多西紫杉醇与替吉奥联合铂类治疗晚期胃癌的Ⅱ期临床观察  

Phase Ⅱ clinical trial of docetaxei, platinum and S-1 for advanced gastric cancer

作　　者：周爱萍[1] 李玉升[1] 杨林[1] 宋岩[1] 孙永琨[1] 张雯[1] 崔成旭[1] 依荷巴丽·迟[1] 袁兴华 吕宁 王金万[1] 

机构地区：[1]中国医学科学院北京协和医学院肿瘤医院内科,北京100021 [2]腹部外科 [3]病理科

出　　处：《中华医学杂志》2012年第24期1677-1680,共4页National Medical Journal of China

摘　　要：目的探索多西紫杉醇、替吉奥联合顺铂（DCS方案）或奥沙利铂（DOS方案）治疗晚期胃癌的疗效及其在综合治疗中的作用。方法共人组初治、经细胞病理学证实的45例晚期胃癌。化疗药物及用法：多西紫杉醇60mg／m^2，d1；替吉奥，前16例患者为每天60mg／m^2，后续患者为80-120mg／d（按体表面积决定），d1-14；DCS方案中顺铂30mg／m^2，d1，2；DOS方案中，奥沙利铂111-127mg／m^2（中位117mg／m^2），d2；21d为1周期。结果43例完成≥1周期DCS或DOS化疗，中位周期数5个（1-8个）。42例可评价疗效：部分缓解（PR）28例（66．7％），疾病稳定（SD）9例，疾病进展（PD）5例。32例单纯化疗患者的中位无进展生存（PFS）7．1个月，中位总生存时间尚未达到。最常见的Ⅲ／Ⅳ度不良反应包括中性粒细胞减少46．5％，血小板减少9．3％，呕吐9．3％、恶心7．0％和腹泻4．7％。14例临床根治性切除困难而无远处转移且完成≥2周期DCS／DOS化疗的患者，10例获得手术切除机会，9例（64．3％）RO切除。结论DCS／DOS治疗晚期胃癌有效率较高，对根治性切除困难但无远处转移的晚期胃癌可起到良好的降期作用，且不良反应可控制。Objective To evaluate the efficacy and safety profile and to explore the role of doeetaxel, S-1 plus eisplatin （DCS） or oxaliplatin （DOS） in the treatment of advanced gastric cancer. Methods A total of 45 patients with advanced gastric cancer were recruited. They received DCS or DOS at the discretion of investigators. Doeetaxel was given intravenously at the dose of 60 mg/m^2 at dl, S-1 60 mg · m^-2 · d^-1 or 80 - 120 mg/d according to individual patient＇s area of body surface orally from dl to d14 and eisplatin 30 mg/m^2 at dl, d2 or oxaliplatin 111 - 127 （median： 117） mg/m^2 at d2. Each cycle was for 21 days. Results Forty-three patients received ≥ 1 complete cycle of DCS/DOS with a median cycle number of 5 （ range ： 1 - 8 ）. Among 42 patients evaluated for efficacy, the outcomes were partial response （ n = 28 ）, stable disease （ n = 9 ） and progression （ n = 5 ）. The response rate was 66. 7 %. Progression-free survival（PFS） of 32 patients on chemotherapy alone was 7.1 months and the median overall survival （OS） was not reached. The most common grade 3/4 adverse effects included neutropenia （46.5%）, thrombocytopenia （9. 3% ）, vomiting （9. 3% ）, nansea （7. 0% ） and diarrhea （4. 7% ）. Ten of fourteen patients with advanced unresectable gastric cancer without clinically detectable distant metastases underwent surgical resection after a median of 4 （ 2 - 6 ） cycles of DCS or DOS and 9 （ 64. 3% ） had R0 resection. Conclusions DCS/DOS is effective for advanced gastric cancer and in the setting of neoadjuvant chemotherapy. And the toxicities of DCS/DOS are manageable.

关 键 词：胃肿瘤 抗肿瘤联合化疗方案 多西紫杉醇 铂类 替吉奥 

分 类 号：R735.2[医药卫生—肿瘤]