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