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Gepubliceerd in: Quality of Life Research 6/2014

01-08-2014

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

Auteurs: Karen E. Hoffman, Stephanie L. Pugh, Jennifer L. James, Charles Scarantino, Benjamin Movsas, Richard K. Valicenti, Andre Fortin, JonDavid Pollock, Harold Kim, David G. Brachman, Lawrence B. Berk, Deborah Watkins Bruner, Lisa A. Kachnic

Gepubliceerd in: Quality of Life Research | Uitgave 6/2014

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Abstract

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.
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Metagegevens
Titel
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
Auteurs
Karen E. Hoffman
Stephanie L. Pugh
Jennifer L. James
Charles Scarantino
Benjamin Movsas
Richard K. Valicenti
Andre Fortin
JonDavid Pollock
Harold Kim
David G. Brachman
Lawrence B. Berk
Deborah Watkins Bruner
Lisa A. Kachnic
Publicatiedatum
01-08-2014
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 6/2014
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-014-0628-5

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