Phase 3 trial of sequential versus combination treatment in colorectal cancer: The C-cubed study
Phase 3 trial of sequential versus combination treatment in colorectal cancer: The C-cubed study
复制标题
DOI：
10.1016/j.ejca.2022.04.009
复制
发表时间：
2022-07-01
影响因子：
8.4
通讯作者：
Yamaguchi，Yoshiyuki
中科院分区：
文献类型：
--
作者：
Inada，Ryo;Nagasaka，Takeshi;Yamaguchi，Yoshiyuki
背景：奥沙利铂和贝伐单抗治疗转移性结直肠癌的最佳治疗策略尚未确定。我们调查是否序贯治疗使用氟嘧啶与贝伐单抗，然后在第一次进展时加入奥沙利铂是更好的，比联合治疗使用氟嘧啶和奥沙利铂与贝伐单抗。MethodsIn序贯治疗，升级从氟嘧啶加贝伐单抗氟嘧啶加奥沙利铂与贝伐单抗的情况下，建议进行性疾病。失败的策略的时间是主要的终点，而次要终点是总生存期，无进展生存期，总反应率和safety.ResultsThree百例患者与以前未经治疗的转移性结直肠癌随机接受序贯治疗（n = 151）或联合治疗（n = 149）。序贯治疗策略失败时间上级优于联合治疗策略失败时间（15.2个月，95%CI，12.5-17.2个月vs.7.8个月，95%CI，6.3-9.5个月;P< 0.001）。然而，序贯治疗组的中位总生存期为27.5（95% CI，24.4 - 32.7）个月，联合治疗组为27.0（95% CI，22.8 - 36.0）个月（风险比，0.92; 95% CI，0.66 - 1.28;P= 0.61）。在序贯治疗臂和51.7%的组合treatment.ConclusionsThe研究结果支持扩展的序贯治疗从氟嘧啶加贝伐单抗选择的患者谁不需要一个客观的反应的威胁性疾病的整体反应率为33.1%。
BackgroundAn optimal treatment strategy using oxaliplatin and bevacizumab for metastatic colorectal cancer has not been defined. We investigated whether the sequential treatment using fluoropyrimidines with bevacizumab followed by the addition of oxaliplatin at first progression was better than a combination treatment using fluoropyrimidines and oxaliplatin with bevacizumab.MethodsIn the sequential treatment, the escalation from fluoropyrimidines plus bevacizumab to fluoropyrimidines plus oxaliplatin with bevacizumab was recommended in case of progressive disease. Time to failure of strategy was the primary end-point, whereas the secondary end-points were overall survival, progression-free survival, overall response rate and safety.ResultsThree hundred patients with previously untreated metastatic colorectal cancer were randomised to receive either the sequential treatment (n = 151) or the combination treatment (n = 149). The sequential treatment was superior to the combination treatment about time to failure of strategy (15.2 months; 95% CI, 12.5–17.2 months vs. 7.8 months: 95% CI, 6.3–9.5 months;P< 0.001). However, the median overall survival was 27.5 (95% CI, 24.4 to 32.7) months in the sequential treatment and 27.0 (95% CI, 22.8 to 36.0) months in the combination treatment (hazard ratio, 0.92; 95% CI, 0.66 to 1.28;P= 0.61). The overall response rate was 33.1% in the sequential treatment arm and 51.7% in the combination treatment.ConclusionsThe findings support the extension of the sequential treatment starting from fluoropyrimidine plus bevacizumab to selected patients who do not need an objective response to the threatening disease.