含雷替曲塞化疗方案一线治疗晚期结直肠癌疗效与安全性评价

目的 回顾性分析晚期结直肠癌患者一线使用雷替曲塞联合奥沙利铂(TOMOX)/伊立替康(TOMIRI)化疗的疗效及安全性。 方法 收集江苏省肿瘤医院2012年08月至2017年05月109例TOMOX/TOMIRI方案一线治疗晚期结直肠癌患者的临床资料。 结果 TOMIRI方案和TOMOX方案均无完全缓解的病例，客观缓解率ORR分别为42.3%(30/71)vs. 42.1%(16/38)，疾病控制率DCR分别为84.5%(60/71)vs. 89.5%(34/38)，无统计学差异(P＞0.05)。分层于原发灶位置时，原发于右半结肠、左半结肠、直肠使用TOMIRI方案的客观缓解率ORR分别为31.8%(7/22)、73.3%(11/15)、35.3%(12/34)，差异有统计学意义(P＜0.05)。毒副反应方面，TOMIRI的腹泻发生率高于TOMOX，而周围神经毒性发生率则相反，且都有统计学差异(P＜0.05)。两组总中位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/TOMIRI方案中位PFS分别为7.0(95%CI，5.5～8.5)个月vs. 8.0(95%CI，6.6～9.5)个月，中位OS分别为28.0(95%CI，20.5～35.5)个月vs. 26.0(95%CI，16.83～35.17)个月，均无统计学差异(P＞0.05)。 结论 雷替曲塞联合奥沙利铂/伊立替康一线治疗晚期结直肠癌，疗效不劣于以5-FU为基础的联合化疗方案，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、直肠癌。

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

【Abstract】 Objective A retrospective analysis was made on the efficacy and safety of combination chemotherapy with Raltitrexed in the first-line treatment of advanced colorectal cancer. Methods The clinical data of 109 patients with advanced colorectal cancer treated with retetrexil combined with irinotecan/oxaliplatin in the first line were collected from August 2012 to May 2017 in jiangsu cancer hospital. 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 < 0.05). There were statistically significant differences in diarrhea and peripheral neurotoxicity (P<0.05) . The median PFS of retetrexil combined with irinoticam/oxaliplatin 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). Conclusion In the first-line treatment of advanced colorectal cancer, the efficacy of retetrexct-based chemotherapy was not inferior to that of the 5-fu-based chemotherapy. 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.