卡培他滨或5-Fu/亚叶酸联合奥沙利铂治疗进展期大肠癌的疗效与安全性分析

Preliminary report on oxaliplatin combined with capecitabineor 5-fluorouracil/folinic acid for treatment of patients with advanced intestinal cancer

目的:比较卡培他滨(希罗达)或5-Fu/亚叶酸双周疗法联合国产奥沙利铂治疗进展期大肠癌的客观疗效及不良反应。方法:入选的60例进展期大肠癌患者分为两组,一组为5-Fu/亚叶酸双周疗法联合奥沙利铂,称5-Fu持续滴注组,共32例。另一组为卡培他滨联合奥沙利铂,称卡培他滨组,共28例。5-Fu持续滴注组平均化疗2.7周期,卡培他滨组平均化疗2.8周期。结果:5-Fu持续滴注组:完全缓解(CR)2例,部分缓解(PR)18例,稳定(NC)7例,进展(PD)5例,总有效率为62.5%。卡培他滨组:完全缓解(CR)2例,部分缓解(PR)16例,稳定(NC)4例,进展(PD)4例,总有效率为64.3%。两组均无治疗相关死亡,5-Fu持续滴注组主要毒副反应有口腔溃烂、腹泻、静脉炎、感觉神经毒性等,大部分为Ⅱ、Ⅲ度,上述不良反应发生率明显高于卡培他滨组(P<0.01)。卡培他滨组较明显的毒副反应为恶心、呕吐、白细胞下降等,多为Ⅰ、Ⅱ度。结论:卡培他滨或5-Fu/亚叶酸双周疗法联合国产奥沙利铂治疗晚期大肠癌疗效均较好,但卡培他滨组临床应用方便、安全,毒副反应轻,患者的化疗依从性更好,是治疗晚期大肠癌较为理想的联合化疗方案。

Objective： To evaluate the efficacy and toxicity of oxaliplatin combined with folinic acid （leucovorin） plus 5- fluorouracil or capecitabine（Xelode）in the treatment of patients with advanced intestinal cancer. Methods： Sixty patients with advanced intestinal cancer were treated with medium-dose folinic acid plus bolus injection and continuous infusion for 48 h of 5-fluorouracil combined with oxaliplatin or capecitabine combined with oxaliplatin. Results：There were two cases complete response,eighteen partial response, seven no changes and five with progression in bimonthly 5-fluorouracil/medium-dose folinic acid group with total response rate of 62.5%. There were two cases complete response , sixteen partial response ,five no changes and four with progression in capecitabine group with total response rate of 64.3%. The main side effects in capecitabine group were nausea, vomiting and leukopenia of mild degree and were tolerable. The main side effects in bimonthly 5-fluorouracil/medium-dose folinic acid group were mucositis, neurotoxicity and diarrhea. The incidences of side effects in bimonthly 5-fluorouracil/medium-dose folinic acid group were higher than those in capecitabine group（ P 〈 0.01 ）. Conclusion： Capecitabine combined with oxaliplatin may be a safe and effective chemotherapy regimen in treatment of the patients with advanced intestinal cancer and is worthwhile for further study.