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目的评价伊立替康联合顺铂与伊立替康单药二线治疗晚期转移性结直肠癌的临床疗效及安全性。方法 143例一线化疗失败的晚期转移性结直肠癌患者分为对照组(74例)和试验组(69例)。对照组第1 d静脉滴注伊立替康250 mg.m-2,90 min。试验组第1 d静脉滴注伊立替康250 mg.m-2,90 min;第1～3 d静脉滴注顺铂25 mg.m-2,1周期均为21 d。化疗结束后比较2组患者近期疗效、药物不良反应及生存期。结果试验组61例完成了2～4个周期的化疗,客观有效率(ORR)为45.9%(28/61),对照组组51例完成了2～4周期化疗,ORR为27.5%(14/51),2组比较差异有统计学意义(P<0.05)。试验组中位生存时间为13.2个月,对照组为8.8个月,2组差异有统计学意义(HR=0.46,95%CI:0.29～0.79,P<0.001)。试验组Ⅲ、Ⅳ度粒细胞下降、恶心呕吐和脱发的发生率高于对照组(P<0.01)。结论伊立替康联合顺铂二线治疗晚期转移性结直肠癌可显著延长患者的生存时间,其主要不良反应为血液学毒性和胃肠道反应。
Objective To evaluate the clinical efficacy and safety of irinotecan combined with cisplatin and irinotecan monotherapy in the treatment of advanced metastatic colorectal cancer. Methods 143 patients with advanced metastatic colorectal cancer who failed in first-line chemotherapy were divided into control group (74 cases) and experimental group (69 cases). The control group on the first day intravenous infusion of irinotecan 250 mg.m-2,90 min. The experimental group intravenous infusion of irinotecan 250 mg.m-2, 90 min on the first day; intravenous cisplatin 25 mg.m-2 on the first day to the third day; Short-term efficacy, adverse drug reactions and survival were compared between the two groups after chemotherapy. Results In the experimental group, 61 cases completed 2 to 4 cycles of chemotherapy with an objective response rate (ORR) of 45.9% (28/61) and 51 cases completed 2 to 4 cycles of chemotherapy with an ORR of 27.5% (14 / 51), the difference between the two groups was statistically significant (P <0.05). The median survival time was 13.2 months in the experimental group and 8.8 months in the control group. The difference between the two groups was statistically significant (HR = 0.46, 95% CI: 0.29-0.79, P <0.001). In the experimental group, the incidence of neutropenia, nausea, vomiting and alopecia were higher than those of the control group (P <0.01). Conclusion The combination of irinotecan and cisplatin in the treatment of advanced metastatic colorectal cancer can significantly prolong the survival time of patients. The main adverse reactions are hematological toxicity and gastrointestinal reactions.