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Mature results from a randomized Phase II trial of cisplatin plus 5-fluorouracil and radiotherapy with or without tirapazamine in patients with resectable Stage IV head and neck squamous cell carcinomas
Version of Record online: 10 MAR 2006
Copyright © 2006 American Cancer Society
Volume 106, Issue 9, pages 1940–1949, 1 May 2006
How to Cite
Le, Q.-T., Taira, A., Budenz, S., Jo Dorie, M., Goffinet, D. R., Fee, W. E., Goode, R., Bloch, D., Koong, A., Martin Brown, J. and Pinto, H. A. (2006), Mature results from a randomized Phase II trial of cisplatin plus 5-fluorouracil and radiotherapy with or without tirapazamine in patients with resectable Stage IV head and neck squamous cell carcinomas. Cancer, 106: 1940–1949. doi: 10.1002/cncr.21785
- Issue online: 18 APR 2006
- Version of Record online: 10 MAR 2006
- Manuscript Accepted: 4 NOV 2005
- Manuscript Revised: 7 OCT 2005
- Manuscript Received: 6 SEP 2005
- National Cancer Institute, Department of Health and Human Services, Public Health Service Grant. Grant Number: CA67166
- head and neck cancers;
The objective of this article was to report the results from a randomized trial that evaluated the efficacy and toxicity of adding tirapazamine (TPZ) to chemoradiotherapy in the treatment of patients with head and neck squamous cell carcinomas (HNSCC).
Sixty-two patients with lymph node-positive, resectable, TNM Stage IV HNSCC were randomized to receive either 2 cycles of induction chemotherapy (TPZ, cisplatin, and 5-fluorouracil [5-FU]) followed by simultaneous chemoradiotherapy (TPZ, cisplatin, and 5-FU) or to receive the same regimen without TPZ. Patients who did not achieve a complete response at 50 Grays underwent surgical treatment. Stratification factors for randomization included tumor site, TNM stage, and median tumor oxygen tension. The primary endpoint was complete lymph node response.
The addition of TPZ resulted in increased hematologic toxicity. There was 1 treatment-related death from induction chemotherapy. The complete clinical and pathologic response rate in the lymph nodes was 90% and 74% for the standard treatment arm and the TPZ arm, respectively (P = .08) and 89% and 90% at the primary site in the respective treatment arms (P = .71). The 5-year overall survival rate was 59%, the cause-specific survival rate was 68%, the rate of freedom from recurrence was 69%, and the locoregional control rate was 77% for the entire group. There was no difference with regard to any of the outcome parameters between the 2 treatement arms. The significant long-term toxicity rate also was found to be similar between the 2 arms.
The addition of TPZ increased hematologic toxicity but did not improve outcomes in patients with resectable, Stage IV HNSCC using the protocol administered this small randomized study. The combination of induction and simultaneous chemoradiotherapy resulted in excellent survival in these patients. Cancer 2006. © 2006 American Cancer Society.