Nipple-sparing subcutaneous mastectomy and immediate reconstruction with implants in breast cancer

Abstract: Introduction: The surgical treatment of breast cancer has changed rapidly since Halsted´s operation was generally abandoned about 50 years ago. In the 1970s partial mastectomy (PM), followed by radiotherapy (RT), was proven to be oncologically safe for smaller cancer tumours that are not multifocal. For others, approximately 40% of breast cancer patients, modified radical mastectomy (MRM) is the most usual operation, often followed by a reconstruction with autogeneous tissues or implants and in combination with tissue expansion. During the past decade, skin-sparing mastectomy has become a standard operation in many places, but sparing of the nipple-areola complex (NAC) is still a very controversial issue. When this trial started in 1988 very few patients were offered any form of reconstruction after MRM. Aim: To evaluate nipple-sparing subcutaneous mastectomy and immediate reconstruction with implants (NSM) for patients with breast cancer not suitable for PM. Patients and methods: During six years 272 patients with breast cancer not suitable for PM were operated on with NSM, and the present papers report results from five trials on those concerning sensibility in the breast (Paper I, 80 patients), circulation in the breast (Paper II, 43 patients), the rate of capsular contracture (CC) in patients with subcutaneously placed saline-filled implants with textured surfaces (Paper III, 107 patients), the CC-rate around MistiGold II® hydrogel-filled implants (Paper IV, 41 patients) and survival, rate of locoregional recurrences (LRR) and the outcome after (first event) LRR (Paper V, 216 patients) as well as the effect of radiotherapy (RT) on these factors (all papers). The operation was performed through a submammary incision in the majority of cases (217 patients). A biopsy for frozen section was taken from underneath the nipple, which was removed only in cases of malignancy in this. 40% of the patients had lymph node metastases; 12% had cancer in situ, 88% invasive cancer. 22% received RT postoperatively, 25% chemotherapy and 57% hormone therapy. At least one year postoperatively, skin sensibilty was measured with von Frey´s monofilaments, circulation with laser Doppler fluxmetry and fluorescein flowmetry, and CC was measured by the Baker/Palmer classification and applanation tonometry under five years postoperatively. Median follow-up in the survival study was 13 years. Results: Normal (<3.2 milliNewton) or subnormal sensibility was found in the operated breast outside the areola, subnormal on the areola outside the nipple. One third of the patients had normal sensibility in the nipple while 14% lacked sensibility. No reduction was found in skin circulation, whether RT was given or not. The CC-rate was 20.6%, significantly higher for irradiated breasts than for non-irradiated ones, 41.7 and 14.5%, respectively, but a single reoperation with capsulotomy gave very good long-term results. All of the Misti Gold II® implants had to be removed because of CC and increase in volume (up to 50%). Disease-free survival (DFS) was 51.3%, overall survival 76.4% (OS) and the rate of LRR 24.1% (after median 13 years). DFS and OS but not LRR were significantly affected by lymph node status.The survival rates compare well with reported results after MRM in other trials. In irradiated patients the rate of LRR was 8.5%. Survival after LRR was slightly better than has been reported after MRM. The specificity at frozen section was 98.5%. At the end of follow-up 85% of the patients had their nipple-areola complexes intact. Conclusions: NSM is an oncologically safe procedure in breast cancer given that frozen section excludes malignancy in a biopsy from underneath the nipple. It results in naturally looking breasts with very satisfactory skin circulation and sensitivity, and the rate of CC is acceptable. Misti Gold II® hydrogel-filled implants are not suitable for this procedure. Radiotherapy dramatically reduces the rate of LRR and increases the rate of CC but does not affect superficial skin circulation.