Category Archives: Breast Cancer

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

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.

Drugs to Avoid for Women Taking Tamoxifen

Blossom Paravattil, Megan Cole, and Danielle Shapiro, MD, MPH, Cancer Prevention and Treatment Fund

The female hormone estrogen makes most cancer tumor cells grow and multiply. The drug tamoxifen was developed to block estrogen and therefore stop that growth, to help treat, prevent, and stop the recurrence of most breast cancer.  Breast cancer that is sensitive to estrogen is called “estrogen receptor-positive breast cancer.”

For tamoxifen to do its job, it needs to be broken down in the body by a key protein known as CYP2D6.  Unfortunately, many common medicines can block or slow down CYP2D6, and that would make tamoxifen less effective.

Certain medications used to treat depression should be avoided by women taking tamoxifen. The antidepressants paroxetine (Paxil) and fluoxetine (Prozac) have been found to increase women’s risk of dying of cancer if they are taking tamoxifen. Women who are on these medications should talk to their doctors about switching to other medicines that don’t affect how tamoxifen works.

The table below shows a list of drugs to avoid and alternative drugs that can be taken instead.

 

Classes of drugs Drugs that are likely to interfere with tamoxifen

Alternative drugs that should be safe to take with tamoxifen

Antidepressants (SSRI/SNRIs) Paxil, Prozac, Wellbutrin, and Cymbalta Effexor, Pristiq, Edronax, Lexapro, and Remeron
Antipsychotics Mellaril, Trilafon, and Orap Navane, Clozaril, Zyprexa, Geodon, and Seroquel
Cardiac Drugs Cardioquin and Ticlid Cardizem
Allergy medications Benadryl (diphenhydramine), Unisom (doxylamine), Dimetapp (Brompheniramine), Tagamet (cimetidine) Zyrtec (cetirizine), Claritin (Loratadine), Fexofenadine (Allegra), Ranitidine (Zantac)
Medications for Infectious Diseases Seldane and Cardioquin Crixivan, Invirase, Viracept, Rescriptor, Viramune, and Sustiva

The Bottom Line

If you are taking tamoxifen, talk to your doctor about any medications  that you are taking (including over-the-counter products, such as cold and allergy medications) to be sure that they don’t interfere with tamoxifen.

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

Reference:

  1. Zosia Chustecka. Medscape News. Drugs to Avoid in Women Taking Tamoxifen. May 05, 2010. Accessed December 2017 Available online: https://www.medscape.com/viewarticle/721306

Question: I Have Been Diagnosed with Breast Cancer. What Are My Options so That I Can Still Have Breasts?


Q: I have been diagnosed with breast cancer. What are my options so that I can still have breasts?

A. We’re not doctors and we don’t provide medical advice, but I can tell you what we know based on research and from speaking with many experts and with women who have had breast implants. If you have been diagnosed with early stage breast cancer (stage I, IIa, IIb, or IIIa) , you probably can keep your breasts, and have a lumpectomy rather than a mastectomy (which removes the entire breast). Early-stage breast cancer patients who undergo a lumpectomy (which removes only the cancer and a small area around it) that is followed by radiation will live just as long as women who have a mastectomy instead.  In fact, the latest research indicates that women with early-stage breast cancer who have a lumpectomy live significantly longer than women of the same age and diagnosis who undergo mastectomy.

Experts recommend a lumpectomy with radiation for most women because it is less traumatic physically and emotionally, and avoids the problems from reconstructing a breast. For more information about this, see a booklet printed by the National Cancer Institute, the NIH, AHRQ, and the National Research Center for Women & Families here.

If you have been diagnosed with a pre-cancerous condition such as Stage 0 breast cancer, including ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS), it is very unlikely that you need a mastectomy. Women with LCIS do not have breast cancer and most will never get breast cancer. They do not need a mastectomy or even a lumpectomy, although they do need regular mammograms. Most women with DCIS can choose lumpectomy with radiation, rather than mastectomy. For more information, see our booklet here.

For women with breast cancer who want to have breasts, the preferred choice is usually to keep their breasts (rather than remove their breasts and create new ones). Although a lumpectomy can make the breast smaller or change the shape, it will still have the sensation of a natural breast. In contrast, a woman who has a mastectomy with reconstruction, either with implants or with tissue transferred from elsewhere in her body, will have “breast shapes” that do not have any feeling. They are numb. Reconstruction also requires at least two surgeries. Reconstructed breasts may look fuller or “younger” but when the options are explained to them, many women would prefer to have sensation in their breast (or breasts), and would prefer not to have to worry about complications and the need for additional surgery.

If a woman needs to have a mastectomy, because the DCIS has spread throughout the breast or the cancer is large, there are several choices for reconstruction: saline breast implants, silicone breast implants, and moving tissue to create a new breast, such as a TRAM flap (Transverse Rectus Abdominis Myocutaneous flap) or DIEP flap (Deep Inferior Epigastric Perforator flap).

Many plastic surgeons know how to reconstruct breasts using breast implants, but few are skilled at moving tissue (which is called autologous tissue transfer). That is one of the reasons why so many plastic surgeons recommend breast implants.

Saline or Silicone? Some surgeons prefer silicone gel breast implants to saline, because they feel more natural. However, saline breast implants are approved by the FDA as “reasonably safe” and silicone gel implants are not. That is why women getting silicone gel breast implants must agree to be in a study. The goal is to find out how many complications or problems arise in these women in order to decide whether they are safe enough to approve. You would be part of an experiment to find out if the implants are “safe enough” for other women.

One problem with silicone breast implants is that they can break without a patient knowing it. Although less embarrassing than an instant deflation (which is likely with saline), breakage without symptoms is a bad thing, not a good thing. If silicone gel breast implants break and leak, the silicone can get into lymph nodes and travel to the lungs, liver, and brain. No research has been done on those risks, but a study by scientists at the National Cancer Institute found that women with breast implants were twice as likely to die from brain cancer or lung cancer compared to other plastic surgery patients. More research is needed, but those findings are cause for concern.

If saline implants break they are usually easy to remove. If silicone implants break, they can leak and can be extremely difficult and expensive to remove carefully. For that reason, we believe that saline are safer than silicone, even though both have very high complication rates.

Risks. All breast implants, even saline implants, are enveloped in an outer shell made of silicone. The envelope also contains other chemicals and heavy metals, such as microscopic amounts of platinum or tin, which vary during the manufacturing process. Unfortunately, some women have a reaction to those substances. Although silicone is considered “biocompatible” and most people don’t have an immediate allergic or autoimmune response, some people do, and many more develop a response years later.

It’s impossible to predict who will have problems with breast implants, and who won’t. It’s important to know that all implants will eventually break, sometimes within a few months or years, and usually within 10 years. Sometimes women who have a mastectomy get breast implants to replace one breast and to make the other breast look more similar to the replaced breast. However, it’s important to know that either silicone or saline breast implants interfere with mammograms. They show up white on the film, hiding tumors that are above or below.

Alternatives to Implants. An alternative to breast implants is “autologous tissue transfer,” such as the TRAM flap and DIEP flap procedures. These procedures use a woman’s own fat and tissue is used to reconstruct the breast. Many women prefer it to implants because it feels more natural and apparently lasts for a very long time (possibly forever, although the procedure has mostly been done in the last 15 years so it’s impossible to say). However, both the TRAM flap and DIEP flap procedures are more expensive than implants, require an especially skilled surgeon for a good result, and the healing process usually takes at least several months and can be painful. Women are only able to get this surgery if they have enough body fat in their abdomen area or back to form breasts. And, like a breast implant reconstruction, the breast has no feeling. For a woman who has the tissue transferred from her abdomen area (in an operation that has been compared to a “tummy tuck”), there is some loss of muscle in that area. That can be a problem for athletic women, but many other women don’t mind.

The DIEP flap is a similar type of reconstruction but does not remove any muscle. Instead, for the DIEP flap, the surgeon only removes fat and other tissue and makes a small cut in the abdominal muscle. Since no part of the abdominal muscle is removed, patients are able to maintain abdominal strength, making this surgery a better option for most women, especially those who are physically active.

Fortunately, TRAM flaps and DIEP flaps are covered by some health insurance companies. These are complicated surgeries with long recovery times and you would need to find a physician who is very experienced doing these procedures, and we highly recommend asking the doctor to put you in touch with other patients who were happy with the reconstruction.

 

For examples of women who had less pain and other symptoms after their implants were removed, see the personal stories on our website at http://www.breastimplantinfo.org/personal-stories/. You also might want to check out www.explantation.com to hear from women who have had their implants removed and not replaced. Many felt healthier, happier, and more attractive afterwards.

We hope this information is helpful. For more information, check out http://www.breastimplantinfo.org/breast-reconstruction/surgical-alternatives/ or feel free to write to us at info@center4research.org / info@stopcancerfund.org

The comments and statements of the National Research Center for Women & Families are believed and intended to be accurate, and where applicable, based on scientific literature. NRC’s statements do not constitute medical diagnoses, medical advice, plans of treatment, or legal opinion, and we are not responsible for the use or application of this information. All medical information should be reviewed with your health care practitioner.

We hope that the information we’ve provided is helpful. In order to maintain this free service to all women and their families, we invite your tax-deductible contributions to NRC (see http://www.center4research.org/contribute/ )

Are Mastectomies Necessary for Women with BRCA1 or BRCA2? What About for Women Without the Breast Cancer Gene?

Diana Zuckerman, PhD, and Megan Polanin, PhD, Cancer Prevention & Treatment Fund

When Angelina Jolie publicly announced her double mastectomy in 2013, she was praised for possibly saving many women’s lives. But we know more today than we did then and experts now agree that too many women are undergoing unnecessary mastectomies. Here are the facts.

A review of 10 studies found that the risk of getting breast cancer for an average woman with BRCA1 is 57%. The risk is 49% for a woman with BRCA2.[1] Keep in mind that for younger women, the lifetime risk of breast cancer is very different from the risk of getting breast cancer in the next 10 years or even 20 years. According to experts, a 40-year-old woman with the BRCA1 gene has a 14% chance of getting breast cancer before she turns 50.[2] That is not nearly as frightening, and with regular screening and all the progress in breast cancer treatments, the survival rate from breast cancer is higher than ever. Many breast cancer patients live long and healthy lives.

Most women are diagnosed with breast cancer at early stages, making it safe to undergo a lumpectomy (which removes just the cancer) rather than a mastectomy (which removes the entire breast). Yet American women are undergoing prophylactic mastectomies at a higher rate than women in other countries — many of them medically unnecessary.[3] Breast cancer experts believe that many women undergoing mastectomies do not need them and are getting them out of fear, not because of the actual risks.

In recent years, we have seen an increase in women with early-stage breast cancer choosing to get a double mastectomy. For example, a 2015 study conducted by researchers at Vanderbilt University reported that, for women diagnosed with early-stage breast cancer in one breast, the rates of double mastectomy increased from 2% to 11% from 1998 to 2011.[4] Researchers found that decisions to have a double mastectomy increased more for two groups of women: 1) Women with ductal carcinoma in situ (DCIS) where there are abnormal cells inside a milk duct in the breast that won’t spread and aren’t dangerous and 2) Women with cancer only in the breast that has not spread to the lymph nodes.

This year, researchers from Emory University and colleagues published a study focused on women diagnosed with early-state breast cancer in one breast.[5] They found that, from 2004 to 2012, the percentage of these women 45 years or older who got double mastectomies more than doubled from 4% to 10%. For women ages 20-44, the percentage tripled from 11% to 33%. Researchers found that it mattered where women lived in the United States. For example, in five Midwestern states (Nebraska, Missouri, Colorado, Iowa, and South Dakota), 42% of the women who got surgery decided to get a double mastectomy.

For many years, experts have known that women who undergo lumpectomies for a non-invasive condition called ductal carcinoma in situ (DCIS) or for early-stage breast cancer live just as long as women undergoing mastectomies. However, the latest research goes a step further: a study conducted in the Netherlands of more than 37,000 women with early-stage breast cancer found that the women undergoing lumpectomies were more likely to be alive 10 years later than women with the same diagnosis who underwent a single or double mastectomy.[7] They were also less likely to have died of breast cancer.

In 2016, Harvard cancer surgeon Dr. Mehra Golshan published a study of almost half a million women with breast cancer in one breast. She reported that those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast.[6]

These are just the most recent studies. For more information about the many studies that show the benefits of less radical surgery, see this article.

The bottom line is that women with DCIS or early-stage breast cancer have more effective and less radical treatment options than mastectomy. We need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.

The research clearly shows that mastectomies are not the best choice for most women if they want to live longer. Women should be aware of treatment choices for breast cancer and encouraged to make decisions based on their own unique situations. For each woman, it is important to weigh her own risk of cancer — in the next few years, and not just over her lifetime – and the risks of various treatments. Each woman should make the decision that is best for her, based on the facts, not on fear.

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

References

  1. Chen, S., & Parmigiani, G. (2007). Meta-analysis of BRCA1 and BRCA2 penetrance. Journal of Clinical Oncology, 25(11), 1329-1333.
  2. Chen, S., Iversen, E. S., Friebel, T., Finkelstein, D., Weber, B. L., Eisen, A., … & Corio, C. (2006). Characterization of BRCA1 and BRCA2 mutations in a large United States sample. Journal of Clinical Oncology, 24(6), 863-871.
  3. Metcalfe, K. A., Birenbaum‐Carmeli, D., Lubinski, J., Gronwald, J., Lynch, H., Moller, P., … & Kim‐Sing, C. (2008). International variation in rates of uptake of preventive options in BRCA1 and BRCA2 mutation carriers. International journal of cancer, 122(9), 2017-2022.
  4. Kummerow, K. L., Du, L., Penson, D. F., Shyr, Y., & Hooks, M. A. (2015). Nationwide trends in mastectomy for early-stage breast cancer. JAMA surgery, 150(1), 9-16.
  5. Nash, R., Goodman, M., Lin, C. C., Freedman, R. A., Dominici, L. S., Ward, K., & Jemal, A. (2017). State variation in the receipt of a contralateral prophylactic mastectomy among women who received a diagnosis of invasive unilateral early-stage breast cancer in the United States, 2004-2012. JAMA surgery.
  6. Wong, S. M., Freedman, R. A., Sagara, Y., Aydogan, F., Barry, W. T., & Golshan, M. (2017). Growing use of contralateral prophylactic mastectomy despite no improvement in long-term survival for invasive breast cancer. Annals of surgery, 265(3), 581-589.
  7. van Maaren, M. C., de Munck, L., de Bock, G. H., Jobsen, J. J., van Dalen, T., Linn, S. C., … & Siesling, S. (2016). 10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study. The Lancet Oncology, 17(8), 1158-1170.
  8. Hwang, E. S., Lichtensztajn, D. Y., Gomez, S. L., Fowble, B., & Clarke, C. A. (2013). Survival after lumpectomy and mastectomy for early stage invasive breast cancer. Cancer, 119(7), 1402-1411.
  9. Kurian, A. W., Lichtensztajn, D. Y., Keegan, T. H., Nelson, D. O., Clarke, C. A., & Gomez, S. L. (2014). Use of and mortality after bilateral mastectomy compared with other surgical treatments for breast cancer in California, 1998-2011. JAMA, 312(9), 902-914.

Are breast implants safe? What is FDA’s Track Record?

Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

In 2013, a study showed that a rare cancer of the immune system, ALCL, which had previously been linked to saline breast implants and silicone breast implants, was caused by breast implants and could be fatal.  The latest research indicates that this cancer is sometimes cured by removing the breast implants, but at other times also requires radiation and chemotherapy; in some cases, the patients died despite treatment. Although the FDA had reported in 2011 that ALCL might be caused by breast implants, the agency didn’t update its website when the 2013 study was published.  It took the FDA more than 3 more years to revise articles on its website indicating that breast implants caused ALCL ( to conclude that breast implants could cause ALCL. The FDA reported that they have received 359 reports of ALCL among women with breast implants through February 2017. It’s likely there are still numerous unreported cases; for example, Australia’s medical agency estimates that one in 1,000women with breast implants develops ALCL.  There is no reason to think American women would be less likely to develop ALCL, and that would result in several thousand U.S. women developing ALCL

This is just the latest bad news for women with breast implants, and for the government agencies that have allowed them on the market with inadequate studies or warnings.  For example, in 2011, tens of thousands of defective breast implants made by PIP were recalled in Europe. An article in the December 2012 issue of the British medical journal Reproductive Health Matters explains how these developments illustrate the strengths and weaknesses of the safeguards intended to protect patients in different countries from unsafe breast implants and other medical devices.  In the U.S., breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. This standard is higher than the FDA requires for hip joints, numerous cardiac devices, and many other medical implants. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in Europe. As a result of these differing standards, the PIP breast implants that were recalled across Europe had already been removed from the U.S. market years earlier. The FDA was justifiably proud that they had done a better job of protecting breast cancer patients and cosmetic augmentation patients than the EU regulatory system. Nevertheless, the FDA track record on breast implants shows how limited those safeguards can be. The FDA required two breast implant companies to conduct enormous 10-year studies of breast implants, but has done little to ensure that the studies are providing useful information to patients.

The authors conclude that neither the European Union nor the U.S. has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation. In addition, the CEO of PIP was sentenced to 4 years in prison by a French Court, and in January 2017, a French court demanded that the German regulatory company that had certified PIP implants as safe pay $60 million euros to women harmed by PIP implants. This is only 3,000 euros each to 20,000 women, however.

Meanwhile, the FDA shows no indication that they will improve their safeguards on breast implants or other medical implants; in fact, those safeguards have weakened since 2012.

For more information about ALCL caused by breast implants, see:

Miranda RN, Aladily TN, Prince HM, et al: Breast implant–associated anaplastic large-cell lymphoma: Long-term follow-up of 60 patients. J Clin Oncol 32:114-120, 2014.

Mazzucco, AE.  Next Steps for Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol, 2014.  Early Release publication. June 16, 2014.

After Mastectomies, an Unexpected Blow: Numb New Breasts

Roni Caryn Rabin, The New York Times: January 29, 2017

After learning she had a high genetic risk for breast cancer, Dane’e McCree, like a growing number of women, decided to have her breasts removed. Her doctor assured her that reconstructive surgery would spare her nipples and leave her with natural-looking breasts.

It did. But while Ms. McCree’s rebuilt chest may resemble natural breasts, it is now completely numb. Her nipples lack any feeling. She cannot sense the slightest touch of her breasts, perceive warmth or cold, feel an itch if she has a rash or pain if she bangs into a door.

And no one warned her.

“I can’t even feel it when my kids hug me,” said Ms. McCree, 31, a store manager in Grand Junction, Colo., who is raising two daughters on her own.

Plastic surgeons performed more than 106,000 breast reconstructions in 2015, up 35 percent from 2000. And they have embraced cutting-edge techniques to improve the appearance of reconstructed breasts and give them a more natural “look and feel” — using a woman’s belly fat to create the new breast, sparing the nipple, minimizing scarring with creative incisions and offering enhancements like larger, firmer lifted breasts.

Read the rest of the article here.

Sientra’s Silimed Brand “Gummy Bear” Silicone Gel Breast Implants Pose Safety Questions

Mingxin Chen, MHS and Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund

gummy-bear-bubblegum

In December 2012, the U.S. Food and Drug Administration (FDA) approved Sientra’s for its “Silimed silicone gel breast implants.” These implants are also called “gummy breast implants” because they are made of a thicker gel that is said to resemble candy gummy bears.

To gain approval, the company was required to submit the results of a clinical trial to prove that the implants were safe and effective. A 5-year study of these implants was published in the November 2012 issue of Plastic and Reconstructive Surgery, authored by three Sientra employees and several plastic surgeons who were paid by Sientra to conduct the research.[1] The study included 1,788 participants with 3,506 breast implants.

Re-operation, Rupture, and Capsular Contracture

The three major complications measured were need for a re-operation, rupture, and capsular contracture. They can occur at any time, and become more common as the implants age. Capsular contracture refers to the formation of scar tissues around breast implants which becomes hard and potentially painful as the patients’ immune system reacts to the implant. MRIs were conducted on 571 of the 1788 participants to assess rupture that has no obvious symptoms.

The study indicated that the overall risk of rupture during the five years of the study was 2%, but that is misleading because the rupture rate was higher when “silent ruptures” measured by MRI were counted. MRI is the most accurate way to determine if an implant is ruptured, and more than 4% of first-time augmentation patients had a rupture within 5 years, which is much higher than expected. The risk of capsular contracture was 9% overall, and did not vary much for the different types of patients.

In contrast, the risk of reoperation varied considerably: 43% for first time reconstruction patients, 48% for reconstruction revision patients, compared to 17% for first time augmentation patients and 30% for augmentation revision patients. Revision patients are those whose previous implants were replaced with the Sientra implants.

Other Complications

There were many other complications affecting appearance and health. Most complications are highest for patients whose implants are for reconstruction after mastectomy; for example, 11% have asymmetry, 5% have an infection; 4% have breast pain, 4% of the implants are not in the correct position, and 3% have abnormal scarring. Complications are even higher for reconstruction patients who had earlier implants replaced by Sientra implants: 15% have breast asymmetry, 7% have implants in the wrong place, 5% have breast lumps or cysts, and 4% have breast pain.

For first-time augmentation patients, 3% have nipple sensation changes (either losing sensation or painfully sensitive) and 3% have sagging breasts. As noted earlier, reoperation, capsular contracture, and rupture are more common. Other complications, such as pain and swelling, add up, but each of these others complication is below 3%. Among revision augmentation patients, 5% have implants in the wrong position, 3% develop sagging breasts, 3% have wrinkling around the implant, and 3% have breasts that look asymmetrical.

Despite these high level of complications within only five years was high, the authors defended the implants. For example, they stated that over half of the patients who removed or replaced their implants did so for cosmetic reasons, predominantly patient request for style/size change. Regardless of the reason however, additional surgery is expensive and puts the patient at risk. And for breast cancer patients who chose mastectomy and implants so they would not have to think about cancer, these surgeries are a very unwelcome reminder.

The authors claimed Silimed is superior to the other two implant brands, Allergan and Mentor, in terms of risk of complications, as its risk of capsular contracture among first-time and revision augmentation patients within 5 years is 9% and 8%, in comparison with Allergan’s 13% and 17%, and Mentor’s 9% and 20%, both within 4 years.

Sientra, based in Santa Barbara, California, is the third largest global manufacturer of silicone implantable devices. The approval of the first gummy bear implants was welcomed by plastic surgeons, who pointed out that these implants had been manufactured and distributed outside of North America for 15 years.  However, the FDA approved the implants based on only 3 years of data, rather than the longer studies that would have been possible since the implants were on the market for 15 years.

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

Reference

Stevens, W. G., Harrington, J., Alizadeh, K., Berger, L., Broadway, D., Hester, T. R., . . . Beckstrand, M. (2012, November). Five-Year Follow-Up Data from the U.S. Clinical Trial for Sientraʼs U.S. Food and Drug Administration–Approved Silimed® Brand Round and Shaped Implants with High-Strength Silicone Gel. Plastic and Reconstructive Surgery, 130(5), 973-981.

Can Vitamin D Prevent Cancer?

Tracy Rupp, PharmD, MPH, RD and Mingxin Chen, MHS, Cancer Prevention & Treatment Fund

Although people all over the world can develop cancer, cancer patients are more likely to survive in areas of the world that receive the most sun.[1]  Since our skin makes vitamin D when exposed to sun, researchers wondered if vitamin D protects against cancer.  New research suggests that vitamin D may help women diagnosed with breast cancer to survive the disease.

The Evidence for the Role of Vitamin D in Breast Cancer

In November 2016, a study published in a major cancer journal looked at the association between vitamin D levels and survival in 1666 women with newly diagnosed invasive breast cancer in California. Among the participants, women with the highest vitamin D levels in their blood (the top one-third among the women in the study) were 28% less likely to die from all causes as compared to women with the lowest vitamin D levels (bottom one-third) in their blood. The association between vitamin D and survival was even stronger in premenopausal women: those with the highest vitamin D levels were 55% less likely to die from all causes and 63% less likely to die from breast cancer, as compared to premenopausal women with the lowest vitamin D levels.[2]

These results are similar to a study published in 2014, which also found that women with higher levels of vitamin D were more likely to survive breast cancer. This study used meta-analysis to pool the results from 5 previously published studies of the relationship between vitamin D levels and mortality from breast cancer. The study found that among 4443 breast-cancer patients, women with the highest vitamin D levels (about 30 ng/mL) were about half as likely to die from breast cancer as those with the lowest levels (less than 20 ng/mL).[3]

Since both studies found that women with higher vitamin D levels were more likely to survive the disease, we wonder: could the chances of improving survival really be so simple? Not necessarily. These two studies can’t tell us which came first: breast cancer or low vitamin D levels. For example, it’s possible that breast cancer causes vitamin D levels to drop. That’s one of the reasons it would be premature to recommend more vitamin D for women diagnosed with breast cancer.

The Evidence for the Role of Vitamin D in Melanoma

A study published in 2016 found that low levels of vitamin D may result in worse outcomes for patients diagnosed with the type of skin cancer called melanoma.[4] In this study, melanoma patients who had vitamin D levels less than 20 ng/mL were more likely to have larger tumors and more advanced disease than melanoma patients with higher levels of vitamin D. The researchers also examined inflammation and found that low vitamin D levels predicted poor outcomes for patients regardless of their levels of inflammation.

This result may seem very surprising, since sunlight exposure increases vitamin D and also increases the risk of developing skin cancer. A study is ongoing in Belgium to see whether vitamin D supplements will reduce the chances of skin cancer returning or worsening.[5] While it’s too early to recommend widespread vitamin D supplements for skin cancer, it’s reasonable to check vitamin D levels in patients with melanoma or who have been treated for melanoma. If their vitamin D levels are low, a supplement is an easy way to try to bring levels into the normal range.

What Is Vitamin D?

Vitamin D helps the body use calcium and phosphorus to make strong bones and teeth. Our bodies make vitamin D when our skin is exposed to direct sunlight. We can also benefit from the vitamin D that is added to milk and cereals.

How Much Vitamin D Is Recommended for Healthy People?

Approximately one-third of children and adults in the U.S. (over 1 year of age) do not get enough vitamin D.[6] The Institute of Medicine recommends the following daily amount of vitamin D for average healthy adults:[7]

  • For those between 1 and 70 years of age, including women who are pregnant or lactating, the recommended dietary allowance (RDA) is 600 IU per day.
  • For those 71 years or older, the recommendation is 800 IU per day.

Experts agree that just 15 minutes of sun at mid-day in the summer is enough. Of course, this varies based on how much skin is exposed (darker skinned people may need more time), the time of the day (mid-day is best for vitamin D), altitude (the higher the altitude you are at the more vitamin D your body can make). It is also more difficult to get enough make enough vitamin D from the sun during the winter. If you live anywhere north of Los Angeles, then you really can’t get much vitamin D from November to March when the sun is very low in the sky. Thus, we have to rely on the vitamin D we were able to store up during the summer or the vitamin D we can take in through our diets and supplements.

How Much Vitamin D Is Too Much?

Given the possible link to reducing cancer, you might wonder if you should take vitamin D supplements even though the results of these studies are not conclusive. It is important to remember that too much of any nutrient, including vitamin D, can be unhealthy. The safe maximum of vitamin D for adults and children older than 8 years of age is about 4000 IU per day.[8]

Dietary supplements are more likely than foods to provide too much vitamin D.  Although too much sun exposure is dangerous because of skin cancer, it will not cause vitamin D toxicity.

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

Reference

  1. Grant WB. Ecologic studies of solar UV-B radiation and cancer mortality rates (abstract), Recent Results Cancer Res. 2003;164: 371-7.
  2. Yao, S., Kwan, M. L., Ergas, I. J., Roh, J. M., Cheng, T. D., Hong, C., . . . Kushi, L. H. (2016). Association of Serum Level of Vitamin D at Diagnosis With Breast Cancer Survival. JAMA Oncology.
  3. Mohr SB, Gorham ED, Kim J, et al. Meta-analysis of vitamin D sufficiency for improving survival of patients with breast cancer. Anticancer Research. 2014;34:1163-66.
  4. Fang S, Sui D, Wang Y, et al. Association of vitamin D Levels with outcome in patients with melanoma after adjustment for C-reactive protein. J Clin Oncol. 2016;34:1741-1747.
  5. Vitamin D supplementation in cutaneous malignant melanoma outcome. ClinicalTrials.gov Identifier: NCT01748448. https://clinicaltrials.gov/ct2/show/NCT01748448?term=Vitamin+D+supplementation+in+cutaneous+malignant+melanoma+outcome&rank=1 Accessed January 19, 2017.
  6. National Center for Health Statistics. NCHS Data Brief: National Health and Nutrition Examination Survey, 2001–2006. Available from: http://www.cdc.gov/nchs/data/databriefs/db59.pdf. Accessed September 21, 2015.
  7. Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: National Academies Press; 2011.
  8. Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: National Academies Press; 2011.

What Women Need to Know About Inflammatory Breast Cancer

Susan Dudley, PhD, Cancer Prevention & Treatment Fund

Inflammatory breast cancer is a rare type of breast cancer that is very fast-growing and aggressive. It makes up only one to five percent of all breast cancer patients—so infrequent that many breast care specialists have never met a patient who has it.

Inflammatory breast cancer does not typically form a lump inside the breast. Instead, the first symptoms are usually clearly visible on the breast, and they are often similar to the symptoms of relatively harmless insect bites, skin conditions, or breast infections that have no relation to cancer.

Be alert for:

  • changes in the size or profile of the breast that can include a) unusual swelling or enlargement, or b) “inversion” or flattening of the nipple
  • changes in the color of the skin on a third or more of the breast that may look like a rash or bruise and may be red or purple
  • changes in the texture of the skin such as thickening, development of “ridges” or of dimples or pits that look a bit like the texture of the skin of an orange
  • changes in how the skin feels such as persistent itchiness or being warm to the touch
  • swelling in the lymph glands that are under the arm or over the collar bone.

Compared to other types of breast cancer, inflammatory breast cancer is more common in younger and African American women, as well as women who are obese. Like other types of breast cancer, inflammatory breast cancer is occasionally diagnosed in men. These men tend to be older than women affected by inflammatory breast cancer.[1]

Even though the chances of having a rare disease like inflammatory breast cancer are extremely small, symptoms like these should never be ignored. A medical evaluation is necessary to rule out more common (and less serious) causes like simple breast infection, as well as other serious problems like Paget’s Disease of the breast (see “A New Kind of Breast Cancer?: Paget’s Disease“)

What to Do

If you have symptoms that persist for more than a few days, well-respected breast surgeon Dr. Susan Love recommends antibiotics and close watching for two weeks. If the problem is caused by a bacterial infection, the medication should result in noticeable improvement in 10-14 days. If the problem is caused by a viral infection, it won’t respond to the antibiotic so it will probably either a) get significantly worse or b) run its course and get much better in 10-14 days. Any of these outcomes is good news. On the other hand, if there is no change in the symptoms within 10 to 14 days with antibiotic treatment, you need to make an appointment with a breast specialist for a biopsy as soon as possible.

Diagnosis and Treatment

The changes that lead to a diagnosis of inflammatory breast cancer usually occur over a period of only a few weeks. It is likely that it has already spread to other parts of the body before any symptoms appear.

Mammograms are not usually effective in detecting inflammatory breast cancer. Even though an MRI exam might provide earlier diagnosis, this is not a realistic option for women without symptoms. A biopsy is needed for an accurate diagnosis. In addition, a diagnosis is more likely if the redness covers at least a third of the breast.[2]

Treatment is similar to the treatment for other invasive breast cancers – including chemotherapy, surgery, radiation, and hormonal therapy. The average survival for patients diagnosed with Stage III inflammatory breast cancer is a little less than five years and the average survival for patients diagnosed with Stage IV inflammatory breast cancer is just under 2 year.[3] Survival rates are significantly worse for African Americans diagnosed with inflammatory breast cancer, possibly because they tend to be diagnosed later.[4]

How Worried Should Women Be?

Inflammatory breast cancer is a rare disease, so the chances of your getting it are quite small. Awareness of what symptoms to look for and of how to go about having those symptoms evaluated is the most important defense against this and any disease.

Additional information about IBC can be found at:

To separate fact from fiction on other Internet Health info, click here.

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

References

  1. Bertucci F, Ueno NT, Finetti P, et al. Gene expression profiles of inflammatory breast cancer: correlation with response to neoadjuvant chemotherapy and metastasis-free survival. Annals of Oncology 2014; 25(2):358-365.
  2. National Cancer Institute. Inflammatory Breast Cancer. January 6, 2016. http://www.cancer.gov/types/breast/ibc-fact-sheet
  3. Surveillance, Epidemiology, and End Results Database, National Cancer Institute, 2015.
  4. Bertucci F, Ueno NT, Finetti P, et al. Gene expression profiles of inflammatory breast cancer: correlation with response to neoadjuvant chemotherapy and metastasis-free survival. Annals of Oncology 2014; 25(2):358-365.

Could a Common and Inexpensive Heart Medicine (Beta-Blockers) Help Cancer Patients Live Longer?

Jessica Cote, Cancer Prevention & Treatment Fund

Beta-blockers are drugs that are usually prescribed for high blood pressure (hypertension), irregularities in heart beat (arrhythmias), and to prevent heart attacks after a first heart attack has already occurred. Beta-blockers work by stopping adrenaline and noradrenaline from triggering the body’s “fight or flight” response to stress or danger.  Beta blockers help the body feel more relaxed, lowering blood pressure and increasing blood flow.

Beta-blockers are taken by so many Americans that they are the fifth most widely prescribed class of drugs.[1]  Since they are safe and inexpensive, wouldn’t it be great if they were effective for treating cancer, too?

Doctors and researchers noticed that when cancer patients took beta-blockers because of their heart disease, they tended to live longer than other cancer patients. They decided to study whether beta-blockers significantly improve survival for several different types of cancer.

How Beta-Blockers Affect Different Types of Cancer

Non-Small Cell Lung Cancer

In a study published in Annals of Oncology in 2013, Hong-Mei Wang and colleagues at the MD Anderson Center in Texas reviewed data from 722 patients with non-small cell lung cancer, the most common type of lung cancer.[2] All patients received radiation therapy to treat their lung cancer, but only some took beta-blockers for heart conditions. Almost all the patients in the study had stage III cancer.

The 155 patients taking beta-blockers survived for an average of almost 24 months while the 567 patients not taking beta-blockers survived for an average of about 18.5 months. In addition to living longer, patients taking beta-blockers lived longer without their lung cancer returning (disease-free survival) and without it spreading to other parts of their body (distant metastasis-free survival). The researchers statistically controlled for other factors that could affect survival, such as the patient’s age, the stage of the cancer, the use of aspirin, and use of chemotherapy, to be sure that the beta-blockers were truly helping slow down the cancer.

Breast Cancer

Six studies published since 2010 have examined how beta-blockers affected breast cancer patients who had been treated with beta blockers for heart disease at the same time they were treated for cancer.[3] All six studies found that breast cancer patients lived longer if they were taking beta-blockers.

A new clinical trial is currently underway to find out what happens to women who take beta-blockers specifically as a breast cancer treatment. However, the results are not yet available.

Ovarian Cancer

Elena Diaz and colleagues at Cedars-Sinai Medical Center published a study in 2012 of 248 women who were treated with surgery and chemotherapy for their ovarian cancer.[4] Twenty-three patients took beta-blockers for high blood pressure or other heart conditions during their cancer treatment. The results showed that women who took beta-blockers were more likely to remain free of ovarian cancer after treatment than women who didn’t take beta-blockers (progression-free survival) and less likely to die from ovarian cancer (disease-specific survival). Women taking beta-blocker lived an average of 56 months after cancer treatment while those not taking beta blocker lived an average of 48 months after treatment. In addition, women who took beta-blockers were 54% less likely to die during the more than 12 years that researchers tracked their health, compared to the women who did not take beta blockers.

Pancreatic Cancer

Hussein Al-Wadei and colleagues at the University of Tennessee published a study in 2009 that showed how beta-blockers were able to halt the progression of pancreatic cancer in animals.[5]  Research is needed to determine if beta-blockers is effective for pancreatic cancer in humans.

Why Might Beta-Blockers Help Cancer Patients?

Adrenaline and noradrenaline, the two neurotransmitters that stimulate the “fight or flight” response, probably trigger tumor growth. When beta-blockers halt the activity of these neurotransmitters, they may therefore help reduce the growth of cancerous tumors.

When the FDA makes a decision to approve a drug, it is always for specific symptoms or diseases, and the risks and benefits for that specific treatment is what the FDA considers. Although generally safe, beta-blockers can cause fatigue, headache, upset stomach, constipation, diarrhea, dizziness, cold hands, shortness of breath, and trouble sleeping.   For that reason, it is not a good idea to use beta-blockers to treat cancer unless there is clear evidence that they are likely to work — that the benefits outweigh those risks.  And, that is the reason that the breast cancer study that is now underway only includes beta blockers for 2 days before and 3 days after the cancer surgery.

In addition to being approved by the FDA to control blood pressure and heart disease, beta-blockers are also approved for preventing migraines, treating essential tremor (ET) in the head, arms and legs, and, as eye drops to treat glaucoma.  Doctors prescribe beta blockers for other reasons , but  taking medicines for non-approved uses can be risky. If a use is not approved, it often means that there is no conclusive evidence showing that the benefits outweigh the risks.  However, it sometimes means that the companies making the drug don’t think FDA approval for the new use will benefit the company financially.  The latter is especially true for drugs that are already on the market and inexpensive, such as beta-blockers.

The Bottom Line

  • Beta-blockers are usually used to treat heart conditions like high blood pressure and an irregular heart beat. New research has shown that these inexpensive drugs may help cancer patients live longer.
  • More research is needed to know which beta-blockers work best when added to cancer surgery, radiation, or chemotherapy, and for which cancers.
  • If you already take beta-blockers for a heart condition, they may provide keep taking them if you are also diagnosed with cancer. If you don’t take beta-blockers but are diagnosed with non-small cell lung cancer or early breast cancer, you may want to ask your doctor whether to take beta-blockers for two days before and three days after your cancer surgery.

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

References

  1. Consumer Reports, Best Buy Drugs: “Using Beta-blockers to treat: High Blood Pressure and Heart Disease.” Updated March 2011. https://www.consumerreports.org/health/resources/pdf/best-buy-drugs/CU-Betablockers-FIN060109.pdf
  2. Wang HM, Liao ZX, Komaki R et al. Improved survival outcomes with the incidental use of beta-blockers among patients with non-small-cell lung cancer treated with definitive radiation therapy. Annals of Oncology 2013.
  3. Barron TI, Sharp L, Visvanathan K. Beta-adrenergic blocking drugs in breast cancer: a perspective review. Therapeutic Advances in Medical Oncology 2012; 4(3):113-125.
  4. Diaz ES, Karlan BY, Andrew JL. Impact of beta blockers on epithelial ovarian cancer survival. Gynecologic Oncology 2012; 127(2):375-378.
  5. Al-Wadei HAN, Al-Wadei  MH, Schuller HM. Prevention of pancreatic cancer by the beta-blocker propranolol. Anticancer Drugs 2009; 20(6):477-482.