吉西他滨调整方案治疗晚期非小细胞肺癌的Ⅱ期临床试验 Translated title: Phase Ⅱ Trial of Improved Regimen with Gemcitabine in Patients with Advanced Non-small Cell Lung Cancer

Abstract

背景与目的

吉西他滨与铂类的联合化疗是晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）最常用的治疗方案。通常3周方案中的吉西他滨需间隔1周给药。为提高依从性，本研究将吉西他滨第8天给药时间调整为第5天，并评价调整方案一线治疗晚期NSCLC的疗效及安全性。

方法

2007年10月-2009年10月共入组83例晚期NSCLC患者，采用吉西他滨1, 000 mg/m ²-1, 250 mg/m ²第1天、第5天静脉滴注30 min，联合顺铂75 mg/m ²，或联合卡铂（AUC=5）第1天静滴，每21天为1周期，每例至少完成2周期治疗后评价疗效，观察毒性反应及无进展生存期和总生存期。

结果

83例患者的客观有效率为37.3%，中位无进展生存期和中位生存期分别为6.1个月和15.0个月，1年、2年生存率分别为57.8%与16.2%。调整方案的主要不良反应为血液学毒性与胃肠道反应，Ⅲ度-Ⅳ度白细胞、血红蛋白、血小板减少发生率分别为26.5%、10.8%、7.2%，联合顺铂治疗组Ⅲ度-Ⅳ度胃肠道反应发生率为27.5%。无治疗相关死亡。

结论

吉西他滨联合铂类5天调整方案一线治疗晚期NSCLC疗效肯定，毒副反应可耐受，值得进一步开展随机对照研究。

Translated abstract

Background and objective

Gemcitabine-platinum-combined with chemotherapy is the most common treatment for advanced non-small cell lung cancer (NSCLC). Gemcitabine is administered once a week in a general three-week schedule. In the present study, gemcitabine is administered on d1 and d5 to improve compliance, and the efficacy and safety of the improved regimen is evaluated in untreated patients with advanced NSCLC.

Methods

A total of 83 patients were enrolled between October 2007 and October 2009. In each cycle, gemcitabine was administered at a dose of 1, 000 mg/m ²-1, 250 mg/m ² via a 30 min intravenous infusion on d1 and d5 followed by cisplatin at a dose of 75 mg/m ² or carboplatin (AUC=5) on d1 every three weeks. At least two cycles of chemotherapy were completed in each case, and clinical response and toxicity of the regimen were observed.

Results

The objective response rate was 37.3%. The median progression free survival and overall survival time were 6.1 months and 15.0 months, respectively. The one-year and two-year survival rates were 57.8% and 16.2%, respectively. Myelosuppression and gastrointestinal responses were the main toxicities. The incidence of grade 3/4 of leucopenia, hypohemia, and thrombocytopenia were 26.5%, 10.8% and 7.2%, respectively. A total of 27.5% of the patients in the cisplatin group had grade 3/4 gastrointestinal responses. Treatment related deaths were not observed in this study.

Conclusion

The regimen is active and well-tolerated in untreated patients with advanced NSCLC. Further randomized controlled studies are necessary.