低剂量吉西他滨延时输注联合奈达铂治疗晚期非小细胞肺癌的临床观察

Clinical Efficacy of Low-dose Gemcitabine in Prolonged Infusion plus Nedaplatin for Advanced/Metastatic Non-small Cell Lung Cancer Patients

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。

Objective To assess the clinical efficacy and tolerability of low-dose gemcitabine in prolonged infusion plus neda-platin 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^-2 continuous intravenous injection for 6 hours, d1, d8, and nedaplatin 80 mg·m^-2, d1;q28d. The control group received gemcitabine 1000 mg·m^-2, 30 min, d1, d8, and nedaplatin 80 mg·m^-2, d1;q28d. 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 respec-tively （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 com-bined with nedaplatin was relatively safe and had a comparable efficacy with the regimen of standard dose of gemcitabine in 30min infu-sion in the treatment of locally advanced/metastatic NSCLC.