TY - JOUR
T1 - The impact of concurrent granulocyte-macrophage colony-stimulating factor on quality of life in head and neck cancer patients
T2 - Results of the randomized, placebo-controlled Radiation Therapy Oncology Group 9901 trial
AU - Hoffman, Karen E.
AU - Pugh, Stephanie L.
AU - James, Jennifer L.
AU - Scarantino, Charles
AU - Movsas, Benjamin
AU - Valicenti, Richard K.
AU - Fortin, Andre
AU - Pollock, Jondavid
AU - Kim, Harold
AU - Brachman, David G.
AU - Berk, Lawrence B.
AU - Bruner, Deborah Watkins
AU - Kachnic, Lisa A.
N1 - Funding Information:
Acknowledgments This project was supported by RTOG grant U10 CA21661 and CCOP grant U10 CA37422, from the National Cancer Institute (NCI). This manuscript’s contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
PY - 2014/8
Y1 - 2014/8
N2 - Purpose: 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). Conclusion: GM-CSF administered concurrently during head and neck radiation does not appear to significantly improve patient-reported QoL symptom burden.
AB - Purpose: 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). Conclusion: GM-CSF administered concurrently during head and neck radiation does not appear to significantly improve patient-reported QoL symptom burden.
KW - GM-CSF
KW - Head and neck cancer
KW - Quality of life
KW - Radiation mucositis
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U2 - 10.1007/s11136-014-0628-5
DO - 10.1007/s11136-014-0628-5
M3 - Article
C2 - 24492945
AN - SCOPUS:84905279485
SN - 0962-9343
VL - 23
SP - 1841
EP - 1858
JO - Quality of Life Research
JF - Quality of Life Research
IS - 6
ER -