奥沙利铂或伊立替康联合5-氟尿嘧啶和亚叶酸钙治疗晚期结直肠癌临床研究

目的观察奥沙利铂（L—OHP）或伊立替康（CPT-11）联合5-氟尿嘧啶（5-Fu）和亚叶酸钙（CF）治疗晚期结直肠癌的临床疗效和患者不良反应。方法76例均经细胞学或病理确诊为晚期结直肠癌，开放性非随机分为L—OHP和CPT-11两组。L—OHP组：L—OHP85mg／nl。静脉滴注2～3h，第1天，CF200mg静脉滴注2h后，5-Fu250mg静脉推注，随后5-Fu600mg／m2静脉持续滴注22h，第1、2天，每2周重复为1个周期。CPT-11组：CPT-11150mg／I／1。静脉滴注，第1天，CF、5-Fu剂量用法同上，每2周重复为1个周期。4个周期后判定疗效和毒副作用。结果L—OHP组共完成化疗220个周期，完全缓解1例，部分缓解15例，总有效率为41．0％；CPT-11组共完成化疗204个周期，完全缓解2例，部分缓解11例，总有效率为35．1％。中位疾病进展时间（MTTP）分别为5．2、5．8个月；中位生存时间分别为13．2、14．0个月；临床获益改善率分别为71．8％、78．4％。毒副作用L—OHP组以骨髓抑制及恶心、呕吐、胃肠反应和外周感觉神经异常为主，CPT-11组以骨髓抑制及延迟性腹泻为主，Ⅲ度延迟性腹泻以CPT-11组多见（P〈0．025）。结论L—OHP或CPT-11联合5-Fu治疗晚期结直肠癌疗效好，毒副作用较小，安全，患者易接受。

Clinical study of oxaliplatin plus 5-Fu and CF vs irintecan plus 5-Fu and CF in patients with advanced/metastatic colorectal cancer

Objective To observe the effect and toxicity of oxaliplatin plus 5-Fu and CF (FOLFOX) vs irinteean plus 5-Fu and CF (FOLFIRI) in patients with advanced/metastatic colorectal cancer. Methods 67 patients with histologicaly confirmed advanced/metastatic colorectal cancer were non-randomized to enter the study. Patients for FOLFOX: oxaliplatin 85 mg/m2 iv 2 h d1.CF 200 mg/m2 iv 2 h followed by 5-Fu 250 mg iv bolus and 5-Fu 600 mg/m2 iv 22 h d1,2 were given, every 2 weeks as one cycle. FOLFIRI: irinotecan 150 mg/m2 iv d1. CF, 5-Fu do so. Efficacy was evaluated at 4 cycles. Results For 39 patients to FOLFOX and 37 patients to FOLFRI, the objective response rate (CR+PR) was 41.0 % vs 35.1%. The median time to progression was 5.2 months vs. 5.8 months in the FOLFOX and FOLFIRI arm. The median survival time was 13.2 months vs. 14.0 months in the FOLFOX and FOLFIRI arm respectively. The clinical benefit rate was 71.8 % vs 78.4 % in the FOLFOX and FOLFIRI ann respectively. There was no significantly differences between two arms (P>0.05). The most frequently observed toxicity reaction was hematological toxicity nausea/vomiting and neurn-sensory toxicity in FOLFOX arm, and hematological toxicity and diarrhea in FOLFIRI arm. FOLFIRI arm had a remarkably higher incidence rate of grade 3 diarrhea than FOLFOX arm(P<0.025). Conclusion FOLFOX and FOLFIRI arm provid high effective and well tolerable treatment for advanced/ metastatic colorectal cancer.