【摘要】 目的评价低剂量吉西他滨延时输注联合奈达铂治疗非小细胞肺癌(NSCLC)的疗效及耐受性。方法选择60例初诊局部晚期/转移性IIIB或IV期非小细胞肺癌患者,按1∶1随机分成两组,研究组:吉西他滨250 mg·m-2,civ 6 h,d1、d8;奈达铂80 mg·m-2,d1;q28d。对照组:吉西他滨1000 mg·m-2,30 min d1、d8;奈达铂80 mg·m-2,d1;q28d。观察和比较两组的治疗反应率(ORR)、无进展生存期(PFS)、总生存期(OS)及其毒副作用。结果研究组与对照组的ORR均为33.3%(P>0.975)。平均随访14个月,两组平均PFS分别为6.5个月和6.3个月(P>0.05);平均OS分别为12.45个月和12.49个月(P>0.05),差异均无统计学意义。两组血液学毒性反应多为轻中度,白细胞减少发生率分别为33.3%和46.6%,贫血发生率分别为33.3%和43.3%,血小板减少的发生率分别为10%和20%;胃肠道反应轻微;脱发相对较常见,发生率分别为87%和70%。所有毒副作用的差异均无统计学意义(P>0.05)。结论低剂量延时输注吉西他滨联合奈达铂治疗局部晚期/转移性NSCLC安全性好,且具有与标准剂量30 min输注方案相当的抗肿瘤效果。更多还原

【Abstract】 Objective To assess the clinical efficacy and tolerability of low-dose gemcitabine in prolonged infusion plus nedaplatin in the treatment of advanced/metastatic non-small cell lung cancer(NSCLC). Methods Sixty patients with newly diagnosed IIIB or IV stage of NSCLC were selected and 1:1 randomized into two groups. The reseach group received gemcitabine 250 mg·m-2continuous intravenous injection for 6 hours,d1,d8,and nedaplatin 80 mg·m-2,d1; q28 d. The control group received gemcitabine 1000 mg·m-2,30 min,d1,d8,and nedaplatin 80 mg·m-2,d1; q28 d. The overall response rate(ORR),progression-free survival(PFS),overall survival(OS) and toxicities were evaluated and comparatively analyzed between the two groups. Results The ORR of research group and control group were both 33.3%(P>0.975). After a median follow-up of 14 months,the PFS of research group and control group were respectively 6.5 months and 6.3 months(P>0.05),and the mean overall survival time were 12.45 months and 12.49 months respectively(P>0.05); differences yet had no statistical significance. Hematologic toxicities were mostly mild-moderate in both groups,with neutropenia of 33.3% and 46.6%,anemia of 33.3% and 43.3%,thrombocytopenia of 10% and 20%,respectively. Both groups had mild gastrointestinal toxicities,but alopecia were common in the two groups with a incidence of 87% and 70% respectively. All the differences of side effects were not statistically significant(P>0.05). Conclusion The regimen of low-dose gemcitabine in prolonged infusion combined with nedaplatin was relatively safe and had a comparable efficacy with the regimen of standard dose of gemcitabine in 30 min infusion in the treatment of locally advanced / metastatic NSCLC.更多还原