固定剂量率输注吉西他滨联合顺铂一线治疗非小细胞肺癌的临床研究  

Gemcitabine fixed dose rate infusion in combination with cisplation as first-line chemotherapy for advanced non-small cell lung cancer

作　　者：周政涛[1,2] 王金万[3] 鲁明骞[1,2] 王杰[1,2] 许新华[1,2] 文彩虹[1,2] 彭绪申[1,2] 

机构地区：[1]三峡大学肿瘤研究所,宜昌443003 [2]湖北省宜昌市中心人民医院肿瘤科,宜昌443003 [3]中国医学科学院中国协和医科大学肿瘤研究所肿瘤医院内科,北京100021

出　　处：《肿瘤》2009年第2期168-171,共4页Tumor

摘　　要：目的:探讨固定剂量率输注吉西他滨联合顺铂一线治疗非小细胞肺癌(non-small cell lung cancer,NSCLC)的疗效和安全性。方法:选择初治的、经病理证实的晚期NSCLC患者。采用吉西他滨联合顺铂方案,吉西他滨(1200mg/m2)以固定剂量率(10mg·m-2·min-1)输注,即120min静脉滴注,d1和d8;顺铂80～100mg/m2,将总量分成3d给药。21d为1个化疗周期。每2个化疗周期后评价疗效,若病情进展,则退出本研究。如果6个化疗周期结束后病情仍无进展,也停止治疗。观察疾病进展时间(time to progression,TTP)和总生存(overall survival,OS)时间。结果:共有47例经病理证实的NSCLC患者进入本次研究,最后可评价疗效者45例,其中完全缓解2例(4.4%),部分缓解15例(33.3%),总有效率为(37.7%)。中位TTP为5个月,中位OS期为11个月,1年生存率为48.3%,2年生存率为14.5%。Ⅲ/Ⅳ度血液学不良反应发生率分别为:白细胞计数下降为23%、中性粒细胞计数下降有22%,血小板计数下降14%以及血红蛋白水平下降16%。绝大多数的非血液学不良反应为Ⅰ～Ⅱ度,Ⅲ度不良反应主要发生于胃肠系统,无Ⅳ度非血液学不良反应的发生。结论:固定剂量率输注吉西他滨联合顺铂治疗晚期NSCLC有效,不良反应可以耐受,与既往资料相比,其有效率和中位生存期似有一定的优势,提示可对此开展进一步的研究。Objective： To explore the efficacy and safety of fixed dose rate infusion of gemcitabine in combination with cisplatin as first-line chemotherapy for advanced non-small cell lung cancer （ NSCLC ）. Methods： The untreated patients with advanced NSCLC confirmed by pathological examination received gemcitabine plus cisplatin regimen. Gemcitabine 1 200 mg/m^2 was infused intravenously at fixed rate （10 mg · m^-2 · min^-1 ） for 120 min on d 1 and d 8 and cisplatin 80-100 mg/m^2 was divided into three parts and each part was administered in 3 days, respectively. Twenty-one days were regarded as one cycle. Clinical efficacy was evaluated after two-cycle therapy. If the disease progressed, the patients were excluded. If the disease had no progression after 6 cycles of chemotherapy, we stoped the combined chemotherapy for the patients. Time to progression （TTP） and overall survival （OS） time were evaluated. Results： Totally 47 chemotherapy NSCLC patients have been enrolled in the study, including 36 males （76.6%） and 11 females （23.4%）, with a median age of 56 years. Eleven （23.4%） subjects had stage Ⅱ B NSCLC and 36 subjects （76.6%） were at stage Ⅳ. Forty-five subjects were assessed for final response. Two cases had complete response （4.4%） and 15 cases had partial response （33.3%）. The overall response rate was 37.7%. The median TFP was 5.0 months （95% CI, 4-6 months） , and median OS time was 11 months （95% CI, 9-13 months）. One-year survival rate was 48.3% and 2-year survival was 14.5%. Grade 3-4 hematologic toxicities were neutropenia （22%）, leucoeytopenia （23%） , thrombocytopenia （ 14% ） , and anemia （ 16% ）. Most non-hematologic toxicities were at grade 1-2. Grade 3 adverse reaction mainly occurred in gastrointestinal system. No grade 4 non-hematologic toxicity occurred. Conclusion： Fixed-dose rate infusion of gemicitabine combined with cisplatin is effective for advanced NSCLC. The adverse reactions are tolerated. The response rate and the

关 键 词：癌 非小细胞肺 化学疗法 吉西他滨 剂量效应关系 药物 

分 类 号：R734.2[医药卫生—肿瘤] R730.53[医药卫生—临床医学]