After reviewing the recent literature on nipple-sparing mastectomy, Dr. Scott Spear and his colleagues1 propose a “Georgetown algorithm” for nipple-sparing mastectomy in the setting of breast cancer. These authors state that “there is a developing consensus by those interested in nipple-sparing mastectomy that it is best suited for women who meet certain criteria.” As reflected in the algorithm, the best candidates for nipple sparing include women with negative axillary lymph nodes and tumors less than 3 cm in diameter that are more than 2 cm from the nipple. Because of concerns about nipple viability in the setting of nipple-sparing mastectomy, the authors note that women with “excessively” large or ptotic breasts should be excluded. I disagree with both of these elements of the algorithm and would like to explain why.
Spear et al. base their recommendations on recently published clinical series.2,3 Why they dismiss earlier studies is unclear. In 1984, Hinton et al.4 reported a series of 98 patients with stage I and II breast cancer subjected to nipple-sparing mastectomies. No differences were noted in local recurrence or overall survival with a median follow-up of 56 months. Kissin and Kark5 made recommendations regarding tumor size and lymph node status for nipple-sparing mastectomy in 1987. Spear et al. note that “there were no scientifically based selection criteria and therefore no possibility of ever demonstrating efficacy.” It seems to me that these authors were very careful with their selection criteria and they did demonstrate efficacy. The question is why such studies were not accepted either then or (apparently) now. I submit that these studies were not generally adopted because of concerns about the size and organization of the trials—a fate that current efforts at advancing nipple preservation should avoid.
What is the best evidence that nipple-sparing mastectomy is a “safe” procedure? Is the best evidence derived from the relatively small, nonrandomized, retrospective data cited above? Or is the best evidence for the safety of nipple-sparing mastectomy the data derived from the breast conservation literature as I originally argued in this Journal more than 7 years ago?6 This question is not just rhetorical because recommendations about nipple sparing should be based on the best data available.
Although they were not designed to do so, breast conservation studies have proven the safety of nipple-sparing mastectomy. In the National Surgical Adjuvant Breast and Bowel Project B-06 trial,7 women were randomized into one of three treatment groups: modified radical mastectomy, lumpectomy alone, and lumpectomy with radiation therapy. In two of these groups, all nipples were spared. In the mastectomy group, all nipples were taken. After 20 years of careful follow-up, there was no difference in survival among any of the groups. Only one conclusion is possible: initial removal of the nipple does not prolong survival in the treatment of breast cancer.
If we think about nipple-sparing mastectomy as just a giant lumpectomy (with skin and nipple preservation), the B-06 trial proves the relative safety of the technique. If we base selection criteria for nipple sparing on small retrospective series or on studies of non–nipple-sparing mastectomy specimens, there is no reasonable store of data on which to base our claims of the safety of the technique. If we base our selection criteria on the selection criteria for the B-06 study, the largest, best controlled study of breast cancer ever performed confirms our practice.
My second objection to the Georgetown algorithm is that women who are at high risk for nipple loss should be excluded from nipple preservation. For the past decade, I have been performing a surgical delay on the nipple and surrounding breast skin in high-risk patients (Figs. 1 through 3). This procedure has the additional advantage that the subnipple biopsy can be subjected to permanent section analysis before mastectomy. In some cases, patients have wanted to change their selection of reconstructive technique (from tissue expander to flap) when they were told that their nipples could not be preserved.
At the risk of seeming disrespectful to the highly eminent and admirable Dr. Spear, I would like to propose a different algorithm (Table 1) for nipple preservation. This algorithm includes all tumors of the breast 4 cm and smaller, with positive or negative lymph nodes, and no skin involvement (the selection criteria used in the B-06 trial). In the B-06 trial, margins less than 1 mm were acceptable. As I argued earlier,7 I believe that the subnipple biopsy of ducts must be at least 1 cm in thickness—it should be a pancake of tissue that includes the cut mammary ducts and surrounding tissue beneath the areola—but I concede that this more rigorous requirement is not strictly based on the B-06 trial. In addition, without the foundation of the B-06 data, I believe that nipple preservation is still possible in patients with tumors larger than 5 cm with clear 1-cm subnipple biopsy specimens. In these situations, the addition of radiation therapy8 would make nipple recurrence highly unlikely.
I would like to congratulate Dr. Spear on his fine work and look forward to his critique of my counteralgorithm.
J. Arthur Jensen, M.D.
John Wayne Cancer Center
Geffen School of Medicine at the University of California, Los Angeles
2001 Santa Monica Boulevard, Suite 790W
Santa Monica, Calif. 90404
1. Spear SL, Hannan CM, Willey SC, Cocilovo C. Nipple sparing mastectomy. Plast Reconstr Surg
2. Gerber B, Krause A, Reimer T, et al. Skin-sparing mastectomy with conservation of the nipple-areolar complex and autologous reconstruction is an oncologically safe procedure. Ann Surg
3. Crowe JP, Kim JA, Yetman R, Banbury J, Patrick RJ, Baynes D. Nipple-sparing mastectomy. Arch Surg
4. Hinton CP, Doyle PJ, Blamey RW, Davies CJ, Holliday HW, Elston CW. Subcutaneous mastectomy for primary operable breast cancer. Br J Surg
5. Kissin MW, Kark AE. Nipple preservation during mastectomy. Br J Surg
6. Jensen JA. When can the nipple-areolar complex safely be spared during mastectomy? Plast Reconstr Surg
7. Fisher B, Stewart MD, Anderson H, et al. Twenty year follow up of a randomized trial comparing total mastectomy, lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med
8. Punglia RS, Morrow M, Winer EP, Harris JR. Local therapy and survival in breast cancer. N Engl J Med
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