目的：观察一线诱导化疗后低剂量吉西他滨持续静脉滴注维持化疗治疗晚期非小细胞肺癌（NSCLC）的疗效和安全性。方法对收治的66例初治ⅢB/Ⅳ期NSCLC患者，采用吉西他滨1000mg/m2（第1、8天）联合顺铂75mg/m2（分3d使用）方案诱导化疗，21d为1个周期。4个周期后有效或稳定的36例按2：1随机分为维持组（24例）和观察组（12例），维持组予低剂量吉西他滨（250mg/m2）6h持续静脉滴注，第1、8天使用，21d为1个周期，维持至疾病进展或患者对化疗毒性不能耐受。观察组停止化疗，观察直至疾病进展。结果维持组和观察组至疾病进展时间（TTP）分别为6.2个月和4.8个月（P=0.039）；中位总生存时间分别为13.1个月和10.8个月（P=0.667）。维持化疗不良反应较轻微，主要表现为中性粒细胞、血小板数降低、贫血及恶心、呕吐。结论常规剂量吉西他滨联合顺铂一线化疗后序贯低剂量吉西他滨持续静脉滴注维持化疗安全、有效，应可进一步扩大样本量行研究是否有总生存时间的获益。%Objective To evaluate the efficacy and safety of prolonged infusion of low- dose gemcitabine in maintenance treatment for advanced non- smal celllung cancer (NSCLC) after first line regimen. Methods Sixty six patients with stageⅢB/Ⅳ NSCLC admitted from March 2008 to October 2009 were enrolled. The patients received gemcitabine 1000 mg/m2 (d1 and d8)plus cisplatin 25 mg/m2 (d1, d2 and d3) every 21 d. Thirty six patients achieving objective response or stable disease fol ow-ing initial gemcitabine plus cisplatin regime were randomized to receive maintenance gemcitabine (continuous injection for 6h with a dose of 250 mg/m2 on d1 and d8, every 21d)plus best supportive care (maintenance arm), or best supportive care only (control arm). Results The time to progress (TTP) throughout the study period was 6.2 and 4.8 months for maintenance and control arms, respectively (P=0.039). Median overal survival (OS) was 13.1 months for maintenance and 10.8 months for control arms(P=0.667). The toxicity profile was mild,with neutropenia,thrombocytopenia,anemia,nausea and vomit being most common toxicities. Conclusion Maintenance treatment with low- dose gemcitabine,fol owing first line regime is feasible and it produces significantly longer TTP compare to best supportive care alone.
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