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StrataXRT for the prevention of acute radiation dermatitis in breast cancer: a systematic review and meta-analysis of randomized controlled trials

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Abstract

Purpose

To evaluate the overall efficacy of StrataXRT, a topical gel dressing, in preventing acute radiation dermatitis (RD) in breast cancer patients undergoing radiotherapy (RT).

Methods

A systematic search was conducted on April 25, 2023 in Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Randomized controlled trials (RCTs) assessing the effectiveness of StrataXRT in preventing acute RD in breast cancer patients undergoing adjuvant RT to the breast or chest wall with or without regional nodes were included. Pooled incidence odds ratio (OR) and 95% confidence interval (CI) were calculated using a random-effects model, with analysis and forest plots generated in RevMan v5.4.

Results

The analysis included three RCTs with a total of 189 patients assessed using per-protocol analysis. Two RCTs compared StrataXRT to standard of care, while the third compared it with Mepitel film and was reported separately. In the former RCTs, the odds ratio (OR) for developing acute grade 3 RD favored StrataXRT at 0.05 (95% CI, 0.01-0.22; P < 0.0001). The OR for developing acute grades 2–3 RD was 0.32 (95% CI, 0.03-3.18; P = 0.33). The RCT comparing StrataXRT with Mepitel film showed insignificant ORs for grade 3 and grades 2-3 RD. One RCT reported significantly lower erythema index (P = 0.008) and melanin index (P = 0.015) in StrataXRT patients. The use of StrataXRT did not raise additional safety concerns.

Conclusion

StrataXRT may help prevent severe acute RD in breast cancer RT patients. Further high quality, large-scale studies are needed to confirm these findings.

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Data availability

The datasets analyzed for this meta-analysis have been obtained from publicly available sources.

Code availability

The statistical code and computational methods employed in this meta-analysis are available upon reasonable request.

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Acknowledgments

None.

Funding

The authors did not receive support from any organization for the submitted work.

Author information

Authors and Affiliations

  1. Department of Radiation Oncology, National University Cancer Institute, National University Hospital, Singapore, Singapore

    Shing Fung Lee & David Chia

  2. Department of Clinical Oncology, Tuen Mun Hospital, New Territories West Cluster, Hospital Authority, Hong Kong, Hong Kong

    Shing Fung Lee & Adrian W Chan

  3. Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada

    Saba Shariati, Milena Gojsevic, Samantha K.F. Kennedy, Thenugaa Rajeswaran & Edward Chow

  4. Cancer Risk Factors and Lifestyle Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPO), Florence, Italy

    Saverio Caini

  5. Department of Oncology, Princess Margaret Hospital, Hospital Authority, Hong Kong, Hong Kong

    Henry Wong

  6. Department of Radiology, The University of Tokyo Hospital, Tokyo, Japan

    Mami Ogita

  7. Department of Radiation Oncology, University of Southern California Keck School of Medicine, Los Angeles, CA, USA

    Jason C. Ye

  8. Genesis Care Victoria, Ringwood Private Hospital, Ringwood East, Victoria, Australia

    Michael Chao

  9. Department of Radiation Oncology, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, Republic of Korea

    KiHoon Sung

  10. Research and Development Department, Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands

    Corina van den Hurk

  11. Departments of Dermatology and Radiation Oncology, University of Rochester Medical Center, Rochester, NY, USA

    Julie Ryan Wolf

  12. Caring Futures Institute, College of Nursing and Health Sciences, Flinders University, Bedford Park, Australia

    Raymond J Chan

  13. Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada

    Tara Behroozian

  14. Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy

    Pierluigi Bonomo

Authors
  1. Shing Fung Lee
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  2. Saba Shariati
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  3. Saverio Caini
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  4. Henry Wong
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  6. Milena Gojsevic
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  7. Mami Ogita
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  11. KiHoon Sung
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  15. Julie Ryan Wolf
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  16. Raymond J Chan
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  18. Pierluigi Bonomo
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  19. Edward Chow
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Contributions

Shing Fung Lee and Henry Wong performed title and abstract screening, full-text screening, resolved conflicts in screening and data extraction. Adrian Wai Chan, Milena Gojsevic, KiHoon Sung, Samantha K.F. Kennedy, Thenugaa Rajeswaran assisted with systematic review, analyses, and manuscript drafts. Tara Behroozian, Pierluigi Bonomo, and Mami Ogita provided expertise on methodology, interpretation of results, and revision of manuscript drafts. Pierluigi Bonomo, Mami Ogita, Jason C. Ye, David Chia, Michael Chao provided clinical expertise on radiation therapy, interpretations of results, and manuscript drafts. Raymond Chan provided expertise in StrataXRT utilization and methodology. Edward Chow is the senior author of the manuscript and provided oversight for the whole project. Shing Fung Lee and Saba Shariati wrote the main manuscript text and prepared all figures and tables. Saverio Caini and Saba Shariati helped prepare figures. Julie Ryan Wolf and Corina van den Hurk are co-Chairs of MASCC Oncodermatology Study Group and assisted with revision of manuscript for final version, as well as supportive oversight for the project. All authors edited the manuscript and provided comments. All authors have read and approved the final version.

Corresponding author

Correspondence to Shing Fung Lee.

Ethics declarations

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Not applicable for systematic review and meta-analysis.

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Not applicable for systematic review and meta-analysis.

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Not applicable for systematic review and meta-analysis.

Competing interests

Edward Chow received the free supply of StrataXRT in a pilot study of StrataXRT in the prevention of radiation dermatitis in breast cancer. Raymond J Chan received funding support from Moogoo and Stratpharma to conduct clinical trials and delivering educational sessions in relation to prevention and management of radiation dermatitis. All other authors have no relevant financial or non-financial interests to disclose.

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Lee, S.F., Shariati, S., Caini, S. et al. StrataXRT for the prevention of acute radiation dermatitis in breast cancer: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer 31, 515 (2023). https://doi.org/10.1007/s00520-023-07983-1

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