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

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Abstract

Purpose

This systematic review and meta-analysis aimed to evaluate the efficacy of Mepitel film in preventing or treating acute radiation dermatitis (RD) in patients with breast cancer in randomized controlled trials (RCTs).

Methods

Embase, APA PsychInfo, Journals@Ovid Full Text, Ovid MEDLINE, PubMed, and Cochrane Trials were searched until December 12, 2022, to identify RCTs on the use of Mepitel film for preventing or treating acute RD from breast cancer radiotherapy. Per-protocol analysis was used to compare outcomes, calculate pooled effect sizes, odds ratio (OR), and 95% confidence intervals (CI), and to create forest plots using random effects analysis in RevMan 5.4.

Results

Three RCTs were included in this review. Mepitel film significantly reduced the incidence of grade 3 RD (OR 0.15 95% CI 0.06, 0.37, p<0.0001) and grade 2 or 3 RD (OR 0.16 95% CI 0.04, 0.65, p=0.01) as scored on either the CTCAE or the RTOG scale. Additionally, Mepitel film significantly reduced RISRAS mean scores assessed by patients and combined researcher and patient (standardized mean difference (SMD) -7.59, 95% CI -14.42, -0.76, p=0.03; SMD -15.36, 95% CI -30.01, -0.71 p=0.04) but not the researcher component of the assessment tool (SMD -17.55, 95% CI -36.94, 1.84, p=0.08).

Conclusion

Mepitel film reduced the incidence of acute RD and improved patient-reported outcomes with minimal side effects, the main one being itchiness. Future research should assess the feasibility of Mepitel film with respect to specific patient-reported outcomes such as health-related quality of life issues associated with its use.

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Data availability

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

Code availability

The datasets analyzed for this meta-analysis have been obtained from publicly available sources, otherwise available in the appendix.

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Acknowledgements

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Funding

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

Author information

Authors and Affiliations

  1. Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

    Saba Shariati, Samantha Kennedy, Irene Karam, Milena Gojsevic, Thenugaa Rajeswaran & Edward Chow

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

    Tara Behroozian

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

    Saverio Caini

  4. Department of Radiation Therapy, University of Otago, Wellington, New Zealand

    Patries M. Herst

  5. MacroStat Inc., Toronto, Ontario, Canada

    Liying Zhang

  6. Canadian Cancer Trials Division, Queen’s Cancer Research Institute, Queen’s University, Kingston, Ontario, Canada

    Keyue Ding

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

    Corina van den Hurk

  8. Departments of Dermatology and Radiation Oncology, University of Rochester Medical Centre, Rochester, New York, USA

    Julie Ryan Wolf

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

    Shing Fung Lee

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

    Shing Fung Lee & Adrian Wai Chan

  11. Department of Oncology, Princess Margaret Hospital, Hospital Authority, Lai Chi Kok, Hong Kong

    Henry Wong

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

    Mami Ogita

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

    Jason C. Ye

  14. Caring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, Australia

    Raymond J. Chan

  15. Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy

    Pierluigi Bonomo

Authors
  1. Saba Shariati
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  2. Tara Behroozian
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  3. Samantha Kennedy
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  4. Saverio Caini
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  5. Patries M. Herst
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  6. Liying Zhang
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  7. Keyue Ding
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  8. Irene Karam
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  9. Corina van den Hurk
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  10. Julie Ryan Wolf
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  11. Shing Fung Lee
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  12. Henry Wong
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  13. Adrian Wai Chan
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  14. Mami Ogita
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  15. Jason C. Ye
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  16. Raymond J. Chan
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  17. Milena Gojsevic
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  18. Thenugaa Rajeswaran
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  19. Pierluigi Bonomo
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  20. Edward Chow
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Contributions

Saba Shariati and Tara Behroozian performed title and abstract screening, full-text screening, resolved conflicts in screening and data extraction. Samantha Kennedy, Milena Gojsevic, and Thenugaa Rajeswaran assisted with systematic review and manuscript revisions. Saba Shariati wrote the main manuscript text and prepared all figures and tables. Saverio Caini and Saba Shariati helped prepare forest plot figures. Patries M. Herst, Liying Zhang, Keyue Ding, Irene Karam MD, Raymond Chan, Shing Fung Lee, Henry Wong, Adrian Wai Chan MBSS, Mami Ogita, and Jason C. Ye, provided expertise on methodology, clinical radiation oncology, interpretation of results, and revision of manuscript drafts. Pierluigi Bonomo and Edward Chow are the senior authors of the manuscript and provided oversight for the whole project. 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 Edward Chow.

Ethics declarations

Ethics approval

Not applicable for systematic review and meta-analysis.

Financial interests

Edward Chow received free supply of Mepitel film in a randomized controlled trial and pilot study of Mepitel film in the prevention of radiation dermatitis in breast cancer. Additionally, Patries Herst received free supply of Mepitel film in a randomized controlled trial of Mepitel film in the prevention of radiation dermatitis in breast cancer.

Non-financial interests

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.

Consent for publication

Not applicable for systematic review and meta-analysis.

Consent for participate

Not applicable for systematic review and meta-analysis.

Conflicts of interest

The authors declare that they have no conflict of interest.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Appendices

Appendix 1: Search strategy

Embase Classic+Embase <1947 to 2022 December 12>

APA PsycInfo <1806 to December Week 2 2022>

Journals@Ovid Full Text <December 12, 2022>

Ovid MEDLINE(R) ALL <1946 to December 12, 2022>

1

radiotherapy.mp.

1336196

2

exp radiotherapy/

1065440

3

radiation.mp.

2121235

4

exp radiation/

1619073

5

1 or 2 or 3 or 4

3560757

6

exp cancer/

10372431

7

limit 6 to English language

8909582

8

limit 7 to yr="1860 -Current"

8904069

9

cancer.mp.

7825455

10

Neoplasms.mp.

5459236

11

exp Neoplasms/

11844144

12

6 or 9 or 10 or 11

13400386

13

breast.mp.

1959916

14

exp breast/

236109

15

13 or 14

1971819

16

Mepitel.mp.

474

17

Mepitel film.mp.

52

18

16 or 17

474

19

random.mp.

1173066

20

randomized.mp.

3274724

21

placebo.mp.

999532

22

control.mp.

12102463

23

trial.mp.

5169910

24

clinical trial.mp.

3283391

25

randomized controlled trial.mp.

2227247

26

19 or 20 or 21 or 22 or 23 or 24 or 25

17385883

27

5 and 7 and 8 and 12 and 15 and 18 and 26

28

PubMed

(radiation OR radiotherapy OR exp radiotherapy) AND (cancer OR exp cancer) AND (breast OR exp breast) AND (Mepitel OR Mepitel film) AND (random OR randomized OR placebo OR control OR trial OR clinical trial OR randomized controlled trial) 8

Cochrane Trials

(radiation OR radiotherapy OR exp radiotherapy) AND (cancer OR exp cancer) AND (breast OR exp breast) AND (Mepitel OR Mepitel film) AND (random OR randomized OR placebo OR control OR trial OR clinical trial OR randomized controlled trial) 18

Appendix 2: Intention-to-treat (ITT) data of included studies

Radiation dermatitis Grade 0

Study

Experimental Event (n)

Experimental Total (n)

Control Event (n)

Control Total (n)

Sample Size (Randomized)

Herst et al. (2014)

not available

80

not available

80

80

Møller et al. (2018)

not available

101

not available

101

101

Behroozian et al. (2022)

28

251

2

125

376

Radiation dermatitis Grade 1

Study

Experimental Event (n)

Experimental Total (n)

Control Event (n)

Control Total (n)

Sample Size (Randomized)

Herst et al. (2014)

not available

80

not available

80

80

Møller et al. (2018)

not available

101

not available

101

101

Behroozian et al. (2022)

184

251

66

125

376

Radiation dermatitis Grade 2 (IIA+IIB)

Study

Experimental Event (n)

Experimental Total (n)

Control Event (n)

Control Total (n)

Sample Size (Randomized)

Herst et al. (2014)

not available

80

not available

80

80

Møller et al. (2018)

not available

101

not available

101

101

Behroozian et al. (2022)

32

251

40

125

376

Radiation dermatitis Grade 2 (IIA+IIB) or 3

Study

Experimental Event (n)

Experimental Total (n)

Control Event (n)

Control Total (n)

Sample Size (Randomized)

Herst et al. (2014)

not available

80

not available

80

80

Møller et al. (2018)

not available

101

not available

101

101

Behroozian et al. (2022)

39

251

57

125

376

Radiation dermatitis Grade 1 or 2 (IIA+IIB) or 3

Study

Experimental Event (n)

Experimental Total (n)

Control Event (n)

Control Total (n)

Sample Size (Randomized)

Herst et al. (2014)

not available

80

not available

80

80

Møller et al. (2018)

not available

101

not available

101

101

Behroozian et al. (2022)

223

251

123

125

376

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Shariati, S., Behroozian, T., Kennedy, S. et al. Mepitel film for the prevention and treatment of acute radiation dermatitis in breast cancer: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer 31, 524 (2023). https://doi.org/10.1007/s00520-023-07982-2

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