CAJ | 학술논문

目的探讨FOLFIRI方案(伊立替康+5-氟尿嘧啶+醛氢叶酸)用于奥沙利铂治疗失败的复发或转移性结直肠癌的临床疗效和安全性.方法为前瞻性、单组开放式、多中心临床研究.一线化疗失败的结直肠癌患者66例,接受FOLFIRI方案化疗,直至病情进展或不良反应不能耐受.每3个周期评价疗效,并观察不良反应.结果 61例患者可评价客观疗效,客观有效率为16.4%,疾病控制率为73.8%.59例患者随访资料完整,中位疾病进展时间(TTP)为5.0个月,中位至死亡时间(TTD)为9.9个月,中位生存时间为18.2个月.不良反应以中性粒细胞减少、恶心呕吐、急性胆碱能综合征、脱发、迟发性腹泻最常见.3和4度中性粒细胞减少的发生率为22.7%.结论 FOLFIRI方案二线治疗奥沙利铂化疗失败的晚期结直肠癌,有较高的肿瘤控制率,患者耐受性好,并可以延长患者的总生存期.
목적 탐토FOLFIRI방안(이립체강+5-불뇨밀정+철경협산)용우오사리박치료실패적복발혹전이성결직장암적림상료효화안전성.방법 위전첨성、단조개방식、다중심림상연구.일선화료실패적결직장암환자66례,접수FOLFIRI방안화료,직지병정진전혹불량반응불능내수.매3개주기평개료효,병관찰불량반응.결과 61례환자가평개객관료효,객관유효솔위16.4%,질병공제솔위73.8%.59례환자수방자료완정,중위질병진전시간(TTP)위5.0개월,중위지사망시간(TTD)위9.9개월,중위생존시간위18.2개월.불량반응이중성립세포감소、악심구토、급성담감능종합정、탈발、지발성복사최상견.3화4도중성립세포감소적발생솔위22.7%.결론 FOLFIRI방안이선치료오사리박화료실패적만기결직장암,유교고적종류공제솔,환자내수성호,병가이연장환자적총생존기.
Objective Irinotecan(CPT-11),a specific inhibitor of topoisomerase Ⅰ,has been proven to be effective in the treatment of refractory or metastatic colorectal cancer.Furthermore,several first line phaseⅢ trials of the combination therapy(FOLFIRI)using CPT-11 and fuorouracil/leucovorin(5-Fu/LV)were reported to have significant improvement in treatment result.Therefore,we designed a multicenter clinical study to observe the overall survival(OS),time to death(TTD),time to progression(TTP),efficacy and safety of FOLFIRI regimen for patients with refractory or metastatic colorectal cancer after first line chemotherapy failure.Methods Patients with metastatic or refractory colorectal cancer after first line oxaliplatin-based chemotherapy failure were enrolled into this prospective,one arm and open-labeled muhicenter study. Irinotecan 180 mg/m2 was administered biweeklv on D1,LV 200 mg/m2 by intravenous infusion in 2 hours before bolus intravenous injection of 5-Fu 400 mg/m2,then followed immediately by intravenous infusion of 5-Fu 2.4 g/m2 in 46 hours.OS,TTD,TTP,response rate(RR)and adverse events were assessed according to RSCIST criteria and NCIC-CTG CTCAE(3.0).Results Sixty-six patients were valuable for safety assessment and and 61 for efficacy.There was no CR patient in this series.Ten patients had PR,35 SD(57.4%)and 16 PD(26.2%)with a response rate of 16.4%(10/61).The median TFP was 5.0 months(1-12 months),median TID 9.9 months(5-27 months)and median OS 18.2 months(7-33 months).The adverse events including nausea,vomiting,anorexia,diarrhea,leucopenia and cholinergic syndrome werefrequent.but usually in Ⅰ-Ⅱ degree.The rate of Ⅲ/Ⅳ degree diarrhea and leucopenia was 7.6% and 22.7%,respectively.Conclusion The regimen of irinotecan plus fuorouracil/leueovorin(FOLFIRI)is effective and well-tolerated as a second-line chemotherapy and may prolong the overall survival for the patient with refractory or metastatic colorectal cancer.