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

Volumn 26, Issue 11, 2015, Pages 2280-2286

  Davidson, Andrew ^a   Veillard, A S ^b   Tognela, A ^b   Chan, M M K ^b   Hughes, B G M ^c,d   Boyer, M ^e   Briscoe, K ^f   Begbie, S ^g   Abdi, E ^h,i   Crombie, C ^j   Long, J ^k   Boyce, A ^l   Lewis, C R ^m   Varma, S ⁿ   Broad, A ^o   Muljadi, N ^b   Chinchen, S ^b   Espinoza, D ^b   Coskinas, X ^b   Pavlakis, N ^p   Millward, M ^q,r   Stockler, M R ^b   more..

^a FIONA STANLEY HOSPITAL   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c THE PRINCE CHARLES HOSPITAL   (Australia)

^d UNIVERSITY OF QUEENSLAND   (Australia)

^e Chris O'Brien Lifehouse ^*  (Australia)

^f Coffs Harbour Health Campus ^*  (Australia)

^g PORT MACQUARIE BASE HOSPITAL   (Australia)

^h Tweed Hospital   (Australia)

ⁱ GRIFFITH UNIVERSITY   (Australia)

^j Nepean Cancer Care Centre   (Australia)

^k NAMBOUR GENERAL HOSPITAL   (Australia)

^l Lismore Base Hospital ^*  (Australia)

^m UNIVERSITY OF NEW SOUTH WALES   (Australia)

ⁿ TOWNSVILLE HOSPITAL   (Australia)

^o GEELONG HOSPITAL   (Australia)

^p ROYAL NORTH SHORE HOSPITAL   (Australia)

^q SIR CHARLES GAIRDNER HOSPITAL   (Australia)

^r UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

more..

Author keywords

chemotherapy; Lung cancer; nitroglycerin; phase III clinical trial

Indexed keywords

CARBOPLATIN; CISPLATIN; GEMCITABINE; GLYCERYL TRINITRATE; LACTATE DEHYDROGENASE; NAVELBINE; PACLITAXEL; ANTINEOPLASTIC AGENT;

ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG EFFECT; DRUG FATALITY; FAINTNESS; FEMALE; FOLLOW UP; HEADACHE; HISTOPATHOLOGY; HUMAN; HYPOTENSION; MALE; MEDICATION COMPLIANCE; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPHIL COUNT; NEUTROPHIL LYMPHOCYTE RATIO; NON SMALL CELL LUNG CANCER; OBJECTIVE TUMOR RESPONSE; ONCOLOGICAL PARAMETERS; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL RATE; SURVIVAL TIME; VERY ELDERLY; AUSTRALIA; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; LUNG NEOPLASMS;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AUSTRALIA; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; FOLLOW-UP STUDIES; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NITROGLYCERIN;

EID: 84947731833     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdv373     Document Type: Article

References (20)

1. Azzoli CG, Temin S, Aliff T et al. 2011 Focused Update of 2009 American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol 2011; 29: 3825-3831.
2. Kiely BE, Alam M, Blinman P et al. Estimating typical, best-case and worst-case life expectancy scenarios for patients starting chemotherapy for advanced nonsmall-cell lung cancer: a systematic review of contemporary randomized trials. Lung Cancer 2012; 77: 537-544.
3. Yasuda H, Yamaya M, Nakayama K et al. Randomized phase II trial comparing nitroglycerin plus vinorelbine and cisplatin with vinorelbine and cisplatin alone in previously untreated stage IIIB/IV non-small-cell lung cancer. J Clin Oncol 2006; 24: 688-694.
4. Yasuda H, Nakayama K, Watanabe M et al. Nitroglycerin treatment may enhance chemosensitivity to docetaxel and carboplatin in patients with lung adenocarcinoma. Clin Cancer Res 2006; 12: 6748-6757.
5. Korde Choudhari S, Chaudhary M, Bagde S et al. Nitric oxide and cancer: a review. World J Surg Oncol 2013; 11: 118.
6. Matthews NE, Adams MA, Maxwell LR et al. Nitric oxide-mediated regulation of chemosensitivity in cancer cells. J Natl Cancer Inst 2001; 93: 1879-1885.
7. Hagen T, Taylor CT, Lam F, Moncada S. Redistribution of intracellular oxygen in hypoxia by nitric oxide: effect on HIF1[alpha]. Science 2003; 302: 1975-1978.
8. Semenza GL, Roth PH, Fang HM, Wang GL. Transcriptional regulation of genes encoding glycolytic enzymes by hypoxia-inducible factor 1. J Biol Chem 1994; 269: 23757-23763.
9. Yeo E-J, Chun Y-S, Cho Y-S et al. YC-1: a potential anticancer drug targeting hypoxia-inducible factor 1. J Natl Cancer Inst 2003; 95: 516-525.
10. Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228-247.
11. Trotti A, Colevas AD, Setser A et al. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 2003; 13: 176-181.
12. Rabin R, Charro FD. EQ-SD: a measure of health status from the EuroQol Group. Ann Med 2001; 33: 337-343.
13. Lin H-W, Lloyd A, Pickard AS, Wilke CT. Health utilities using the EQ-5D in studies of cancer. Pharmacoeconomics 2007; 25: 365+.
14. Spitzer WO, Dobson AJ, Hall J et al. Measuring the quality of life of cancer patients: a concise QL-Index for use by physicians. J Chronic Dis 1981; 34: 585-597.
15. Dingemans A-MC, Groen HJM, Herder J et al. A randomized phase II study of paclitaxel-carboplatin-bevacizumab (PCB) with or without nitroglycerin patches (NTG) in patients ( pts) with stage IV nonsquamous non-small cell lung cancer (NSCLC): Nvalt 12 (NCT01171170). J Clin Oncol 2014; 32: 5s.
16. Reinmuth N, Meyer A, Hartwigsen D et al. Randomized, double-blind phase II study to compare nitroglycerin plus oral vinorelbine plus cisplatin with oral vinorelbine plus cisplatin alone in patients with stage IIIB/IV non-small cell lung cancer (NSCLC). Lung Cancer 2014; 83: 363-368.
17. Cooper WA, Lam DCL, O'Toole SA, Minna JD. Molecular biology of lung cancer. J Thora Dis 2013; 5: S479-S490.
18. Gandara DR, Kawaguchi T, Crowley J et al. Japanese-US common-arm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a model for assessing population-related pharmacogenomics. J Clin Oncol 2009; 27: 3540-3546.
19. Lara PN, Redman MW. The hazards of randomized phase II trials. Ann Oncol 2012; 23: 7-9.
20. Maitland ML, Hudoba C, Snider KL, Ratain MJ. Analysis of the yield of phase II combination therapy trials in medical oncology. Clin Cancer Res 2010; 16: 5296-5302.