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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)

Journal Article


Abstract


  • Purpose: To select one of two chemoradiotherapy regimens for locally advanced squamous cell carcinoma (SCC) of the head and neck as the experimental arm for the next Trans-Tasman Radiation Oncology Group phase III trial. Patients and Methods: One hundred twenty-two previously untreated patients with stage III/IV SCC of the head and neck were randomized to receive definitive radiotherapy (70 Gy in 7 weeks) concurrently with either cisplatin (75 mg/m 2) plus tirapazamine (290 mg/m2/d) on day 2 of weeks 1, 4, and 7, and tirapazamine alone (160 mg/m2/d) on days 1, 3, and 5 of weeks 2 and 3 (TPZ/CIS), or cisplatin (50 mg/m2) on day 1 and infusional fluorouracil (360 mg/m2/d) on days 1 through 5 of weeks 6 and 7 (chemoboost). Results: Three-year failure-free survival rates were 55% with TPZ/CIS (95% CI, 39% to 70%) and 44% with chemoboost (95% CI, 30% to 60%; log-rank P = .16). Three-year locoregional failure-free rates were 84% in the TPZ/CIS arm (95% CI, 71% to 92%) and 66% in the chemoboost arm (95% CI, 51 % to 79%; P = .069). More febrile neutropenia and grade 3 or 4 late mucous membrane toxicity were observed with TPZ/CIS, while acute skin radiation reaction was more severe and prolonged with chemoboost. Compliance with protocol treatment was satisfactory on both arms. Conclusion: Both regimens are feasible and are associated with significant but acceptable toxicity profiles in the cooperative group setting. Based on the promising efficacy seen in this trial, TPZ/CIS is being evaluated in a large phase III trial. �� 2005 by American Society of Clinical Oncology.

UOW Authors


  •   Jackson, Michael (external author)

Publication Date


  • 2005

Citation


  • Rischin, D., Peters, L., Fisher, R., Macann, A., Denham, J., Poulsen, M., . . . McClure, B. (2005). 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). Journal of Clinical Oncology, 23(1), 79-87. doi:10.1200/JCO.2005.01.072

Scopus Eid


  • 2-s2.0-16644377045

Web Of Science Accession Number


Start Page


  • 79

End Page


  • 87

Volume


  • 23

Issue


  • 1

Place Of Publication


Abstract


  • Purpose: To select one of two chemoradiotherapy regimens for locally advanced squamous cell carcinoma (SCC) of the head and neck as the experimental arm for the next Trans-Tasman Radiation Oncology Group phase III trial. Patients and Methods: One hundred twenty-two previously untreated patients with stage III/IV SCC of the head and neck were randomized to receive definitive radiotherapy (70 Gy in 7 weeks) concurrently with either cisplatin (75 mg/m 2) plus tirapazamine (290 mg/m2/d) on day 2 of weeks 1, 4, and 7, and tirapazamine alone (160 mg/m2/d) on days 1, 3, and 5 of weeks 2 and 3 (TPZ/CIS), or cisplatin (50 mg/m2) on day 1 and infusional fluorouracil (360 mg/m2/d) on days 1 through 5 of weeks 6 and 7 (chemoboost). Results: Three-year failure-free survival rates were 55% with TPZ/CIS (95% CI, 39% to 70%) and 44% with chemoboost (95% CI, 30% to 60%; log-rank P = .16). Three-year locoregional failure-free rates were 84% in the TPZ/CIS arm (95% CI, 71% to 92%) and 66% in the chemoboost arm (95% CI, 51 % to 79%; P = .069). More febrile neutropenia and grade 3 or 4 late mucous membrane toxicity were observed with TPZ/CIS, while acute skin radiation reaction was more severe and prolonged with chemoboost. Compliance with protocol treatment was satisfactory on both arms. Conclusion: Both regimens are feasible and are associated with significant but acceptable toxicity profiles in the cooperative group setting. Based on the promising efficacy seen in this trial, TPZ/CIS is being evaluated in a large phase III trial. �� 2005 by American Society of Clinical Oncology.

UOW Authors


  •   Jackson, Michael (external author)

Publication Date


  • 2005

Citation


  • Rischin, D., Peters, L., Fisher, R., Macann, A., Denham, J., Poulsen, M., . . . McClure, B. (2005). 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). Journal of Clinical Oncology, 23(1), 79-87. doi:10.1200/JCO.2005.01.072

Scopus Eid


  • 2-s2.0-16644377045

Web Of Science Accession Number


Start Page


  • 79

End Page


  • 87

Volume


  • 23

Issue


  • 1

Place Of Publication