Clinical investigation of isosorbide mononitrate plus vinorelbine and cisplatin in patients with previously untreated advanced non-small cell lung cancer
10.3760/cma.j.issn.1673-422X.2013.08.021
- VernacularTitle: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
- Author:
Zhaokun ZHONG
;
Ping WANG
;
Yao ZHANG
;
Weijun CHEN
;
Ze YU
;
Lei LIU
;
Dongmei ZHOU
- Publication Type:Journal Article
- Keywords:
Carcinoma,non-small-cell lung;
Drug therapy;
Cisplatin;
Vinorelbine
- From:
Journal of International Oncology
2013;40(8):625-629
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the efficacy and safety of isosorbide mononitrate sustained release tables plus vinorelbine and cisplatin in patients with previously untreated advanced non-small-cell lung cancer (NSCLC).Methods One hundred and ten patients with stage ⅢB-Ⅳ NSCLC were randomly assigned to group A (57 cases) and group B (53 cases) by random mumber table.Patients in group A were treated with vinorelbine 25 mg/m2 on the first and eighth day 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 significandy higher than that for patients in group B (30.8%,16/52 patients; x2 =8.120,P =0.004).Median TTP and median OS in group A were longer than those in group B (8.2 vs 5.8 months,x2 =10.684,P =0.001 ; 11.6 vs 9.0 months,x2 =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.