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|Title:||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||Authors:||Chan, Matthew M K ;Davidson, A.;Veillard, A.S.;Hughes, B.G.;Boyer, M.;Briscoe, K.;Begbie, S.;Abdi, E.;Crombie, C.;Long, J.;Boyce, A.;Lewis, C.R.;Varma, S.;Broad, A.;Muljadi, N.;Chinchen, S.;Espinoza, D.;Coskinas, X.;Pavlakis, N.;Millward, M.;Stockler, M.R.||Issue Date:||Nov-2015||Source:||Volume 26, Issue 11, pp. 2280-2286||Journal title:||Annals of Oncology||Abstract:||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. CLINICAL TRIALS NUMBER: Australian New Zealand Clinical Trials Registry Number ACTRN12608000588392.||URI:||https://elibrary.cclhd.health.nsw.gov.au/cclhdjspui/handle/1/1915||DOI:||10.1093/annonc/mdv373||Pubmed:||https://pubmed.ncbi.nlm.nih.gov/26347110/||ISSN:||0923-7534||Publicaton type:||Journal Article||Keywords:||Cancer||Study or Trial:||Randomized Controlled Clinical Trial/Controlled Clinical Trial|
|Appears in Collections:||Oncology / Cancer|
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