NO方案与NP方案治疗晚期非小细胞肺癌的疗效：一项前瞻性随机试验

[Efficacy of NO regimen and NP regimen on advanced non-small cell lung cancer: a prospective randomized trial].

作者信息

Gao Jian-Fei, Zhang Xin-Hua, Wang Jun, Rao Zhi-Guo, Zhu Yu-Ze, Ou Wu-Ling, Zhang Bi-Cheng, Du Guang-Zu

机构信息

Department of Oncology, Wuhan General Hospital, Guangzhou Command of PLA, Wuhan, Hubei, P. R. China.

出版信息

Ai Zheng. 2005 Aug;24(8):990-3.

PMID:16086879

Abstract

BACKGROUND & OBJECTIVE: Oxaliplatin (LOHP) is an effective drug in treatment of non-small cell lung cancer (NSCLC) with mild toxicities to gastrointestinal tract, kidney, and bone marrow. Cisplatin (DDP) plus vinorelbine (NVB) constitute the first-line regimen (NP regimen) for NSCLC. This study was to compare the short-term response, long-term outcome, and adverse events between advanced NSCLC patients received NO regimen (LOHP plus NVB) and NP regimen.

METHODS

A total of 90 patients with advanced NSCLC were randomized into NO group (58 patients, 25 mg/m(2) of NVB, day 1 and day 8; 130 mg/m(2) of LOHP, day 1) and NP group (32 patients, 25 mg/m(2) of NVB, day 1 and day 8; 50 mg/m(2) of DDP, day 2 and day 3). The short-term response, long-term outcome, adverse events, and survival status of the 2 groups were observed.

RESULTS

The response rates were 33.33% in NO group, and 35.48% in NP group, but no significant difference was detected between the 2 groups (P > 0.05). The clinical benefit response rate was significantly higher in NO group than in NP group (80.70% vs. 64.52%, P < 0.05). The median time to progression (TTP) was 17 weeks in NO group, and 15 weeks in NP group; the median time of remission was 21 weeks in NO group, and 19 weeks in NP group; the median survival time was 39 weeks in NO group, and 37 weeks in NP group; the 1-year survival rate was 37.93% in NO group, and 31.25% in NP group. No significant differences were detected between the 2 groups. The incidence rates of phlebitis and grade I-II peripheral neuritis were significantly higher in NO group than in NP group (77.59% vs. 50.00%, P<0.01; 43.10% vs. 15.63%, P<0.01). The incidence rate of grade III-IV nausea/vomiting was significantly higher in NP group than in NO group (31.25% vs. 3.45%, P<0.05).

CONCLUSIONS

The efficacy of NO regimen on advanced NSCLC is similar to that of NP regimen, but the clinical benefit response rate is higher in NO group than in NP group. In short, NO regimen may be recommended as the first-line chemotherapy regimen for advanced NSCLC.

摘要

背景与目的

奥沙利铂（乐沙定，LOHP）是治疗非小细胞肺癌（NSCLC）的一种有效药物，对胃肠道、肾脏和骨髓的毒性较轻。顺铂（DDP）加长春瑞滨（NVB）构成NSCLC的一线治疗方案（NP方案）。本研究旨在比较接受NO方案（LOHP加NVB）和NP方案的晚期NSCLC患者的短期疗效、长期预后及不良事件。

方法

90例晚期NSCLC患者被随机分为NO组（58例，NVB 25mg/m²，第1天和第8天；LOHP 130mg/m²，第1天）和NP组（32例，NVB 25mg/m²，第1天和第8天；DDP 50mg/m²，第2天和第3天）。观察两组的短期疗效、长期预后、不良事件及生存状况。

结果

NO组的有效率为33.33%，NP组为35.48%，两组间差异无统计学意义（P>0.05）。NO组的临床受益反应率显著高于NP组（80.70%对64.52%，P<0.05）。NO组的中位疾病进展时间（TTP）为17周，NP组为15周；NO组的中位缓解时间为21周，NP组为19周；NO组的中位生存时间为39周，NP组为37周；NO组的1年生存率为37.93%，NP组为31.25%。两组间差异无统计学意义。NO组静脉炎和Ⅰ-Ⅱ级周围神经病变的发生率显著高于NP组（77.59%对50.00%，P<0.01；43.10%对15.63%，P<0.01）。NP组Ⅲ-Ⅳ级恶心/呕吐的发生率显著高于NO组（31.25%对3.45%，P<0.05）。