三药联合方案治疗晚期转移性结直肠癌的疗效和安全性比较

  目的  探讨5-氟尿嘧啶（5-FU）/亚叶酸（leucovorin，LV）联合伊立替康和奥沙利铂（FOLFOXIRI）方案与卡培他滨联合伊立替康和奥沙利铂（CAPRINOX）方案一线应用于晚期不可切除结直肠癌的安全性及初步疗效的差异。  方法  回顾性分析北京大学肿瘤医院2013年1月至2018年11月诊治的晚期转移性结直肠癌（metastatic colorectal cancer，mCRC）患者73例，所有患者均为一线化疗，按照治疗方案分为两组，其中45例为FOLFOXIRI方案组，28例为CAPRINOX方案组，根据化疗的客观缓解率（objective response rate，ORR）、转化根治性切除率及不良反应对比两种化疗方案的临床疗效和安全性。  结果  FOLFOXIRI方法的ORR、中位无疾病进展时间（median progression free survival，mPFS）、R0切除的比例与CAPRINOX方法比较差异无统计学意义（60% vs. 57.1%，7.7个月vs. 9.6个月，24.4% vs. 17.9%；P>0.05）。所有患者在治疗期间，未出现治疗相关性死亡，两组主要不良反应包括白细胞减少、中性粒细胞减少、疲乏、恶心、呕吐、腹泻、脱发、转氨酶升高和周围神经毒性，FOLFOXIRI组3/4级不良反应发生率为33.3%（15/45），CAPRINOX组3/4级不良反应发生率为46.4%（13/28），差异无统计学意义（P=0.263）。  结论  FOLFOXIRI和CAPRINOX均是一线治疗mCRC的有效方案，三药联合方案近期疗效高，不良反应可以耐受。 

Comparison of efficacy and safety of triple- drug treatment regimens for metastatic colorectal cancer

  Objective  To evaluate the preliminary efficacy and safety of the 5-fluorouracil/leucovorin, irinotecan, and oxaliplatin (FOLFOXIRI) and capecitabine, irinotecan, and oxaliplatin (CAPIRINOX) regimens as first-line therapy for unresectable advanced colorectal cancer.  Methods  Between January 2013 and November 2018, 73 patients with metastatic colorectal cancer (mCRC) were analyzed. All patients received first-line chemotherapy. Of them, 45 patients were administered FOLFOXIRI, and the remaining 28 patients were administered CAPIRINOX. The clinical outcomes and safety profiles were evaluated according to the objective response rate (ORR), conversion resection rate, and adverse effects.  Results  The ORR, median progression-free survival (mPFS), and R0 resection rate in the FOLFOXIRI group were not statistically different from those in the CAPIRINOX group (60% vs. 57.1%, 7.7 months vs. 9.6 months, 24.4%vs. 17.9%, respectively; P>0.05). No treatment-related deaths occurred. The major adverse events were leukopenia, neutropenia, fatigue, nausea, vomiting, diarrhea, alopecia, aspartate aminotransferase/alanine aminotransferase elevation, and neurotoxicity. The total rate of grade 3/4 adverse events in the FOLFOXIRI group was 33.3% (15/45), while the total rate of grade 3/4 adverse events in the CAPIRINOX group was 46.4% (13/28). Toxicities between the two groups were not statistically significant (P=0.263).  Conclusions  Both the FOLFOXIRI and CAPIRINOX regimens are effective as first-line treatment for metastatic colorectal cancer. The triple-agent chemotherapy was associated with good efficacy and tolerable toxicity.