A Phase II Multi-institutional Trial of Chemoradiation Using Weekly Docetaxel and Erythropoietin for High-Risk Postoperative Head and Neck Cancer Patients
- Department of Radiation Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States)
- Department of Medical Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States)
- Department of Otolaryngology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States)
- Department of Head and Neck Surgery, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States)
- Department of Biostatistics, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States)
- Department of Clinical Trials Office, Vanderbilt University Medical Center, Nashville, Tennessee (United States)
- Department of Radiation Oncology, University of Colorado Health Sciences Center, Denver, Colorado (United States)
- Department of Otolaryngology, University of Colorado Health Sciences Center, Denver, Colorado (United States)
- Department of Medical Oncology, University of Colorado Health Sciences Center, Denver, Colorado (United States)
Purpose: To determine efficacy and toxicities of postoperative concurrent chemoradiation using docetaxel in high-risk head and neck cancer. Methods and Materials: High-risk patients were enrolled 2-8 weeks after surgery. Treatment included 60 Gy for 6 weeks with weekly docetaxel 25 mg/m{sup 2} and erythropoietin alpha 40,000 U for hemoglobin {<=}12 g/dL. Primary endpoints included locoregional control (LC), disease-free survival (DFS), and patterns of failure (POF). Secondary endpoints were toxicity and quality of life. Results: Eighteen patients were enrolled (14 male, 4 female), aged 24-70 years (median, 55 years). Primary site included oropharynx = 7, oral cavity 8, hypopharynx = 1, and larynx = 2. Pathologic American Joint Committee on Cancer Stage was III = 3 patients, IV = 15 patients. High-risk eligibility included {>=}2 positive lymph nodes = 13, extracapsular extension = 10, positive margins = 8 (11 patients with two or more risk factors). Docetaxel was reduced to 20 mg/m{sup 2}/week after 5 patients had prolonged Grade 3 or higher mucositis. Overall, number of doses delivered was 2 of 6 = 1, 3 of 6 2, 4 of 6 = 2, 5 of 6 = 4, 6 of 6 = 9 patients. With median follow-up of 30 months (range, 5-66), 10 (56%) patients are alive and have no evidence of disease (NED); POF: three local recurrences (two with distant) and 1 distant only. One-year survival was 76%, median PFS and DFS had not been reached. Three-year LC was 82%. No Grade 3 or higher late toxicities were observed, although a few cases of prolonged mucositis and taste loss (>3 months) were seen, particularly at 25 mg/m{sup 2}/week. Conclusion: Postoperative radiation therapy with weekly docetaxel 20 or 25 mg/m{sup 2}/week for high-risk postoperative head and neck cancer caused intolerable mucosal toxicity, prompting early study termination. Further studies should consider 15 mg/m{sup 2}. Actuarial 3-year LC is 82%, similar to cisplatin-based chemoradiation regimens. Distant metastasis remains an important issue requiring additional systemic interventions.
- OSTI ID:
- 20951574
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 67, Issue 5; Other Information: DOI: 10.1016/j.ijrobp.2006.11.033; PII: S0360-3016(06)03504-8; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
Similar Records
Preclinical and Pilot Clinical Studies of Docetaxel Chemoradiation for Stage III Non-Small-Cell Lung Cancer
RTOG 0417: Efficacy of Bevacizumab in Combination With Definitive Radiation Therapy and Cisplatin Chemotherapy in Untreated Patients With Locally Advanced Cervical Carcinoma