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目的对比评价重组人血管内皮抑素(商品名恩度)联合奥沙利铂+亚叶酸钙+5-氟尿嘧啶(FOLFOX4方案)或者伊立替康+亚叶酸钙+5-氟尿嘧啶(FOLFIRI方案)一线治疗进展期结直肠癌(CRC)的疗效和安全性。方法回顾性分析2008年1月至2012年12月间局部晚期不能手术或转移性CRC患者43例,分别接受恩度联合FOLFOX4方案(29例,FOLFOX4组)或FOLFIRI方案(14例,FOLFIRI组)进行一线化疗。3个周期后按照RECIST 1.1标准评价客观疗效,根据NCI CTC 3.0标准评价不良反应,同时观察无进展生存期(PFS)和总生存期(OS)。结果 FOLFOX4组患者中,肿瘤低分化、原发灶未切除以及肝转移比例明显高于FOLFIRI组(均P<0.05)。有40例患者可评价客观疗效,其中FOLFOX4组27例,FOLFIRI组13例。FOLFOX4组患者中,CR 1例,PR 16例,SD 7例,PD 3例,客观缓解率(RR)为63.0%,疾病控制率(DCR)为88.9%;中位PFS为5.6个月,中位OS为15.7个月。FOLFIRI组患者中,PR 5例,SD 6例,PD 2例,RR为38.5%,DCR为84.6%;中位PFS为5.4个月,中位OS为16.5个月。两组患者的客观疗效、中位PFS和中位OS差异均无统计学意义(P>0.05)。两组最常见的不良反应均为消化道反应和骨髓抑制,以1~2级为主。FOLFOX4组患者血小板下降的发生率显著高于FOLFIRI组(P=0.006),FOLFIRI组患者3~4级腹泻的发生率有高于FOLFOX4组的趋向(P=0.057)。结论恩度联合FOLFOX4方案或FOLFIRI方案一线治疗进展期CRC的客观疗效和生存时间差异无统计学意义(P>0.05),不良反应均较轻微但各有侧重,临床上应根据患者实际情况选择用药方案。
Objective To compare and evaluate the first-line treatment of recombinant human endostatin (brand name Endo) combined with oxaliplatin + leucovorin + 5-fluorouracil (FOLFOX4 regimen) or irinotecan + leucovorin + 5- fluorouracil (FOLFIRI regimen) Efficacy and safety of advanced colorectal cancer (CRC). Methods Forty-three patients with locally advanced unresectable or metastatic CRC were retrospectively analyzed. The patients underwent enteccept combined with FOLFOX4 regimen (FOLFOX4 group, 29 cases) or FOLFIRI regimen (FOLFIRI group, 14 cases) First-line chemotherapy. After 3 cycles, the objective efficacy was evaluated according to the RECIST 1.1 standard. The adverse reactions were evaluated according to the NCI CTC 3.0 standard. Progression-free survival (PFS) and overall survival (OS) were also observed. Results In FOLFOX4 group, the proportion of poorly differentiated tumor, unresectable primary tumor and hepatic metastasis was significantly higher than that of FOLFIRI group (all P <0.05). Forty patients were evaluated for objective efficacy, including 27 in the FOLFOX4 group and 13 in the FOLFIRI group. In the FOLFOX4 group, CR was 1, PR 16, SD 7 and PD 3, the objective response rate (RR) was 63.0%, disease control rate (DCR) was 88.9%; median PFS was 5.6 months, OS is 15.7 months. In the FOLFIRI group, 5 were PR, 6 were SD, and 2 were PD. The RR was 38.5% and the DCR was 84.6%. The median PFS was 5.4 months and the median OS was 16.5 months. There was no significant difference in objective curative effect, median PFS and median OS between the two groups (P> 0.05). The two groups of the most common adverse reactions are gastrointestinal reactions and bone marrow suppression, mainly in 1 to 2. The incidence of thrombocytopenia in FOLFOX4 group was significantly higher than that in FOLFIRI group (P = 0.006). The incidence of grade 3-4 diarrhea in FOLFIRI group was higher than that in FOLFOX4 group (P = 0.057). Conclusions There is no significant difference in the objective curative effect and survival time between Endo combined with FOLFOX4 regimen and FOLFIRI regimen in the first-line treatment of advanced CRC (P> 0.05). Adverse reactions are mild but have different emphases. The clinical choice should be based on the actual situation of patients Program.