Details

Autor(en) / Beteiligte

• Davidson, A.
• Veillard, A.-S.
• Tognela, A.
• Chan, M.M.K.
• Hughes, B.G.M.
• 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.
• Hughes, Brett
• Boyer, Michael
• Briscoe, Karen
• Davidson, Andrew
• Begbie, Stephen
• Abdi, Ehtesham
• Crombie, Catherine
• Long, Jeremy
• Jasas, Kevin
• Lewis, Craig
• Boyce, Adam
• Vama, Suresh
• Broad, Adam
• Broaddge, Vy
• Gibbs, David
• Blum, Robert
• McLachlan, Sue-Anne
• Haydon, Andrew
• Bray, Victoria
• Vardy, Janette
• Mallesara, Girish
• Lowenthal, Ray
• Asghari, Ray
• Tiley, Susan
• Hayes, Theresa
• Islam, Mohammed
• Ackland, Steven
• Adams, Jacqui
• Pavlakis, Nick
• Stockler, Martin
• Muljadi, Nick
• Coskinas, Xanthi
• Chinchen, Sarah
• Chan, Matthew
• Tognela, Annette
• Ferraro, Danielle
• Cosman, Rasha

Titel

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

Ist Teil von

• Annals of oncology, 2015-11, Vol.26 (11), p.2280-2286

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2015

Quelle

MEDLINE

Beschreibungen/Notizen

• 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 starting one of five, prespecified, platinum-based doublets as first-line chemotherapy for advanced NSCLC were randomly allocated treatment with or without nitroglycerin 25mg patches for 2 days before, the day of, and 2 days after, each chemotherapy infusion. Progression-free survival (PFS) was the primary end point. 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. The addition of topical nitroglycerin to carboplatin-based, doublet chemotherapy in NSCLC had no demonstrable benefit and should not be used or pursued further. Australian New Zealand Clinical Trials Registry Number ACTRN12608000588392.