Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan
Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, Nagoya, Japan.
Oncologist. 2018 Aug;23(8):919-927. doi: 10.1634/theoncologist.2017-0640. Epub 2018 Jul 26.
PURPOSE: The aim of this randomized, multicenter, noncomparative, phase II trial was to investigate the efficacy and safety of two potential first-line treatments, capecitabine and oxaliplatin (CapOX) plus bevacizumab (BEV) and capecitabine and irinotecan (CapIRI) plus bevacizumab, in Japanese patients with metastatic colorectal cancer (mCRC). PATIENTS AND METHODS: Patients with untreated mCRC were randomly assigned to receive either CapOX plus bevacizumab (CapOX/BEV arm: bevacizumab 7.5 mg/kg and oxaliplatin 130 mg/m on day 1 and oral capecitabine 2,000 mg/m on days 1-14, every 3 weeks) or CapIRI plus bevacizumab (CapIRI/BEV arm: bevacizumab 7.5 mg/kg and irinotecan 200 mg/m on day 1 and capecitabine 1,600 mg/m on days 1-14, every 3 weeks). The primary endpoint was overall response rate (ORR), and the secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. RESULTS: A total of 107 patients were enrolled. The intent-to-treat population comprised 54 patients in the CapOX/BEV arm and 53 patients in the CapIRI/BEV arm. The median follow-up period was 35.5 months. ORR was 56% in the CapOX/BEV arm and 55% in the CapIRI/BEV arm. Median PFS and OS were 12.4 and 26.7 months in the CapOX/BEV arm and 11.5 and 28.7 months in the CapIRI/BEV arm, respectively. The frequencies of hematological and nonhematological adverse events above grade 3 were 13% and 30% in the CapOX/BEV arm and 25% and 23% in the CapIRI/BEV arm, respectively. CONCLUSION: CapOX plus bevacizumab and CapIRI plus bevacizumab are equally effective and feasible as the first-line treatments in Japanese patients with mCRC. IMPLICATIONS FOR PRACTICE: The CCOG-1201 study was designed to evaluate the efficacy and safety of capecitabine and oxaliplatin plus bevacizumab and capecitabine and irinotecan plus bevacizumab as a first-line treatment in Japanese patients with metastatic colorectal cancer. This article reports on the trial and efforts to define the role of these regimens, including the effect of status and polymorphisms in metastatic colorectal cancer.
目的：本随机、多中心、非对照、Ⅱ期临床试验旨在研究两种潜在一线治疗方案（卡培他滨联合奥沙利铂和贝伐珠单抗[CapOX/BEV]以及卡培他滨联合伊立替康和贝伐珠单抗[CapIRI/BEV]）在未经治疗的转移性结直肠癌（mCRC）日本患者中的疗效和安全性。
患者和方法：未经治疗的 mCRC 患者被随机分配接受 CapOX/BEV 治疗（CapOX/BEV 组：贝伐珠单抗 7.5 mg/kg，奥沙利铂 130 mg/m2 于第 1 天，卡培他滨 2000 mg/m2 于第 1-14 天，每 3 周 1 次）或 CapIRI/BEV 治疗（CapIRI/BEV 组：贝伐珠单抗 7.5 mg/kg，伊立替康 200 mg/m2 于第 1 天，卡培他滨 1600 mg/m2 于第 1-14 天，每 3 周 1 次）。主要终点为总缓解率（ORR），次要终点包括无进展生存期（PFS）、总生存期（OS）和安全性。
结果：共纳入 107 例患者。意向治疗人群包括 CapOX/BEV 组 54 例患者和 CapIRI/BEV 组 53 例患者。中位随访时间为 35.5 个月。CapOX/BEV 组和 CapIRI/BEV 组的 ORR 分别为 56%和 55%。CapOX/BEV 组和 CapIRI/BEV 组的中位 PFS 和 OS 分别为 12.4 个月和 26.7 个月、11.5 个月和 28.7 个月。CapOX/BEV 组和 CapIRI/BEV 组≥3 级血液学和非血液学不良事件的发生率分别为 13%和 30%、25%和 23%。
结论：CapOX 联合贝伐珠单抗和 CapIRI 联合贝伐珠单抗作为日本 mCRC 患者的一线治疗方案同样有效且可行。
临床意义：CCOG-1201 研究旨在评估卡培他滨联合奥沙利铂和贝伐珠单抗与卡培他滨联合伊立替康和贝伐珠单抗作为日本转移性结直肠癌患者一线治疗的疗效和安全性。本文报告了该试验，并努力确定这些方案的作用，包括状态和基因多态性对转移性结直肠癌的影响。
World J Gastroenterol. 2010-7-7
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