Search

Nintynine pts with ≥ 3cm BC, 56 considered having a resectable tumor (group A, T2 3cm or T3, N0-1, M0) and 43 a locally advanced tumor (group B, T4 and/or N2, M0), were treated with PCT consisting of 3 cycles of CEF (CTX 400 mg/m2, EPI 50 mg/m2, 5-FU 500 mg/m2) iv on days 1 and 8, ± G-CSF 300 μg/day so every other day from day 5 to 17. The aims of the study were 1) to substitute conservative for mutilating surgery (group A) or to make resectable unreectable tumors (group B); 2) to improve disease free survial and overall survival (group A and B). Fiftysix pts in the group A and 41 in the group B are evaluable. There were 2 pCR and 46 pPR in group A (85.7%) and 1 pCR and 33 pPR in group B (82.9%). Only 1 pt in group A progressed during treatment. Myclosoppression was the most important side effect, with G3-G4 neutropenia in 42/58 pts (72.41%) treated with CEF plus G-CSF, and in 41/51 pts (80%) treated with CEF alone; the planned dose-intensity of CEF was maintained in 79.31% of the G-CSF pts, and in 31% of the no-G-CSF pts (p<0.0001). For this reason the study is continuing with G-CSF in all of the pts. Breast conserving surgery was carried out in 20/54 pts in group A (37%) and in 8/41 pts in group B(19.5%). The relative low percentage of quandrantectomy in group A was related to a particulary, unfavourable patient population with bifocal or multifocal residual malignancy, or with an extensive intraductal component, and central or retroareolar tumors. After surgery, responsive pts recieved 3 adjuvant cycles of the same CT; non responsive pts recieved 3 cycles of an alternative non-cross resistant adjuvant CT (Vinorelbine + Mitomycin C). Adjuvant CT was followed by RT in pts treated with quadrantectomy or with T4 and/or N2 tumors, and TAM in those with ER+tumors. With a median follow-up of 25 months (range 1–64), we have documented a new disease manifestation in 18 pts in group A (33%) and 16 pts in group B (37.2%). Among the 18 pts who relapsed in group A and the 16 who had a recurrence in group B, 16 and 15, respectively, had a response to PCT (88.8% and 93.7%). The majority of relapsed pts had axillary positive lymphnodes at surgery (66.6 pts group A and 75% group B), notwithstanding the good response to PCT of primary tumor. Therfore, the response to induction chemotherapy of primary tumor may be not sufficient to select the appropriate adjuvant treatment, which should be based on both the response of primary tumor and axillary lymphnodes. In this regard, new biologic parameters (gp 170, p53, bcl-2) will be analyzed.