含雷替曲塞化疗方案一线治疗晚期结直肠癌的疗效及安全性

Retrospective study on the safety and efficacy of combination chemotherapy regimens with Raltitrexed in the first-line treatment of advanced colorectal cancer

目的分析雷替曲塞联合奥沙利铂(TOMOX)/伊立替康(TOMIRI)一线治疗晚期结直肠癌的疗效及安全性。方法回顾分析2012年8月至2017年5月江苏省肿瘤医院收治的109例晚期结直肠癌患者的临床资料,其中71例使用雷替曲塞联合伊立替康(TOMIRI组)化疗方案,38例使用雷替曲塞联合奥沙利铂(TOMOX组)化疗方案,比较两组患者的近期疗效、不良反应、疾病无进展时间(PFS)及总生存期(OS)。结果TOMIRI组和TOMOX组均无完全缓解病例,客观缓解率分别为42.3%(30/71)和42.1%(16/38),疾病控制率分别为84.5%(60/71)和89.5%(34/38),差异无统计学意义(P>0.05)。按原发灶位置分层比较,右半结肠、左半结肠、直肠癌使用TOMIRI方案的客观缓解率分别为31.8%(7/22)、73.3%(11/15)、35.3%(12/34),差异有统计学意义(P=0.022)。不良反应方面,TOMIRI组的腹泻发生率为53.5%(38/71),高于TOMOX组的29.0%(11/38);而TOMIRI组无周围神经毒性发生,TOMOX组为39.5%(15/38),差异有统计学意义(P<0.05)。所有患者的总中位PFS为8.0(95%CI 7.1~8.9)个月,总中位OS为27.0(95%CI 19.6~34.4)个月。TOMOX组中位PFS为7.0(95%CI 5.5~8.5)个月,与TOMIRI组的8.0(95%CI 6.6~9.5)个月比较差异无统计学意义(P>0.05);TOMOX组的中位OS为28.0(95%CI 20.5~35.5)个月,与TOMIRI组的26.0(95%CI 16.83~35.17)个月比较差异无统计学意义(P>0.05)。结论雷替曲塞联合奥沙利铂或伊立替康一线治疗晚期结直肠癌的疗效不劣于经典的5-氟尿嘧啶联合奥沙利铂或伊立替康方案,尤以TOMOX表现出较好的疗效和安全性,TOMIRI治疗左半结肠癌的缓解率高于右半结肠癌及直肠癌。

Objective A retrospective analysis was made on the efficacy and safety of Raltitrexed combined with Oxaliplatin(TOMOX)/Irinotecan(TOMIRI)in the first-line treatment of advanced colorectal cancer.Methods 109 patients with advanced colorectal cancer were enrolled from Jiangsu Cancer Hospital from August 2012 to May 2017,including 71 patients in the Raltitrexed plus Irinotecan(TOMIRI group)and 38 patients in the Raltitrexed plus Oxaliplatin(TOMOX group),the short-term efficacy,adverse reactions,disease progression-free time(PFS)and overall survival time(OS)were compared between the two groups.Results TOMIRI and TOMOX had no complete response,with an ORR of 42.3%(30/71)vs.42.1%(16/38),and a DCR of 84.5%(60/71)vs.89.5%(34/38),with no statistically significant difference(P>0.05).When stratified at the location of the primary lesion,the ORR of TOMIRI were 31.8%(7/22),73.3%(11/15)and 35.3%(12/34)in the right,left colon and rectum respectively,with statistically significant differences(P=0.022).The incidence of diarrhea of TOMIRI group was 53.5%(38/71),higher than that of TOMOX group 29.0%(11/38),while the peripheral neurotoxicity of TOMIRI group was 0.0%,lower than that of TOMOX group 39.5%(15/38).There were statistically significant differences between the two adverse reactions(P<0.05).The median PFS of two groups was 8.0(95%CI 7.1-8.9)months and meanwhile the median OS was 27.0(95%CI 19.6-34.4)months.The median PFS of TOMIRI and TOMOX was 8.0(95%CI 6.6-9.5)months vs.7.0(95%CI 5.5-8.5)months,and the median OS was 26.0(95%CI 16.83-35.17)months vs.28.0(95%CI 20.5-35.5)months respectively,with non-statistics significant difference(P>0.05).Conclusions In the first-line treatment of advanced colorectal cancer,the efficacy of Raltitrexed combined with Oxaliplatin/Irinotecan was not inferior to the classical regimen of 5-FU combined with Oxaliplatin/Irinotecant.It's worth mentioning that TOMOX showed better safety,and the remission rate of the left colon cancer treated by TOMIRI was higher than that of the right colon cancer and rectum.