Tag Archives: breast cancer

What Genentech is doing to fix biotech’s diversity problem

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

Fortune Editors, Fortune: April 7, 2021

There’s a big problem with clinical trials: a lack of diversity. And that issue is ultimately detrimental to countless people’s lives and health.

Take, for example, breast cancer research. For a long time, the thinking in the health care world was that Black women didn’t develop breast cancer as often as white women, but when they did, they were more likely to die because of it.

“There was this assumption that it was an issue of access to care, the quality of care,” says Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank that analyzes the latest research and helps consumers and organizations put that information to work. But “if you looked at the research, you saw that the original major studies of breast cancer treatment were done on white women.”

That meant the research featured fewer women with triple-negative breast cancer, which Black women develop more often than white women. “Because [women with triple-negative breast cancer] weren’t studied,” Zuckerman continues, “[the researchers] didn’t realize that the treatments that they were studying would not work on those types of cancer.”

Zuckerman talks with Fortune’s Ellen McGirt on this week’s episode of Leadership Next, a podcast about the changing rules of business leadership. Also on the episode with McGirt and cohost Alan Murray is Alexander Hardy, who became CEO of biotech company Genentech two years ago.

Hardy has made it clear that he’s committed to boosting diversity within the biotech world and in clinical trials, and he was already doing so before the pandemic. But COVID-19 crystallized some of the issues in the U.S.

[….]

During the show, Hardy also discusses the ways the COVID-19 pandemic has changed the biotech industry, and how those changes could spill over into research on diseases such as Alzheimer’s, ALS, and cancer.

To read the entire article and listen to the podcast, click here.

FDA blasts Merck’s Keytruda data for new breast cancer indication

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

Ed Silverman, Stat News: February 5, 2021

Merck (MRK5 ) may have readily turned its Keytruda cancer drug into a medical and financial juggernaut, but its bid to win regulatory approval for at least one additional use may not come so easily, judging by documents from the Food and Drug Administration. The drug maker wants to sell the medicine to combat high-risk, early-stage triple-negative breast cancer along with chemotherapy before surgery, and then by itself after surgery.

[…]

Given the FDA review, though, the likelihood of a recommendation next week is not high, according to Ira Loss of Washington Analysis, who tracks pharmaceutical regulatory and legislative matters for investors. “The agency believes, and we think the (FDA expert) committee will agree, that further data from the trial are needed to make an informed decision,” he wrote to investors.

Another FDA watcher was even more blunt. “It’s important to have good treatment because this disproportionately occurs among Black women,” said Diana Zuckerman, who heads the National Center for Health Research, a nonprofit think tank. “But they’re saying this may not be needed, may not work and may be harmful – that’s pretty damning. And there are some real safety issues that can have terrible impact on patients… This is one of the most negative reviews I’ve ever seen.”

[….]

Read the full article here

Statement on Keytruda for Early Stage Triple Negative Breast Cancer

Breast Cancer, Breast Cancer, Testimony & Briefings, , ,

February 9, 2021

The National Center for Health Research is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products.  We don’t accept funding from companies that make those products, so we have no conflicts of interest.  We welcome the opportunity to provide our views on Merck’s application for approval of Keytruda for the indication of high-risk early stage triple negative breast cancer.

Triple negative breast cancer has a lower survival rate than other breast cancers.  However, chemotherapy clearly improves 5-year survival.  Patients need additional treatment options but the bottom line for patients is that FDA should not approve an indication that is not proven to have clinically meaningful benefits, especially when the treatment has clear risks.   

The first issue to address is whether there is evidence that immune checkpoint inhibitors (ICIs) are effective for TNBC.  We agree with FDA scientists that “there is still uncertainty regarding ICIs for TNBC” based on the results from several clinical trials.

  • KEYNOTE-119 failed to meet its primary OS endpoint. 
  • KEYNOTE-355 has not met its OS endpoint. 
  • IMpassion130: clinical benefits need to be confirmed
  • IMpassion131 interim OS results favored control group

The second major issue pertains to pCR data in the study.  The results indicate only 7.5% improvement in pCRs at IA3 (the most recent interim analysis), which the FDA scientists point out may not be clinically meaningful even if statistically significant.  We agree.  The problem is that it is impossible to determine how this slight improvement would affect overall survival, and even if it does, how much neoadjuvant and adjuvant use each contribute to any benefit. 

FDA scientists were clear to the sponsor that there were concerns with their study design and that the application for approval was premature since the study was not yet completed.  The agency made it clear that that the event free survival (EFS) study results were not statistically significant, not clinically meaningful, and did not show a “stable trend.” 

FDA reviewers are clear that data on overall survival “are too immature to provide a conclusive interpretation regarding the difference in OS between treatment arms.” 

What about safety?

At IA3 (the most recent interim analysis), there were 96 deaths, which FDA points out “accounts for only 32% of the events needed for the final analysis. Therefore, the OS estimate may be unreliable, and the treatment effect size reported is subject to uncertainty.”

It is notable that the study included patient-reported outcomes (PROs), but unfortunately, KEYNOTE-522 was not designed to compare differences in PROs (symptoms, side effects, health-related quality of life), nor were these patient-reported endpoints prospectively identified and statistically tested. 

PRO assessments should have been more frequent, both for neoadjuvant and adjuvant treatments

Since many high-risk, early-stage TNBC patients will be cured with standard therapy, the key issue is whether this drug has benefits that outweigh the risks.  The benefits are unclear.  Therefore, the evidence of the drug’s “added toxicity” is worrisome.  FDA scientists concluded that “Some of these toxicities may be irreversible or require lifelong medication in patients cured of their breast cancer.

Although the sponsor counted 2 deaths due to immune-mediated adverse events, the FDA counted 4.  Either way, these deaths must be considered worrisome given the lack of clear evidence of a meaningful benefit.  And, there are many other serious adverse events in addition to the small number of deaths.   All-grade and grade ≥3 immune-mediated AEs and infusion reactions occurred more frequently in Keytruda patients compared to placebo:    43% vs. 22% for all grade AEs, and 15% vs. 2% for high grade AEs.  In fact, 10% of Keytruda patients had immune-mediated AEs and infusion reactions leading to hospitalization compared to 1% of placebo.  These included the following relatively high number of adverse events:

  • Infusion reactions (18%), 
  • Hypothyroidism (15%), 
  • Severe skin reactions (6%)
  • Hyperthyroidism (5%), adrenal insufficiency (3%), pneumonitis (2%), and thyroiditis (2%).

It is important to note that these adverse events were not resolved at the last assessment in the study for 19% of Keytruda patients.   It is also important to note that 16% of the Keytruda patients initiated thyroid hormone replacement during the study.

In summary, we agree with FDA scientists that the deaths are “particularly concerning in this curative disease setting.”

  • “All grade and grade ≥3 immune-mediated AEs were increased in [Keytruda] patients.’
  • Some “may be severe or lifelong.” 
  • The adjuvant treatment has fewer adverse events but “has not demonstrated a significant effect on any efficacy endpoint, and may be adding risk without benefit.”

Based on our analysis, we agree with the overall conclusions made by FDA scientists: 

  1. Neoadjuvant Keytruda “confers only a small absolute improvement in pCR rate of questionable clinical meaningfulness.”
  2. Event-free survival and overall survival are “immature and unreliable.”
  3.  “The design and results of KEYNOTE-522 do not currently support a role for adjuvant [Keytruda].”
  4. “Supportive data of clinical benefit … are lacking.” 
  5. Adding Keytruda “is associated with increased toxicity … which may be severe, irreversible, and/or require life-long medication in potentially curable and otherwise healthy patients.” 

In conclusion, the FDA and the medical community do patients no favors to approve a treatment that is not proven to benefit them and at the same time is proven to cause harm for a substantial percentage of patients.  The studies should be continued to determine whether the benefit of adding Keytruda to other treatments outweigh the risks.

 

This written statement was submitted to the FDA on February 8, 2021 and an oral version with PowerPoint slides was presented at the FDA Advisory Committee meeting on February 9, 2021.

We are pleased that the FDA Advisory Committee agreed with our views and voted 10-0 on February 9 in favor of deferring an FDA regulatory decision until the study is completed.

We can’t ever go to the doctor with our guard down’: Why Black women are 40% more likely to die of breast cancer

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

Maria Aspan: Fortune Magazine June 30, 2020

Racism kills Black Americans, and has long before COVID-19. But its toxic combination with sexism has particularly vast and disastrous consequences for the health of Black women.

While Black people in the U.S. are dying from the COVID-19 pandemic at a disproportionately high rate, this national health crisis underlines an even grimmer status quo: Black Americans are also much more likely to die from far more common and longstanding health problems every day. Black women are at particularly high risk of heart disease and strokes, and are at least three times as likely to die as a result of childbirth as white women, contributing to the overall alarmingly high maternal mortality rate in the United States.

Then there are the shocking statistics around breast cancer, which affects one in every eight women and is the most common non-skin cancer affecting women. Black women are less likely to develop it—but 40% more likely to die from it than white women, according to the U.S. Centers for Disease Control and Prevention.

The reasons behind this awful disparity are wide-ranging, and include systemic problems both within healthcare and far beyond it. Now the disproportionately high toll of COVID-19 on the Black population in the U.S. and the simultaneous national reckoning over racism are drawing new attention to the racial inequities hurting Black women—and amplifying the voices of doctors, scientists, and public health experts who have long sounded the alarm.

[…]

Women of all races could be legally omitted from government-funded clinical trials before 1993, and are still often under-represented in most research studies of conditions that affect them. Pregnancy and menstrual cycles are thought to “complicate” the results of trials that are mostly conducted on white men, who are seen as the “norm.”

This can obviously backfire. In 2013, the U.S. Food and Drug Administration sharply cut its recommended dosages of Ambien for women, after years of complaints about grogginess and falling asleep while driving, when followup tests showed that women metabolized the active ingredient in sleeping aids much more slowly than men.

When it comes to clinical trials funded by pharmaceutical companies, “the FDA encourages but does not require diversity in clinical trials,” says Diana Zuckerman, a scientist and president of the National Center for Health Research. “Worse, the agency frequently approves drugs and devices for all adults, even if they were primarily studied on white adults.”

One treatment that the FDA approved in April, for the “triple-negative” type of breast cancer that disproportionately affects Black women, was approved after being tested on 108 patients. Eight of them, or 7%, were Black. Another breast-cancer treatment was approved last year after being tested on 234 patients; seven of them, or 3%, were Black.

[…]

Read the full article here

Hormonal Therapy for Pre-menopausal Women with Early Stage Breast Cancer

Breast Cancer,
Anna Mazzucco, PhD, Brandel France de Bravo, MPH, Caroline Halsted, Danielle Shapiro, MD, MPH, and Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund

Breast cancer is the most common type of cancer in women around the world, and the second leading cause of cancer deaths among U.S. women. The survival rate for early-stage breast cancer is very high.  For women whose breast cancer is diagnosed before it has spread, the 5-year survival rate is 99%.  For women whose breast cancer has spread to the lymph nodes, the 5-year survival rate is 85%.

Women who are diagnosed with early-stage breast cancer almost always undergo surgery to remove the cancer (either lumpectomy/partial mastectomy or mastectomy). Most will also choose at least one other treatment in addition to surgery:

1) If they have a lumpectomy, they often undergo radiation either to shrink the tumor before surgery or to kill any cancer cells in the breast that were missed during surgery.

2) If their cancer is estrogen receptor positive (about 84% of breast cancers), many women will try to take hormonal therapy for at least five years after surgery to lower the chance of cancer in either breast in the future. For pre-menopausal women, the standard treatment is tamoxifen.[1]

Types of Hormonal Therapies for Early Stage Breast Cancer

Hormonal therapy (also called endocrine therapy or anti-estrogen therapy) is the opposite of the type of hormones women sometimes take to reduce the symptoms of menopause. It lowers your estrogen levels instead of increasing them.[1]

Hormonal therapy is recommended for most women with breast cancer, and sometimes it is taken by women who have not been diagnosed with breast cancer but are at high risk for it based on their genes or family history. When hormonal therapy is used before breast cancer develops, it is called “primary prevention” or “chemoprevention.” Chemoprevention is completely different from the drugs used in chemotherapy to treat breast cancer.[1] See our article on breast cancer prevention.

How Does Hormonal Therapy Work?

Tamoxifen is a selective estrogen receptor modulator (SERM), which means it blocks estrogen in breast tissue, but promotes it in other tissues (such as in bone and the inner lining of the uterus). Tamoxifen is only effective in breast cancers that are estrogen receptor positive.[3,4]

How Effective Are the Treatments?

The effectiveness of treatments is often reported in terms of risk or risk reduction. Risk is another word for chance–what is the chance that something will happen, such as cancer returning or the patient dying? Risk can be reported in terms of relative risk or absolute risk. Let’s use simple numbers to show what we mean: In a study, 100 women are given a new drug and 100 other women are given an older drug.  What if the study showed that 4 patients (4%) taking the older drug became nauseous compared to only 2 patients (2%) taking the new drug.  The relative risk of patients getting nauseous is 50% lower for patients taking the new drug, and that sounds impressive. But the absolute difference is only 2% — when you subtract 2% taking the new drug compared to 4% taking the old drug.

Based on the statistics, the odds may favor taking the new drug. But if the new drug costs much more or has other side effects, a patient might decide she is willing to take the 2% greater risk of becoming nauseous. We prefer to focus on the absolute difference in risk as it is more informative for patients than the relative risk.

Tamoxifen therapy after surgery for early-stage breast cancer reduces the chances of breast cancer returning and the chances of dying from breast cancer.  But it is important to consider exactly what the benefits are likely to be for you.

Benefits of 5-Year Therapy

Does tamoxifen prevent breast cancer recurrence?

A landmark report showed that about 26% of women taking tamoxifen for 5 years after their cancer was removed had a breast cancer recurrence within 10 years, compared to about 40% of women not taking tamoxifen.[6] In that study, women with early-stage breast cancer includes women with Stage 1, Stage 2, and Stage 3A; in other words, it ranges from a very tiny breast cancer to a large cancer that has spread to several lymph nodes.  The researchers defined breast cancer recurrence as the first appearance of any breast cancer including, cancer in the same breast, cancer in the opposite breast, or distant spread of cancer. However, women who took tamoxifen for 5 years had a 0.6% chance per year of having their breast cancer return in the same breast (this is called local recurrence) compared to a 1.1% chance per year in women who did not take tamoxifen.

Does tamoxifen prevent breast cancer deaths in women with breast cancer recurrence?

Most  women who had a recurrence did not die of breast cancer:  About 17% of women younger than 45 years and 22% of women aged 45-54 years who took tamoxifen died from breast cancer within 10 years of the initial diagnosis, compared to, respectively,  20% and 28% of women those same ages who did not take tamoxifen.[6]

Does tamoxifen save lives?

The benefits of tamoxifen vary depending on  certain characteristics of early-stage breast cancers, including size of the tumor, types of cancer cells, and how many lymph nodes the cancer had spread to prior to surgery.  These issues can help doctors predict the chances of breast cancer recurrence.  Therefore, it is important for you to talk with your doctor about these specific issues and which treatment options may be right for you.  Remember that some benefits (such as survival) might be more important to you than others (such as recurrence) – or not!

Preventing Breast Cancer in the Opposite Breast

About 1 in 20 (5%) women diagnosed with breast cancer will develop breast cancer in the opposite breast within the 10 years after first breast cancer diagnosis. A 2017 study in the prestigious medical journal JAMA found that taking tamoxifen can reduce the percentage of those women from developing cancer in the opposite breast within 10 years, from about 5% to  2%.[7] Unfortunately, the study authors did not report on breast cancer deaths or deaths for any other reason. Therefore, we do not know whether tamoxifen’s reduction of cancer in the opposite breast had any impact on the women’s longevity.

Benefits of Extending Therapy

One popular option is to change from tamoxifen to an aromatase inhibitor when menopause is reached (menopause occurs when a woman has not had a menstrual period for a continuous 12 months).  Read more about aromatase inhibitors in our article on post-menopausal early stage breast cancer.

Extending tamoxifen for an additional 5 years can also decrease a woman’s chances of breast cancer recurrence by about 4% in the 10 years after surgery if her cancer had spread to her lymph nodes prior to surgery.[2]  However, women who had early-stage breast cancer that did not spread to their lymph nodes did not benefit from more than 5 years of tamoxifen.[2]

In addition to reducing recurrence, the studies also found that taking tamoxifen for 10 years instead of 5 years reduced the chances of dying from breast cancer within those 10 years from about 15% to about 12%. These differences are small and disappear for women with the earliest stage breast cancers. Even more important, overall survival –how long a woman lives after her initial diagnosis of breast cancer–was not significantly affected by taking tamoxifen for more than 5 years.[2]  In other words, even if a woman taking tamoxifen for 10 years was less likely to die of breast cancer within those 10 years, she was not less likely to die from any cause.

When considering your treatment options, talk with your doctor about your overall health and your heart health, because all women (including women with breast cancer) are more likely to die from heart disease than breast cancer. And some treatments for breast cancer can harm your heart.  Read more about heart health and breast cancer in our article.

Side Effects and Risks of Treatment

Tamoxifen increases the chances of developing endometrial cancer and blood clots in the legs and lungs.[3,16] In a Danish study, the 5-year risk of developing blood clots was about 1.2% in breast cancer patients taking tamoxifen compared to 0.5% in breast cancer patients who were not taking tamoxifen.[10]  Tamoxifen often causes side effects similar to those experienced in menopause, including hot flashes and irregular periods.[16] In one study, 41% of women taking tamoxifen experienced hot flashes, and 10% experienced abnormal periods .[19]

The Bottom Line

There are many ways to treat early-stage breast cancer in pre-menopausal women, in addition to surgery. A woman’s age, tumor characteristics, and personal wishes/goals may affect the benefits and risks of different treatments. Talk with your doctor about which treatment options may be right for you by asking about the exact benefits of specific treatments on recurrence and overall survival, and considering these specific issues and not just what is best for cancer patients on average.

Footnotes:

  1. American Cancer Society. Cancer Treatment and Survivorship: Facts and Figures 2016-2017. Available online: https://www.cancer.org
  2. Burstein HJ. et al. Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression. Journal of Clinical Oncology. 2017;34(14): 1689-1701. Doi: 1200/JCO.2015.65.9573
  3. National Cancer Institute. Breast Cancer Treatment (PDQ). (Nov. 2017). Available online: https://www.cancer.gov/types/breast/patient/breast-treatment-pdq#section/_125
  4. Adjuvant Therapy for Breast Cancer. (Aug. 2017). Available online: https://emedicine.medscape.com/article/1946040-overview#showall
  5. Colleoni M. et al. Annual Hazard Rates of Recurrence for Breast Cancer During 24 Years of Follow-Up: Results From the International Breast Cancer Study Group Trials I to V. J Clin Oncol. 2016;34(9): 927-935. doi: 1200/JCO.2015.62.3504
  6. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet. 2011;378(9793): 771-784. doi:1016/S0140-6736(11)60993-8
  7. Gierach GL, Curtis RE, Pfeiffer RM, et al. Association of Adjuvant Tamoxifen and Aromatase Inhibitor Therapy With Contralateral Breast Cancer Risk Among US Women With Breast Cancer in a General Community Setting. JAMA Oncol. 2017;3(2): 186–193. doi:1001/jamaoncol.2016.3340
  8. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015;386(10001): 1341 – 1352. doi: http://dx.doi.org/10.1016/S0140-6736(15)61074-1
  9. Pohlmann PR and Isaacs C. Extended Adjuvant Endocrine Therapy for Postmenopausal Women: Treating Many to Benefit a Few, JNCI: Journal of the National Cancer Institute. 2018;110(1): djx142, doi: https://doi.org/10.1093/jnci/djx142
  10. Burstein HJ, Prestrud AA, Seidenfeld J, et al. American Society of Clinical Oncology Clinical Practice Guideline: Update on Adjuvant Endocrine Therapy for Women With Hormone Receptor–Positive Breast Cancer. Journal of Clinical Oncology. 2010;28(23):3784-3796. doi:10.1200/JCO.2009.26.3756.
  11. Blok EJ, et al. Optimal Duration of Extended Adjuvant Endocrine Therapy for Early Breast Cancer; Results of the IDEAL Trial (BOOG 2006-05). JNCI: Journal of the National Cancer Institute. 2018; 110(1): djx134, https://doi.org/10.1093/jnci/djx134
  12. Van de Velde, C.J.H. et al. Optimal duration of extended letrozole treatment after 5 years of adjuvant endocrine therapy; results of the randomized phase III IDEAL trial (BOOG 2006–05). European Journal of Cancer. 2017;72(Supp1):S9. doi: http://dx.doi.org/10.1016/S0959-8049(17)30108-9
  13. Gianni L. et al. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncology. 2011;12(3): 236-44. doi: https://doi.org/10.1016/S1470-2045(11)70033-X
  14. Cameron D. et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017;389(10075): 1195-1205. doi: https://doi.org/10.1016/S0140-6736(16)32616-2
  15. Stenger M. ASCO Post: 11-Year Follow-up of Adjuvant Trastuzumab in the HERA Trial. (March 2017). Available online: http://www.ascopost.com/News/48405
  16. Gogas H, Markopoulos C, Blamey R. Should women be advised to take prophylactic endocrine treatment outside of a clinical trial setting? Ann Oncol. 2005;16:1861-1866. Available online: https://watermark.silverchair.com
  17. Fisher B, et al. J Natl Cancer Inst. 1994; 86:527-537.
  18. Bonneterre, et al. J Clin Oncol. 2000; 18:3748-3757.
  19. Howell A, et al. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet. 2005;365(9453): 60-2. doi: 1016/S0140-6736(04)17666-6
  20. Bliss JM. et al. Disease-Related Outcomes With Long-Term Follow-Up: An Updated Analysis of the Intergroup Exemestane Study. Journal of Clinical Oncology. 2012;30(7): 709-717. doi: 1200/JCO.2010.33.7899
  21. Drugs and Diseases: Gosarelin. Available online: https://reference.medscape.com/drug/zoladex-la-goserelin-342129
  22. Drugs and Diseases: Trastuzumab. Available online: https://reference.medscape.com/drug/herceptin-ogivri-trastuzumab-342231#5

 

Less Radical Surgery Is a Healthier Choice for Women with Breast Cancer

Breast Cancer, news-you-can-use,
Brandel France de Bravo, MPH and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

Experts have long advised that lumpectomy patients live as long as mastectomy patients.  But the latest research, based on hundreds of thousands of women, indicates that women with DCIS or early-stage breast cancer are more likely to live longer, healthier lives if they choose less radical surgery. And their quality of life will also be better.

Five enormous studies indicate that lumpectomy patients live longer.

In a 2021 study of almost 49,000 Swedish women followed for 6 years after surgery for early-stage breast cancer, the women who underwent lumpectomy with radiation therapy lived longer on average than those who underwent mastectomy with or without radiation therapy. The benefit of lumpectomy was true when diagnosis, other medical problems, social class, and other demographic factors were statistically controlled. [1]

In a study of almost half a million women with breast cancer in one breast, Harvard cancer surgeon Dr Mehra Golshan reported in 2016 that those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast.[2] On average, women who underwent a lumpectomy instead of mastectomy lived longer than women undergoing either a single or double mastectomy for cancer in only one breast.

Similarly, a study of more than 37,000 women, also published in 2016, women with early-stage breast cancer who underwent lumpectomy with radiation were more likely to be alive 10 years later, compared to women who underwent mastectomies.[3] They were also less likely to have died of breast cancer or of other causes. This was true even when age and factors that could influence survival were taken into account.

Dr. Shelly Hwang and her colleagues found similar results in a 2013 study of more than 112,000 California women who had lumpectomies to remove their early-stage breast cancer were more likely to be alive and free of breast cancer 5 years after surgery than women who had mastectomies.[4] The women had been diagnosed between 1990 and 2004 with either Stage 1 or 2 breast cancer. All of them had either a lumpectomy with radiation or a mastectomy. After surgery, their health was monitored for an average of 9 years (the women were all studied for 5-14 years). The women who had a lumpectomy and radiation tended to live longer than the women who had mastectomies, when controlling for age at diagnosis, race, income, education levels, tumor grade or the number of lymph nodes with cancer. Lumpectomy with radiation was especially effective for women who were 50 years and older with hormone-receptor positive tumors: they were 19% less likely to die of any cause during the study than women just like them who had mastectomies. Perhaps more surprising, they were 13% less likely to die of breast cancer than women just like them who had mastectomies.

What about bilateral mastectomies rather than single mastectomies? In a study published in 2014, Dr Allison Kurian and her colleagues at Stanford studied 189,734 California patients diagnosed from 1998 to 2011 with early-stage breast cancer in one breast, ranging from Stage 0 (DCIS) to Stage 3.[5] The study showed that the percentage of women having both breasts when only one breast had cancer (called bilateral mastectomies) increased dramatically, but there was no advantage to that more radical approach.  Instead, the women who underwent lumpectomies (removing only the cancer, not the entire breast) lived longer and were more likely to be alive 10 years after diagnosis compared to women undergoing a mastectomy.  Women who had both breasts surgically removed did not live longer than those undergoing a mastectomy on one breast.

Compared to women in other countries, women in the U.S. who are diagnosed with early-stage breast cancer are more likely to remove both breasts even if only one has cancer. It is not known why bilateral mastectomy provides no medical advantage, but a study of more than 4,000 cancer patients by Dr. Fahima Osman at the University of Toronto indicates that having a healthy breast removed in addition to the breast with cancer increases the chances of medical complications.[7] Removing the healthy breast (“contralateral breast”) doubled the chances of having wound complications in the first month after surgery: from about 3% for women who had only the breast with cancer removed to about 6% for women who also had the healthy breast removed. About 4% of women who had a single mastectomy experienced some kind of complication (not necessarily wound-related) in the 30 days after surgery, compared to 8% of women who had both breasts removed. The risk of cancer in that healthy breast was already less than 1% per year unless the woman has a BRCA gene or some other very high risk factor.[7] Hormone therapy that blocks estrogen, such as aromatase inhibitors or other pills, can further reduce that already low risk.

Quality of Life

The above studies show that women undergoing lumpectomy live longer than those undergoing mastectomy.  But what about their quality of life?  A study of 560 young women with early-stage (stage 0-3) breast cancer published in JAMA Surgery in 2021, found that women who underwent lumpectomies had a better quality of life than women who underwent mastectomies, regardless of whether they had reconstructive surgery. The women were all 40 years old or younger when they were diagnosed, and their quality of life was evaluated an average of 5-6 years after surgery.  Women’s quality of life tended to be lowest for women who had undergone mastectomy with radiation therapy. [6]

Women who are diagnosed with breast cancer sometimes choose more radical treatments than they need in an effort to “do everything possible” to fight the cancer. It is important to know that research on hundreds of thousands of breast cancer patients who completed their treatment show that being physically active, eating healthy foods, and maintaining a healthy weight all are effective ways to help breast cancer patients live longer. [9]

The Bottom Line: These enormous studies of women in the U.S. and other countries make it clear that women with DCIS or early-stage breast cancer (stages 1-3) should undergo surgery to remove only the DCIS lesion or the cancer, not the entire breast. The women who undergo lumpectomy with radiation usually live longer than those who undergo single mastectomy or bilateral mastectomy, with or without radiation. The one study of young women with breast cancer found that although many undergo mastectomy with reconstruction, their quality of life would be better if they underwent lumpectomy instead. In addition, mastectomy patients who have breast implants are more likely to kill themselves compared to mastectomy patients without implants. Unfortunately, the fear of breast cancer and desire to “get rid of the problem” has resulted in too many women undergoing medically unnecessary mastectomies that do more harm than good. Physicians and breast cancer advocacy groups need to make sure that patients understand why lumpectomy with radiation is a better idea.

For a free booklet on treatment options for DCIS, click here.  For a free booklet on treatment options for early-stage breast cancer, click here.

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

References 

    1. de Boniface J, Szulkin R, Johansson ALV. Survival After Breast Conservation vs Mastectomy Adjusted for Comorbidity and Socioeconomic Status: A Swedish National 6-Year Follow-up of 48 986 Women. JAMA Surg. 2021;156(7):628–637. doi:10.1001/jamasurg.2021.1438
    2. Wong, S., Freedman, R., Sagara, Y., Aydogan, F., Barry, W., & Golshan, M. Growing Use of Contralateral Prophylactic Mastectomy Despite no Improvement in Long-term Survival for Invasive Breast Cancer. Annals of Surgery. 2016 March; doi:10.1097/SLA.0000000000001698
    3. Marissa C. van Maaren, et al, “10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study”. Lancet Oncol. 2016 Aug; 17(8): 1158–1170. Published online 2016 Jun 22. doi: 10.1016/S1470-2045(16)30067-5
    4. Hwang ES, et al “Survival after lumpectomy and mastectomy for early stage invasive breast cancer: The effect of age and hormone receptor status” Cancer2013 April 1; 119(7); DOI: 10.1002/cncr.27795.
    5. Kurian, Allison W., Daphne Y. Lichtensztajn, Theresa H. M. Keegan, David O. Nelson, Christina A. Clarke, and Scarlett L. Gomez. “Use of and Mortality After Bilateral Mastectomy Compared With Other Surgical Treatments for Breast Cancer in California, 1998-2011.” The Journal of the American Medical Association2014; 312(9): 902-914. DOI:10.1001/jama.2014.10707
    6. Dominici L, Hu J, Zheng Y, et al. Association of Local Therapy With Quality-of-Life Outcomes in Young Women With Breast Cancer. JAMA Surg. Published online September 01, 2021. doi:10.1001/jamasurg.2021.3758
    7. Osman, Fahima, et al “Increased postoperative complications in bilateral mastectomy patients compared to unilateral mastectomy: an analysis of the NSQIP database.” 2013 Oct; 20(10): 3212–3217. Published online 2013 Jul 12. doi: 10.1245/s10434-013-3116-1
    8. National Cancer Institute. Breast Cancer Treatment (PDQ®). http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional/page1
    9. Brooks, M (2022) “Lifestyle changes can reduce risk of death after breast cancer.” Medscape. https://www.medscape.com/viewarticle/983131?src=mkm_ret_221113_mscpmrk_BC_monthly&uac=140425SY&impID=4853207

Breast implants and mammography: what we know and what we don’t know

Breast Cancer, Prevention, Uncategorized, ,
Elizabeth Santoro, RN, MPH and Dr. Diana Zuckerman

There has been a lot of attention given to mammography screening in recent years. Some of this information has been confusing to women—at what age should I first have a mammogram, how frequently should I have repeat mammograms, and are mammograms even effective? These are questions that women both with and without breast implants have been trying to understand. Despite this confusion, the U.S. Preventive Services Task Force recommends screening every two years for women ages 50-74 who have an average risk of breast cancer. Women at high risk because of family history, BRCA gene mutations, or other reasons should discuss a screening schedule with their doctor.  But, what does this mean for women who have breast implants? Are women with breast implants faced with different risks when undergoing a mammography screening? Will women with implants require special considerations during the procedure?

Delayed Breast Cancer Detection

Breast implants can interfere with the detection of breast cancer, because the implants can obscure the mammography image of a tumor. Implants therefore have the potential to delay the diagnosis of breast cancer. Although mammography can be performed in ways that minimize the interference of the implants, as described below, Miglioretti and her colleagues found that even so, 55% of breast tumors were missed, compared to 33% of tumors for women without implants.1  They also found that among newly diagnosed breast cancer patients who did not have any symptoms, the augmented women had larger tumors than those who did not have implants.

What is the impact of this possible delay in diagnosis?  Research findings have been inconsistent, but a 2013 Canadian systematic review of 12 studies found that women with breast cancer who had breast implants are diagnosed with later-stage cancers than women with breast cancer who did not have implants.2

A delay in diagnosis could result in the woman needing more radical surgery or the delay could be fatal.  A 2013 Canadian meta-analysis of five studies found that if women who had breast augmentation later developed breast cancer, they were more likely to die from it than women diagnosed with breast cancer who did not have breast augmentation.3

These studies indicate that for an individual woman, a delay in diagnosis could potentially result in death, and more research is needed to determine how often that happens, and under what circumstances. From a public health perspective, delays in diagnosis could potentially necessitate more radical surgery: a cancer that could have been treated at an earlier stage with breast-sparing treatments, such as lumpectomy, may instead require a mastectomy.3,4

What are the other possible problems that implants can cause regarding mammography?

A study by FDA scientist Dr. S. Lori Brown and colleagues describes problems that were reported to the FDA related to breast implants and mammography screening.5 The authors found 66 adverse events that were reported as either occurring during the mammogram or involving breast implants interfering with the mammogram. Forty-one reports of either silicone or saline breast implants- – almost two out of three reports– pertained to ruptures that were suspected as happening during mammography. The other 25 reports included delayed breast cancer detection, inability to perform the mammogram due to capsular contracture or because of fear that the implant would rupture, and pain/soreness during and after the procedure.

Description of the FDA Study

This study examined data from the Manufacturer and User Facility Device Experience (MAUDE) database. This FDA database collects mandatory or voluntary reports of medical device adverse events from physicians, breast implant manufactures, consumers, and others. The reports were received between June 1992 and October 2002 for events that occurred between June 1972 and June 2002. The mean age of the implant was 14.5 years, and ranged from 2-29 years.

The use of the MAUDE database has limitations. The FDA does not verify the information that is provided. Therefore, the FDA cannot guarantee that the information is accurate and complete. In addition, in some cases, a doctor and a patient could potentially report the same problem.  On the other hand, most problems are not reported even once, since patient and physician reporting is voluntary. It is well-documented that the vast majority of problems arising from medical products are not reported to the FDA. As a result of these shortcomings, these data cannot be used to calculate the number of new adverse events expected for a given number of people in a defined time period.

Key Implications of the Studies on Implants and Mammograms

Potential Implant Rupture

The FDA warns that all implants will eventually break, and research shows that most women who have implants for ten years or longer will have at least one broken implant.6 The risk of breast implant rupture is known to increase as the implant ages. A study by Holmich and colleagues suggested that during the first ten years a woman has implants, most implants do not break, between 11-20 years most will break, and by the time they are more than 20 years almost all have broken.7 Women with implants have been told that mammography is safe for them, but the results of the Brown study suggest that the risk of rupture can be exacerbated by mammography.

Brown and her colleagues also reviewed the published research on implant rupture during mammography and found an additional 17 cases reported in medical journals. According to the American Society of Plastic Surgery, approximately half of the women who get breast implants are in their 20′s or early 30′s,8 which means that the implants are already broken or vulnerable by the time these women are old enough for screening mammograms.

Mammography may therefore increase the risk of a rupture earlier in the typical lifespan of implants, and the squeezing involved in mammography probably increases the risk of leakage in implants that are already ruptured. The potential risk of rupture or leakage needs to be weighed against the benefits of mammography by each individual woman. For women who are concerned about breast cancer, knowledge of mammography problems might discourage women from getting breast implants, or encourage them to have their implants removed and not replaced. Current guidelines encourage women with breast implants to have regular mammograms provided that the technician knows the woman has implants prior to the procedure and that special techniques are utilized.6 In light of this new research, those guidelines need to be reconsidered, especially for women with silicone gel breast implants, where leakage can cause permanent disfigurement and has unknown health risks.

Avoidance of Mammography

The Brown study also found that implants sometimes make it impossible to perform a mammogram. This can happen for two reasons. First, conditions such as capsular contracture, where the scar tissue around the implant tightens and causes the breast to become hard and misshapen, can make it very difficult or even impossible to perform the mammogram.9, 10 The compression of the breast that is required in order to perform the mammogram can be extremely painful if there is capsular contracture, and in some cases the hardness of the breast makes it impossible to compress the breast for the mammogram. Some women avoid getting mammograms because they are afraid of rupture and the latest research indicates that this is a reasonable concern.

Biomaterials testing of breast implants indicates that implants should only break under the most traumatic circumstances, and yet implants break for no apparent reason, as well as under pressure from mammograms.11 It is difficult to know how much risk a mammogram increases the risk of rupture since so little is understood about why implants break and under what circumstances.

What Does this Mean for Women?

Women considering breast implants and women with breast implants need to be informed consumers, and that includes knowing about the problems that arise from having mammograms with breast implants. This is true for all women, but especially breast cancer patients who may use implants on a healthy breast so that it will match the reconstructed breast after a mastectomy. (Detection of cancer in the reconstructed breast is unlikely to be a problem because mammography is not used after a mastectomy. Since breast cancer survivors are at greater risk for breast cancer in the breast that was not removed, compared to women who have not had breast cancer, survivors should have regular mammograms of the surviving breast, and need to know the risks.

Women with breast implants and those considering breast implants need to know that they will have a different mammography experience than women without implants, to try to improve the accuracy. The special techniques used will push the implant back to try to move it out of the way, and extra views will be taken. Even so, as reported earlier in this article, mammograms performed on women with implants will still miss more tumors than is typical of mammograms for women who do not have implants.7, 12 In addition, women with implants should expect that mammography will require more views and take longer, thus costing more and exposing them to increased levels of radiation. Unfortunately, the most common problem, capsular contracture, can make mammography more painful, less accurate, or even impossible to perform. In such cases other, more expensive tests, such as an MRI or ultrasound, may be required.

Women also need to understand that even if breast implants do not cause contracture or other problems, they will still interfere with mammography and mammograms might still cause rupture and leakage.

The bottom line is that women considering breast implants and those who already have them need to be informed about potential problems with mammography so that they can make the decisions that will help them reduce the risk of breast cancer and avoid the problems that arise with implant breakage and leakage.

For more information on breast implants, see www.breastimplantinfo.org.

Related Content:
What you need to know: Breast cancer, suicide, mastectomy, and breast implants
Summary of: Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide
2016 Update: When should women start regular mammograms? 40? 50? And how often is “regular”?

 

Can a handful of nuts a day keep cancer away?

Breast Cancer, Colon Cancer, Diet, Habits, & Other Behaviors, Ovarian Cancer, Pancreatic Cancer, Prevention, , ,
By Krista Kleczewski, Claire Karlsson, and Edyth Dwyer

Evidence is growing about the many ways in which eating nuts, seeds, and legumes can improve your health. Eating walnuts or legumes like peanuts, beans, or lentils have been linked to healthier hearts and a lower risk of diabetes, but now studies show they may also cut your risk of getting cancer! Here’s what we know and don’t know.

In addition to erroneously thinking that peanuts are nuts, many people think almonds, cashews, and pecans as nuts, but they are actually types of seeds. The difference is based on the plant they grow on, where peanuts grow underground below the plant roots, nuts and seeds grow inside or outside the plant’s fruit. Although this article uses the term “nuts,” the studies we describe include many combinations of nuts, seeds, and legumes. It’s also important to note that each study has different methods, and they need to be interpreted differently. Some studies looked at fewer than 100 people and closely tracked their diet and health, while others were meta-analyses that collected results from many studies of thousands of people and summarized their findings. 

What are some health benefits of nuts?

 In 2015, a Dutch study of 120,000 men and women between the ages of 55-69 found that those who ate about half a handful of nuts or peanuts each day were less likely to die from respiratory disease, neurodegenerative diseases, diabetes, cardiovascular diseases, or cancer than those who consumed no nuts or seeds.[1] The same benefit was not seen for peanut butter, however, which suggests that the salt, vegetable oils, and trans fatty acids in peanut butter may counterbalance the benefits of the peanuts. A serving of nuts is about the size of 30 almonds, and a study found that eating several servings a week had health benefits. A 5-year study conducted in Spain of 7,000 men and women aged 55 to 80 years old found that eating at least three servings of nuts per week reduced the risk of cardiovascular and cancer death.[2] Another study similarly found eating nuts – especially walnuts — reduces the risk of developing cancers, diabetes and heart disease when eaten as a part of the Mediterranean Diet, which also emphasizes fruits, vegetables, whole grains, and legumes.[3] Walnuts were highlighted by the study as reducing inflammation associated with certain cancers and other conditions like diabetes and heart disease. More evidence is needed, however, to determine the specific impact of walnuts on cancer risk.

Breast Cancer

Eating large amounts of peanuts, walnuts, or almonds can reduce the risk of developing breast cancer, according to a 2015 study of 97 breast cancer patients.[4] The researchers compared the lifetime consumption of peanuts, walnuts and almonds among breast cancer patients with the consumption of those without breast cancer, finding that women who ate large quantities were half to one-third as likely to develop breast cancer. No difference was found between people who ate a small amount of nuts, legumes and seeds and those who ate none at all, suggesting that a person needs to consume a substantial amount of these over their lifetime to reduce their chances of developing breast cancer.

Another study looked at the risk of breast cancer for people who ate nuts and peanuts compared to people who did not. Some types of breast cancers respond to the body’s natural hormone estrogen, growing faster when exposed to estrogen. These are called Estrogen Receptor (ER) positive cancers. ER negative cancers are not influenced by exposure to estrogen. In a study of over 4,000 women in the Netherlands, those who ate 10 grams (a large handful) of nuts per day had a 45% lower risk of developing ER negative breast cancer when compared to those who ate no nuts, but it did not significantly affect ER positive breast cancer.[5,6] Since ER negative breast cancer occurs in only a third of the 12% of women who are diagnosed with breast cancer, the risk to the average person decreased overall by about half of 1% when their diet included that many nuts. 

Girls who regularly eat nuts in their diet may be less likely to develop breast cancer as adults. A 2020 study of more than 9,000 girls between the ages of 9-15, and found that girls who regularly ate peanut butter or any kind of nuts were 36% less likely than girls who did not to have developed benign breast conditions when followed up with 10 years later. Although not dangerous, benign breast conditions (such as breast cysts or hyperplasia) increase a woman’s chances of eventually getting breast cancer. [7]

Can eating nuts, legumes and seeds reduce colorectal cancer risk?

To find out whether snacking on foods with peanuts lowers your chances of getting colorectal cancer (also called colon cancer), researchers studied more than 23,000 adults in Taiwan, ages 30 and older.[8] The researchers reported in 2006 that women who ate meals with peanut products at least twice each week were less likely to develop colorectal cancer. More research is needed to see if this benefit is actually from the peanuts.

A 2021 meta-analysis collected results from over 40 studies, and it examined whether eating more nuts would have an impact on colon cancer risk. Researchers found that eating 5 grams of nuts per day could decrease the risk of colon cancer by 25%.[9] Since the lifetime risk of colon cancer is about 4%, a 25% reduction would mean a decrease from 4% to 3% of the overall risk of colon cancer for people regularly eating nuts. Five grams is about 5-6 almonds, and this study found that the benefits of eating nuts started for people averaging just 2 grams per day and continued to decrease for people eating up to 9 grams per day.  After that, the effects leveled off, so eating more than 9 grams was not more beneficial than eating 9 grams. A meta-analysis combines results from many studies, so the 2-9 grams per day were average amounts, whether the person eats them all in one day or spread out over the course of a week. 

In one of the largest studies of diet and cancer, which was conducted in 10 European countries, researchers discovered that eating nuts and seeds reduced women’s chances of developing colon cancer, but did not lower the risk for men.[10] Women who ate a modest daily amount of nuts and seeds (about 16 peanuts or a small handful of nuts or seeds) every day were less likely to develop colon cancer, and women who ate the largest quantities of these foods were the least likely to develop colon cancer. Again, more research is needed to understand these findings.

Researchers have also investigated whether a diet containing nuts and peanuts can improve patient chances of survival for those who have already been diagnosed with colon cancer. In a study of over 800 patients with advanced (stage III) colon cancer, patients who ate more nuts were more likely to survive after treatment, without being re-diagnosed with colon cancer.[11] This study measured a serving of nuts to be one ounce, or about 15 cashews. When compared to those who ate no nuts, those who ate 2 or more servings of nuts per week had 46% lower risk of re-diagnosis of their cancer, as well as a 53% lower risk of dying from the cancer. This study has several important limitations to keep in mind. Not only was it a relatively small study, but it only examined Stage III colon cancer patients, comparing cancer patients who ate nuts to those who did not eat nuts. This means that the results cannot be generalized to the average American’s risk of colon cancer. 

Pancreatic Cancer

Eating nuts also seems to lower the risk of developing diabetes, which may then lower the risk of developing pancreatic cancer.[12] In addition, a large study of women found that frequently eating nuts was associated with less chance of developing pancreatic cancer,13 one of the most deadly cancers.

A 2021 meta-analysis that examined results from over 30 studies, found that the chances of developing pancreatic cancer risk decreased for those who ate more nuts. The average lifetime risk of developing pancreatic cancer is about 1.5%. Because the results show a 6% lower risk for those eating nuts, this means the overall risk of pancreatic cancer may lower from 1.5% to 1.4% for people who regularly eat nuts.[9]

Ovarian cancer

A 2010 study examined the possible link between ovarian cancer and foods high in phytoestrogens and/or fiber, including nuts, beans, and soy.[15] They found that these foods seemed to help prevent “borderline ovarian cancer”—slow-growing tumors that are less dangerous and more likely to affect younger women. However, these foods did not seem to protect against the more aggressive types of ovarian cancer.

What makes nuts good for your health?

There is still some debate about why nuts might be so beneficial. Omega-3 fatty acids are found in peanuts, walnuts, and some seeds, and researchers think their health benefits may help to prevent cancer.[16] The omega-3 acids can help protect cell structures and walls, and since they are anti-inflammatory; that might reduce the risk of cancer for people who regularly eat peanuts, walnuts, and seeds. [17]

Some research has shown that walnuts can also improve your gut biome, meaning it helps you grow healthy bacteria in your gut.[18]  To test this, an experiment was done on 18 people, where some were assigned to eat walnuts and others ate no nuts. Blood and fecal samples were tested, and researchers were able to see changes in the bacteria, and lower levels of “secondary bile” which suggests the nuts decreased inflammation in their intestines. This experiment studied a very small group of people, so more research is needed to understand why these nuts, seeds, and legumes improve the risk of cancer over a lifetime. 

 

The Bottom Line

There is growing evidence that nuts, legumes, and seeds reduce the risk for several types of cancer, as well as having other health benefits. Researchers are still investigating whether the health benefits of nuts are because people who eat nuts have a healthier overall diet, but tree nuts seem to have some health benefits on their own. Peanuts and peanut butter may also have benefits, but the higher levels of fat and sodium could explain why these legume products show fewer health benefits. Peanuts, walnuts, almonds, and other nuts are high in calories, so don’t overdo it. It seems safe to assume that adding these foods to your diet, in small quantities several times a week, is a good idea, especially if you use them to replace less healthy snacks.

 

 

 

  1. Brandt, P., & Schouten, L. Relationship of tree nut, peanut and peanut butter intake with total and cause-specific mortality: A cohort study and meta-analysis. (2015). International Journal of Epidemiology, 44(3), 1038-1049. doi:10.1093/ije/dyv039  
  2. Guasch-Ferré, M., Bulló, M., Martínez-González, M.A., Ros, E., Corella, D., et al. Frequency of nut consumption and mortality risk in the PREDIMED nutrition intervention trial. (2013). BMC Med; 11: 164. doi: 10.1186/1741-7015-11-164  
  3. Toner, CD., Communicating clinical research to reduce cancer risk through diet: Walnuts as a case example (2014). Nutr Res Pract. 8(4): 347–351. doi: 10.4162/nrp.2014.8.4.347  
  4. Soriano-Hernandez, A.D., Madrigal-Perez D.G., Galvan-Salazar H.R., Arreola-Cruz A., Briseño-Gomez L., Guzmán-Esquivel J., Dobrovinskaya O., Lara-Esqueda A., Rodríguez-Sanchez I.P., Baltazar-Rodriguez L.M., Espinoza-Gomez F., Martinez-Fierro M.L., de-Leon-Zaragoza L., Olmedo-Buenrostro B.A., Delgado-Enciso I. (2015). The Protective Effect of Peanut, Walnut, and Almond Consumption on the Development of Breast Cancer. 2015;80(2):89-92. doi: 10.1159/000369997.  
  5. van den Brandt P.A., Nieuwenhuis L. Tree nut, peanut, and peanut butter intake and risk of postmenopausal breast cancer: The Netherlands Cohort Study. Cancer Causes Control, (2018). 29(1):63–75.
  6. Putti T.C., El-Rehim D.M.A., Rakha E.A., Paish C.E., Lee A.H.S., Pinder S.E., et al. Estrogen receptor-negative breast carcinomas: a review of morphology and immunophenotypical analysis. (2005). Mod Pathol, 18(1):26–35.
  7. Berkey C.S., Tamimi R.M., Willett W.C., Rosner B., Hickey M., Toriola A.T., et al. Adolescent alcohol, nuts, and fiber: combined effects on benign breast disease risk in young women. (2020). NPJ Breast Cancer;6(1):61.
  8. Yeh, C. C., You, S. L., Chen, C. J., & Sung, F. C. Peanut consumption and reduced risk of colorectal cancer in women: a prospective study in Taiwan. (2006). World Journal of Gastroenterology, 12(2), 222.  
  9. Naghshi, S., Sadeghian, M., Nasiri, M., Mobarak, S., Asadi, M., Sadeghi, O. Association of total nut, tree nut, peanut, and peanut butter consumption with cancer incidence and mortality: A comprehensive systematic review and dose-response meta-analysis of observational studies. (2021). Adv Nutr, 12(3):793–808.
  10. Jenab, M., Ferrari, P., Slimani, N., Norat, T., Casagrande, C., Overad, K., Riboli, E. et al. Association of nut and seed intake with colorectal cancer risk in the European Prospective Investigation into Cancer and Nutrition. (2004). Cancer Epidemiology Biomarkers & Prevention, 13(10), 1595-1603.  
  11. Fadelu T., Zhang S., Niedzwiecki D., Ye X., Saltz L.B., Mayer R.J., et al. Nut consumption and survival in patients with stage III colon cancer: Results from CALGB 89803 (alliance). (2018). J Clin Oncol,36(11):1112–20.
  12. Jenkins, D. J., Kendall, C. W., Banach, M. S., Srichaikul, K., Vidgen, E., Mitchell, S., Josse, R. G., et al. Nuts as a replacement for carbohydrates in the diabetic diet. (2011). Diabetes care, 34(8), 1706-1711.  
  13. Bao, Y., Hu, F. B., Giovannucci, E. L., Wolpin, B. M., Stampfer, M. J., Willett, W. C., & Fuchs, C. S. Nut consumption and risk of pancreatic cancer in women. (2013). British journal of cancer.  
  14. Lee J.T., Lai G.Y., Liao L.M., Subar A.F., Bertazzi P.A., Pesatori A.C., et al. Nut consumption and lung cancer risk: Results from two large observational studies. (2017). Cancer Epidemiol Biomarkers Prev,26(6):826–36.
  15. Hedelin, M., Löf, M., Andersson, T. M. L., Adlercreutz, H., & Weiderpass, E. Dietary phytoestrogens and the risk of ovarian cancer in the women’s lifestyle and health cohort study. (2011). Cancer Epidemiology Biomarkers & Prevention, 20(2), 308-317.  
  16. Fabian C.J., Kimler BF, Hursting S.D.. Omega-3 fatty acids for breast cancer prevention and survivorship. (2015) Breast Cancer Res;17(1):62. https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-015-0571-6
  17. Freitas R.D.S., Campos M.M.. Protective effects of omega-3 fatty acids in cancer-related complications. (2019). Nutrients;11(5):945. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6566772/#:~:text=Omega%2D3%20polyunsaturated%20fatty%20acids,structure%20and%20fluidity%20of%20membranes
  18. Holscher H.D., Guetterman H.M., Swanson K.S., An R., Matthan N.R., Lichtenstein A.H., et al. Walnut consumption alters the gastrointestinal Microbiota, microbially derived secondary bile acids, and health markers in healthy adults: A randomized controlled trial. (2018). J Nutr;148(6):861–7.

The Cancer Prevention and Treatment Fund Responds to CDC study on Camp Lejeune Drinking Water Health Hazards

news-you-can-use, ,
By Anna E. Mazzucco, PhD and Diana Zuckerman, PhD, President of the Cancer Prevention and Treatment Fund
Updated March 24, 2014

The contaminated water at the Camp Lejeune Marine Corps base is a national disgrace that has jeopardized the health of many adults and children. Now the government’s focus needs to be on assisting all those who have been harmed – and that should include preventing cancer and other diseases in those who are not currently sick but at risk because of their exposure years ago. Righting the wrong that was done to our armed service families requires more than research and passing the buck – it requires a plan of action based on solid scientific information.

The Cancer Prevention and Treatment Fund expresses its strong support for the adults and children who have been harmed by contaminated drinking water at Camp Lejeune Marine Corps Base.  This unprecedented environmental disaster has been a tragic disservice to the courageous men and women of our military.

The new analysis by the Centers for Disease Control and Prevention indicates that pregnant women who were more exposed to contaminated drinking water at Camp Lejeune were 4 times as likely to give birth to children with serious birth defects such as spina bifida, compared to women who were less exposed.  There was also a slight increase in childhood cancers such as leukemia among these children.  A study published (reported) in 2014 found increased risk of death among Camp Lejeune residents from several cancers including kidney, liver, cervical, esophageal, multiple myeloma and Hodgkin lymphoma, in comparison to residents of another military base which did not have contaminated water.  Previous reports have indicated that men living or working on the base from the mid-1950s until 1987 were much more likely to develop breast cancer than men in the general population, but that study has not yet been completed.  Breast cancer is a rare occurrence among men, and is especially dangerous because men often do not recognize the symptoms or seek treatment in a timely manner. In addition, men with breast cancer often experience unique and significant physical, social and psychological issues.

The Cancer Prevention and Treatment Fund is dedicated to helping children and adults reduce their risks of getting all types of cancer, and assists them in choosing the safest and most effective treatments. We use research-based information to encourage more effective programs, policies and medical treatments. We strongly urge the federal government to continue investigating the link between exposure to trichloroethylene (TCE) and other known contaminants in the Camp Lejeune drinking water, and an increased risk for diseases among children and adults.  It is likely that the exposures could cause several different types of cancer, but those other cancers would not be as noticeable as male breast cancer, since that is so rare.

Choosing wisely: tests and treatments cancer patients usually DON’T need

Medical Treatments with Cancer Risks, , , ,
By Jennifer Yttri, PhD
2013

The thought of cancer is so frightening that many patients depend on their physicians to make all the decisions about screening, prevention, and treatment.  Or they may ask for whatever “new cure” they have heard about.  That can result in too many tests or treatments that do more harm than good.  Not every test, procedure, or medication is appropriate for every patient, and many are over-used. What is beneficial for one person isn’t worth the risks for another.

The best health decisions can be made when physicians take the time to talk with their patients and patients ask questions rather than just assuming the doctor always knows best.

The ABIM Foundation and Consumer Reports collaborated with specialty medical societies to create lists of “5 Things Physicians and Patients Should Question” as part of a national effort called Choosing Wisely (www.choosingwisely.org). These medical groups represent more than 500,000 physicians. The lists contain evidence-based recommendations made by experts. Here is the list of their recommendations on cancer.

Breast cancer screening

Breast cancer screening is done through mammograms, which are like x-rays.  A breast cancer diagnosis involves giving the cancer a stage (0 through 4, with 4 being the most advanced) based on the size of the tumor, how advanced it is, and how likely it is to spread. Other imaging tests, like PET, CT, and bone scans are not recommended for screening early stage breast cancer (stages 0-3), patients newly diagnosed with Ductal Carcinoma In Situ (DCIS), or people without symptoms. This testing does not benefit patients, and false-positives (test results that indicate cancer when no cancer is present) can lead to unnecessary procedures and misdiagnosis. For anyone who has been treated for early-stage breast cancer and is symptom free, mammograms and regular clinical exams are the best ways to check that the cancer has not come back.  Advanced imaging tests and tumor marker tests should only be used for patients with later-stage breast cancer.

Cancer therapy

The first round of cancer therapy works best at reducing or eliminating a tumor. Multiple treatments, including chemotherapy, will not always help get rid of cancer, especially more advanced cancers or tumors that return. After three different treatments, another round is unlikely to improve quality or length of life. It is better to stop therapy and not suffer through the side effects of treatment.  (In fact, there is some evidence that patients live longer, with better quality of life, if they stop aggressive treatments earlier.)

Cervical cancer screening

Women over 65 should stop being screened for cervical cancer if they have not previously shown risk for disease. Women under 30 should not have HPV tests to screen for cervical cancer. Women with mild dysplasia or cervical intraepithelial neoplasia (CIN1) for less than two years should not be treated for cervical cancer, as CIN1 is usually caused by a short-term HPV infection and goes away within a year.   See below for information about HPV testing. Pap smears should be used to screen for cervical cancer.

Colon cancer screening

For people who are at an average risk for developing colon cancer, tests such as stool tests and sigmoidoscopy can be used instead of colonoscopy to screen for colon cancer. Abnormal results from these tests require follow-up with a colonoscopy. The plasma test named methylated Septin 9 (SEPT9) is an alternative screening test but it is not recommended unless the more conventional tests and colonoscopy are not feasible.

HPV testing

HPV testing is not recommended for low risk infections, such as for HPV associated with genital warts. HPV testing should be used to identify high risk infections in patients with abnormal Pap smears or other clinical symptoms associated with high risk HPV infections.

Ovarian cancer screening

Women at average risk who do not have symptoms should not be screened for ovarian cancer. Screening using ultrasound or blood serum testing might detect early signs of cancer, but ovarian cancer is uncommon in women of average risk without symptoms. An abnormal result that isn’t cancer might require invasive follow-up, and those risks outweigh the benefit of early detection.

Ovarian cysts

Small, simple cysts are common in women and usually won’t affect their health. If one is found, the doctor will schedule an ultrasound to determine if the cyst is benign (not cancer). If the cyst is not cancerous, a follow up ultrasound and surgery is not recommended unless the cyst causes symptoms, like pelvic pain. If the cyst is suspected to be cancerous, a follow up ultrasound is not recommended because the cyst should just be surgically removed.  A second ultrasound is only recommended for larger cysts that the doctor could not be sure about.

Palliative care for bone metastasis

Cancers that spread to bones are often very painful. Local radiation is sometimes used to treat patients with one or a few bone metastases, but some doctors question if the increased risk of cancer warrants radiation as treatment for pain. The American Society for Radiation Oncology recommends using one dose of radiation to relieve pain from any bone metastasis. While another dose might be needed in the future, starting with one dose makes sense, since patients with bone cancer have a short life expectancy.

Prostate cancer screening

Men who do not have symptoms generally should not be screened for prostate cancer using a prostate-specific antigen (PSA) test or digital rectal exam as it can lead to treatments that may do more harm than good. Gleason and prostate-specific antigen (PSA) tests are used to measure how aggressive prostate cancer is and how likely it is to spread. Imaging tests can then be performed to identify exactly where cancer has spread. These imaging tests, such as bone scans, PET, and CT, are not recommended for detecting disease in men who are newly diagnosed with low-grade prostate cancer. Imaging tests are expensive, can expose men to high levels of radiation, and are unlikely to provide more information about early prostate cancer. Only men with Gleason scores above 7 and PSA levels above 10 nanograms/mL should consider imaging tests.

Prostate specific antigen (PSA)

High PSA levels may be a sign of prostate cancer. However, having a low PSA level does not prevent prostate cancer nor does it mean there is no cancer. It was thought that antibiotics might lower PSA and protect men from prostate cancer. This has not been proven in clinical tests and is not recommended as an alternative preventive therapy.

Stage 1 non-small cell lung cancer (NSCLC)

Lung cancer is the most common type of cancer to spread to the brain. However, the chance of patients with Stage 1 lung cancer developing brain metastasis is very low. Because of the rate of false positives is much higher than the actual rate of brain metastasis, brain imaging by MRI or CT is not recommended for patients with stage 1 NSCLC unless they have neurologic symptoms.

Thyroid scans

Radioactive iodine is absorbed by the thyroid and can be used to give doctors a picture of what the thyroid looks like, how it is functioning, and if there are any nodules in the area. Imaging with radioactive iodine is not recommended for determining whether thyroid nodules are benign or cancerous unless the patient is hyperthyroid. Nodules should be biopsied if the thyroid functions normally.