Miao Lulu, Fan Yun, Huang Zhiyu, Lin Nengming, Luo Lvhong, Yu Haifeng
Chemotherapy Center, Zhejiang Cancer Hospital, Hangzhou 310022, China.
Zhongguo Fei Ai Za Zhi. 2012 Jan;15(1):1-5. doi: 10.3779/j.issn.1009-3419.2012.01.01.
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.
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/m²-1,250 mg/m² via a 30 min intravenous infusion on d1 and d5 followed by cisplatin at a dose of 75 mg/m² 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.
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.
The regimen is active and well-tolerated in untreated patients with advanced NSCLC. Further randomized controlled studies are necessary.
吉西他滨联合铂类化疗是晚期非小细胞肺癌（NSCLC）最常用的治疗方法。吉西他滨通常采用三周方案，每周给药一次。在本研究中，为提高依从性，于第1天和第5天给予吉西他滨，并对该改良方案在未经治疗的晚期NSCLC患者中的疗效和安全性进行评估。
2007年10月至2009年10月共纳入83例患者。每周期中，吉西他滨于第1天和第5天以1000mg/m² - 1250mg/m²的剂量经30分钟静脉输注给药，随后每三周的第1天给予顺铂75mg/m²或卡铂（AUC = 5）。每例患者至少完成两个周期的化疗，并观察该方案的临床反应和毒性。
客观缓解率为37.3%。中位无进展生存期和总生存期分别为6.1个月和15.0个月。一年和两年生存率分别为57.8%和16.2%。骨髓抑制和胃肠道反应是主要毒性。3/4级白细胞减少、贫血和血小板减少的发生率分别为26.5%、10.8%和7.2%。顺铂组共有27.5%的患者出现3/4级胃肠道反应。本研究未观察到与治疗相关的死亡。
该方案在未经治疗的晚期NSCLC患者中具有活性且耐受性良好。有必要进一步开展随机对照研究。
