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.

[A new technique for post-mastectomy breast reconstruction: the Muscular Flag Flap (MFF)]. / Una nuova tecnica per la ricostruzione mammaria post-mastectomia: il muscular FLAG FLAP (MFF).

The possibility of breast reconstruction after a mastectomy resulting from breast cancer is still not widely exploited, and perhaps because it is relatively uncommon and unknown, is not widely practised. The plastic surgeons who were pioneers in this field know just how hard it has been to reach the stage we are at today. This leads to longer operating times, in the context of over-worked operating theaters in which time was already at a premium, and this is expecially the case in peripheral hospitals lacking in-house resources for surgical reconstruction and dependent on outisde specialist consultants. In order to address this problem, a new single-operation surgical technique, MFF (Muscular Flag Flap) has been developed. The surgical techniques adopted at present are based on immediate reconstruction or successive reconstruction. The MFF technique was developed as a response to demand for intraoperative reconstruction even when "demolition" is extensive and the breast large. This will reduce the need to operate the contralateral breast. Upper and lower pectoralis major muscle flaps are created in order to produce a large enough pocket for the final prothesis. The elasticity of this muscle is such that a large pocket is possible. The pectoralis major muscle will then envelop at least two thirds of the prosthesis. Projection of the reconstructed cone and a more anatomically normal profile are obtained. This method gives excellent esthetic results in a single operation. Thanks to the collaboration of the hospitals of Ivrea, Pinerolo and Alba over a period of approximately one year, about 80 patients have been very successfully treated using this techhnique. Rapid functional and social recovery have been observed, with no particular problems. In view of the above, we confirm that this new surgical technique will be of considerable benefit to patients.

[Palliative gastric resection]. / Le resezioni gastriche palliative.

The surgical treatment of stomach carcinoma is reassessed. Stress is laid on the more aggressive attitude with regard to advanced gastric cancer where total or partial palliative resection is the only operation offering good results. This tendency emerges both from the series presented and those reported in the literature. It is concluded that if more aggressive surgery is justified in IVth stage stomach tumours it must still depend on the patient's general condition.

[Tumors of the anus]. / I tumori dell'ano.

On the basis of an analysis of a personal series of anal tumours, it is concluded that the polychemotherapeutic protocol with mitomycin and 5-fluorouracil and extensive local tumour removal proposed by Nigro et al. could present a valid alternative to Miles anorectal amputation. The treatment proposed offers better quality of life for the patient without changing oncological radicality and survival.

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.

Differential patterns of bone turnover in relation to bone pain and disease extent in bone in cancer patients with skeletal metastases.

BACKGROUND: The alteration of the bone microenvironment as a consequence of skeletal metastases is poorly understood. The aim of this study was to search for patterns of bone markers in relation to primary tumor type, bone pain, and number of sites involved in patients with bone metastases. METHODS: We studied 323 patients with bone metastases from various primary malignancies. We sequentially measured the serum concentrations of bone alkaline phosphatase [by an electrophoretic technique (BALP)], carboxy-terminal telopeptide of type I collagen (ICTP), calcium (CaS), intact parathyroid hormone (PTH), and the fasting urinary excretion of calcium (Ca:Cr). Immunoradiometric serum bone alkaline phosphatase (I-BALP) and urinary excretion of deoxypyridinoline (DPYD) were also assessed in the 175 cases. Data were analyzed as a function of bone pain (assessed by a validated pain questionnaire), the number of radiographically confirmed sites of bone involvement, and the most frequent primary tumor types: breast cancer (BC; 124 patients), prostate cancer (PC; 90 patients), and non-small cell lung cancer (LC; 49 patients). RESULTS: Serum BALP and I-BALP correlated with the number of radiologically identified blastic bone lesions. BALP and I-BALP were more frequently increased in PC (72% for both measurements) than in BC (50% and 60%, respectively) or LC (3% and 5%, respectively; P <0.001 for BALP and P = 0.001 for I-BALP). ICTP and DPYD values did not differ among PC, BC, and LC, but they did show a direct relationship with the disease extent in bone (P <0. 001). CaS and Ca:Cr did not vary significantly according to the bone tumor burden. Bone pain directly correlated with ICTP (P <0.001), DPYD (P = 0.002), CaS (P <0.002), and Ca:Cr (P = 0.001), whereas the relationship was inverse for serum PTH (P = 0.002). When patients were stratified according to the primary tumor, ICTP correlated with the bone pain in all subsets (P <0.005, <0.005, and <0.001 for BC, PC, and LC, respectively), as did CaS and Ca:Cr in LC patients (P = 0.01 and 0.02, respectively) but not in PC and BC patients. CONCLUSIONS: The patterns of bone turnover markers differ among the primary tumor types. Both resorption and formation markers reflect the number of radiographically identified sites of bone metastases, whereas resorption markers and serum calcium but not formation markers correlate with bone pain.