Tirapazamine, cisplatin, and radiation versus cisplatin and radiation for advanced squamous cell carcinoma of the head and neck (TROG 02.02, headstart): A phase III trial of the trans-tasman radiation oncology group

Journal of Clinical Oncology

Volumn 28, Issue 18, 2010, Pages 2989-2995

  Rischin, Danny ^a   Peters, Lester J ^a   O'Sullivan, Brian ^a   Giralt, Jordi ^a   Fisher, Richard ^a   Yuen, Kally ^a   Trotti, Andy ^a   Bernier, Jacques ^a   Bourhis, Jean ^a   Ringash, Jolie ^a   Henke, Michael ^a   Kenny, Lizbeth ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; TIRAPAZAMINE; ANTINEOPLASTIC AGENT; TRIAZINE DERIVATIVE;

ABNORMAL LABORATORY RESULT; ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; CANCER RADIOTHERAPY; CANCER SURVIVAL; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DYSPHAGIA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEAD AND NECK SURGERY; HEARING LOSS; HUMAN; HYPOPHARYNX CARCINOMA; INFECTION; KIDNEY DISEASE; LARYNX CARCINOMA; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MOUTH CARCINOMA; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MUSCLE CRAMP; NAUSEA; NEUTROPENIA; OROPHARYNX CARCINOMA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RADIATION DERMATITIS; RADIATION DOSE; RANDOMIZED CONTROLLED TRIAL; SALIVARY GLAND DISEASE; SENSORY NEUROPATHY; SIDE EFFECT; SQUAMOUS CELL CARCINOMA; STRIDOR; TREATMENT FAILURE; TREATMENT OUTCOME; VOICE CHANGE; VOMITING; CANCER STAGING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FOLLOW UP; HEAD AND NECK TUMOR; INTERNATIONAL COOPERATION; MIDDLE AGED; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY; PATHOLOGY; SURVIVAL RATE; TUMOR RECURRENCE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SQUAMOUS CELL; CISPLATIN; COMBINED MODALITY THERAPY; FEMALE; FOLLOW-UP STUDIES; HEAD AND NECK NEOPLASMS; HUMANS; INTERNATIONAL AGENCIES; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; QUALITY OF LIFE; RADIOTHERAPY DOSAGE; SURVIVAL RATE; TREATMENT OUTCOME; TRIAZINES;

EID: 77954600498     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.27.4449     Document Type: Article

References (29)

1. Adelstein D, Adams GL, Li Y, et al: A phase III comparison of standard radiation therapy (RT) versus RT plus concurrent cisplatin (DDP) versus splitcourse RT plus concurrent DDP and 5-fluorouracil (5FU) in patients with unresectable squamous cell head and neck cancer (SCHNC): An intergroup study. Proc Am Soc Clin Oncol 19:411a, 2000 (abstr 1624)
2. Calais G, Alfonsi M, Bardet E, et al: Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst 91:2081-2086, 1999 (Pubitemid 30019568)
3. Pignon JP, Maitre AL, Maillard E, et al: Metaanalysis of chemotherapy in head and neck cancer (MACH-NC): An update on 93 randomised trials and 17,346 patients. Radiother Oncol 92:4-14, 2009
4. Nordsmark M, Bentzen SM, Rudat V, et al: Prognostic value of tumor oxygenation in 397 head and neck tumors after primary radiation therapy: An international multi-center study. Radiother Oncol 77:18-24, 2005 (Pubitemid 41503384)
5. Dorie MJ, Brown JM: Tumor-specific, schedule-dependent interaction between tirapazamine (SR 4233) and cisplatin. Cancer Res 53:4633-4636, 1993 (Pubitemid 23304391)
6. Dorie MJ, Menke D, Brown JM: Comparison of the enhancement of tumor responses to fractionated irradiation by SR 4233 (tirapazamine) and by nicotinamide with carbogen. Int J Radiat Oncol Biol Phys 28:145-150, 1994 (Pubitemid 24012866)
7. Rischin D, Peters L, Hicks R, et al: Phase I trial of concurrent tirapazamine, cisplatin, and radiotherapy in patients with advanced head and neck cancer. J Clin Oncol 19:535-542, 2001 (Pubitemid 32112868)
8. Rischin D, Peters L, Fisher R, et al: Tirapazamine, cisplatin, and radiation versus fluorouracil, cisplatin, and radiation in patients with locally advanced head and neck cancer: A randomized phase II trial of the Trans-Tasman Radiation Oncology Group (TROG 98.02). J Clin Oncol 23:79-87, 2005 (Pubitemid 41702625)
9. Peters LP, O'Sullivan B, Giralt J, et al: Critical impact of radiotherapy protocol compliance and quality in the treatment of advanced head and neck cancer: Results from TROG 02.02. J Clin Oncol 28:2996-3001, 2010
10. Kalbfleisch JD, Prentice R: The Statistical Analysis of Failure Time Data. New York, NY, Wiley, 1980
11. List MA, D'Antonio LL, Cella DF, et al: The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale: A study of utility and validity. Cancer 77:2294-2301, 1996 (Pubitemid 26162422)
12. Ringash J, O'Sullivan B, Bezjak A, et al: Interpreting clinically significant changes in patientreported outcomes. Cancer 110:196-202, 2007 (Pubitemid 46986433)
13. Ringash J, Bezjak A, O'Sullivan B, et al: Interpreting differences in quality of life: The FACT-H&N in laryngeal cancer patients. Qual Life Res 13:725-733, 2004 (Pubitemid 38509973)
14. Rischin D, Hicks RJ, Fisher R, et al: Prognostic significance of [18F]-misonidazole positron emission tomography-detected tumor hypoxia in patients with advanced head and neck cancer randomly assigned to chemoradiation with or without tirapazamine: A substudy of Trans-Tasman Radiation Oncology Group Study 98.02. J Clin Oncol 24:2098-2104, 2006 (Pubitemid 46622121)
15. Rischin D, Fisher R, Peters L, et al: Hypoxia in head and neck cancer: Studies with hypoxic positron emission tomography imaging and hypoxic cytotoxins. Int J Radiat Oncol Biol Phys 69:S61-S63, 2007 (Pubitemid 47369395)
16. Beck R, Roper B, Carlsen JM, et al: Pretreatment 18F-FAZA PET predicts success of hypoxia-directed radiochemotherapy using tirapazamine. J Nucl Med 48:973-980, 2007 (Pubitemid 46909926)
17. Corry J, Rischin D, Smith JG, et al: Radiation with concurrent late chemotherapy intensification ('chemoboost') for locally advanced head and neck cancer. Radiother Oncol 54:123-127, 2000 (Pubitemid 30116762)
18. Garden AS, Harris J, Vokes EE, et al: Preliminary results of Radiation Therapy Oncology Group 97-03: A randomized phase II trial of concurrent radiation and chemotherapy for advanced squamous cell carcinomas of the head and neck. J Clin Oncol 22:2856-2864, 2004 (Pubitemid 41079904)
19. Overgaard J, Horsman MR: Modification of hypoxia-induced radioresistance in tumors by the use of oxygen and sensitizers. Semin Radiat Oncol 6:10-21, 1996 (Pubitemid 26029371)
20. Rajendran JG, Schwartz DL, O'Sullivan J, et al: Tumor hypoxia imaging with [F-18] fluoromisonidazole positron emission tomography in head and neck cancer. Clin Cancer Res 12:5435-5441, 2006 (Pubitemid 44497258)
21. Duan JX, Jiao H, Kaizerman J, et al: Potent and highly selective hypoxia-activated achiral phosphoramidate mustards as anticancer drugs. J Med Chem 51:2412-2420, 2008 (Pubitemid 351628502)
22. Hicks KO, Pruijn FB, Secomb TW, et al: Use of three-dimensional tissue cultures to model extravascular transport and predict in vivo activity of hypoxia-targeted anticancer drugs. J Natl Cancer Inst 98: 1118-1128, 2006 (Pubitemid 44288786)
23. Jameson M, Rischin D, Pegram M, et al: A phase I trial of PR-104, a nitrogen mustard prodrug activated by both hypoxia and aldo-keto reductase 1C3, in patients with solid tumors. Cancer Chemother Pharmacol 65:791-801, 2010
24. von Pawel J, von Roemeling R, Gatzemeier U, et al: Tirapazamine plus cisplatin versus cisplatin in advanced non-small-cell lung cancer: A report of the international CATAPULT I study group - Cisplatin and Tirapazamine in Subjects with Advanced Previously Untreated Non-Small-Cell Lung Tumors. J Clin Oncol 18:1351-1359, 2000 (Pubitemid 30159856)
25. Adelstein DJ, Li Y, Adams GL, et al: An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol 21:92-98, 2003
26. Al Sarraf M, LeBlanc M, Giri PG, et al: Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: Phase III randomized Intergroup study 0099. J Clin Oncol 16:1310-1317, 1998 (Pubitemid 28175745)
27. Bonner JA, Harari PM, Giralt J, et al: Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med 354:567-578, 2006 (Pubitemid 43209104)
28. Fakhry C, Westra WH, Li S, et al: Improved survival of patients with human papillomaviruspositive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst 100: 261-269, 2008 (Pubitemid 351480538)
29. Brockstein B, Haraf DJ, Rademaker AW, et al: Patterns of failure, prognostic factors and survival in locoregionally advanced head and neck cancer treated with concomitant chemoradiotherapy: A 9-year, 337-patient, multi-institutional experience. Ann Oncol 15:1179-1186, 2004 (Pubitemid 39199304)