Multicenter, randomized phase III study of adjuvant chemotherapy for axillary positive breast cancer (APBC) comparing 6 cycles (cy) of FEC vs 4 cy of FEC followed by 8 weekly paclitaxel (T) administrations: Safety analysis of GEICAM 9906 trial

Abstract

596 Background: Role of weekly T in adjuvant treatment of breast cancer is presently under evaluation in several studies like GEICAM 9906. Objective: This study compared differences in toxicity profile between arms. Methods: Patients (pt) with operable APBC, age: 18–70, Karnofsky ≥ 90, adequate bone marrow, renal and hepatic function, were randomized to receive 6 FEC cy (Fluorouracil 600 mg/m2 [F], Epirubicin 90 mg/m2 [E], Cyclophosphamide 600 mg/m2 [C]) day 1 every 3 weeks (Arm A) or 4 cy of the same schedule followed by 8 weekly doses of T 100 mg/m2 (Arm B). 1.249 pt were recruited in 30 months. 633 pt in arm A and 610 pt in arm B were analyzed for toxicity. Study was conducted as per GCP/ICH with 100% source data verification. Results: Median age was 50.4 years (Arm A) vs 50.2 (Arm B). Median number of FEC cy (A vs B) and T doses were 6 (range 1–6) vs 4 (range 1–4) and 8 (range 1–8), respectively. No statistical differences were found between relative dose-intensities (RDI) of E (98.8 vs 98.8%) and C (...