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

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. and Stockler, M. R. (2015) 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. Annals of Oncology, 26 11: 2280-2286. doi:10.1093/annonc/mdv373


Author 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.
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
Journal name Annals of Oncology   Check publisher's open access policy
ISSN 1569-8041
0923-7534
Publication date 2015-09-07
Year available 2015
Sub-type Article (original research)
DOI 10.1093/annonc/mdv373
Open Access Status Not yet assessed
Volume 26
Issue 11
Start page 2280
End page 2286
Total pages 7
Place of publication Oxford, United Kingdom
Publisher Oxford University Press
Collection year 2016
Language eng
Formatted 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.
Keyword Lung cancer
Nitroglycerin
Chemotherapy
Phase III clinical trial
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
School of Medicine Publications
 
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