Wu Zhi-Yong, Guan Hui-Hong, Lin Ze-Xiao, Yang Hong-Kai, Zhou Lan, Cai Qi-Chun
J Chemother. 2014 Oct;26(5):306-11. doi: 10.1179/1973947813Y.0000000139. Epub 2013 Dec 6.
This study sought to investigate the efficacy and tolerability of the regimen of low-dose gemcitabine combined with carboplatin in chemo-naïve patients with non-small cell lung cancer (NSCLC). The study involved 37 chemo-naive patients with unresectable stage IIIB or stage IV NSCLC. The predominant histological type was squamous carcinoma (22/37), and the performance status (PS) was 2 in 23 patients (62%). All received gemcitabine, 250 mg/m(2) in 6-hour infusion on days 1 and 8 plus carboplatin area under the curve (AUC) = 5 on day 1, every 28 days. The overall response rate (ORR) was 62·2% and disease stabilization was achieved in 21·6% of the patients. After a median follow-up duration of 13 months, the median overall survival (OS) time was 14·0 months (95% CI 13·3-16·6 months), and the median progression-free survival (PFS) time was 7·0 months (95% CI 6·1-8·9 months). Hematological toxicities were well-tolerated with the development of grade 3/4 neutropenia and thrombocytopenia in 10·3 and 10·3% of patients respectively, and the gastrointestinal toxicities were mild.
本研究旨在调查低剂量吉西他滨联合卡铂方案对未经化疗的非小细胞肺癌(NSCLC)患者的疗效和耐受性。该研究纳入了37例未经化疗、无法切除的IIIB期或IV期NSCLC患者。主要组织学类型为鳞状细胞癌(22/37),23例患者(62%)的体能状态(PS)为2。所有患者均接受吉西他滨治疗,第1天和第8天静脉滴注6小时,剂量为250mg/m²,同时第1天给予卡铂,曲线下面积(AUC)=5,每28天重复一次。总缓解率(ORR)为62.2%,21.6%的患者病情稳定。中位随访13个月后,中位总生存期(OS)为14.0个月(95%CI 13.3 - 16.6个月),中位无进展生存期(PFS)为7.0个月(95%CI 6.1 - 8.9个月)。血液学毒性耐受性良好,分别有10.3%的患者出现3/4级中性粒细胞减少和血小板减少,胃肠道毒性较轻。