贝伐单抗
福克斯
医学
奥沙利铂
叶酸
危险系数
临床终点
卡培他滨
内科学
结直肠癌
肿瘤科
随机对照试验
中性粒细胞减少症
无进展生存期
外科
置信区间
化疗
癌症
作者
Evaristo Maiello,G. Di Maggio,Stefano Cordio,Saverio Cinieri,Francesco Giuliani,Salvatore Pisconti,Antonio Rinaldi,Antonio Febbraro,Tiziana Pia Latiano,Michele Aieta,Antônio Rossi,Daniele Rizzi,Massimo Di Maïo,Giuseppe Colucci,Roberto Bordonaro
标识
DOI:10.1016/j.clcc.2020.01.003
摘要
Introduction Biweekly schedule of XELOX-2 (capecitabine plus oxaliplatin) showed interesting results in first-line therapy of patients with metastatic colorectal cancer (mCRC). Bevacizumab plus FOLFOX-4 (oxaliplatin, folinic acid, and infusional 5-fluorouracil) is among standard first-line treatment options in this setting. We performed a phase II randomized trial in order to evaluate the activity of bevacizumab plus either FOLFOX-4 or XELOX-2 in first-line therapy of patients with mCRC. Materials and Methods Patients with mCRC were randomized, in a 1:2 ratio, to first-line bevacizumab plus either FOLFOX-4 (Arm A), as calibration arm, or XELOX-2 (Arm B), up to 12 cycles. Patients without progression were further randomized to maintenance bevacizumab alone or with the same induction fluoropyrimidine. The primary endpoint was objective response rate (ORR); secondary endpoints included progression-free survival, overall survival, and toxicity. The study design was formally non-comparative, but exploratory comparison was performed. Results Forty-five patients were randomized in arm A and 87 in arm B with an ORR of 55.6% versus 48.3% (P = .43), respectively. After a median follow-up of 47.2 months, progression-free survival was 10.0 versus 9.9 months (hazard ratio, 0.96; 95% confidence interval, 0.65-1.41; P = .84) and overall survival was 29.8 versus 25.0 months (hazard ratio, 1.21; 95% confidence interval, 0.77-1.92; P = .41), respectively. The main grade 3 to 4 toxicities (% A/B) were: neutropenia 15/3 and nausea 9/5. Conclusion This exploratory analysis showed that biweekly XELOX-2 plus bevacizumab has a comparable ORR with FOLFOX-4 plus bevacizumab in patients with mCRC.
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