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21 December 2016

A study published in JAMA Surgery found that in women with early stage breast cancer, a surgeon recommendation against removal of the unaffected, healthy breast (known as a contralateral prophylactic mastectomy or CPM) often led to the patient not undergoing that procedure. However, if the surgeon did not make a specific recommendation for or against the procedure, the patient often did undergo CPM.

Over the past 10-15 years, the rates of CPM have been increasing in patients with early stage breast cancer.  While a woman may have valid reasons for this decision, the increasing CPM rates are concerning for many reasons. CPM does not improve outcomes or survival from breast cancer, and complications can be significant. Earlier this year, the American Society of Breast Surgeons (ASBrS) published a consensus statement recommending against the routine use of CPM in average risk women. The statement also advised physicians to make a specific recommendation for or against CPM when counseling patients.

CPM has been associated with younger age, receipt of genetic testing (even with negative results), family history of breast cancer, receipt of MRI, higher education level, and increased worry about breast cancer recurrence. In the JAMA Surgery study, the authors assessed patient knowledge about and motivations for CPM. In addition, they evaluated the impact of surgeon recommendations regarding CPM.

Over 2500 women completed the survey. Among those who considered CPM, 38% knew that it would not improve survival, and 44% knew that it did not prevent breast cancer recurrence. In the group of patients considered to be at average risk for the development of another breast cancer (no genetic abnormality or other high risk factors):

  • 598 (39%) received a recommendation against CPM and 12 (2%) received it
  • 746 (47%) received no recommendation from their physician and 148 (19%) received it

Very few patients who received a recommendation against CPM underwent the procedure. This does not mean that we should go back to the days of physicians telling patients what to do. Rather, the authors noted that “shared decision making requires that physicians participate actively in ensuring that patients’ knowledge is accurate.” This point was reinforced in the invited commentary published with the article. While CPM may turn out to be the right decision for an individual patient, it is important that the decision is made after education and careful consideration of the potential risks, benefits, and limitations of the surgery.

 

During the April 2016 meeting of the American Society of Breast Surgeons (ASBrS), a consensus conference was held to discuss contralateral prophylactic mastectomy (CPM). CPM is the removal of the healthy, opposite breast, and the rates of CPM have been increasing, for various reasons.

A patient’s decision to undergo a CPM is very difficult and is unique to each individual with breast cancer. Consensus statements and guidelines are not mandates. Rather, they are recommendations based on the best available evidence. In addition, the ASBrS statement specifically states that this document was developed to guide patient and physician discussion, and should not influence insurance coverage for the procedure.

The summary of the document states: “The consensus group agreed that CPM should be discouraged for an average risk woman with unilateral (one side) breast cancer. However, patient’s values, goals and preferences should be included to optimize shared decision making when discussing CPM. The final decision whether or not to proceed with CPM is a result of the balance between benefits and risks of CPM and patient preference”

The full statement is available online (open access) in two parts. Part 1 covers the data on CPM outcomes and risks. Part 2 discusses additional considerations and a framework for shared decision making.

Some key points noted in the manuscript include:

  • Breast conservation is preferable in appropriate patients, and neoadjuvant therapy and/or oncoplastic approaches should be considered to facilitate breast conservation
  • The risk of contralateral breast cancer (breast cancer developing in the opposite breast – CBC) in an average risk woman with breast cancer is 0.1-0.6% per year. CBC risk is higher for women diagnosed at a young age, those with a strong family history of breast cancer, and genetic mutation carriers
  • CPM does not appear to be associated with a survival benefit, with the possible exception of BRCA mutation carriers
  • CPM doubles the rate of surgical complications
  • Bilateral reconstruction may provide for improved cosmetic outcome
  • Sentinel lymph node surgery on the CPM side should not be routinely performed
  • CPM is a cost effective strategy in women with BRCA mutations. There is insufficient evidence to support cost-effectiveness in average risk women, and this is highly dependent on quality of life assumptions
  • 80-90% of women report satisfaction with their decision to undergo CPM but 20-30% of these women report post-surgical dissatisfaction with cosmesis, body image, and sexuality. Women should be counseled on the potential long term outcomes of CPM on body image and sexuality
  • CPM rates should not be used as a national quality measure
  • Additional education, resources on risks and benefits, stronger patient engagement, and enhanced decision making guidelines are needed. Shared decision making that includes a comprehensive discussion of risks and benefits is important

As I noted above, this is a difficult decision, and one that should not be made without significant education, thought, and discussion. The decision making process will likely be different for each woman. It is important that patients take their time to become educated about all of their options, and work with a treatment team who will provide you with the necessary time, educational resources, and support, to make the decision that is right for you.

19 January 2015

This past weekend, I gave a talk at the Southern California Chapter of the American College of Surgeons Annual Meeting – the title of the talk was Increasing Mastectomy Rates – Science vs. Personal Choice.

There is a tremendous amount of literature documenting the increasing mastectomy rates. The talk focused on women with early stage breast cancer at average risk for developing a recurrence or new cancer – women without a BRCA gene mutation. As has been my practice for several years when giving a talk which includes the patient experience, I asked you for input, and received a lot of information. The following is a summary of the talk, including your perspective.

The use of mastectomy for breast cancer has been documented as early as the 1500s, despite the fact that general anesthesia did not come into use until the 1840s. Sir William Halsted described the radical mastectomy, which involved removal of the breast, all of the overlying skin, the pectoral (chest) muscle, and a significant number of lymph nodes. It was a very aggressive surgery but at the time, many women at the time presented with advanced disease – cancers that grew through the skin or chest muscle. The Halsted theory was that if the breast and lymph nodes could be removed with an extensive “en bloc” surgery, the cancer had a lower likelihood of spreading. However, despite this aggressive approach, the dismal survival rates from breast cancer did not improve.

Halsted died in 1922, but the radical mastectomy remained the surgical procedure of choice until the 1960-70s. The landmark NSABP B04 trial, led by Dr. Bernard Fisher, demonstrated that regardless of surgical decision (radical mastectomy vs. total mastectomy – no removal of the muscle) the survival rates were equivalent, and these results have held up for 25 years(1). The Fisher theory was that cancer may be metastatic from the beginning, and that a more extensive surgical procedure would not be expected to improve survival rates. The NSABP B06 trial demonstrated equivalent survival rates whether women underwent mastectomy, lumpectomy / radiation, or lumpectomy alone. However, if radiation therapy was not performed, the risk of local recurrence (cancer returning in the breast) was 39.2%, compared to 14.3% with radiation(2). This is the basis for our current recommendation of lumpectomy followed by radiation therapy for early stage breast cancer. A 1990 NIH consensus panel stated that “breast conservation treatment is an appropriate method of primary therapy for the majority of women with early-stage breast cancer and is preferable because it provides survival rates equivalent to those of mastectomy while preserving the breast’’(3).

This was seen as a major scientific advance, and one that was embraced by patients – no longer did women need to have a breast removed for early stage disease, and from the early to mid 1990s, lumpectomy rates started increasing while mastectomy rates decreased.

The Women’s Health and Cancer Rights act of 1998 stated that if an insurance company covered the procedure of mastectomy, they were required to cover reconstructive surgery, including procedures performed on the other breast to produce a symmetrical appearance, as well as prosthetics for lymphedema. This set the stage for immediate reconstruction, which prior to this time was generally not performed (or recommended) on a regular basis.

We think of the “Celebrity Effect” when we hear Angelina Jolie, Amy Robach, and others discuss their decisions. But in 1987, Nancy Regan underwent a mastectomy for breast cancer, and she received a significant amount of criticism for her decision, both from the medical community as well as from advocacy groups. Women who underwent breast cancer surgery from the end of 1987 to early 1988 were 25% less likely to undergo lumpectomy compared to earlier in 1987, prior to her diagnosis(4). Lumpectomy rates subsequently increased, but she later wrote “This is a very personal decision, one that each woman must make for herself. This was my choice, and I don’t believe I should have been criticized for it”(5).

Around 2004, it was noted that mastectomy rates started rising(6). This trend was seen nationally as well as in many individual institutions.

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In addition to an increase in mastectomies being performed for early stage breast cancer, an increase has been seen in contralateral prophylactic mastectomy – removal of the other, non-cancerous breast. Many studies have been published confirming this trend, and also evaluating factors associated with an increased mastectomy rate(7,8,9). They include:
– Young age, Caucasian race
– Higher economic status, better insurance, availability of reconstruction
– Family history of breast cancer or genetic testing – even if the genetic testing was negative
– Undergoing an MRI, even if the MRI was normal

Patient factors have also been evaluated. Many studies have cited that women make their decisions out of fear. Interestingly, there seems to be some intellectual disconnect – women report that they understand there is no improvement in survival, yet state that they made their decision “to live longer”. The physician has been identified as a very important source of information, yet only 1/3 of women stated that a desire to follow their physician’s recommendation was important in making their decision. Many women over-estimate their risk of developing a new breast cancer – some reporting they think their risk is as high as 50%. Other studies have reported that women make their decisions to gain a sense of control over cancer, but that many have an exaggerated sense of control, stating that they are making the decision “so I don’t have to go through this again”, while admitting that they are aware that mastectomy does not reduce the rate of metastatic disease. The impact of a family member / friend experience was also noted to be very important. All of us make decisions in our daily lives based on personal experience rather than hard facts – a woman facing a decision about breast cancer surgery is no different. Finally, many woman remain very satisfied with their decision even 20 years after the surgery. However, it is important to note that 10-30% report issues related to self-esteem, body image, sexuality, emotional stability, and overall quality of life (10, 11, 12).

Some facts(10, 13, 14, 15):
– For women at average risk of breast cancer (BRCA negative) the rate of developing a new breast cancer is approximately 0.5 – 0.75% per year. This can be reduced if the women undergoes chemotherapy and/or endocrine therapy
– Mastectomy for early stage breast cancer or contralateral prophylactic mastectomy does not reduce the likelihood that breast cancer will metastasize (spread to other areas of the body)
– The complication rate increases with more surgery – bilateral mastectomy is associated with 30-40% risk of complications including infection, fluid accumulation, and re-operation.

So what did you, the #BCSM Community have to say? Out of those who responded:
– “I knew survival rates were the same” – most patients well informed, had surgeons who presented all sides, supported their decision
– 40% said decisions influenced by family/friend experience
– 15% had lumpectomy initially, then opted for bilateral mastectomy after anxiety of repeat imaging and biopsies.
– 6 patients: lumpectomy and radiation: significant problems with wound healing, fibrosis and later underwent a mastectomy
– 5 patients subsequently developed metastatic disease; no regrets on their decision
– 3 patients required multiple surgeries due to revisions, infection, lost implant – no regrets
– 2 patients felt pushed into their decision, one by family members and another by their physician – both regretted their decision

There are a lot of comments on the original blog post; here are a few I received by email:
– “I wish doctors, researchers and the media understood (some do) – there are many valid reasons for choosing a mastectomy, even with the state-of-science today”
– “The focus is on ‘simple’ surgery – the potential toxicity of radiation therapy is grossly minimized. While serious and long-term side effects of radiation therapy may be rare, they do occur. It is ironic now that patients have a choice in treatment selection, there is so much hand-wringing by the medical establishment in the choices that many women make”
– “We are diligent. We are thoughtful. We have good reasons for choosing the “big surgery”. Our doctors explain the risk factors, we process the information, we understand the full ramifications of our choice, and are still confident that this is the right choice for our set of circumstances.
– It may not fit the medically necessary criteria, but it may fit with the emotionally necessary criteria. I hear your evidence based science and I’ll raise you five intangibles…”

So what is the answer? Clearly physicians have a responsibility to educate our patients not only on the lack of overall survival benefit, on the complication rates. Physicians also need to do a better job of assessing and explaining a patient’s risk of developing a recurrence or a new breast cancer. And patients should be encouraged to take their time, obtain opinions, and carefully consider all options prior to making a decision. But rather than irrational fear, what many of see in our practice is “Reasonable Fear”. Patient’s biases and personal experiences need to be acknowledged. Some bias, but not all, can be overcome with education. But until science advances to allow us to truly predict who will and will not develop a recurrence or a new breast cancer, personal choice should remain an option.

References:
1. Fisher B et al. 25 Year follow up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. NEJM 2002;347 (8)
2. Fisher B et al. 20 Year follow up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer NEJM 2002;347 (16)
3. NIH Consensus Conference: Treatment of Early Stage Breast Cancer. JAMA 1991 265
4. Nattinger AB, et al Effect of Nancy Regan’s mastectomy on choice of surgery for breast cancer by US women. JAMA 1998 (279) 10 762-766
5. Olson, J: “Bathsheba’s Breast: Women, Cancer and History” The Johns Hopkins University Press 2002
6. McGuire KP, et al Are mastectomies on the rise? A 13 year trend analysis of the selection of mastectomy versus breast conservation therapy in 5865 patients. Ann Surg Oncol 2009 16:2682-2690
7. Mahmood U, et al Increasing national mastectomy rates for the treatment of early stage breast cancer. Ann Surg Oncol 2013 20:1436-1443
8. Yao K, et al Trends in contralateral prophylactic mastectomy for unilateral cancer: A report from the national cancer database 1998-2007. Ann Surg Oncol 2010(17) 2554-2562
9. King TA, et al Clinical management factors contribute to the decision for contralateral prophylactic mastectomy. J Clin Oncol 29:2158-2164 97-200
10. Rosenberg SM, et al Perceptions, knowledge and satisfaction with contralateral prophylactic mastectomy among young women with breast cancer Ann Intern Med 2013;159:373-381
11. Covelli AM, et al ‘Taking control of cancer’: Understanding women’s choice for mastectomy.  Ann Surg Oncol DOI 10.1245/s10434-014-4033-7
12. Frost MH, et al Contralateral prophylactic mastectomy: Long term consistency of satisfaction and adverse effects and the significance of informed decision making, quality of life, and personality traits. Ann Surg Oncol 2011 18:3110-3116
13. Fayanju O et al Contralateral prophylactic mastectomy after unilateral breast cancer: a systematic review and meta-analysis. Ann Surg 2014; 260:1000-1010  
14. Roberts A et al Cost effectiveness of contralateral prophylactic mastectomy for prevention of contralateral prophylactic mastectomy. Ann Surg Oncol 2014 21:2209-2217
15. Miller ME et al  Operative risks associated with contralateral prophylactic mastectomy: A single institution experience. Ann Surg Oncol 2013 204113-4120.

** 6 December 2018 – Editor’s Note:
The NSABP B-39 clinical trial results were recently presented at the San Antonio Breast Cancer Symposium. This study compared 3 forms of radiation therapy. After 10 year followup, approximately 4% of patients who underwent whole-breast irradiation after lumpectomy developed cancer recurrence in the same breast. This is lower than what was quoted below (10-15%, point #3) which was based on older data. This new study demonstrates that the recurrence rate after lumpectomy and radiation (4%) is nearly equivalent to that of mastectomy (1-3%).

3 June 2014

A study was recently published evaluating the reasons why women diagnosed with breast cancer might undergo a contralateral prophylactic mastectomy. First, some definitions:
–       Mastectomy – removal of the entire breast
–       Prophylactic mastectomy – removal of a breast that does not have cancer
–       Contralateral prophylactic mastectomy (CPM) – removal of the breast that does NOT have cancer, in a patient undergoing mastectomy for cancer on the other side

The study, which was published in JAMA Surgery, concluded that “Many women considered CPM and a substantial number received it, although few had a clinically significant risk of contralateral breast cancer. Receipt of magnetic resonance imaging at diagnosis contributed to receipt of CPM. Worry about recurrence appeared to drive decisions for CPM although the procedure has not been shown to reduce recurrence risk. More research is needed about the underlying factors driving the use of CPM.”

Some background information:
1.  Over 25 years’ worth of data exists showing that long-term survival is equivalent whether a woman undergoes a lumpectomy or a mastectomy:  In other words, you will not live any longer if your breast is removed.

2.  There is no difference in the likelihood of metastatic disease (spread outside the breast – most commonly bones, liver, lung and brain) whether you have a lumpectomy or mastectomy.

**see editor’s note, above. 
3.  Lumpectomy followed by radiation therapy (this is also called breast conservation therapy, or BCT) generally has low rates of “in breast recurrence” or “in breast new primary” – low rates of the original cancer coming back in the same breast, or a new cancer developing in the same breast.  These rates are historically about 10-15%, although these rates are likely reduced with modern adjuvant antihormonal, radiation, and chemo- therapies.

4.  Even though much more breast tissue is removed (~99% of breast tissue cells) mastectomy is still associated with a 1-3% risk of cancer recurrence at the site of breast removal.  This is usually in the skin or muscle.

5.  CPM is associated with a 20-40% complication rate, especially unplanned additional surgery

6.  The average woman’s risk of developing a new cancer in the opposite breast is approximately 0.5-1% per year. If a cancer develops in the contralateral (other) breast, it is considered a “new primary” – a whole new breast cancer. Even though it might be the same type as the original cancer, it is generally not considered a recurrence. If the original cancer is estrogen / progesterone receptor positive, taking tamoxifen or aromatase inhibitors can reduce the risk of cancer returning after a lumpectomy, and can reduce the risk of a new cancer developing in the other breast. However, lumpectomy or mastectomy for the original cancer does not alter the rate of new breast cancer development.

7.  Women who carry a BRCA gene mutation have a 60-80+% lifetime risk of developing breast cancer in either breast, and a high risk of developing a new breast cancer, so bilateral mastectomy is often recommended. These patients are generally excluded from the discussions regarding whether or not CPM is a reasonable option due to their extremely high risk.

Over the past 20 years, research studies have supported a “less is more” approach to breast cancer surgery such as: BCT,  narrower margins of normal tissue removed around cancer, and less extensive lymph node removal. Before instituting these changes, studies were done to ensure that less aggressive surgery does not impact long-term survival rates. Despite these advances, there has recently been a steady increase in the rate of mastectomy, as well as CPM.  In article after article, physicians are scratching their heads.  The use of MRI, inadequate education, unrealistic expectations from reconstructive surgery, the “celebrity effect”, as well as fear and anxiety have been blamed.

The “new” study and our thoughts:
The recent study in JAMA Surgery focused on a small subset of women (8%) from a national database that elected CPM as part of treatment for unilateral breast cancer.  The authors reported that of 106 patients who received CPM, “80% indicated it was done to prevent breast cancer from developing in the other breast,” leaving only 21 patients (1.5%) from their sample of 1447 surveyed women that elect CPM for reasons other than the prevention of the development of a new contralateral breast cancer.  However, the author’s conclusions ignore this and direct the reader’s attention instead to patients’ concern for recurrence, stating, again, that “worry about recurrence appeared to drive decisions for CPM.”

The problem with this type of analysis is this:  when ‘patient fear’ is discussed, it frequently is implied by the reporting media that hysterical women are running to the operating room to be unnecessarily operated on by uneducated surgeons.

Judging the merits of a surgical procedure or treatment on the fact that few women “are likely to experience a survival benefit,” is not reflective of the complexity of the treatment decision-making process for women with a new diagnosis of breast cancer.  Faced with a multitude of decisions to make in a short time frame, it is not surprising that many such patients will report anxiety concerning recurrence.

The truth is simple:  surgical choice is a combination of factors. There is little doubt that some physicians do not spend the time needed to hear the concerns of their patients and respond to them appropriately. Conversely, some patients do not want to hear all of the facts, preferring simply to opt for what seems the “safest” approach, even though the science says otherwise.

What we see in our offices is a rational fear: Many women understand that the type of surgery does not determine their survival.  While of utmost importance, survival is not the only thing that is important to women being treated for breast cancer. Women worry about having to repeat the whole process in another year or so if something new shows up on a mammogram or if a lump is felt. Women question the value of annual mammography for surveillance when their initial tumor was not picked up by a mammogram. Women have seen their family members and friends develop complications from radiation therapy and from attempts to perform additional surgery after radiation therapy. While women understand that a mastectomy is no guarantee that they will remain cancer-free, to many it is such a significant decrease in the rate of recurrence or new primary cancer that they feel it is an acceptable trade off for the complication rates that have been reported in patients who undergo a CPM with reconstruction.  Physicians also agonize over the decision.  Properly educated patients are in the best position to make decisions regarding their own breast health care, but even the best education does not alleviate all anxieties, nor can it eliminate all risk.

Physicians and researchers talk about the increasing rate of CPM as a crisis. But the real crisis is that at this point, we simply do not have options for women that they are comfortable with. Unnecessary surgery is a concern for patients and physicians. However, until we can look a woman in the eye and give her more accurate information about her individual risk of recurrence or new primary disease, it is our opinion that the decision for CPM should be between a woman, her family, and her physicians.

Additional Reading:
JAMA Editorial: Contralateral Prophylactic Mastectomy – An Opportunity for Shared Decision Making
Medscape Article – Misconceptions and Fear Prompt Contralateral Mastectomy
The Patient Perspective: Blog Post by Catherine Guthrie

Deanna J. Attai, MD
Michael S. Cowher, MD