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

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

Research output: Contribution to journalArticle

18 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1841-1858
Number of pages18
JournalQuality of Life Research
Volume23
Issue number6
DOIs
StatePublished - 2014

Fingerprint

Radiation Oncology
Granulocyte-Macrophage Colony-Stimulating Factor
Head and Neck Neoplasms
Radiotherapy
Placebos
Quality of Life
Arm
Radiation
Neck
Head
Mucositis
Oropharynx
Mouth
Neoplasms
Therapeutics
Randomized Controlled Trials
Eating
Demography
Pain
Wounds and Injuries

Keywords

  • GM-CSF
  • Head and neck cancer
  • Quality of life
  • Radiation mucositis

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Medicine(all)

Cite this

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

In: Quality of Life Research, Vol. 23, No. 6, 2014, p. 1841-1858.

Research output: Contribution to journalArticle

Hoffman, Karen E. ; Pugh, Stephanie L. ; James, Jennifer L. ; Scarantino, Charles ; Movsas, Benjamin ; Valicenti, Richard K ; Fortin, Andre ; Pollock, Jondavid ; Kim, Harold ; Brachman, David G. ; Berk, Lawrence B. ; Bruner, Deborah Watkins ; Kachnic, Lisa A. / 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. In: Quality of Life Research. 2014 ; Vol. 23, No. 6. pp. 1841-1858.
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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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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.

PY - 2014

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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.

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KW - Quality of life

KW - Radiation mucositis

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