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
- Department of Radiation Oncology, University of California, Davis Medical Center, Sacramento, CA (United States)
- Department of Statistics, Radiation Therapy Oncology Group, Philadelphia, PA (United States)
- Oral Oncology Department, Harper Hospital/Wayne State University, Detroit, MI (United States)
- Rex Healthcare Cancer Center, Raleigh, NC (United States)
- Division of Geriatric Oncology, University of South Florida H. Lee Moffitt Cancer Center, Tampa, FL (United States)
- Department of Radiation Therapy/Oncology L'Hotel-Dieu de Quebec, Notre Dame Hospital, Quebec City, Quebec (Canada)
- Department of Radiation Oncology, Shiffler Cancer Center, Wheeling Hospital, Wheeling, WV (United States)
- Department of Radiation Oncology, Wayne State University, Detroit, MI (United States)
- Department of Radiation Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)
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.
- OSTI ID:
- 20944712
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 67, 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); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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