Cetuximab Plus Capecitabine and Irinotecan Compared With Cetuximab Plus Capecitabine and Oxaliplatin As First-Line Treatment for Patients With Metastatic Colorectal Cancer: AIO KRK-0104-A Randomized Trial of the German AIO CRC Study Group
Cetuximab Plus Capecitabine and Irinotecan Compared With Cetuximab Plus Capecitabine and Oxaliplatin As First-Line Treatment for Patients With Metastatic Colorectal Cancer: AIO KRK-0104-A Randomized Trial of the German AIO CRC Study Group
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DOI：
10.1200/jco.2010.31.1936
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发表时间：
2011-03-01
影响因子：
45.3
通讯作者：
Heinemann, Volker
中科院分区：
文献类型：
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作者：
Moosmann, Nicolas;von Weikersthal, Ludwig Fischer;Heinemann, Volker
研究目的：AIO KRK-0104随机II期临床试验研究了西妥昔单抗联合卡培他滨和伊立替康（CAPIRI）或卡培他滨和奥沙利铂（CAPOX）一线治疗转移性结直肠癌（mCRC）的疗效和安全性。（第1天400 mg/m2，随后每周250 mg/m2）+CAPIRI（伊立替康200 mg/m2，第1天;卡培他滨800 mg/m2，每日两次，第1天至第14天，每3周一次;或西妥昔单抗加CAPOX（奥沙利铂130 mg/m2，第1天;卡培他滨1，000 mg/m2，每日两次，第1天至第14天，每3周一次）。主要研究终点是客观反应率（ORR）。结果在意向治疗患者人群（n = 177）中，CAPIRI加西妥昔单抗的ORR为46%（95%CI，35至57），CAPOX加西妥昔单抗的ORR为48%（95%CI，37至59）。在81.4%的意向治疗人群中进行了KRAS基因突变状态分析。CAPIRI+西妥昔单抗组KRAS野生型患者的ORR为50.0%，PFS为6.2个月，OS为21.1个月。在CAPOX+西妥昔单抗组中，观察到ORR为44.9%，PFS为7.1个月，OS为23.5个月。虽然KRAS野生型和突变亚组的ORR和PFS相当，但生存期更长的趋势与KRAS野生型相关。这两种方案都有可管理的毒性档案和safe.ConclusionThis随机试验表明，除了西妥昔单抗CAPIRI或CAPOX是有效和安全的一线治疗mCRC。在分析的治疗方案中，ORR和PFS不因KRAS基因突变状态而异。J Clin Oncol 29：1050-1058. (c)2011年美国临床肿瘤学会
PurposeThe AIO KRK-0104 randomized phase II trial investigated the efficacy and safety of cetuximab combined with capecitabine and irinotecan (CAPIRI) or capecitabine and oxaliplatin (CAPOX) in the first-line treatment of metastatic colorectal cancer (mCRC).Patients and MethodsA total of 185 patients with mCRC were randomly assigned to cetuximab (400 mg/m(2) day 1, followed by 250 mg/m(2) weekly) plus CAPIRI (irinotecan 200 mg/m(2), day 1; capecitabine 800 mg/m(2) twice daily days 1 through 14, every 3 weeks; or cetuximab plus CAPOX (oxaliplatin 130 mg/m(2) day 1; capecitabine 1,000 mg/m(2) twice daily day 1 through 14, every 3 weeks). The primary study end point was objective response rate (ORR).ResultsIn the intention-to-treat patient population (n = 177), ORR was 46% (95% CI, 35 to 57) for CAPIRI plus cetuximab versus 48% (95% CI, 37 to 59) for CAPOX plus cetuximab. Analysis of the KRAS gene mutation status was performed in 81.4% of the intention to treat population. Patients with KRAS wild-type in the CAPIRI plus cetuximab arm showed an ORR of 50.0%, a PFS of 6.2 months and an OS of 21.1 months. In the CAPOX plus cetuximab arm, an ORR of 44.9%, a PFS of 7.1 months and an OS of 23.5 months were observed. While ORR and PFS were comparable in KRAS wild-type and mutant subgroups, a trend toward longer survival was associated with KRAS wild-type. Both regimens had manageable toxicity profiles and were safe.ConclusionThis randomized trial demonstrates that the addition of cetuximab to CAPIRI or CAPOX is effective and safe in first-line treatment of mCRC. In the analyzed regimens, ORR and PFS did not differ according to KRAS gene mutation status. J Clin Oncol 29:1050-1058. (c) 2011 by American Society of Clinical Oncology