ABSTRACT
PURPOSE: To evaluate the impact that pre- and postoperatively administered chemotherapy with cyclophosphamide, methotrexate and fluorouracil (CMF) and postoperative chemotherapy vs. postoperative chemotherapy alone have on long-term prognosis. PATIENTS AND METHODS: The ABCSG conducted a nationwide randomized phase III trial in high-risk endocrine non-responsive breast cancer patients comparing pre- and postoperative chemotherapy containing CMF as preoperative treatment vs. postoperative chemotherapy alone between 1991 and 1999. From 1996 the ABCSG-07 protocol was amended to also allow randomization of high-risk endocrine-responsive patients. Of 423 eligible patients with high-risk primary breast cancer, 203 patients were randomly assigned to preoperatively receive three cycles of CMF (cyclophosphamide, methotrexate, fluorouracil; 600/40/600 mg/m(2)) intravenously on day 1 and 8, while 195 patients received postoperative chemotherapy alone. In both groups, three cycles of CMF were given initially, and another three cycles of CMF were administered in node-negative patients, whereas node-positive patients received three cycles of EC (epirubicin, cyclophosphamide; 70/600 mg/m(2)). RESULTS: Overall response rate to preoperative chemotherapy with three cycles of CMF was 56.2%; complete pathological response was achieved in 12 patients (5.9%). Recurrence-free survival was significantly better in patients receiving chemotherapy postoperatively (HR 0.7, 0.515-0.955; P = 0.024). No survival difference was observed between the two therapy groups (HR 0.800, 0.563-1.136; P = 0.213). DISCUSSION: Preoperative chemotherapy with CMF has to be considered as insufficient in high-risk breast cancer patients. Delayed surgery and anthracycline-based chemotherapy result in shorter recurrence-free survival but not overall survival.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Chemotherapy, Adjuvant/methods , Colorectal Neoplasms/metabolism , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/pathology , Cyclophosphamide/administration & dosage , Disease-Free Survival , Female , Fluorouracil/administration & dosage , Humans , Medical Oncology/methods , Methotrexate/administration & dosage , Middle Aged , Prospective Studies , Risk , Treatment OutcomeABSTRACT
INTRODUCTION: In many countries sentinel node biopsy (SNB) has become the standard of care in breast cancer based on a large number of observational studies but without results from prospective randomized trials. The goal of our study was to evaluate the oncological safety of the SNB in breast cancer in a multicenter, nonrandomized setting with comparable groups. PATIENTS AND METHODS: Between 1996/05 and 2004/11, 2942 patients from 14 departments in Austria with unicentric, unilateral, invasive disease without neoadjuvant therapy were collected in a database. The recommendations of the Austrian Sentinel Node Study Group were to complete a training period (phase I) with 50 cases of SNB followed by axillary lymph node dissection (ALND) to prove a detection rate of > or = 90% and a false-negative rate of < or = 5%. In the executing period (phase II), SNB was followed by ALND only if the sentinel node (SN) contained metastases. We compared the results on disease-free survival, local recurrence rates, distant recurrence rates and overall survival of both groups. Cases from phases I and II generated groups I (n=671) and 2 (n=2271 cases), respectively. RESULTS: Overall mean follow-up time: 34.41 months. CONCLUSION: SNB followed by ALND only in cases with metastases in the SN is a safe procedure and at least equal to ALND in all cases.
