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
|
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Published in |
Annals of Oncology, September 2015
|
DOI | 10.1093/annonc/mdv373 |
Pubmed ID | |
Authors |
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. Pavlakis, M. Millward, M.R. Stockler, on behalf of the Australasian Lung cancer Trials Group, Brett Hughes, Michael Boyer, Karen Briscoe, Andrew Davidson, Stephen Begbie, Ehtesham Abdi, Catherine Crombie, Jeremy Long, Kevin Jasas, Craig Lewis, Adam Boyce, Suresh Vama, Adam Broad, Vy. Broaddge, David Gibbs, Robert Blum, Sue-Anne McLachlan, Andrew Haydon, Victoria Bray, Janette Vardy, Girish Mallesara, Ray Lowenthal, Ray Asghari, Susan Tiley, Theresa Hayes, Mohammed Islam, Steven Ackland, Jacqui Adams, Nick Pavlakis, Martin Stockler, Nick Muljadi, Xanthi Coskinas, Sarah Chinchen, Matthew Chan, Annette Tognela, Danielle Ferraro, Rasha Cosman |
Abstract |
We sought to determine if the substantial benefits of topical nitroglycerin with first line, platinum-based, doublet chemotherapy in advanced non-small-cell lung cancer (NSCLC) seen in a phase 2 trial could be corroborated in a rigorous, multicenter, phase 3 trial. Patients starting one of five, pre-specified, 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 endpoint. 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 v 4.8 months, HR=1.07, 95% CI 0.86 to 1.32, P=0.55), overall survival (median 11.0 v 10.3 months, HR=0.99, 95% CI 0.79 to 1.24, P=0.94), or objective tumor response (31% v 30%, relative risk=1.03, 95% CI 0.82 to 1.29, P=0.81). Headache, hypotension, syncope, diarrhea, dizziness and anorexia were more frequent in those allocated nitroglycerin. The addition of topical nitroglycerin to carboplatin-based, doublet chemotherapy in NSCLC had no demonstrable benefit and should not be used or pursued further. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Australia | 2 | 100% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Practitioners (doctors, other healthcare professionals) | 1 | 50% |
Members of the public | 1 | 50% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 45 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 6 | 13% |
Student > Master | 5 | 11% |
Other | 4 | 9% |
Lecturer | 3 | 7% |
Student > Ph. D. Student | 3 | 7% |
Other | 7 | 16% |
Unknown | 17 | 38% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 9 | 20% |
Nursing and Health Professions | 7 | 16% |
Agricultural and Biological Sciences | 2 | 4% |
Unspecified | 1 | 2% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 2% |
Other | 6 | 13% |
Unknown | 19 | 42% |