关键词: 紫杉醇脂质体, 非小细胞肺癌, 有效性, 安全性, 临床研究

Abstract:

Background and purpose: Regional lymph node metastasis was significantly associated with the prognosis of patients with non-small cell lung cancer (NSCLC). This study was designed to compare paclitaxel liposome plus cisplatin (LP) with gemcitabine and cisplatin (GP) in patients with regional lymph node metastasis of advanced NSCLC as a first-line treatment. Methods: A total of 55 patients were randomly assigned to receive either liposomal paclitaxel (175 mg/m2) and cisplatin (75 mg/m2) or gemcitabine (1 000 mg/m2) and cisplatin (75 mg/m²) every 3 weeks. Results: Objective response rate (ORR) of lung primary foci was 37.9% in the LP arm and 30.8% in the GP arm (P＞0.05) and the disease control rate (DCR) was 91.3% and 80.8% respectively (P＞0.05); ORR of regional metastasis lymph node was higher in the LP arm (44.8% vs 15.4%, P＜0.05).There was no significant difference in DCR (93.1% vs 73.1%, P=0.101), although slight trends favoring paclitaxel liposome were seen; There was significant difference in median overall survival (17.0 vs 12.0 months, P＜0.05). LP was associated with significantly less thrombocytopenia and gastrointestinal side effects (P＜0.05), but no significant difference was observed in hyphemia, leucopenia, hepatotoxicity, renal toxicity and allergic reactions (P＞0.05). Conclusion: Liposomal paclitaxel plus cisplatin is superior to gemcitabine plus cisplatin with less toxicity and better tolerated, it deserves further research and clinic application for patients with regional lymph node metastasis of advanced NSCLC.

Key words: Liposomal paclitaxel, Non-small cell lung cancer, Effectiveness, Safety, Clinical trial