小剂量多西他赛联合替吉奥一线治疗晚期胃癌的单中心临床研究  

A single centre clinical trial of docetaxel and S-1 combination therapy as first line treatment in patients with advanced or recurrent gastric cancer

作　　者：李倩[1] 刘天舒[1] 崔越宏[1] 余一祎[1] 冯艺[1] 王妍[1] 郭曦[1] 庄荣源[1] 周宇红[1] 金文[1] 

机构地区：[1]复旦大学附属中山医院肿瘤内科,上海200052

出　　处：《中国癌症杂志》2012年第8期595-600,共6页China Oncology

摘　　要：背景与目的:晚期胃癌不能根治,替吉奥(S-1)及多西他赛均是治疗晚期胃癌的有效药物,但标准剂量DCF(多西他赛、顺铂、氟尿嘧啶)方案的耐受性欠佳,限制了其在临床中的应用。观察小剂量多西他赛联合标准剂量S-1一线治疗晚期胃癌患者的疗效及不良反应。方法:收集40例局部晚期不能手术、复发或伴有远处转移的胃腺癌患者。多西他赛40 mg/m2第1天静脉滴注,联合S-1 80 mg/m2第1～14天口服,每21 d重复,直至疾病进展或不能耐受。评估该方案的客观疗效、中位疾病无进展生存期(progression-free survival,PFS)及中位生存期(median survival time,MST),观察化疗临床受益反应(clinical benefit response,CBR)及不良反应。结果:1例残胃复发患者因上消化道出血,2例腹膜转移患者因肠梗阻未完成第1个周期化疗,37例患者可评价疗效,累计完成211个周期化疗,中位治疗周期数为6(3～14)。CR 1例(2.7%),PR 15例(40.5%),SD 17例(46.0%),PD 4例(10.8%),总有效率43.2%,疾病控制率可达89.2%。最佳CBR有效者19例(51.4%),17例稳定(45.9%),1例无效(2.7%)。中位PFS为6.0个月,MST为11.5个月。本方案主要的血液学和非血液学不良反应分别是白细胞/中性粒细胞降低(50%)和疲乏(50%),多为Ⅰ、Ⅱ级。Ⅲ、Ⅳ级不良反应发生率较低:白细胞/中性细胞粒下降7例(17.5%),恶心4例(10.0%),食欲减低3例(7.5%),疲乏2例(5%),血小板降低、出血各1例(2.5%)。3例因Ⅲ、Ⅳ级不良反应S-1减量20%。结论:小剂量多西他赛联合标准剂量S-1一线治疗晚期胃癌疗效令人满意,不良反应多为轻度,给药方便,是值得推广和尝试的有效胃癌姑息化疗方案。Background and purpose： Advanced gastric cancer was incurable. S-1 and docetaxel were effective treatment for the advanced cancer. But toxicities of DCF regimen with standard dose were serious and poor tolerated. This clinical trial evaluated the toxicity and efficacy of first line chemotherapy regimen of low dose docetaxel and S-1 for advanced or recurrent gastric cancer. Methods： Forty eligible patients with advanced or recurrent adenocareinoma of the stomach were enrolled and treated with intravenous docetaxel 40 mg/m2 on day 1 and oral S- 1 80 mg/m2 per day on day 1 to 14 every 3 weeks. Treatment was continued until tumor progression or unacceptable toxicity. Tumor response was evaluated every 3 cycles or tumor progression suspected. Toxicity and clinical benefit response （CBR） of every cycle were recorded. Results： One remnant stomach recurrent cancer patient and 2 peritoneal metastasis patients withdraw in the first cycle because of hemorrhage in upper gastrointestinal and intestinal obstruction. Thirty-seven patients completed at least 1 cycle and received a total of 211 cycles of treatment （median 6, range 3-14）. CBR was evaluated in 37 patients： 19 （51.3%） effective, 17 （45.9%） stable and 1 （2.7%） patients invalid. All 37 patients were evaluable for efficacy： 1 （2.7%） complete response and 15 （40.5%） partial responses, 17 （46.0%） stable disease, 4 （10,8%） progressive disease. The overall response rate was 43.2% and the tumor control rate was 89.2%. Median progression-free survival and median overall survival times were 6.0 and 11.5 months, respectively. The most common hematologic toxicities were leukopenia/neutropenia （50%）, anemia （25%）, thrombopenia （2.5%）. The most common non-hematologic toxicities were anorexia （50%）, appetite loss （47.5%）, nausea （30%）. Less common toxicities included neurotoxicity （15%）, alopecia （12.5%）, hand-foot syndrome （7.5%）, diarrhea （7.5%）, hemorrhage of upper gastrointestinal （5.0%）,

关 键 词：晚期胃癌 姑息化疗 多西他赛 替吉奥 

分 类 号：R735.2[医药卫生—肿瘤]