Liu Lian, Wang Xiu-Wen, Li Li, Zhang Xin, Zhang Wen-Dong, Yu Xue-Jun
Department of Chemotherapy, Cancer Center, Qilu Hospital of Shandong University, Jinan, Shandong, 250012, P. R. China.
Ai Zheng. 2006 Aug;25(8):990-4.
BACKGROUND & OBJECTIVE: Vinorelbine (NVB), paclitaxel (TAX), and gemcitabine (GEM) are first-line chemotherapeutic drugs in the treatment for non-small cell lung cancer (NSCLC) currently. There are many domestically retrospective studies to compare efficacies and adverse reactions among these three regimens, all of which has composed of cisplatin (DDP). This randomized study was to investigate the efficacies and toxicities of these three regimens in NSCLC treatment, in order to choose a feasible regimen for NSCLC patients.
A total of 276 NSCLC patients were randomly assigned to a regimen of NP (NVB plus DDP ), or TP (TAX plus DDP), or GP (GEM plus DDP). Efficacies and toxicities were analyzed and compared after two cycles.
The response rates were 42.3% (41/97) in NP arm, 43.0% (40/93) in TP arm, and 43.4% (36/83) in GP arm, and complete remission rates were 1.0% (1/97), 2.2% (1/93) and (0/83) respectively, without significant difference. The median survival time, disease-free survival time and 1-year survival rate were 8.5 months, 4.1 months and 31.9%; 8.8 months, 3.8 months and 33.3%, and 9.2 months, 3.9 months, 31.3%, respectively in NP, TP and GP arms without significant difference. The major adverse reactions were stage 3 to 4 myelo-suppression, nausea/vomiting, fatigue and phlebitis. There were highest incidences of leucopenia (42.2%), neutropenia (36.2%) and lowest incidence of thrombocytopenia (53.0%) in GP arm compared to NP arm (77.8%, 67.7%, 12.1%) or TP arm (71.0%, 57.0%, 13.0%) statistically (P<0.01 for all). The rates of nausea/vomiting in GP arm (16.8%) and TP arm (25.8%) were significantly lower than in NP arm (41.4%)(P<0.05); and the rate of fatigue in GP arm (38.5%) or phlebitis in NP arm was most frequent among the three arms (P=0.000, 0.008 respectively).
There is no significant difference in short-term efficacy of chemotherapy regimen NP, TP and GP. TP and GP regimens, both of which possesses its own advantage, are more tolerable than NP regimen which has the most side effects.
长春瑞滨（NVB）、紫杉醇（TAX）和吉西他滨（GEM）是目前治疗非小细胞肺癌（NSCLC）的一线化疗药物。国内有许多回顾性研究比较这三种方案的疗效和不良反应，这些研究均包含顺铂（DDP）。本随机研究旨在探讨这三种方案治疗NSCLC的疗效和毒性，以便为NSCLC患者选择可行的方案。
共276例NSCLC患者被随机分为NP（NVB加DDP）、TP（TAX加DDP）或GP（GEM加DDP）方案组。两个周期后分析并比较疗效和毒性。
NP组有效率为42.3%（41/97），TP组为43.0%（40/93），GP组为43.4%（36/83），完全缓解率分别为1.0%（1/97）、2.2%（1/93）和0（0/83），差异无统计学意义。NP组、TP组和GP组的中位生存时间、无病生存时间和1年生存率分别为8.5个月、4.1个月和31.9%；8.8个月、3.8个月和33.3%；9.2个月、3.9个月和31.3%，差异无统计学意义。主要不良反应为3～4级骨髓抑制、恶心/呕吐、乏力和静脉炎。与NP组（77.8%、67.7%、12.1%）或TP组（71.0%、57.0%、13.0%）相比，GP组白细胞减少（42.2%）、中性粒细胞减少（36.2%）发生率最高，血小板减少（53.0%）发生率最低，差异有统计学意义（P均<0.01）。GP组（16.8%）和TP组（25.8%）恶心/呕吐发生率显著低于NP组（41.4%）（P<0.05）；GP组乏力发生率（38.5%）或NP组静脉炎发生率在三组中最高（分别为P=0.000、0.008）。
化疗方案NP、TP和GP的短期疗效无显著差异。TP和GP方案各有优势，耐受性均优于不良反应最多的NP方案。
