奥沙利铂联合表柔吡星和5-Fu治疗晚期胃癌疗效和安全性研究

Efficacy and safety of oxaliplatin combined with 5-fluorouracil and epirubicin for advanced gastric cancer

目的REAL2研究中使用奥沙利铂的EOF方案由于较好的疗效和安全性获得了广泛关注,但中国胃癌患者对REAL2研究中的三药联合EOF方案耐受性较差,本研究使用了改良的EOF方案,将氟尿嘧啶(5-Fu)由原来的静脉输注21天改为5天,观察奥沙利铂联合5-Fu/LV、表柔吡星治疗晚期胃癌的疗效及不良反应。方法30例晚期胃癌患者,初治19例,复治11例。表柔吡星50mg/m^2静脉注射d1,奥沙利铂130mg/m^2静脉滴注2小时d1,5-Fu 375～425mg/(m^2·d)d1～5静脉持续输注120小时,每3周重复,每化疗2个疗程评价1次疗效。结果30例患者中,总缓解率43.33%,完全缓解1例,部分缓解12例。初治病例缓解率52.63%(10/19),略高于REAL2研究中标准EOF方案的42.4%缓解率,复治病例缓解率27.33%(3/11)。KPS评分提高10分以上者10例(33.33%)。在治疗中,主要的Ⅲ～Ⅳ度不良反应为:中性粒细胞减少33.3%(10/ 30),血小板减少10%(3/30),贫血13.33%(4/30),恶心呕吐23.33%(7/30),REAL2研究中标准EOF方案的Ⅲ～Ⅳ度中性粒细胞减少29.9%,与本研究类似,标准EOF方案中的Ⅲ～Ⅳ度血小板减少4.3%,贫血6.5%,恶心呕吐13.8%,略低于本研究,但在本研究中没有观察到Ⅲ～Ⅳ度发热性中性粒细胞减少及血栓栓塞等严重不良反应,而REAL2研究中,发热性中性粒细胞减少和血栓栓塞均为8.5%。结论奥沙利铂联合5-Fu及表柔吡星的改良EOF方案治疗晚期胃癌疗效较好,毒副作用可以很好耐受,值得临床进一步应用。

Objective To evaluate short-term efficacy and toxicity of modified combination chemotherapy of oxaliplatin, 5-fluorouracil and epirubicin （mEOF） for advanced gastric cancer. Methods Totally 30 advanced gastric cancer patients, including 19 cases of first-line treatment and 11 cases of second-line treatment were treated with epirubicin 50mg/m^2iv d1, oxaliplatin 130 mg/m^2ivgtt 2h d1, and 5-fluorouracil 375 -425 mg/m^2/d dl -5 civ 120 h, repeated every 3 weeks. The efficacy was evaluated every 2 cycles. Results In all 30 patients, the overall response rate was 43.33%, including 1 case of CR and 12 cases of PR. The response rate of the first-line treatment was 52.63% （ 10/19）, which was higher than the response rate of standard EOF regimen in REAL2 study （42.4%）. The response rate of the secondline treatment was 27.33% （3/11）. In 10 patients, KPS increased by more than 10. During treatment, 3/4 grade adverse events including neutropenia （33.3%）, thrombocytopenia （10%）, anaemia （13.33%）, and nausea/vomiting （23.33%） occured. Comparing with the standard EOF regimen in REAL2 study, there is almost the same neutropenia （29.9% in REAL2 ）, but thrombocytopenia （4. 3% ） , anaemia （6.5%） and nausea/vomiting （ 13.8% ） of standard EOF regimen were lower than mEOF in this study. However, in this study no febrile neutropenia and thromboembolism were observed in contrast to both 8.5% in REAL2 study. Conclusion Modified combination chemotherapy of oxaplipla- tin, 5-fluorouracil and epirubicin （mEOF） has good efficacy and is well tolerated in advanced gastric cancer.