FOLFOXIRI改良方案一线治疗晚期胃癌疗效及安全性分析

目的:分析FOLFOXIRI改良方案一线治疗晚期胃癌的疗效及安全性。方法:选取2016年7月至2019年3月于中国医学科学院肿瘤医院采用FOLFOXIRI改良方案一线治疗的晚期胃癌20例。药物用法:奥沙利铂85 mg/m2静点d1,伊立替康120 mg/m2静点d1,亚叶酸钙200 mg/m2静点d1,氟尿嘧啶2400 mg/m2持续静点44 h,每14天为1个周期。主要终点为客观缓解率(objective response rate,ORR)。次要终点包括无进展生存时间(progression free survival,PFS)、总生存时间(overall survival,OS)、疾病控制率(disease control rate,DCR)、缓解持续时间(duration of response,DOR)、安全性。结果:中位治疗8个周期,ORR为50%,DCR为95%。中位起效时间为1.6个月,中位DOR为8.7个月。中位随访时间19.5个月,中位PFS为9.5个月(95%CI:7.309~11.691),中位OS为19.9个月(95%CI:9.754~30.046)。常见不良反应包括中性粒细胞减少、肝功能异常、腹泻等。主要3级不良反应为中性粒细胞减少(50%)、腹泻(10%)、ALT升高(10%),无≥4级不良反应。结论:降低伊立替康剂量的FOLFOXIRI改良方案在晚期胃癌一线治疗中初步显示出良好的疗效和耐受性,值得进一步开展临床研究。

Efficacy and safety analysis of dose-modified FOLFOXIRI as first-line chemotherapy in advanced gastric cancer

  Objective:   To evaluate the efficacy and safety of dose-modified FOLFOXIRI as first-line chemotherapy in advanced gastric cancer patients.   Methods:   Twenty patients without prior chemotherapy were enrolled between July 2016 and March 2019 at the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Treatment consisted of oxaliplatin 85 mg/m2 on day 1, irinotecan 120 mg/m2 on day 1, leucovorin 200 mg/m2 on day 1, and 5-fluorouracil 2400 mg/m2 as a 44-h continuous infusion starting on day 1; treatment was repeated every two weeks. The primary endpoint was objective response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.   Results:   The median number of treatment cycles was eight. ORR and DCR were 50% and 95%, respectively. The median time to response was 1.6 months, and the median DOR reached 8.7 months. The median follow-up was 19.5 months, the median PFS was 9.5 months (95% CI:7.309-11.691), and the median OS was 19.9 months (95% CI:9.754-30.046). The most common adverse enents (AEs) were leukopenia, elevation of ALT and AST, and diarrhea. Grade 3 neutropenia, diarrhea, and elevation of ALT occurred in 50%, 10%, and 5% patients, respectively. No Grade 4/5 AEs were observed.   Conclusion:   The dose-modified FOLFOXIRI showed promising antitumor activity and was well tolerated by advanced gastric cancer patients without previous treatment.