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吉西他滨联合奥沙利铂与吉西他滨联合顺铂作为老年晚期非小细胞肺癌一线化疗的随机研究

[A randomized study of gemcitabine plus oxaliplatin versus gemcitabine plus cisplatin as the 1st line chemotherapy for advanced non-small cell lung cancer in elderly patients].

作者信息

Li Zhixi, Hou Mei, Wang Haiyan, Wang Zeyang

机构信息

Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, China.

出版信息

Zhongguo Fei Ai Za Zhi. 2011 Jul;14(7):588-92. doi: 10.3779/j.issn.1009-3419.2011.07.05.

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 1st line chemotherapy for elderly patients with advanced NSCLC.

METHODS

Sixty-six advanced NSCLC patients confirmed with pathology or cytology, who had not received treatment, were randomly divided into GO group (The patients received gemcitabine 1,000 mg/m² on day 1 and day 8 and oxaliplatin 130 mg/m² on day 1 by intravenous infusion, with 21 days as one cycle) and GP group (The patients received gemcitabine 1,000 mg/m² on day 1 and day 8 and cisplatin 25 mg/m² 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

There were no statistical differences between GO and GP groups in the efficiency 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 significantly different.

CONCLUSIONS

The clinical efficiency of GO and GP regimens as the 1st 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.

摘要

背景与目的

铂类化疗被认为是晚期非小细胞肺癌(NSCLC)的标准治疗方法。本研究旨在评估吉西他滨联合奥沙利铂(GO)方案与吉西他滨联合顺铂(GP)方案作为老年晚期NSCLC患者一线化疗的疗效和安全性。

方法

66例经病理或细胞学确诊且未接受过治疗的晚期NSCLC患者被随机分为GO组(患者于第1天和第8天静脉输注吉西他滨1000mg/m²,第1天静脉输注奥沙利铂130mg/m²,21天为一个周期)和GP组(患者于第1天、第2天和第3天静脉输注顺铂25mg/m²,第1天和第8天静脉输注吉西他滨1000mg/m²,21天为一个周期)。所有接受2个或更多周期治疗的患者均可进行评估。

结果

GO组和GP组在疾病有效率(36.4%对40.6%,P = 0.801)、中位无进展生存期(24周对18周,P = 0.565)、中位生存时间(44周对36周,P = 0.918)方面无统计学差异,但Ⅲ级和Ⅳ级贫血(0对33.3%,P < 0.001)以及Ⅲ级和Ⅳ级恶心/呕吐(0对27.3%,P = 0.004)有显著差异。

结论

GO方案和GP方案作为老年晚期NSCLC患者一线化疗的临床疗效相似,但GO方案的毒性更易于耐受且更安全。

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