Long-Term Results of a Phase III Randomized Trial of Postoperative Radiotherapy With or Without Carboplatin in Patients With High-Risk Head and Neck Cancer
Article first published online: 2 JAN 2009
Copyright © 2008 The Triological Society
Volume 118, Issue 3, pages 444–449, March 2008
How to Cite
Argiris, A., Karamouzis, M. V., Johnson, J. T., Heron, D. E., Myers, E., Eibling, D., Cano, E., Urba, S., Gluckman, J., Grandis, J. R., Wang, Y. and Agarwala, S. S. (2008), Long-Term Results of a Phase III Randomized Trial of Postoperative Radiotherapy With or Without Carboplatin in Patients With High-Risk Head and Neck Cancer. The Laryngoscope, 118: 444–449. doi: 10.1097/MLG.0b013e31815b48f4
- Issue published online: 2 JAN 2009
- Article first published online: 2 JAN 2009
- Manuscript Accepted: 14 SEP 2007
- Head and neck cancer;
- postoperative treatment;
- randomized trial
Background: The role of postoperative radiotherapy and carboplatin in squamous cell carcinoma of the head and neck (SCCHN) has not been established.
Methods: Patients with macroscopically resected stage III/IV SCCHN with high-risk pathologic features (≥3 lymph nodes, extracapsular extension, perineural or angiolymphatic invasion, or involved margins) were randomized to receive postoperative radiotherapy alone (arm A) or the same radiotherapy plus carboplatin 100 mg/m2 intravenously once weekly during radiation (arm B). The primary endpoint was 2-year disease-free survival.
Results: Seventy-six patients were randomized, of whom 72 were eligible and analyzable (36 in each arm). The study was prematurely closed because of slow accrual. With a median follow-up of 5.3 years, the disease-free survival at 2 and 5 years was 71% and 53% in arm B versus 58% (P = .27) and 49% (P = .72) in arm A. The overall survival at 2 and 5 years was 74% and 47% in arm B versus 51% (P = .04) and 41% (P = .61) in arm A. Serious toxicities were infrequent in both arms.
Conclusions: We could not demonstrate a benefit with the addition of carboplatin to postoperative radiotherapy, possibly because of insufficient sample size.