• Int. J. Radiat. Oncol. Biol. Phys. · Apr 2015

    Randomized Controlled Trial

    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.

    • George Shenouda, Qiang Zhang, K Kian Ang, Mitchell Machtay, Matthew B Parliament, Diane Hershock, Mohan Suntharalingam, Alexander Lin, Marvin Rotman, Abdenour Nabid, Susan Hong, Sarwat Shehata, Anthony J Cmelak, Khalil Sultanem, and Quynh-Thu Le.
    • McGill University, Montreal, Quebec, Canada. Electronic address: George.shenouda@muhc.mcgill.ca.
    • Int. J. Radiat. Oncol. Biol. Phys. 2015 Apr 1; 91 (5): 907-15.

    PurposeThis 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 MaterialsThe 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.ResultsA 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.ConclusionsThis 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.Copyright © 2015 Elsevier Inc. All rights reserved.

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