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Title: A Phase II Multi-institutional Trial of Chemoradiation Using Weekly Docetaxel and Erythropoietin for High-Risk Postoperative Head and Neck Cancer Patients

Abstract

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,more » 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.« less

Authors:
 [1];  [2];  [3];  [3];  [4];  [4];  [5];  [6];  [7];  [8];  [9];  [10]
  1. Department of Radiation Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States)
  2. Department of Medical Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States)
  3. Department of Otolaryngology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States)
  4. Department of Head and Neck Surgery, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States)
  5. Department of Biostatistics, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States)
  6. Department of Clinical Trials Office, Vanderbilt University Medical Center, Nashville, Tennessee (United States)
  7. Department of Radiation Oncology, University of Colorado Health Sciences Center, Denver, Colorado (United States)
  8. Department of Otolaryngology, University of Colorado Health Sciences Center, Denver, Colorado (United States)
  9. Department of Medical Oncology, University of Colorado Health Sciences Center, Denver, Colorado (United States)
  10. Department of Radiation Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee (United States). E-mail: anthony.cmelak@vanderbilt.edu
Publication Date:
OSTI Identifier:
20951574
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 67; Journal 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)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CLINICAL TRIALS; ELDERLY PEOPLE; ERYTHROPOIETIN; FAILURES; HEAD; HEALTH HAZARDS; HEMOGLOBIN; LARYNX; LYMPH NODES; METASTASES; NECK; NEOPLASMS; ORAL CAVITY; PATIENTS; RADIATION DOSES; RADIOTHERAPY; SURGERY; TOXICITY

Citation Formats

Willey, Christopher D., Murphy, Barbara A., Netterville, James L., Burkey, Brian B., Shyr, Yu, Shakhtour, Bashar, Kish, Bonnie, Raben, David, Chen Changhu, Song, John I., Kane, Madeleine A., and Cmelak, Anthony J. A Phase II Multi-institutional Trial of Chemoradiation Using Weekly Docetaxel and Erythropoietin for High-Risk Postoperative Head and Neck Cancer Patients. United States: N. p., 2007. Web. doi:10.1016/j.ijrobp.2006.11.033.
Willey, Christopher D., Murphy, Barbara A., Netterville, James L., Burkey, Brian B., Shyr, Yu, Shakhtour, Bashar, Kish, Bonnie, Raben, David, Chen Changhu, Song, John I., Kane, Madeleine A., & Cmelak, Anthony J. A Phase II Multi-institutional Trial of Chemoradiation Using Weekly Docetaxel and Erythropoietin for High-Risk Postoperative Head and Neck Cancer Patients. United States. doi:10.1016/j.ijrobp.2006.11.033.
Willey, Christopher D., Murphy, Barbara A., Netterville, James L., Burkey, Brian B., Shyr, Yu, Shakhtour, Bashar, Kish, Bonnie, Raben, David, Chen Changhu, Song, John I., Kane, Madeleine A., and Cmelak, Anthony J. Sun . "A Phase II Multi-institutional Trial of Chemoradiation Using Weekly Docetaxel and Erythropoietin for High-Risk Postoperative Head and Neck Cancer Patients". United States. doi:10.1016/j.ijrobp.2006.11.033.
@article{osti_20951574,
title = {A Phase II Multi-institutional Trial of Chemoradiation Using Weekly Docetaxel and Erythropoietin for High-Risk Postoperative Head and Neck Cancer Patients},
author = {Willey, Christopher D. and Murphy, Barbara A. and Netterville, James L. and Burkey, Brian B. and Shyr, Yu and Shakhtour, Bashar and Kish, Bonnie and Raben, David and Chen Changhu and Song, John I. and Kane, Madeleine A. and Cmelak, Anthony J.},
abstractNote = {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.},
doi = {10.1016/j.ijrobp.2006.11.033},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 5,
volume = 67,
place = {United States},
year = {Sun Apr 01 00:00:00 EDT 2007},
month = {Sun Apr 01 00:00:00 EDT 2007}
}