Phase III trial comparing 4-cycle doxorubicin plus cyclophosphamide followed by 4-cycle taxan with 8-cycle taxan as adjuvant therapy for node-positive breast cancer: Results of N-SAS-BC02 trial.
T. Watanabe, M. Kuranami, K. Inoue, N. Masuda, K. Aogi, H. Iwata, H. Mukai, S. Tanaka, T. Yamaguchi,
Y. Ohashi
Background: Anthracyclines are the key agents in postoperative regimens for breast cancer (BC). However, relatively rare but life threatening toxicity such as cardiac failure and secondary leukemia are the major concern with anthracycline containing regimens. Retrospective analyses suggested that anthracyclines can be excluded in some pts.
Methods: Eligibility included node positive BC age less than 70 yo. Pts were randomized to receive either AC (doxorubicin 60 mg/m2 + cyclophosphamide 600 mg/m2) every(q) 3 weeks(wks) x 4 -> P (paclitaxel) 175 mg/m2 q3 wks x 4 (ACP), the same AC -> D (docetaxel) 75 mg/m2 q3 wks x 4 (ACD), P 175 mg/m2 q3 wks x 8 (PTX) or D 75 mg/m2 q3 wks x 8 (DTX). Comparison included P vs. D (ACP+PTX vs. ACD+DTX) and with AC or without AC (ACP+ACD vs. PTX+DTX). The primary endpoint was disease free survival (DFS) and the secondary endpoints included overall survival, adverse events (AE) and quality of life (QOL). The trial was powered to prove the non-inferiority of regimens without AC to those with AC (threshold hazard ratio [HR] 1.321) in terms of DFS.
Results: 1,060 pts were accrued between Dec. 2000 and Mar.2006. 270 DFS events and 106 deaths after a median follow-up of 46.5 months were observed. In all randomised patients, 8 cycles taxane is not inferior to 4 cycles AC -> 4 cycles taxane in terms of DFS (HR:1.26 , 95% CI; 0.99–1.60, p=0.67). In the subset of HER-2 positive patients, 4 cycles AC -> 4 cycles taxane produced superior DFS to 8 cycles taxane (HR:1.63, 95% CI:1.05 - 2.54) but this is not observed in patients with HER-2 negative patients (HR:1.13, 95% CI: 0.85 - 1.50). D 75 mg/m2 tends to show superior DFS to P 175 mg/m2 (HR: 0.81, 95% CI; 0.64–1.03, p=0.08). Nausea and vomiting was more frequent with AC -> a taxane than 8 cycles taxane. Edema and febrile neutropenia was more frequently observed with D 75 mg/m2 than P 175 mg/m2. The incidence of sensory neuropathy was higher with P 175 mg/m2 than D 75 mg/m2.
Conclusions: AC improved DFS in the subset of pts with HER-2 overexpressing BC but not in non-selected population. DFS was better in the arms containing D than in the arms with P. Higher incidence of severe AEs was observed in the arms containing D than in arms with P.
編輯: ludongcn 作者:丁香園通訊員
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