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, Quynh Thu Le

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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.

Original languageEnglish (US)
Pages (from-to)907-915
Number of pages9
JournalInternational Journal of Radiation Oncology Biology Physics
Volume91
Issue number5
DOIs
StatePublished - Apr 1 2015

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Radiation Oncology
Erythropoietin
radiation therapy
Radiotherapy
cancer
hemoglobin
Hemoglobins
Carcinoma, squamous cell of head and neck
progressions
fractionation
toxicity
pretreatment
Disease-Free Survival
therapy
Survival

All Science Journal Classification (ASJC) codes

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Shenouda, George ; Zhang, Qiang ; Ang, K. Kian ; Machtay, Mitchell ; Parliament, Matthew B. ; Hershock, Diane ; Suntharalingam, Mohan ; Lin, Alexander ; Rotman, Marvin ; Nabid, Abdenour ; Hong, Susan ; Shehata, Sarwat ; Cmelak, Anthony J. ; Sultanem, Khalil ; Le, Quynh Thu. / 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. In: International Journal of Radiation Oncology Biology Physics. 2015 ; Vol. 91, No. 5. pp. 907-915.
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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.",
author = "George Shenouda and Qiang Zhang and Ang, {K. Kian} and Mitchell Machtay and Parliament, {Matthew B.} and Diane Hershock and Mohan Suntharalingam and Alexander Lin and Marvin Rotman and Abdenour Nabid and Susan Hong and Sarwat Shehata and Cmelak, {Anthony J.} and Khalil Sultanem and Le, {Quynh Thu}",
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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. / Shenouda, George; Zhang, Qiang; Ang, K. Kian; Machtay, Mitchell; Parliament, Matthew B.; Hershock, Diane; Suntharalingam, Mohan; Lin, Alexander; Rotman, Marvin; Nabid, Abdenour; Hong, Susan; Shehata, Sarwat; Cmelak, Anthony J.; Sultanem, Khalil; Le, Quynh Thu.

In: International Journal of Radiation Oncology Biology Physics, Vol. 91, No. 5, 01.04.2015, p. 907-915.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Long-term results of radiation therapy oncology group 9903

T2 - 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

AU - Shenouda, George

AU - Zhang, Qiang

AU - Ang, K. Kian

AU - Machtay, Mitchell

AU - Parliament, Matthew B.

AU - Hershock, Diane

AU - Suntharalingam, Mohan

AU - Lin, Alexander

AU - Rotman, Marvin

AU - Nabid, Abdenour

AU - Hong, Susan

AU - Shehata, Sarwat

AU - Cmelak, Anthony J.

AU - Sultanem, Khalil

AU - Le, Quynh Thu

PY - 2015/4/1

Y1 - 2015/4/1

N2 - 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.

AB - 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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