less and move more throughout the day. Even a little exercise is better than none. It is never too late to begin.

To read about the benefits of exercise during cancer treatment, click here: https://stopcancerfund.org/pz-diet-habits-behaviors/exercise-cancer-treatment-benefits/

References

  1. Moore, S. C., Lee, I. M., Weiderpass, E., Campbell, P. T., Sampson, J. N., Kitahara, C. M., Keadle, S. K., Arem, H., Berrington de Gonzalez, A., Hartge, P., Adami, H. O., Blair, C. K., Borch, K. B., Boyd, E., Check, D. P., Fournier, A., Freedman, N. D., Gunter, M., Johansson, M., & Patel, A. V. (2016). Association of leisure-time physical activity with risk of 26 types of cancer in 1.44 million adults. JAMA Internal Medicine, 176(6), 816–825. https://doi.org/10.1001/jamainternmed.2016.1548
  2. National Cancer Institute. (2025, March 26). Cancer risk decreases with more physical activity [Press release]. https://www.cancer.gov/news-events/press-releases/2025/light-intensity-physical-activity-cancer-risk
  3. Patricios, J., Constantinou, D., Goff, P., Kolbe-Alexander, T., Capostagno, B., Gossage, S., & van Rensburg, D. C. J. (2025). Regular physical activity before cancer diagnosis may lower progression and death risks. British Journal of Sports Medicine. https://doi.org/10.1136/bjsports-2024-108699
  4. Key, T., Appleby, P., Barnes, I., & Reeves, G. (2002). Endogenous sex hormones and breast cancer in postmenopausal women: Reanalysis of nine prospective studies. Journal of the National Cancer Institute, 94(8), 606–616. https://doi.org/10.1093/jnci/94.8.606
  5. McTiernan, A., Tworoger, S. S., Ulrich, C. M., Yasui, Y., Irwin, M. L., Rajan, K. B., Sorensen, B., Rudolph, R. E., Bowen, D., Stanczyk, F. Z., Potter, J. D., & Schwartz, R. S. (2004). Effect of exercise on serum estrogens in postmenopausal women: A 12-month randomized clinical trial. Cancer Research, 64(8), 2923–2928. https://doi.org/10.1158/0008-5472.CAN-03-3393
  6. National Cancer Institute. (n.d.). Physical activity and cancer fact sheet. U.S. Department of Health and Human Services. https://www.cancer.gov/about-cancer/causes-prevention/risk/obesity/physical-activity-fact-sheet
  7. Orange, S. T., Dodd, E., Nath, S., Bowden, H., Jordan, A. R., Tweddle, H., Hedley, A., Chukwuma, I., Hickson, I., & Sharma Saha, S. (2025). Exercise serum promotes DNA damage repair and remodels gene expression in colon cancer cells. International Journal of Cancer. https://doi.org/10.1002/ijc.70271
  8. Holmes, M. D., Chen, W. Y., Feskanich, D., Kroenke, C. H., & Colditz, G. A. (2005). Physical activity and survival after breast cancer diagnosis. JAMA, 293(20), 2479–2486. https://doi.org/10.1001/jama.293.20.2479
  9. McNeely, M. L., Campbell, K. L., Rowe, B. H., Klassen, T. P., Mackey, J. R., & Courneya, K. S. (2006). Effects of exercise on breast cancer patients and survivors: A systematic review and meta-analysis. Canadian Medical Association Journal, 175(1), 34–41. https://doi.org/10.1503/cmaj.051073
  10. Meyerhardt, J. A., Heseltine, D., Niedzwiecki, D., Hollis, D., Saltz, L. B., Mayer, R. J., Thomas, J., Nelson, H., Whittom, R., Hantel, A., Schilsky, R. L., & Fuchs, C. S. (2006). Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: Findings from CALGB 89803. Journal of Clinical Oncology, 24(22), 3535–3541. https://doi.org/10.1200/JCO.2006.06.0863
  11. Fong, D. Y. T., Ho, J. W. C., Hui, B. P. H., Lee, A. M., Macfarlane, D. J., Leung, S. S. K., Cerin, E., Chan, W. Y. Y., Leung, I. P. F., Lam, S. H. S., Taylor, A. J., & Cheng, K. K. (2012). Physical activity for cancer survivors: Meta-analysis of randomized controlled trials. BMJ, 344, e70. https://doi.org/10.1136/bmj.e70
  12. Meyerhardt, J. A., Giovannucci, E. L., Holmes, M. D., Chan, A. T., Chan, J. A., Colditz, G. A., & Fuchs, C. S. (2006). Physical activity and survival after colorectal cancer diagnosis. Journal of Clinical Oncology, 24(22), 3527–3534. https://doi.org/10.1200/JCO.2006.06.0855
  13. Spence, R. R., Heesch, K. C., & Brown, W. J. (2010). Exercise and cancer rehabilitation: A systematic review. Cancer Treatment Reviews, 36(2), 185–194. https://doi.org/10.1016/j.ctrv.2009.11.003
  14. Sternfeld, B., Weltzien, E., Quesenberry, C. P., Jr., Castillo, A. L., Kwan, M., Slattery, M. L., & Caan, B. J. (2009). Physical activity and risk of recurrence and mortality in breast cancer survivors: Findings from the LACE study. Cancer Epidemiology, Biomarkers & Prevention, 18(1), 87–95. https://doi.org/10.1158/1055-9965.EPI-08-0595
  15. Rees-Punia, E., Teras, L. R., Newton, C. C., Gapstur, S. M., Patel, A. V., Gaudet, M. M., Islami, F., Campbell, P. T., & McCullough, M. L. (2026). Leisure-time physical activity and cancer mortality among cancer survivors. JAMA Network Open, 9(2), e2556971. https://doi.org/10.1001/jamanetworkopen.2025.56971
  16. Cao, C., Friedenreich, C. M., & Yang, L. (2022). Association of daily sitting time and leisure-time physical activity with survival among US cancer survivors. JAMA Oncology, 8(3), 395–403. https://doi.org/10.1001/jamaoncol.2021.6590
  17. Gilchrist, S. C., Howard, V. J., Akinyemiju, T., Judd, S. E., Cushman, M., Hooker, S. P., & Diaz, K. M. (2020). Association of sedentary behavior with cancer mortality in middle-aged and older US adults. JAMA Oncology, 6(8), 1210–1217. https://doi.org/10.1001/jamaoncol.2020.2045

The Benefits of Exercise During Cancer Treatment

Diet, Habits, & Other Behaviors, Treatment & Management

Farmin Shahabuddin, MPH, Cancer Prevention and Treatment Fund

You may have heard that regular exercise can reduce your likelihood of developing cancer, but did you know it is also good for cancer patients who are going through treatment?

Is Exercise Good for Everyone with Cancer?

If you or someone you love is going through cancer treatment, you may wonder whether exercise is safe or even possible. The answer, according to a growing body of research, is yes. In 2022, the American Society of Clinical Oncology (ASCO) formally recommended that cancer doctors encourage their patients to do regular physical activity during treatment.1

Until recently, most of the research on exercise and cancer focused on patients with breast or colon cancer. However, newer studies have shown that exercise benefits people with many different types of cancer.2,3 A large 2025 review combined data from 151 studies involving nearly 1.5 million cancer patients with breast, prostate, lung, colorectal, and skin cancers. Across all these cancer types, patients who were physically active were less likely to die from their cancer than those who were not active.4

Of course, exercising during treatment can feel difficult. Cancer and its treatments can cause fatigue, pain, and other symptoms that make physical activity challenging. But exercise does not have to be intense to be helpful. Even gentle stretching, short walks, or light movement throughout the day can make a difference. A 2022 review of 15 clinical trials found that even patients with advanced cancers who participated in exercise programs at a low level of effort saw improvements in fatigue, independence, quality of life, and sleep.5

How Does Exercise Help Cancer Patients?

You may be wondering why exercise helps during cancer treatment. Researchers have found that it works in several ways. Exercise lowers levels of certain hormones, such as estrogen, that can fuel the growth of some cancers, and it reduces inflammation throughout the body, which is believed to play a role in how cancer develops and spreads.⁶ A 2026 clinical trial also found that patients who followed a simple home-based walking and resistance band program had a healthier immune response during chemotherapy, which may explain why they experienced fewer side effects like mental fatigue and difficulty thinking.⁷

Physical Benefits of Exercise During Treatment

The ASCO review found that exercise during cancer treatment led to improvements in heart and lung fitness, muscle strength, and energy levels.1 Other studies have found that cancer patients who exercise during treatment have lower body fat, lower blood pressure, and stronger bones, which means fewer fractures.8,9 Patients who exercised also reported less nausea and better sleep.8 The most commonly reported improvement was reduced fatigue, which is one of the most challenging side effects of cancer treatment.8,9

Beyond helping reduce side effects, exercise may also help cancer patients live longer. A 2025 review that followed nearly 1.5 million cancer patients for 6 months to several years after their diagnosis found that those who were physically active were less likely to die from their cancer than those who were not active. The benefit was seen across several types of cancer. Breast cancer patients who exercised were 31% less likely to die from their cancer, followed by colorectal cancer patients at 29%, prostate cancer patients at 27%, and lung cancer patients at 24%, compared to patients with those cancers who did not exercise.4 

Mental and Emotional Benefits

Cancer patients who exercised during treatment also reported improved mental and emotional well-being.2 They frequently reported a higher quality of life, less anxiety, and felt more motivated.8 Cancer patients over the age of 80 who exercised regularly during their weeks or months of treatment reported fewer memory problems.10 A review of studies that was published in 2025 noted that exercise during treatment can help improve emotional health, reduce symptoms of depression, and support overall psychological well-being across many cancer types.6

Exercise May Help Relieve “Chemo Brain”

“Chemo brain” (also known as chemo fog) is a common side effect of chemotherapy that affects many cancer patients receiving chemotherapy. Common symptoms include having trouble learning new tasks, remembering names, paying attention, and concentrating. Chemo brain can be upsetting and make everyday life much harder.

Fortunately, research suggests that exercise can help. A 2021 study found that patients who averaged  2.5 to 5 hours of moderate exercise (like brisk walking) per week or 1.5 to 2.5 hours of vigorous exercise (such as running) per week before, during, and after chemotherapy for breast cancer were less likely to report chemo brain symptoms than patients who did not exercise.11

A 2026 clinical trial tested a home-based exercise program in 687 cancer patients at 20 cancer centers across the United States.7 All patients were about to start chemotherapy. They were randomly assigned to either follow the exercise program or receive their usual care. The exercise program included daily walking and resistance band exercises at a light to moderate level of effort for 6 weeks. Before starting chemotherapy, patients in both groups were walking about 4,000 to 5,000 steps a day from their normal daily activities. After 6 weeks, patients who did not follow the exercise program were walking about half as many steps, while patients on the exercise program kept up their usual amount of walking.7 

Among patients receiving chemotherapy in 2-week cycles, those on the exercise program reported less overall cognitive impairment and less mental fatigue compared to those who did not exercise.7 In the exercise group, 92% of patients said they had a more positive view of exercise after the study, and 97% said they would recommend the program to other patients receiving chemotherapy.⁷

What Kind of Exercise Should I Do?

Light to moderate physical activity was the most common type of exercise studied in cancer patients.1,2 Combining activities that get your heart rate up, like walking or swimming, with activities that build muscle strength, like using light weights or resistance bands, led to greater health benefits than either type alone.2,9 The 2026 clinical trial described above found that a simple program of daily walking plus resistance band exercises, done at home without a gym or special equipment, was enough to make a meaningful difference during chemotherapy.7 Walking is the easiest way to start. Studies show that walking 3 to 5 hours per week provides the greatest benefit, but even 1 hour of walking per week showed improvements over no activity at all.3

The most important thing is to make exercise a habit. Start small by taking the stairs instead of the elevator or taking a walk during the day if you can. It is better to start small and keep it up than to try to do too much and give up. Do not miss the chance to get at least some benefit from this easy, free way to fight cancer.

The Bottom Line

Cancer patients who engage in even light or moderate physical activity regularly during treatment can expect fewer side effects, including less fatigue, fewer problems with concentration and memory, and better overall fitness and health. A home-based program of walking and resistance band exercises has been shown to reduce chemo brain and mental fatigue during chemotherapy. Exercise benefits people with all types of cancer, including those with advanced disease. Even a little exercise is better than none, and it is never too late to begin.

References

  1. Ligibel, J. A., Bohlke, K., May, A. M., Clinton, S. K., Demark-Wahnefried, W., Gilchrist, S. C., Irwin, M. L., Late, M., Mansfield, S., Marshall, T. F., Meyerhardt, J. A., Thomson, C. A., Wood, W. A., & Alfano, C. M. (2022). Exercise, diet, and weight management during cancer treatment: ASCO guideline. Journal of Clinical Oncology, 40(22), 2491–2507. https://doi.org/10.1200/JCO.22.00687
  2. Fong, D. Y. T., Ho, J. W. C., Hui, B. P. H., Lee, A. M., Macfarlane, D. J., Leung, S. S. K., Cerin, E., Chan, W. Y. Y., Leung, I. P. F., Lam, S. H. S., Taylor, A. J., & Cheng, K.-K. (2012). Physical activity for cancer survivors: Meta-analysis of randomised controlled trials. BMJ, 344, e70. https://doi.org/10.1136/bmj.e70
  3. Holmes, M. D., Chen, W. Y., Feskanich, D., Kroenke, C. H., & Colditz, G. A. (2005). Physical activity and survival after breast cancer diagnosis. JAMA, 293(20), 2479–2486. https://doi.org/10.1001/jama.293.20.2479
  4. Ungvari, Z., Fekete, M., Varga, P., Munkácsy, G., Fekete, J. T., Lehoczki, A., Buda, A., Kiss, C., Ungvari, A., & Győrffy, B. (2025). Exercise and survival benefit in cancer patients: Evidence from a comprehensive meta-analysis. GeroScience, 47(3), 5235–5255. https://doi.org/10.1007/s11357-025-01647-0
  5. Rodríguez-Cañamero, S., Cobo-Cuenca, A. I., Carmona-Torres, J. M., Pozuelo-Carrascosa, D. P., Santacruz-Salas, E., Rabanales-Sotos, J. A., Cuesta-Mateos, T., & Laredo-Aguilera, J. A. (2022). Impact of physical exercise in advanced-stage cancer patients: Systematic review and meta-analysis. Cancer Medicine, 11(19), 3714–3727. https://doi.org/10.1002/cam4.4746
  6. Albini, A., La Vecchia, C., Magnoni, F., Garrone, O., Morelli, D., Janssens, J. Ph., Maskens, A., Rennert, G., Galimberti, V., & Corso, G. (2025). Physical activity and exercise health benefits: Cancer prevention, interception, and survival. European Journal of Cancer Prevention, 34(1), 24–39. https://doi.org/10.1097/CEJ.0000000000000898
  7. Mustian, K. M., Lin, P.-J., Chakrabarti, A., Mattick, L. J., Samuel, S., Gada, U., Altman, B. J., Vertino, P. M., Kleckner, A. S., Kleckner, I. R., Guido, J. J., Li, C.-S., Peppone, L. J., Kamen, C. S., Loh, K. P., Rousey, S. R., Onitilo, A. A., Melnik, M., Mohile, S. G., & Janelsins, M. C. (2026). Effects of exercise on cognitive impairment in patients receiving chemotherapy: A multicenter phase III randomized controlled trial. Journal of the National Comprehensive Cancer Network, 24(3), 91–99. https://doi.org/10.6004/jnccn.2025.7118
  8. Knols, R., Aaronson, N. K., Uebelhart, D., Fransen, J., & Aufdemkampe, G. (2005). Physical exercise in cancer patients during and after medical treatment: A systematic review of randomized and controlled clinical trials. Journal of Clinical Oncology, 23(16), 3830–3842. https://doi.org/10.1200/JCO.2005.02.148
  9. Spence, R. R., Heesch, K. C., & Brown, W. J. (2010). Exercise and cancer rehabilitation: A systematic review. Cancer Treatment Reviews, 36(2), 185–194. https://doi.org/10.1016/j.ctrv.2009.11.003
  10. Sprod, L. K., Mohile, S. G., Demark-Wahnefried, W., Janelsins, M. C., Peppone, L. J., Morrow, G. R., Lord, R., Gross, H., & Mustian, K. M. (2012). Exercise and cancer treatment symptoms in 408 newly diagnosed older cancer patients. Journal of Geriatric Oncology, 3(2), 90–97. https://doi.org/10.1016/j.jgo.2012.01.002
  11. Salerno, E. A., Culakova, E., Kleckner, A. S., Heckler, C. E., Lin, P.-J., Matthews, C. E., Conlin, A., Weiselberg, L., Mitchell, J., Mustian, K. M., & Janelsins, M. C. (2021). Physical activity patterns and relationships with cognitive function in patients with breast cancer before, during, and after chemotherapy in a prospective, nationwide study. Journal of Clinical Oncology, 39(29), 3283–3292. https://doi.org/10.1200/JCO.20.03514

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