Breast-conservative surgery with and without radiotherapy in patients aged 55-75 years with early-stage breast cancer: a prospective, randomized, multicenter trial analysis after 108 months of median follow-up.

OBJECTIVES: Breast-conserving therapy (BCT), including postoperative whole breast irradiation (WBI), is generally accepted as the treatment of choice for most patients with early-stage breast cancer. The question whether WBI is mandatory in all patients remains one of the most controversial issues in BCT. To answer this question, a randomized, prospective, multicentre study was launched in January 2001. Primary endpoints of the study were to assess the cumulative incidence of in-breast-recurrences (IBR) and overall survival (OAS) after conservative surgery (BCS) with or without WBI. METHODS: From January 2001 until December 2005, 749 patients with unifocal infiltrating breast cancer up to 25 mm, 0-3 positive axillary lymph nodes, no extensive intraductal component or lymphvascular invasion from 11 centres in Italy, were randomly assigned to BCS+WBI (arm 1:373 patients) or BCS alone (arm 2:376 patients). Treatment arms were well balanced in terms of baseline characteristics. Systemic adjuvant therapy was administered according to the institutional policies. Kaplan-Meier method was used for survival analysis and log-rank test to evaluate the difference between the two arms. RESULTS (Last analysis 31.12.2012): After median follow-up of 108 months, 12 (3.4%) IBR were observed in arm 1 and 16 (4.4%) in arm 2. OAS was 81.4% in arm 1 and 83.7% in arm 2. There was no statistically significant difference regarding IBR and death in the two treatment groups. CONCLUSIONS: These data are promising and suggest that WBI after BCS can be omitted in selected patients with early stage breast cancer without exposing them to an increased risk of local recurrence and death. Longer follow-up is needed to further consolidate these results.

Conservative surgery with and without radiotherapy in elderly patients with early-stage breast cancer: a prospective randomised multicentre trial.

Breast conserving therapy (BCT) including postoperative irradiation of the remaining breast tissue is generally accepted as the best treatment for the majority of patients with early-stage breast cancer. The question is whether there is a necessity for irradiating all patients. Between 2001 and 2005, 749 women aged 55-75 years with infiltrating breast carcinoma were randomly assigned to breast conservative surgery, with or without radiotherapy (RT), to evaluate the incidence of in-breast recurrence (IBR). After 5 years of median follow-up, the cumulative incidence of IBR was 2.5% in the surgery-only arm and 0.7% in the surgery plus RT arm. There are no differences in terms of overall survival and distant disease-free survival. The preliminary evaluation suggests that breast irradiation after conservative surgery can be avoided without exposing these patients to an increased risk of distant-disease recurrence. Prolonged follow-up will further clarify the possible risks and late sequelae potentially induced by breast RT.

Nipple sparing mastectomy: an innovative skin incision for an alternative approach.

Choice of the most appropriate surgical treatment for breast cancer patients can also be a technical issue. Cosmetic results after conservative surgery can be poor in certain instances and, at the same time, total mastectomy can appear as an over-treatment. For some selected patients, the "nipple sparing mastectomy" (NSM) is an alternative surgical treatment and more and more papers on this technique are appearing in the literature. One hundred and two NSMs have been performed in our department between June 2003 and October 2006, initially via periareolar skin incision, now through a skin incision on the lateral aspect of the breast to reduce the necrotic risk for the nipple. The lateral skin incision saves the integrity of skin blood supply, allows for a complete breast gland removal and saves the integrity of the body image of women who show no scars when seen upfront.

A prospective, randomized, controlled clinical trial of tissue adhesive (2-octylcyanoacrylate) versus standard wound closure in breast surgery.

BACKGROUND: Recent studies suggest that the use of tissue adhesive for closure of both traumatic lacerations and incisional surgical wounds leads to cosmetic outcome comparable to conventional sutures. To date, no studies have investigated tissue adhesive in breast surgery and costs. Our aim was to compare the tissue adhesive 2-octylcyanoacrylate (OCA) with standard suture in breast surgery. METHODS: A prospective randomized study was conducted in which 151 patients were assessed for eligibility, and 133 were randomly allocated to skin closure with OCA adhesive or monofilament suture. Cosmetic outcome with blinded assessment, wound management by the patients, complication rates, and economic outcome were recorded. RESULTS: There was no difference in cosmetic score in the 2 groups, nor in complications at the early, 6-month, and 1-year follow-up. Patient satisfaction with the wound closed with OCA was rated significantly higher when compared with standard suture (P <.0001). The application of the tissue adhesive was significantly faster than that for standard suture (P <.001). In economic terms total costs were less in the tissue adhesive group, mainly due to lower postoperative costs of physician and assistant services (P <.001). CONCLUSIONS: OCA is effective and reliable in skin closure for breast surgery, yielding similar cosmetic results to standard suture. OCA is faster than standard wound closure and offers several practical advantages over suture repair for patients. Cost analysis has found that OCA adhesive can significantly decrease health care costs.

Hemodynamic parameters of anesthetized pigs: a comparative study of farm piglets and Göttingen and Yucatan miniature swine.

We studied the evolution in time of the main hemodynamic parameters in farm piglets and Göttingen and Yucatan miniature swine anesthetized with droperidol, flunitrazepam, and alpha-chloralose. Measurements included arterial pressure, heart rate, intraventricular pressure, and maximum rate of increase during contraction (dp/dt max). For each parameter and each strain of swine, we determined the mean stability period defined as the longest period of time during which the observed values ranged between their mean value +/- 15% and the mean absolute values during the stability period. In our experimental conditions, the parameters remained constant for 2 to 3.5 hours. Only minor interstrain variations were noticed.

Central small size breast cancer: how to overcome the problem of nipple and areola involvement.

For centrally located small tumours we have sought, with the aid of a plastic surgeon, to achieve the same radicality as in the other quadrants, while achieving a good cosmetic result. We considered 37 patients with small centrally located breast carcinoma, in whom we performed a new surgical technique. From analysis of this series it emerged that a high percentage (54.1%) had nipple and areolar involvement, suggesting their removal; it is no problem to sacrifice these when a good cosmetic result can be achieved by plastic remodelling.