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目的探讨卡培他滨联合奥沙利铂(Cape Ox)方案一线化疗序贯卡培他滨维持治疗用于不可切除的转移性结直肠癌的疗效及安全性。方法 60例转移性结直肠癌随机分为研究组(例数=30)和对照组(例数=30),研究组接受Cape Ox(奥沙利铂联合卡培他滨)方案化疗6周期,达SD及以上者接受卡培他滨维持化疗,对照组接受单纯Cape Ox方案化疗,直到肿瘤进展或不可耐受。结果研究组的中位总生存(OS)和疾病控制时间(DDC)分别为20.5个月和8.5个月,对照组分别为19.7个月及8.0个月,均无统计学差异。两组的RR率均为57%。6周期后对照组周围神经毒性发生率明显增加,研究组和对照组Ⅲ/Ⅳ神经毒性发生率分别为7%和27%,具有统计学差异(P=0.038),两组总体Ⅲ/Ⅳ度不良事件无统计学差异。结论 Cape Ox方案一线化疗序贯卡培他滨维持治疗与Cape Ox不间断化疗具有相似的总生存及疾病控制时间,而周围神经毒性反应明显减少。
Objective To investigate the efficacy and safety of capecitabine plus capecitabine in first-line chemotherapy with capecitabine in the treatment of unresectable metastatic colorectal cancer. Methods Sixty patients with metastatic colorectal cancer were randomly divided into study group (n = 30) and control group (n = 30). The study group received six cycles of Cape Ox (oxaliplatin plus capecitabine) regimen chemotherapy, Up to SD and above were given capecitabine for maintenance chemotherapy and the control group received simple Cape Ox regimen until tumor progression or intolerance. Results The median overall survival (OS) and disease control time (DDC) in the study group were 20.5 months and 8.5 months, respectively, and those in the control group were 19.7 months and 8.0 months, respectively, with no significant difference. RR rates were 57% in both groups. After 6 cycles, the incidence of neurotoxicity around the control group increased significantly. The incidence of neurotoxicity of Ⅲ / Ⅳ in study group and control group was 7% and 27% respectively, with statistical difference (P = 0.038). The overall Ⅲ / Ⅳ degree There was no significant difference in adverse events. Conclusions Capex first-line chemotherapy followed capecitabine maintenance has similar overall survival and disease control as Cape Ox non-stop chemotherapy, with a noticeable reduction in peripheral neurotoxic responses.