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
| Autor: | Jacqui Adams, M.M.K. Chan, Ray Asghari, Xanthi Coskinas, Karen Briscoe, Michael Millward, Theresa Hayes, A. Davidson, A. Tognela, Matthew T. V. Chan, Susan Tiley, Nick Muljadi, Vy. Broaddge, Catherine Crombie, Mohammed Islam, N. Pavlakis, Ray M. Lowenthal, Andrew Davidson, Rasha Cosman, X. Coskinas, M.R. Stockler, C. Crombie, Robert Blum, Craig R. Lewis, C.R. Lewis, Nick Pavlakis, Adam Boyce, S. Begbie, Martin R. Stockler, Stephen Begbie, David Gibbs, Michael Boyer, Annette Tognela, Steven Ackland, Sue-Anne McLachlan, David Espinoza, Andrew Haydon, E Abdi, B.G.M. Hughes, Girish Mallesara, Jeremy Long, Janette L. Vardy, Adam Broad, J. Long, Kevin Jasas, N. Muljadi, A. Broad, Suresh Vama, S. Chinchen, Victoria J Bray, Anne-Sophie Veillard, S. Varma, M. Boyer, K. Briscoe, E. Abdi, A. Boyce, Brett G.M. Hughes, Sarah Chinchen, Danielle Ferraro |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Lung Neoplasms Gastroenterology law.invention Nitroglycerin chemistry.chemical_compound Randomized controlled trial law Carcinoma Non-Small-Cell Lung Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Humans Medicine Progression-free survival Lung cancer Aged Aged 80 and over business.industry Australia Hematology Middle Aged medicine.disease Interim analysis Chemotherapy regimen Gemcitabine Carboplatin Oncology chemistry Anesthesia Female business Follow-Up Studies medicine.drug |
| Zdroj: | Annals of Oncology. 26:2280-2286 |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/annonc/mdv373 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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