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Title: The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective Phase III study by Radiation Therapy Oncology Group 9901

Abstract

Purpose: Based on early clinical evidence of potential mucosal protection by granulocyte-macrophage colony stimulating factor (GM-CSF), the Radiation Therapy Oncology Group conducted a double-blind, placebo-controlled, randomized study to test the efficacy and safety of GM-CSF in reducing the severity and duration of mucosal injury and pain (mucositis) associated with curative radiotherapy (RT) in head-and-neck cancer patients. Methods and Materials: Eligible patients included those with head-and-neck cancer with radiation ports encompassing >50% of oral cavity and/or oropharynx. Standard RT ports were used to cover the primary tumor and regional lymphatics at risk in standard fractionation to 60-70 Gy. Concurrent cisplatin chemotherapy was allowed. Patients were randomized to receive subcutaneous injection of GM-CSF 250 {mu}g/m{sup 2} or placebo 3 times a week. Mucosal reaction was assessed during the course of RT using the National Cancer Institute Common Toxicity Criteria and the protocol-specific scoring system. Results: Between October 2000 and September 2002, 130 patients from 36 institutions were accrued. Nine patients (7%) were excluded from the analysis, 3 as a result of drug unavailability. More than 80% of the patients participated in the quality-of-life endpoint of this study. The GM-CSF did not cause any increase in toxicity compared with placebo. There was nomore » statistically significant difference in the average mean mucositis score in the GM-CSF and placebo arms by a t test (p = 0.4006). Conclusion: This placebo-controlled, randomized study demonstrated no significant effect of GM-CSF given concurrently compared with placebo in reducing the severity or duration of RT-induced mucositis in patients undergoing definitive RT for head-and-neck cancer.« less

Authors:
 [1];  [2];  [3];  [4];  [5];  [6];  [7];  [8];  [9];  [10]
  1. Department of Radiation Oncology, University of California, Davis Medical Center, Sacramento, CA (United States). E-mail: janice.ryu@ucdmc.ucdavis.edu
  2. Department of Statistics, Radiation Therapy Oncology Group, Philadelphia, PA (United States)
  3. Oral Oncology Department, Harper Hospital/Wayne State University, Detroit, MI (United States)
  4. Rex Healthcare Cancer Center, Raleigh, NC (United States)
  5. Division of Geriatric Oncology, University of South Florida H. Lee Moffitt Cancer Center, Tampa, FL (United States)
  6. Department of Radiation Oncology, University of California, Davis Medical Center, Sacramento, CA (United States)
  7. Department of Radiation Therapy/Oncology L'Hotel-Dieu de Quebec, Notre Dame Hospital, Quebec City, Quebec (Canada)
  8. Department of Radiation Oncology, Shiffler Cancer Center, Wheeling Hospital, Wheeling, WV (United States)
  9. Department of Radiation Oncology, Wayne State University, Detroit, MI (United States)
  10. Department of Radiation Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)
Publication Date:
OSTI Identifier:
20944712
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 67; Journal Issue: 3; Other Information: DOI: 10.1016/j.ijrobp.2006.09.043; PII: S0360-3016(06)03225-1; 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; CHEMOTHERAPY; FRACTIONATED IRRADIATION; HEAD; INJURIES; LEUKOCYTES; MACROPHAGES; NECK; NEOPLASMS; ORAL CAVITY; PAIN; PATIENTS; RADIOTHERAPY; SAFETY STANDARDS; SUBCUTANEOUS INJECTION; TOXICITY

Citation Formats

Ryu, Janice K., Swann, Suzanne, LeVeque, Francis, Scarantino, Charles W., Johnson, Darlene J., Chen, Allan, Fortin, Andre, Pollock, JonDavid, Kim, Harold, and Ang, Kian K. The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective Phase III study by Radiation Therapy Oncology Group 9901. United States: N. p., 2007. Web. doi:10.1016/j.ijrobp.2006.09.043.
Ryu, Janice K., Swann, Suzanne, LeVeque, Francis, Scarantino, Charles W., Johnson, Darlene J., Chen, Allan, Fortin, Andre, Pollock, JonDavid, Kim, Harold, & Ang, Kian K. The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective Phase III study by Radiation Therapy Oncology Group 9901. United States. doi:10.1016/j.ijrobp.2006.09.043.
Ryu, Janice K., Swann, Suzanne, LeVeque, Francis, Scarantino, Charles W., Johnson, Darlene J., Chen, Allan, Fortin, Andre, Pollock, JonDavid, Kim, Harold, and Ang, Kian K. Thu . "The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective Phase III study by Radiation Therapy Oncology Group 9901". United States. doi:10.1016/j.ijrobp.2006.09.043.
@article{osti_20944712,
title = {The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective Phase III study by Radiation Therapy Oncology Group 9901},
author = {Ryu, Janice K. and Swann, Suzanne and LeVeque, Francis and Scarantino, Charles W. and Johnson, Darlene J. and Chen, Allan and Fortin, Andre and Pollock, JonDavid and Kim, Harold and Ang, Kian K.},
abstractNote = {Purpose: Based on early clinical evidence of potential mucosal protection by granulocyte-macrophage colony stimulating factor (GM-CSF), the Radiation Therapy Oncology Group conducted a double-blind, placebo-controlled, randomized study to test the efficacy and safety of GM-CSF in reducing the severity and duration of mucosal injury and pain (mucositis) associated with curative radiotherapy (RT) in head-and-neck cancer patients. Methods and Materials: Eligible patients included those with head-and-neck cancer with radiation ports encompassing >50% of oral cavity and/or oropharynx. Standard RT ports were used to cover the primary tumor and regional lymphatics at risk in standard fractionation to 60-70 Gy. Concurrent cisplatin chemotherapy was allowed. Patients were randomized to receive subcutaneous injection of GM-CSF 250 {mu}g/m{sup 2} or placebo 3 times a week. Mucosal reaction was assessed during the course of RT using the National Cancer Institute Common Toxicity Criteria and the protocol-specific scoring system. Results: Between October 2000 and September 2002, 130 patients from 36 institutions were accrued. Nine patients (7%) were excluded from the analysis, 3 as a result of drug unavailability. More than 80% of the patients participated in the quality-of-life endpoint of this study. The GM-CSF did not cause any increase in toxicity compared with placebo. There was no statistically significant difference in the average mean mucositis score in the GM-CSF and placebo arms by a t test (p = 0.4006). Conclusion: This placebo-controlled, randomized study demonstrated no significant effect of GM-CSF given concurrently compared with placebo in reducing the severity or duration of RT-induced mucositis in patients undergoing definitive RT for head-and-neck cancer.},
doi = {10.1016/j.ijrobp.2006.09.043},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 3,
volume = 67,
place = {United States},
year = {Thu Mar 01 00:00:00 EST 2007},
month = {Thu Mar 01 00:00:00 EST 2007}
}