Please use this identifier to cite or link to this item: https://repository.southwesthealthcare.com.au/swhealthcarejspui/handle/1/3371
Journal 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: Davidson, A.
Veillard, A. S.
Tognela, A.
Chan, M. M.
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.
Australasian Lung cancer Trials, Group
Australasian Lung cancer Trials Group, Altg
SWH Author: Davidson, Adee
Keywords: Adult
Aged
80 and Over
Antineoplastic Combined Chemotherapy Protocols
Australia
Carcinoma
Female
Follow-Up Studies
Humans
Lung Neoplasms
Male
Middle Aged
Nitroglycerin
Chemotherapy
Lung Cancer
Phase 3 Clinical Trial
Issue Date: 2015
Date Accessioned: 2023-03-17T04:56:46Z
Date Available: 2023-03-17T04:56:46Z
Accession Number: 26347110
Url: https://www.ncbi.nlm.nih.gov/pubmed/26347110
Description Affiliation: Department of Medical Oncology, Fiona Stanley Hospital, Perth andrew.davidson@health.wa.gov.au.
NHMRC Clinical Trials Centre, University of Sydney, Sydney.
Department of Medical Oncology, The Prince Charles Hospital, Brisbane School of Medicine, University of Queensland, Brisbane.
Department of Medical Oncology, Chris O'Brien Lifehouse, Camperdown.
Department of Medical Oncology, Coffs Harbour Health Campus, Coffs Harbour.
Department of Medical Oncology, Port Macquarie Base Hospital, Port Macquarie.
Department of Medical Oncology, The Tweed Hospital, Tweed Heads School of Medicine & Dentistry, Griffith University, Southport.
Department of Medical Oncology, Nepean Cancer Care Centre, Kingswood.
Department of Medical Oncology, Nambour General Hospital, Nambour.
Department of Medical Oncology, Lismore Base Hospital, Lismore.
Prince of Wales Hospital Clinical School, University of New South Wales, Randwick.
Department of Medical Oncology, The Townsville Hospital, Townsville.
Department of Medical Oncology, Geelong Hospital, Geelong.
Department of Medical Oncology, Royal North Shore Hospital, St Leonards.
Department of Medical Oncology, Sir Charles Gardiner Hospital, Nedlands School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia.
Format Startpage: 2280-6
Source Volume: 26
Issue Number: 11
Database: Medline
Notes: (ALTG)
eng
Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
England
2015/09/09
Ann Oncol. 2015 Nov;26(11):2280-6. doi: 10.1093/annonc/mdv373. Epub 2015 Sep 7.
DOI: 10.1093/annonc/mdv373
Date: Nov
NLM
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://repository.southwesthealthcare.com.au/swhealthcarejspui/handle/1/3371
Journal Title: Annals of Oncology
Type: Journal Article
Appears in Collections:SWH Data Contributions



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