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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

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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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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.

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Authors and Affiliations

  1. Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1202, Houston, TX, 77030, USA

    Karen E. Hoffman

  2. RTOG Statistical Center, Philadelphia, PA, USA

    Stephanie L. Pugh & Jennifer L. James

  3. Rex Cancer Center, Raleigh, ND, USA

    Charles Scarantino

  4. Henry Ford Health System, Detroit, MI, USA

    Benjamin Movsas

  5. University of California Davis, Sacramento, CA, USA

    Richard K. Valicenti

  6. L’ Hotel-Dieu de Quebec, Quebec, QC, Canada

    Andre Fortin

  7. The Schiffler Cancer Center, Wheeling Hospital, Wheeling, WV, USA

    JonDavid Pollock

  8. Karamanos Cancer Institute, Wayne State University, Detroit, MI, USA

    Harold Kim

  9. Arizona Oncology Services Foundation, Phoenix, AZ, USA

    David G. Brachman

  10. H. Lee Moffitt Cancer Center, Tampa, FL, USA

    Lawrence B. Berk

  11. University of Pennsylvania School of Nursing, Philadelphia, PA, USA

    Deborah Watkins Bruner

  12. Boston Medical Center MBCCOP, Boston, MA, USA

    Lisa A. Kachnic

Authors
  1. Karen E. Hoffman
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  2. Stephanie L. Pugh
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  3. Jennifer L. James
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  5. Benjamin Movsas
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  7. Andre Fortin
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  9. Harold Kim
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  11. Lawrence B. Berk
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  12. Deborah Watkins Bruner
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  13. Lisa A. Kachnic
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Corresponding author

Correspondence to Karen E. Hoffman.

Appendix

Appendix

See Tables 7, 8 and Fig. 2.

Table 7 Site-specific mucosal injury tool
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Table 8 National Cancer Institute Common Toxicity Criteria version 2 (NCI-CTC v2.0) Mucosal injury scoring
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Fig. 2
figure 2figure 2figure 2figure 2

RTOG-modified University of Washington Head and Neck Symptom Questionnaire

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Hoffman, K.E., Pugh, S.L., James, J.L. et al. 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. Qual Life Res 23, 1841–1858 (2014). https://doi.org/10.1007/s11136-014-0628-5

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  • DOI: https://doi.org/10.1007/s11136-014-0628-5

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