A phase III randomized trial of adding topical nitroglycerin to first-line chemotherapy for advanced nonsmall-cell lung cancer: The Australasian lung cancer trials group NITRO trial

A. Davidson, A.S. Veillard, A. Tognela, M.M.K. Chan, B.G.M. Hughes, M. Boyer, K. Briscoe, S. Begbie, E. Abdi, C. Crombie, J. Long, A. Boyce, C.R. Lewis, S. Varma, A. Broad, N. Muljadi, S. Chinchen, D. Espinoza, X. Coskinas, N. PavlakisMichael Millward, M.R. Stockler

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    17 Citations (Scopus)

    Abstract

    © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Background: We sought to determine whether the substantial benefits of topical nitroglycerin with first-line, platinum-based, doublet chemotherapy in advanced nonsmall-cell lung cancer (NSCLC) seen in a phase II trial could be corroborated in a rigorous, multicenter, phase III trial. Patients and methods: Patients starting one of five, prespecified, platinum-based doublets as first-line chemotherapy for advanced NSCLC were randomly allocated treatment with or without nitroglycerin 25 mg patches for 2 days before, the day of, and 2 days after, each chemotherapy infusion. Progression-free survival (PFS) was the primary end point. Results: Accrual was stopped after the first interim analysis of 270 events. Chemotherapy was predominantly with carboplatin and gemcitabine (79%) or carboplatin and paclitaxel (18%). The final analysis included 345 events in 372 participants with a median follow-up of 33 months. Topical nitroglycerin had no demonstrable effect on PFS [median 5.0 versus 4.8 months, hazard ratio (HR) = 1.07, 95% confidence interval (CI) 0.86-1.32, P = 0.55], overall survival (median 11.0 versus 10.3 months, HR = 0.99, 95% CI 0.79-1.24, P = 0.94), or objective tumor response (31% versus 30%, relative risk = 1.03, 95% CI 0.82-1.29, P = 0.81). Headache, hypotension, syncope, diarrhea, dizziness, and anorexia were more frequent in those allocated nitroglycerin. Conclusion: The addition of topical nitroglycerin to carboplatin-based, doublet chemotherapy in NSCLC had no demonstrable benefit and should not be used or pursued further.
    Original languageEnglish
    Pages (from-to)2280-2286
    Number of pages7
    JournalAnnals of Oncology
    Volume26
    Issue number11
    Early online date7 Sep 2015
    DOIs
    Publication statusPublished - Nov 2015

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