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Minimal clinically important differences in the EORTC QLQ-BN20 in patients with brain metastases

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Abstract

Introduction

Quality of life (QOL) is an important treatment endpoint in advanced cancer patients with brain metastases. In clinical trials, statistically significant changes can be reached in a large enough population; however, these changes may not be clinically relevant.

Objective

The objective of this study was to determine the minimal clinically important difference (MCID) for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire brain module (EORTC QLQ-BN20) in patients with brain metastases.

Methods

Patients undergoing radiotherapy for brain metastases completed the EORTC QLQ-BN20 and QLQ-C30/C15-PAL at baseline and 1-month follow-up. MCIDs were calculated for both improvement and deterioration using anchor- and distribution-based approaches. The anchor of overall QOL (as assessed by question 30 or question 15 on the QLQ-C30 and QLQ-C15-PAL, respectively) was used to determine meaningful change.

Results

A total of 99 patients were included. The average age was 61 years, and the most common primary cancer sites were the lung and breast. Statistically significant meaningful differences were seen on two scales. A decrease of 6.1 (95 % confidence interval (CI) 0.8 to 11.4) units and 13.8 (0.2 to 27.4) units was required to represent clinically relevant deterioration of seizures and weakness of legs, respectively. Distribution-based MCID estimates tended to be closer to 0.5 SD on the EORTC QLQ-BN20.

Conclusion

Understanding MCIDs allows physicians to determine the impact of treatment on patients’ QOL and allows for determination of sample sizes for clinical trials. Future studies should be conducted to validate our findings in a larger population of patients with brain metastases.

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Acknowledgments

We thank the generous support of Dr. Mark Clemons, a participating investigator from The Ottawa Hospital Cancer Centre in Canada and the Bratty Family Fund, Michael and Karyn Goldstein Cancer Research Fund, Pulenzas Cancer Research Fund, Joseph and Silvana Melara Cancer Research Fund and Ofelia Cancer Research Fund.

Conflict of interest

None

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Authors and Affiliations

  1. Rapid Response Radiotherapy Program, Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Avenue, Toronto, ON, Canada, M4N 3M5

    Erin Wong, Liying Zhang, May Tsao, Gillian Bedard, Nemica Thavarajah, Paul Cheon, Cyril Danjoux, Natalie Pulenzas & Edward Chow

  2. Department of Radiation Oncology, Tom Baker Cancer Centre, Calgary, AB, Canada

    Marc Kerba

  3. Parc de Salut Mar Hospital de l’Esperança, Barcelona, Spain

    Palmira Foro Arnalot

  4. Department of Radiation Oncology, Cross Cancer Institute, Edmonton, AB, Canada

    Brita Danielson

Authors
  1. Erin Wong
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  2. Liying Zhang
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  3. Marc Kerba
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  4. Palmira Foro Arnalot
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  5. Brita Danielson
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  6. May Tsao
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  7. Gillian Bedard
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  8. Nemica Thavarajah
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  9. Paul Cheon
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  10. Cyril Danjoux
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  11. Natalie Pulenzas
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  12. Edward Chow
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Corresponding author

Correspondence to Edward Chow.

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Wong, E., Zhang, L., Kerba, M. et al. Minimal clinically important differences in the EORTC QLQ-BN20 in patients with brain metastases. Support Care Cancer 23, 2731–2737 (2015). https://doi.org/10.1007/s00520-015-2637-5

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  • DOI: https://doi.org/10.1007/s00520-015-2637-5

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