Long-Term Results of Radiation Therapy Oncology Group 9903: A Randomized Phase 3 Trial to Assess the Effect of Erythropoietin on Local-Regional Control in Anemic Patients Treated With Radiation Therapy for Squamous Cell Carcinoma of the Head and Neck
- McGill University, Montreal, Quebec (Canada)
- NRG Oncology Statistics and Data Management Center (United States)
- University of Texas MD Anderson Cancer Center, Houston, Texas (United States)
- University Hospitals of Cleveland, Cleveland, Ohio (United States)
- Cross Cancer Institute, Edmonton, Alberta (Canada)
- University of Pennsylvania Medical Center, Philadelphia, Pennsylvania (United States)
- University of Maryland Medical System, Baltimore, Maryland (United States)
- Brooklyn Minority-based Community Clinical Oncology Program, State University of New York Downstate Medical Center, Brooklyn, New York (United States)
- Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke (Québec), Québec (Canada)
- Akron City Hospital, Akron, Ohio (United States)
- Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario (Canada)
- Vanderbilt University Medical Center, Nashville, Tennessee (United States)
- Stanford University Medical Center, Stanford, California (United States)
Purpose: This paper reports long-term results of RTOG 9903, to determine whether the addition of erythropoietin (EPO) would improve the outcomes of radiation therapy (RT) in mildly to moderately anemic patients with head and neck squamous cell carcinoma (HNSCCa). Methods and Materials: The trial included HNSCCa patients treated with definitive RT. Patients with stage III or IV disease received concomitant chemoradiation therapy or accelerated fractionation. Pretreatment hemoglobin levels were required to be between 9.0 and 13.5 g/dL (12.5 g/dL for females). EPO, 40,000 U, was administered weekly starting 7 to 10 days before RT was initiated in the RT + EPO arm. Results: A total of 141 of 148 enrolled patients were evaluable. The baseline median hemoglobin level was 12.1 g/dL. In the RT + EPO arm, the mean hemoglobin level at 4 weeks increased by 1.66 g/dL, whereas it decreased by 0.24 g/dL in the RT arm. With a median follow-up of 7.95 years (range: 1.66-10.08 years) for surviving patients and 3.33 years for all patients (range: 0.03-10.08 years), the 5-year estimate of local-regional failure was 46.2% versus 39.4% (P=.42), local-regional progression-free survival was 31.5% versus 37.6% (P=.20), and overall survival was 36.9% versus 38.2% (P=.54) for the RT + EPO and RT arms, respectively. Late toxicity was not different between the 2 arms. Conclusions: This long-term analysis confirmed that despite the ability of EPO to raise hemoglobin levels in anemic patients with HNSCCa, it did not improve outcomes when added to RT. The possibility of a detrimental effect of EPO could not be ruled out.
- OSTI ID:
- 22458663
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 91, Issue 5; Other Information: Copyright (c) 2015 Elsevier Science B.V., Amsterdam, The 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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