The impact of concurrent granulocyte-macrophage colony-stimulating factor on quality of life in head and neck cancer patients: results of the randomized, placebo-controlled Radiation Therapy Oncology Group 9901 trial.
OBJECTIVE
The Radiation Therapy Oncology Group (RTOG) conducted a randomized, placebo-controlled trial evaluating the efficacy of GM-CSF in reducing mucosal injury and symptom burden from curative radiotherapy for head and neck (H&N) cancer.


METHODS
Eligible patients with H&N cancer receiving radiation encompassing ≥50 % of the oral cavity or oropharynx received subcutaneous GM-CSF or placebo. Quality of life (QoL) was assessed using the RTOG-modified University of Washington H&N Symptom Questionnaire at baseline 4, 13, 26, and 48 weeks from radiation initiation.


RESULTS
Of 125 eligible patients, 114 were evaluable for QoL (58 GM-CSF, 56 placebo). Patient demographics, clinical characteristics, and baseline symptom scores were well balanced between the treatment arms. At the end of the acute period (13 weeks), patients in both arms reported negative change in total symptom score indicating increase in symptom burden relative to baseline (mean -18.4 GM-CSF, -20.8 placebo). There was no difference in change in total symptom score (p > 0.05) or change in mucous, pain, eating, or activity domain scores (p > 0.01) between patients in the GM-CSF and placebo arms. Analysis limited to patients treated per protocol or with an acceptable protocol deviation also found no difference in change in total symptom score (p > 0.05) or change in domain scores (p > 0.01) between treatment arms. Provider assessment of acute mucositis during treatment did not correlate with patient-reported mucous domain and total symptom scores (p > 0.05).


CONCLUSIONS
GM-CSF administered concurrently during head and neck radiation does not appear to significantly improve patient-reported QoL symptom burden.
Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1202, Houston, TX, 77030, USA, khoffman1@mdanderson.org.
Karen E
KE
Hoffman
Stephanie L
SL
Pugh
Jennifer L
JL
James
Charles
C
Scarantino
Benjamin
B
Movsas
Richard K
RK
Valicenti
Andre
A
Fortin
JonDavid
J
Pollock
Harold
H
Kim
David G
DG
Brachman
Lawrence B
LB
Berk
Deborah Watkins
DW
Bruner
Lisa A
LA
Kachnic
D002170:Canada; D017281:Cost of Illness; D004311:Double-Blind Method; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000523:psychology* / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D011788:Quality of Life; D011832:Radiation Injuries / Q000517:prevention & control; D011837:Radiation-Protective Agents / Q000009:adverse effects / Q000627:therapeutic use; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires; D014481:United States
D011837:Radiation-Protective Agents; D016178:Granulocyte-Macrophage Colony-Stimulating Factor