国际肿瘤学杂志

国际肿瘤学杂志 ›› 2013, Vol. 40 ›› Issue (8): 625-629.

• 论著 • 上一篇    下一篇

单硝酸异山梨酯联合长春瑞滨和顺铂治疗晚期非小细胞肺癌的临床观察

仲昭坤, 王萍, 张耀等   

  1. 264000烟台，烟台山医院肿瘤内科
  • 出版日期:2013-08-08 发布日期:2013-08-15
  • 通讯作者: 周冬梅，E-mail:zhoudongmei68@163.com E-mail:zhoudongmei68@163.com

Clinical investigation of isosorbide mononitrate plus vinorelbine and cisplatin in patients with previously untreated advanced stage non–small-cell lung cancer

ZHONG  Zhao-Kun, WANG  Ping, ZHANG  Yao, et al   

  1. Department of Oncology, Yantai Shan Hospital, Yantai 264000, China

  • Online:2013-08-08 Published:2013-08-15
  • Contact: ZHOU Dong-mei, E-mail: zhoudongmei68@163.com E-mail:zhoudongmei68@163.com

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摘要： 目的 观察单硝酸异山梨酯对长春瑞滨和顺铂治疗Ⅲb～Ⅳ期初治非小细胞肺癌（NSCLC）的化疗增敏作用。方法 110例Ⅲb～Ⅳ期初治的NSCLC患者采用随机数字表方法随机进入试验组（A组，57例，长春瑞滨+顺铂+单硝酸异山梨酯缓释片）和对照组（B组，53例，长春瑞滨+顺铂），2周期化疗后，按实体瘤疗效评价标准（RECIST）1.1标准评价近期疗效，美国国立癌症研究所抗癌药物不良反应评定标准（NCI-CTC）3.0评价不良反应，并随访至疾病进展。结果 A、B两组有效率分别为58.2%（32/55）和30.8%（16/52），两组间比较，χ2=8.120，P=0.004；中位疾病进展时间分别为8.2个月和5.8个月（χ2=10.684，P=0.001）；中位生存期分别为11.6个月和9.0个月（χ2=11.231，P=0.001）；鳞癌的化疗效果更好（RR=2.438，95% CI 为1.136～5.231，P=0.022）。A组头痛发生率显著高于B组（P<0.001），血液学毒性及胃肠道反应两组差异无统计学意义。结论 单硝酸异山梨酯可以增加长春瑞滨联合顺铂方案治疗ⅢB～Ⅳ期NSCLC患者化疗的敏感性。

关键词: 癌, 非小细胞肺, 药物疗法, 顺铂, 长春瑞滨

Abstract: Objective To investigate the efficacy and safety of isosorbide mononitrate sustained release tables plus vinorelbine and cisplatin in patients with previously untreated advanced stage non–small-cell lung cancer (NSCLC). Methods 110 patients with stage ⅢB-Ⅳ NSCLC were randomly assigned to group A(57 cases) and group B(53 cases). Patients in group A were treated with vinorelbine 25 mg/m2 on days 1 and 8 and cisplatin 25 mg/m2 on day 2-4, with transdermally applied isosorbide mononitrate sustained release tables (40 mg, daily for 8 days) , and patients in group B were treated with vinorelbine and cisplatin. Response to treatment was assessed by RECIST1.1 and adverse effect was assessed by NCI-CTC（3.0）. Results The response rate in group A (58.2%, 32/55 patients) was significantly higher than that for patients in group B (30.8%, 16/52 patients; χ2=8.120, P=0.004). Median TTP and median OS in group A were longer than those in group B (8.2 v 5.8 months, χ2=10.684, P=0.001; 11.6 v 9.0 months, χ2=11.231, P=0.001). While，patients with squamous carcinoma showed better response to chemotherapy (RR=2.438, 95%CI 1.136-5.231, P=0.022). Adverse effect difference was not significant between group A and group B, except headache. The rate of grade 1 to 2 headache in group A (34.5%; 19 of 55 patients) was significantly higher than that in group B (3.8%; 2 of 52 patients; P<0 .001). Conclusion Use of isosorbide mononitrate sustained release tables combined with vinorelbine and cisplatin may improve overall response, TTP and OS in patients with advanced stage NSCLC.

Key words: Carcinoma, non-small-cell lung, Drug therapy, Cisplatin, Vinorelbine