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/m2 on day 1 and oral capecitabine 2,000 mg/m2 on days 1-14, every 3 weeks) or CapIRI plus bevacizumab (CapIRI/BEV arm: bevacizumab 7.5 mg/kg and irinotecan 200 mg/m2 on day 1 and capecitabine 1,600 mg/m2 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 KRAS status and UGT1A1 polymorphisms in metastatic colorectal cancer.
摘要
目的.该随机、多中心、非对照 II 期试验旨在研究两种潜在一线治疗方案,即卡培他滨和奥沙利铂(CapOX)联合贝伐单抗(BEV)以及卡培他滨和伊立替康(CapIRI)联合贝伐单抗,对日本转移性结直肠癌患者(mCRC)的疗效和安全性。
患者与方法.未经治疗的 mCRC 患者被随机分配为接受 CapOX 联合贝伐单抗(CapOX/BEV组:贝伐单抗7.5 mg/kg、奥沙利铂130 mg/m2,第1天,卡培他滨2 000 mg/m2,口服,第1–14天,每3周一次)或CapIRI联合贝伐单抗(CapIRI/BEV组:贝伐单抗7.5 mg/kg、伊立替康200 mg/m2,第1天,卡培他滨1 600 mg/m2,第1–14天,每3周一次)。主要终点是总缓解率(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.共招募107名患者。意向性治疗人群包括54名CapOX/BEV组患者和53名CapIRI/BEV 组患者。中位随访期为35.5个月。CapOX/BEV组的ORR为56%,而CapIRI/BEV组的ORR为55%。CapOX/BEV组的中位PFS与OS分别为12.4和26.7个月,而CapIRI/BEV组的中位PFS与OS分别为11.5和28.7个月。高于3级的血液学和非血液学不良事件发生率在CapOX/BEV组分别为13%和30%,在CapIRI/BEV组分别为25%和23%。
结论.日本mCRC患者一线治疗CapOX联合贝伐单抗和CapIRI联合贝伐单抗同样有效和可行。
对临床实践的提示:CCOG‐1201 研究旨在评估卡培他滨和奥沙利铂联合贝伐单抗以及卡培他滨和伊立替康联合贝伐单抗在日本转移性结直肠癌患者一线治疗方案的疗效和安全性。本文报道了确定这些方案作用的试验和成果,包括 KRAS 状态和 UGT1A1 多态性在转移性结直肠癌中的作用。
Keywords: Bevacizumab; Capecitabine; Irinotecan; Metastatic colorectal cancer; Oxaliplatin; UGT1A1.
© AlphaMed Press 2018.