吉西他滨联合奥沙利铂或顺铂一线治疗老年晚期非小细胞肺癌的随机研究 Translated title: A Randomized Study of Gemcitabine plus Oxaliplatin versus Gemcitabine plus Cisplatin as the 1 ^st Line Chemotherapy for Advanced Non-small Cell Lung Cancer in Elderly Patients

Abstract

背景与目的

以铂类为基础的化疗是晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）的标准治疗方案。本研究旨在评价吉西他滨联合奥沙利铂和吉西他滨联合顺铂一线治疗老年晚期NSCLC的疗效及毒副反应。

方法

未经过治疗的经病理学或细胞学确诊的老年晚期NSCLC患者66例随机分成GO（吉西他滨1, 000 mg/m ²第1、8天+奥沙利铂130 mg/m ²第1天静脉滴注，每3周重复）组33例和GP（吉西他滨1, 000 mg/m ²第1、8天+顺铂25 mg/m ²第1、2、3天静脉滴注，每3周重复）组33例，至少治疗2周期，评价疗效及不良反应。

结果

GO组与GP组在治疗有效率（36.4% vs 40.6%, P=0.801）、中位无进展生存期（24周 vs 18周， P=0.565）、中位生存期（44周 vs 36周， P=0.918）等方面的差异无统计学意义，而在3级-4级贫血（0 vs 33.3%, P < 0.001）及3级-4级恶心呕吐（0 vs 27.3%, P=0.004）等方面的差异有统计学意义。

结论

对于老年晚期NSCLC，一线使用吉西他滨联合奥沙利铂或顺铂两种方案疗效相当，但吉西他滨联合奥沙利铂方案治疗耐受性好，临床应用更安全。

Translated abstract

Background and objective

Platinum-based chemotherapy is considered the standard treatment of advanced non-small cell lung cancer (NSCLC). The aim of this study is to evaluate the efficacy and safety of gemcitabine plus oxaliplatin (GO) versus gemcitabine plus cisplatin (GP) regimens as the 1 ^st line chemotherapy for elderly patients with advanced NSCLC.

Methods

Sixty-six advanced NSCLC patients confrmed with pathology or cytology, who had not received treatment, were randomly divided into GO group (The patients received gemcitabine 1, 000 mg/m ² on day 1 and day 8 and oxaliplatin 130 mg/m ² on day 1 by intravenous infusion, with 21 days as one cycle) and GP group (The patients received gemcitabine 1, 000 mg/m ² on day 1 and day 8 and cisplatin 25 mg/m ² on day 1, day 2 and day 3) by intravenous infusion, with 21 days as one cycle). All patients who received 2 or more cycles could be evaluated.

Results

Tere were no statistical differences between GO and GP groups in the efciency of disease (36.4% vs 40.6%, P=0.801), the median progression-free survival (24 weeks vs 18 weeks, P=0.565), the median survival time (44 weeks vs 36 weeks, P=0.918), but anemia at grade Ⅲ and Ⅳ (0 vs 33.3%, P < 0.001) and nausea/vomiting at grade Ⅲ and Ⅳ (0 vs 27.3%, P=0.004) were signifcantly different.

Conclusion

The clinical efciency of GO and GP regimens as the 1 ^st line chemotherapy for advanced NSCLC in elderly patients was similar, but the toxicity of GO regimen has the tendency to be more tolerable and safer.