Clinical observation on combined treatment of isosorbide mononitrate with vinorelbine and cisplatin in advanced non-small cell lung cancer

Objective: To investigate the efficacy and safety of isosorbide mononitrate plus vinorelbine and cisplatin for treating patients with 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/m(2)) on days 1 and 8, and cisplatin (25 mg/m(2)) on day 2-4, with transdermally applying isosorbide mononitrate sustained release tables (40 mg, daily for 8 days). 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 in group B (30.8%, 16/52 patients; chi(2)=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,chi(2)=10.684, P=0.001; 11.6 v 9.0 months,chi(2)=11.231, P=0.001). Patients with squamous carcinoma showed better response to chemotherapy (RR=2.438, 95% CI 1.136-5.231, P=0.022). The difference of adverse effect was not significant between group A and B, except for 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: Using of isosorbide mononitrate sustained release tables combined with vinorelbine and cisplatin may improve overall response, TTP and OS in patients with advanced stage NSCLC.