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Filling in the gaps: reporting of concurrent supportive care therapies in breast cancer chemotherapy trials

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Abstract

Background

Supportive care interventions can have a substantial impact on side effects of chemotherapy. Consequently, accurate reporting of such interventions is essential when interpreting clinical trial results. This study determined the prevalence and quality of reporting of supportive care treatment for common chemotherapy-induced toxicities in phase III, breast cancer chemotherapy trials.

Methods

A systematic review of phase III trials of breast cancer trials incorporating chemotherapy published in the last 5 years was undertaken. Trials were identified through MEDLINE, EMBASE, BIOSIS, and the Cochrane Library. Supportive treatments evaluated were use of antiemetics, colony-stimulating growth factors, and antibiotics. Reporting quality was rated as “good”, “fair”, “poor”, or “absent” using predetermined criteria.

Results

Sixty-two trials met inclusion criteria. In 41 studies (66%), details regarding prophylactic antiemetic treatment were not provided. Growth factor use was not reported in 20 trials (32%). Instructions for the use of prophylactic antibiotics were absent in 45 trials (72%).

Conclusion

There are significant deficiencies in reporting of use of prophylactic supportive care agents in breast cancer trials. Omission of supportive care instructions may impact substantially on patient management and health care system expenditure. Recommendations for the type, dose, and frequency of supportive care drugs should be provided and reported on in trials.

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Acknowledgments

This project was supported by a fellowship grant (OF) from the Canadian Association of Medical Oncology/Canadian Institute of Health Research Fellowship.

Conflict of interest

All authors declare they have no relevant conflicts of interest.

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Authors and Affiliations

  1. Division of Medical Oncology and Hematology, Department of Medicine, University of Toronto, Toronto, Canada

    Orit Freedman & Eitan Amir

  2. Division of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada

    Orit Freedman, Eitan Amir & Mark Clemons

  3. Department of Psychosocial Oncology and Palliative Care and Ontario Cancer Institute, Princess Margaret Hospital, University Health Network, Toronto, Canada

    Camilla Zimmermann

  4. Campbell Family Institute for Breast Cancer Research, Toronto, Canada

    Mark Clemons

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  1. Orit Freedman
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Correspondence to Eitan Amir.

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Freedman, O., Amir, E., Zimmermann, C. et al. Filling in the gaps: reporting of concurrent supportive care therapies in breast cancer chemotherapy trials. Support Care Cancer 19, 315–322 (2011). https://doi.org/10.1007/s00520-010-1069-5

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