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Clinical Trial
. 2015 Apr 1;91(5):907-15.
doi: 10.1016/j.ijrobp.2014.12.018. Epub 2015 Feb 7.

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  1 , Qiang Zhang  2 , K Kian Ang  3 , Mitchell Machtay  4 , Matthew B Parliament  5 , Diane Hershock  6 , Mohan Suntharalingam  7 , Alexander Lin  6 , Marvin Rotman  8 , Abdenour Nabid  9 , Susan Hong  10 , Sarwat Shehata  11 , Anthony J Cmelak  12 , Khalil Sultanem  13 , Quynh-Thu Le  14
Affiliations
Clinical 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 et al. Int J Radiat Oncol Biol Phys. .

Abstract

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.

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Conflict of interest statement

Conflict of interest: none.

Figures

Fig. 1
Fig. 1
Trial profile flow chart showing randomization and treatment.
Fig. 2
Fig. 2
Time to local-regional failure of the 2 arms of RTOG 9903 of radiation therapy (RT) versus RT plus erythropoietin (EPO).
Fig. 3
Fig. 3
Local-regional progression-free survival of the 2 arms of RTOG 9903, comparing radiation therapy (RT) versus RT plus erythropoietin (EPO).
Fig. 4
Fig. 4
Overall survival of RTOG 9903 patients treated with radiation therapy (RT) versus RT plus erythropoietin (EPO).
See this image and copyright information in PMC

Comment in

  • In Regard to Shenouda et al.
    Clavo B, Santana-Rodríguez N, Llontop P. Clavo B, et al. Int J Radiat Oncol Biol Phys. 2015 Nov 15;93(4):939-40. doi: 10.1016/j.ijrobp.2015.06.036. Epub 2015 Oct 19. Int J Radiat Oncol Biol Phys. 2015. PMID: 26530770 No abstract available.

References

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