Study: What is the risk of breast cancer recurrence after nipple-sparing mastectomy?
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This study is about:
The risk of recurrence following nipple-sparing mastectomy among women with breast cancer.
Why is this study important?
When women have immediate breast reconstruction (at the same time as mastectomy) their breast tissue is removed, but most of the breast skin is retained to accommodate the reconstruction. A traditional mastectomy also removes the nipple and areola (the darker skin around the nipple). During breast reconstruction the surgeon can also recreate the nipple using the patient’s skin. Tattooing can be used to create the appearance of an areola.
With a nipple-sparing mastectomy (NSM) the surgeon saves the nipple and areola along with the breast skin. However, as a surgeon is performing a NSM, a sample of tissue immediately below the nipple-areola complex is examined by a pathologist. If this sample contains invasive cancer or , it is considered positive and the nipple is removed often with the areola. The advantage of NSM is cosmetic. NSM mastectomy incisions are usually made in the crease beneath the breast or horizontally from the areola towards the arm, so that after reconstruction, the new breasts appear to be unchanged.
While NSM improves cosmetic and psychological outcomes, many doctors and patients are concerned that sparing the nipple and areola may increase the risk for breast cancer recurrence, especially since the data on long-term risk of recurrence following NSM is limited. This study is important because it adds to a growing body of evidence suggesting that the long-term risk of local (in the tissue surrounding the breast), regional (to the ), and distant recurrence (in other parts of the body) following NSM is low.
Results from a large, single-institution study entitled "Oncologic Safety of Nipple-Sparing Mastectomy in Women with Breast Cancer" were published in the September 2017 issue of the Journal of the American College of Surgeons. This study followed outcomes of 2,182 NSMs performed at Massachusetts General Hospital from 2007 to 2016. Long-term outcomes were assessed in 311 patients with 0 to III breast cancer; however, 75% of patients followed were 0-I.
- At an average follow-up of 51 months, 17 patients (5.5%) had a recurrence.
- None of the patients in the study population (2,182) had a recurrence that involved the retained nipple or areola.
- At the time of surgery, the nipple margin contained tumor in 20 (6.4%) breasts.
- The rate of nipple loss due to necrosis was 1.7% for all NMS performed during this period.
In this study, the recurrence rate is comparable to that of standard mastectomy matched for and treatment. It is important to note that breast cancer rarely originates or recurs in the nipple, even in high-risk patients.
What does this mean for me?
For many women who face mastectomy, preserving their nipples allows them to keep an emotionally significant part of themselves that boosts their post mastectomy/reconstruction self-image. And although these women lose their own breast tissue, keeping their own nipples enhances the overall natural appearance of their reconstructed breasts. NSM also offers an added bonus: women can forego having new nipples surgically created as part of their reconstruction process. Anyone who has NSM should understand the risk of the procedure and the risk of recurrence related to retaining their nipples and/or areolas.
Importantly, not all women are candidates for NSM which is determined by the size and shape of the breast, location of the current nipple, previous history of radiation, body mass index, and location and size of the cancer. In this study, the body mass index was low suggesting that most patients were thin. Being overweight or obese may make some women ineligible for NSM.
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Smith BL, Tang R, Rai U, et al. “Oncologic Safety of Nipple-Sparing Mastectomy in Women with Breast Cancer.” Journal of the American College of Surgeons. 2017; 225(3):361-365.
“Nipple-Sparing Mastectomy Has Low Rate of Breast Cancer Recurrence.” Press Release from the Journal of the American College of Surgeons.
FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
This article is relevant for:
Breast cancer patients who are considering or have had a nipple sparing mastectomy
This article is also relevant for:
Triple negative breast cancer
Her2+ breast cancer
People with a genetic mutation linked to cancer risk
Breast cancer survivors
Women under 45
Women over 45
Be part of XRAY:
Nipple-sparing mastectomies (NSMs) improve post mastectomy cosmetic outcomes for women who have breast cancer or have a high-risk for it. An increasing number of women undergoing mastectomy for breast cancer are candidates for NSM, including those with larger, node-positive cancers who receive (before surgery) chemotherapy and/or post-mastectomy radiation therapy. As a result, more women are requesting NSM. However, many surgeons and patients are concerned about long-term local recurrence or a new primary breast cancer that could results from breast tissue left beneath the retained nipple.
Researchers of this study wanted to know:
What is the long-term risk of recurrence following NSM?
Population(s) looked at in the study:
Between 2007 and 2012 at Massachusetts General Hospital, 2,182 NSMs were performed in 1,258 patients who were treated for breast cancer or risk reduction. Patients were excluded only if they had cancerous cells in their nipple-areola complex, locally advanced breast cancer in the skin, inflammatory breast cancer, bloody nipple discharge, or if their overly large or droopy breasts would result in undesirable nipple placement on their reconstructed breasts. Data on patients and tumor characteristics; local and systemic treatments; and local, regional and distant recurrence were obtained from patients’ medical records. Outcomes were determined for 311 women with 0 to III breast cancer; within this cohort:
- 240 (77%) had invasive cancer and 71 (23%) had ductal carcinoma in situ ()
- Tumor stages among the 284 patients who did not receive chemotherapy included:
- 25.0% 0
- 50.7% I
- 17.6% II
- 6.7% III
- 33 (11%) of 297 patients had germline mutations in high-risk genes (20 in , 10 in , 2 in p53, and 1 in ).
Median follow-up was 51 months (ranging from 4 to 101 months). During the follow-up period, 17 patients developed a recurrence. Estimated disease-free survival was 95.7% at 3 years and 92.3% at 5 years. No recurrence involved the retained nipple-areola complex. Among patients with recurrent disease there were:
- 11 (37%) locoregional recurrences
- 8 (2.7%) distant recurrences
- 2 patients with simultaneous locoregional and distant recurrences
- 3 of the 7 chest wall recurrences in mutation carriers were:
- 1 patient with a p53 mutation and breast cancer
- 2 patients with mutations, 1 of whom had triple-negative cancer and refused chemotherapy
- No recurrences were found in the retained nipple-areola complex in any of the 2,182 patients who had NSM performed during the study period
The authors recognize there may have been a selection bias and that NSM may have been offered disproportionately to patients who had a good prognosis. Although Massachusetts General no longer bases their recommendations for NSM on tumor size, receptor status or , these factors may have influenced recommendations during the study period. The researchers also concede that although their follow-up period is long enough to exclude early recurrences with aggressive breast cancer types, it may not be sufficient for determining risk of recurrence for hormone receptor-positive cancers, especially since the predicted risk of recurrence in this population of patients with predominately disease would be predicted to be low. They are planning a supplemental study with a longer follow-up period to better estimate the risk of recurrence after NSM in these patients.
Women with any of the following conditions are not candidates for NSM: any evidence of cancerous involvement of the nipple and/or areola; tumors close to the nipple-areola complex that could compromise margins; locally advanced breast cancer involving the skin, or inflammatory breast cancer; or large or sagging breasts that would result in an undesirable nipple placement on the reconstructed breast. Furthermore, NSM is not without challenges, and there is no guarantee that everyone who has it will experience ideal or even satisfactory results. Loss of sensation in the nipples is expected after NSM because nerves are cut when tissue is removed. Patients with unrealistic expectations, who struggle emotionally or who expect full nipple sensation to return may not be good candidates for a NSM.
To date, no study has compared recurrence rates between NSM and standard mastectomy by randomly assigning women to one or the other procedure. However, the low local recurrence rate observed in this and other studies suggest that patients who undergo NSM do not have an increased risk of recurrence. Women planning a mastectomy should ask their surgeons whether they are eligible for a nipple-sparing operation, and what benefits and limitations they should expect.
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(back to top)
- Am I a good candidate for NSM?
- What will my nipple look and feel like after NSM?
- What is my risk of my breast cancer returning after NSM?
- Are there other risks with the procedure?
The following are studies related to breast reconstruction or no reconstruction after mastectomy.
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- NCT04491591: Implementing BREASTChoice Into Practice. Breast reconstruction after mastectomy is a highly personal decision. A clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences, was created to be used to address these issues. This study will evaluate whether BREASTChoice assists reconstruction decisions.
- NCT02927912: Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With I-II Breast Cancer Undergoing Surgery With Reconstruction. This study will look at the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with I-II breast cancer undergoing surgery with reconstruction.
- NCT04293146: Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC. This study will compare the effect of under-the-muscle versus over-the-muscle reconstruction on quality-of-life outcomes.
Who covered this study?
More women with breast cancer opting for nipple-sparing mastectomies This article rates 5.0 out of 5 stars
US News and World Report
'Nipple-sparing' mastectomies don't raise odds of cancer's return: study This article rates 4.0 out of 5 stars
Bel Marra Health
Study finds low rate of breast cancer recurrence after nipple-sparing mastectomy This article rates 3.0 out of 5 stars