CAJ | 학술논문

目的评价多西他赛联合奥沙利铂及卡培他滨方案(DOX方案)治疗进展期胃癌的临床疗效和不良反应.方法采用单中心非对照Ⅱ期临床研究,进展期胃癌患者30例入组.DOX方案为:多西他赛75 mg/m~2,第1天,静脉滴注2 h;奥沙利铂130 mg/m~2,第1天,静脉滴注2 h:卡培他滨1000 mg/m~2,2次/d,口服,1～14 d;每21 d为1周期.至少2周期后评价疗效及不良反应.结果入组30例患者均根据RECIST标准评估疗效,完全缓解1例,部分缓解2例,稳定25例,进展2例;有效率为10.0%(3/30),疾病控制率为93.3%(28/30).中位随访时间261 d,全组患者中位无进展生存期197 d,中位总生存期466 d.不良反应:18例(60.0%)发生Ⅲ~Ⅳ度白细胞减少,13例(43.3%)发生Ⅲ~Ⅳ度中性粒细胞减少,9例(30.0%)出现粒细胞减少性发热,8例(26.7%)发生Ⅲ~Ⅳ度乏力.结论 DOX方案治疗进展期胃癌疗效较好,有一定的耐受性,值得进一步扩大样本量开展后续研究.
목적 평개다서타새연합오사리박급잡배타빈방안(DOX방안)치료진전기위암적림상료효화불량반응.방법 채용단중심비대조Ⅱ기림상연구,진전기위암환자30례입조.DOX방안위:다서타새75 mg/m~2,제1천,정맥적주2 h;오사리박130 mg/m~2,제1천,정맥적주2 h:잡배타빈1000 mg/m~2,2차/d,구복,1～14 d;매21 d위1주기.지소2주기후평개료효급불량반응.결과 입조30례환자균근거RECIST표준평고료효,완전완해1례,부분완해2례,은정25례,진전2례;유효솔위10.0%(3/30),질병공제솔위93.3%(28/30).중위수방시간261 d,전조환자중위무진전생존기197 d,중위총생존기466 d.불량반응:18례(60.0%)발생Ⅲ~Ⅳ도백세포감소,13례(43.3%)발생Ⅲ~Ⅳ도중성립세포감소,9례(30.0%)출현립세포감소성발열,8례(26.7%)발생Ⅲ~Ⅳ도핍력.결론 DOX방안치료진전기위암료효교호,유일정적내수성,치득진일보확대양본량개전후속연구.
Objective To assess the efficacy and safety of docetaxel plus oxaliplatin and capecitabine (DOX) in the treatment of advanced gastric adenocarcinoma. Methods A total of 30 patients were recruited to receive DOX regimen (docetaxel 75 mg/m~2 day 1, oxaliplatin 130 mg/m~2 day 1, and capecitabine 1000 mg/m~2 bid d1-14, repeated every 3 weeks). Only those who completed at least 2 cycles were assessed. Results The number of patients with complete response, partial response, stable disease and progressive disease were 1, 2, 25 and 2, respectively. The objective response rate was 10.0%(3/30) and the disease control rate was 93.3%(28/30). After a median follow-up of 261 days, the median progression free survival and overall survival time were 197 days and 466 days, respectively. The most common grade Ⅲ to Ⅵ toxicity was hematologic toxicity. The percentage of patients with grade Ⅲ to Ⅵ leucopenia, neutropenia and febrile neutropenia were 60.0%, 43.3% and 30.0%, respectively. The most common grade Ⅲ to Ⅵ non-hematologic toxicitywas fatigue, nausea, vomiting, anorexia, diarrhea, and hand-foot syndrome. Conclusions DOX regimen demonstrates promising efficacy in the treatment of advanced gastric adenocarcinoma. The associated toxicity can be well tolerated and controlled. Large scale clinical trial is necessary to obtain further evidence.