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Randomized Phase II Trial Comparing Nitroglycerin Plus Vinorelbine and Cisplatin With Vinorelbine and Cisplatin Alone in Previously Untreated Stage IIIB/IV Non–Small-Cell Lung Cancer

From the Department of Geriatric and Respiratory Medicine, and Department of Radiology, Tohoku University School of Medicine, Sendai; and Department of Internal Medicine, Furukawa City Hospital, Furukawa, Japan

Address reprint requests to Hiroyasu Yasuda, MD, PhD, Department of Geriatric and Respiratory Medicine, Tohoku University School of Medicine, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan; e-mail:yasuda{at}geriat.med.tohoku.ac.jp

PURPOSE: To investigate the efficacy and safety of nitroglycerin plus vinorelbine and cisplatin in patients with previously untreated stage IIIB/IV non–small-cell lung cancer (NSCLC) as the experimental arm for the next phase III trial.

PATIENTS AND METHODS: One hundred twenty patients with stage IIIB/IV NSCLC were randomly assigned to vinorelbine 25 mg/m² on days 1 and 8 and cisplatin 80 mg/m² on day 1, with transdermally applied nitroglycerin (25 mg/patient daily for 5 days; arm A) or with placebo patch (arm B) every 3 weeks for a maximum of four cycles in a double-blind and controlled trial. Primary efficacy end points were the best confirmed response rate and time to disease progression (TTP).

RESULTS: The response rate in arm A (72%; 43 of 60 patients) was significantly higher than that for patients in arm B (42%; 25 of 60 patients; P < .001). Median TTP in arm A was longer than that in arm B (327 v 185 days). No severe adverse effect was recognized for either arm. The rate of grade 1 to 2 headache in arm A (30%; 18 of 60 patients) was significantly higher than that in arm B (2%; one of 60 patients; P < .001, ² test).

CONCLUSION: Use of nitroglycerin combined with vinorelbine and cisplatin may improve overall response and TTP in patients with stage IIIB/IV NSCLC. The arm A regimen is being evaluated in a large phase III trial.

Supported in part by a Grant-In-Aid for Scientific Research from the Ministry of Education, Science and Culture (Grant No. 17790524) of the Japanese government (H.Y); a Grant-In-Aid for Scientific Research from the Ministry of Education, Science and Culture (Grant No. 16590732), and the Ministry of Welfare and Labor of the Japanese government (M.Y.); and the Japanese Foundation for Aging and Health (K.Y.).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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				H. Yasuda, K. Nakayama, M. Watanabe, S. Suzuki, H. Fuji, S. Okinaga, A. Kanda, K. Zayasu, T. Sasaki, M. Asada, et al. Nitroglycerin Treatment May Enhance Chemosensitivity to Docetaxel and Carboplatin in Patients with Lung Adenocarcinoma. Clin. Cancer Res., November 15, 2006; 12(22): 6748 - 6757. [Abstract] [Full Text] [PDF]