贝伐珠单抗联合 FOLFOX-4 或 XELOX-2 一线治疗转移性结直肠癌患者：意大利南部肿瘤组（GOIM 2802）的一项多中心随机 II 期试验。

Bevacizumab in Combination With Either FOLFOX-4 or XELOX-2 in First-line Treatment of Patients With Metastatic Colorectal Cancer: A Multicenter Randomized Phase II Trial of the Gruppo Oncologico dell'Italia Meridionale (GOIM 2802).

机构信息

Division of Medical Oncology, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo (Foggia), Italy.

出版信息

Clin Colorectal Cancer. 2020 Jun;19(2):109-115. doi: 10.1016/j.clcc.2020.01.003. Epub 2020 Jan 30.

DOI:10.1016/j.clcc.2020.01.003

PMID:32089455

Abstract

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.

摘要

简介

XELOX-2（卡培他滨加奥沙利铂）每两周一次的方案在转移性结直肠癌（mCRC）的一线治疗中显示出了有趣的结果。贝伐珠单抗联合 FOLFOX-4（奥沙利铂、亚叶酸钙和持续输注 5-氟尿嘧啶）是该治疗环境下的标准一线治疗选择之一。我们进行了一项 II 期随机试验，以评估贝伐珠单抗联合 FOLFOX-4 或 XELOX-2 一线治疗 mCRC 患者的疗效。

材料和方法

mCRC 患者以 1:2 的比例随机分配至一线贝伐珠单抗联合 FOLFOX-4（A 组，作为校准组）或 XELOX-2（B 组），最多 12 个周期。无进展的患者进一步随机分为单独维持贝伐珠单抗或联合相同诱导氟嘧啶。主要终点为客观缓解率（ORR）；次要终点包括无进展生存期、总生存期和毒性。研究设计为非比较性，但进行了探索性比较。

结果

A 组有 45 例患者随机分组，B 组有 87 例患者随机分组，ORR 分别为 55.6%和 48.3%（P=0.43）。中位随访 47.2 个月后，无进展生存期分别为 10.0 个月和 9.9 个月（风险比，0.96；95%置信区间，0.65-1.41；P=0.84），总生存期分别为 29.8 个月和 25.0 个月（风险比，1.21；95%置信区间，0.77-1.92；P=0.41）。主要的 3-4 级毒性（% A/B）为：中性粒细胞减少 15/3 和恶心 9/5。