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01.09.2023 | Review

Mepitel Film for the prevention of acute radiation dermatitis in head and neck cancer: a systematic review and meta-analysis of randomized controlled trials

verfasst von: Shing Fung Lee, Henry C. Y. Wong, Adrian Wai Chan, Saverio Caini, Saba Shariati, Dirk Rades, Raymond J. Chan, Samantha K. F. Kennedy, Julie Ryan Wolf, Corina van den Hurk, Tara Behroozian, Pierluigi Bonomo, Francis C. H. Ho, Edward Chow, Patries Herst

Erschienen in: Supportive Care in Cancer | Ausgabe 9/2023

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Abstract

Purpose

This systematic review and meta-analysis evaluates the efficacy of Mepitel Film in preventing acute radiation dermatitis (RD) in patients with head and neck cancer (HNC) across randomized controlled trials (RCTs).

Methods

Embase, MEDLINE, and Cochrane Central Register of Controlled Trials were searched on 5 March 2023 to identify relevant RCTs. RD assessment tools and outcomes were compared across studies. Pooled effect sizes and 95% confidence intervals (CI) were estimated based on random-effects analysis using RevMan 5.4.

Results

Three RCTs conducted between 2018 and 2020 were included. Mepitel Film decreased RD severity when compared to Sorbolene or Biafine but not when compared to mometasone. A per-protocol analysis of two of the trials revealed that, overall, Mepitel Film significantly reduced the incidence of grade 2–3 RD (odds ratio (OR), 0.24; 95% CI, 0.09–0.65; p = 0.005) and moist desquamation (OR, 0.21; 95% CI, 0.10–0.46; p < 0.0001) and decreased average patient, researcher, and combined components of the Radiation-Induced Skin Reaction Assessment Scale (the standardized mean difference (SMD) for patient ratings, − 2.56; 95% CI, − 3.15 to − 1.96, p < 0.00001; SMD for researcher ratings, − 3.47; 95% CI, − 6.63 to − 0.31, p = 0.03; SMD for combined scores, − 3.68; 95% CI, − 6.43 to − 0.92, p = 0.009). Noted issues with Mepitel Film included itchiness and poor adherence.

Conclusion

While there were discrepancies across studies, Mepitel Film demonstrated a decrease in the incidence of grade 2–3 RD and moist desquamation. These findings emphasize the need for further examining Mepitel Film’s efficacy across diverse patient groups and the importance of standardizing RD severity assessment methodologies and control arms.

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Barton MB, Jacob S, Shafiq J, Wong K, Thompson SR, Hanna TP, Delaney GP (2014) Estimating the demand for radiotherapy from the evidence: a review of changes from 2003 to 2012. Radiother Oncol 112:140–144CrossRefPubMed

Bolderston A, Lloyd NS, Wong RK, Holden L, Robb-Blenderman L (2006) The prevention and management of acute skin reactions related to radiation therapy: a systematic review and practice guideline. Support Care Cancer 14:802–817CrossRefPubMed

Behroozian T, Goldshtein D, Ryan Wolf J, van den Hurk C, Finkelstein S, Lam H, Patel P, Kanee L, Lee SF, Chan AW, Wong HCY, Caini S, Mahal S, Kennedy S, Chow E, Bonomo P, Behroozian T, Goldshtein D, Ryan Wolf J et al (2023) MASCC clinical practice guidelines for the prevention and management of acute radiation dermatitis: part (1) systematic review. eClinicalMedicine 58:101886CrossRefPubMedPubMedCentral

Leventhal J, Young MR (2017) Radiation dermatitis: recognition, prevention, and management. Oncology 31(885-887):894–889

Rzepecki A, Birnbaum M, Ohri N, Daily J, Fox J, Bodner W, Kabarriti R, Garg M, Mehta K, Kalnicki S, McLellan BN (2022) Characterizing the effects of radiation dermatitis on quality of life: a prospective survey-based study. J Am Acad Dermatol 86:161–163CrossRefPubMed

Singh M, Alavi A, Wong R, Akita S (2016) Radiodermatitis: a review of our current understanding. Am J Clin Dermatol 17:277–292CrossRefPubMed

Herst PM, Bennett NC, Sutherland AE, Peszynski RI, Paterson DB, Jasperse ML (2014) Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients. Radiother Oncol 110:137–143CrossRefPubMed

Møller PK, Olling K, Berg M, Habæk I, Haislund B, Iversen AM, Ewertz M, Lorenzen EL, Brink C (2018) Breast cancer patients report reduced sensitivity and pain using a barrier film during radiotherapy - a Danish intra-patient randomized multicentre study. Tech Innov Patient Support Radiat Oncol 7:20–25CrossRefPubMedPubMedCentral

Behroozian T, Milton L, Karam I, Zhang L, Ding K, Lou J, Gallant F, Rakovitch E, Tran W, Soliman H, Leung E, Vesprini D, Szumacher E, Chen H, Donovan E, Lam J, Spadafora S, Wronski M, Lavoie C et al (2023) Mepitel Film for the prevention of acute radiation dermatitis in breast cancer: a randomized multicenter open-label phase III trial. J Clin Oncol 41:1250–1264CrossRefPubMed

10.

Herst PM (2014) Protecting the radiation-damaged skin from friction: a mini review. J Med Radiat Sci 61:119–125CrossRefPubMedPubMedCentral

11.

Wooding H, Yan J, Yuan L, Chyou T-Y, Gao S, Ward I, Herst PM (2018) The effect of Mepitel Film on acute radiation-induced skin reactions in head and neck cancer patients: a feasibility study. Br J Radiol 91:20170298CrossRefPubMed

12.

Anderson G, Ebadi M, Vo K, Novak J, Govindarajan A, Amini A (2021) An updated review on head and neck cancer treatment with radiation therapy. Cancers 13:4912CrossRefPubMedPubMedCentral

13.

Bressan V, Stevanin S, Bianchi M, Aleo G, Bagnasco A, Sasso L (2016) The effects of swallowing disorders, dysgeusia, oral mucositis and xerostomia on nutritional status, oral intake and weight loss in head and neck cancer patients: a systematic review. Cancer Treat Rev 45:105–119CrossRefPubMed

14.

Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, Chou R, Glanville J, Grimshaw JM, Hróbjartsson A, Lalu MM, Li T, Loder EW, Mayo-Wilson E, McDonald S et al (2021) The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 372:n71CrossRefPubMedPubMedCentral

15.

Higgins JPT, Green S Cochrane handbook for systematic reviews of interventions version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from https://www.cochrane-handbook.org/. Accessed 24 June 2023

16.

Higgins JPT, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, Savović J, Schulz KF, Weeks L, Sterne JAC (2011) The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 343:d5928CrossRefPubMedPubMedCentral

17.

Guyatt G, Gutterman D, Baumann MH, Addrizzo-Harris D, Hylek EM, Phillips B, Raskob G, Lewis SZ, Schünemann H (2006) Grading strength of recommendations and quality of evidence in clinical guidelines: report from an american college of chest physicians task force. Chest 129:174–181CrossRefPubMed

18.

Higgins JP, Thompson SG, Deeks JJ, Altman DG (2003) Measuring inconsistency in meta-analyses. BMJ 327:557–560CrossRefPubMedPubMedCentral

19.

DerSimonian R, Laird N (1986) Meta-analysis in clinical trials. Control Clin Trials 7:177–188CrossRefPubMed

20.

Yan J, Yuan L, Wang J, Li S, Yao M, Wang K, Herst PM (2020) Mepitel Film is superior to Biafine cream in managing acute radiation-induced skin reactions in head and neck cancer patients: a randomised intra-patient controlled clinical trial. J Med Radiat Sci 67:208–216CrossRefPubMedPubMedCentral

21.

Rades D, Narvaez CA, Splettstößer L, Dömer C, Setter C, Idel C, Ribbat-Idel J, Perner S, Bartscht T, Olbrich D, Schild SE, Carl J (2019) A randomized trial (RAREST-01) comparing Mepitel® Film and standard care for prevention of radiation dermatitis in patients irradiated for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). Radiother Oncol 139:79–82CrossRefPubMed

22.

Paterson D, Poonam P, Bennett N, Peszynski R, Van Beekhuizen M, Jasperse M, Herst P (2012) Randomized intra-patient controlled trial of mepilex lite dressings versus aqueous cream in managing radiation-induced skin reactions postmastectomy. J Cancer Sci Ther 4:347–356CrossRef

23.

Dejonckheere CS, Dejonckheere E, Layer JP, Layer K, Sarria GR, Koch D, Abramian A, Kaiser C, Lindner K, Bachmann A, Anzböck T, Röhner F, Schmeel FC, Schmeel LC (2023) Barrier films for the prevention of acute radiation dermatitis in breast cancer: a systematic review and meta-analysis of randomised controlled trials. Breast 71:31–41. https://doi.org/10.1016/j.breast.2023.07.001CrossRefPubMedPubMedCentral

24.

Chan RJ, Blades R, Jones L, Downer TR, Peet SC, Button E, Wyld D, McPhail S, Doolan M, Yates P (2019) A single-blind, randomised controlled trial of StrataXRT® - a silicone-based film-forming gel dressing for prophylaxis and management of radiation dermatitis in patients with head and neck cancer. Radiother Oncol 139:72–78CrossRefPubMed

25.

O’Dell K, Kearney R (2018) Feasibility study: use of a silicone gel in head and neck skin care. Journal of Medical Radiation Sciences 65:99–113

26.

Rutten LI (2018) Feasibility of Strata XRT in the treatment of radiation dermatitis in head and neck cancer patients (Thesis, Bachelor of Radiation Therapy with Honours). University of Otago

27.

Hindley A, Zain Z, Wood L, Whitehead A, Sanneh A, Barber D, Hornsby R (2014) Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiation therapy: results of a randomized trial. Int J Radiat Oncol Biol Phys 90:748–755CrossRefPubMed

28.

Ho AY, Olm-Shipman M, Zhang Z, Siu CT, Wilgucki M, Phung A, Arnold BB, Porinchak M, Lacouture M, McCormick B, Powell SN, Gelblum DY (2018) A randomized trial of mometasone furoate 0.1% to reduce high-grade acute radiation dermatitis in breast cancer patients receiving postmastectomy radiation. Int J Radiat Oncol Biol Phys 101:325–333CrossRefPubMed

29.

Miller RC, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Stoffel TJ, Haselow RE, Schaefer PL, Bearden JD 3rd, Atherton PJ, Loprinzi CL, Martenson JA (2011) Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: a phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. Int J Radiat Oncol Biol Phys 79:1460–1466CrossRefPubMed

30.

Neben-Wittich MA, Atherton PJ, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Loprinzi CL, Burger KN, Martenson JA, Miller RC (2011) Comparison of provider-assessed and patient-reported outcome measures of acute skin toxicity during a phase III trial of mometasone cream versus placebo during breast radiotherapy: the North Central Cancer Treatment Group (N06C4). Int J Radiat Oncol Biol Phys 81:397–402CrossRefPubMed

31.

Liao Y, Feng G, Dai T, Long F, Tang J, Pu Y, Zheng X, Cao S, Xu S, Du X (2019) Randomized, self-controlled, prospective assessment of the efficacy of mometasone furoate local application in reducing acute radiation dermatitis in patients with head and neck squamous cell carcinomas. Medicine 98:e18230CrossRefPubMedPubMedCentral

32.

Fisher J, Scott C, Stevens R, Marconi B, Champion L, Freedman GM, Asrari F, Pilepich MV, Gagnon JD, Wong G (2000) Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. Int J Radiat Oncol Biol Phys 48:1307–1310CrossRefPubMed

33.

Fenig E, Brenner B, Katz A, Sulkes J, Lapidot M, Schachter J, Malik H, Sulkes A, Gutman H (2001) Topical Biafine and Lipiderm for the prevention of radiation dermatitis: a randomized prospective trial. Oncol Rep 8:305–309PubMed

34.

Szumacher E, Wighton A, Franssen E, Chow E, Tsao M, Ackerman I, Andersson L, Kim J, Wojcicka A, Ung Y, Sixel K, Hayter C (2001) Phase II study assessing the effectiveness of Biafine cream as a prophylactic agent for radiation-induced acute skin toxicity to the breast in women undergoing radiotherapy with concomitant CMF chemotherapy. Int J Radiat Oncol Biol Phys 51:81–86CrossRefPubMed

35.

Momm F, Bartelt S, Haigis K, Grosse-Sender A, Witucki G (2005) Spectrophotometric skin measurements correlate with EORTC/RTOG-common toxicity criteria. Strahlenther Onkol 181:392–395CrossRefPubMed

36.

Böhner AMC, Koch D, Schmeel FC, Röhner F, Schoroth F, Sarria GR, Abramian AV, Baumert BG, Giordano FA, Schmeel LC (2020) Objective evaluation of risk factors for radiation dermatitis in whole-breast irradiation using the spectrophotometric L*a*b color-space. Cancers 12:2444CrossRefPubMedPubMedCentral

37.

Schmeel LC, Koch D, Stumpf S, Leitzen C, Simon B, Schüller H, Vornholt S, Schoroth F, Müdder T, Röhner F, Garbe S, Schmeel FC, Schild HH, Wilhelm-Buchstab TM (2018) Prophylactically applied Hydrofilm polyurethane film dressings reduce radiation dermatitis in adjuvant radiation therapy of breast cancer patients. Acta Oncol 57:908–915CrossRefPubMed

38.

Schmeel LC, Koch D, Schmeel FC, Bücheler B, Leitzen C, Mahlmann B, Kunze D, Heimann M, Brüser D, Abramian AV, Schoroth F, Müdder T, Röhner F, Garbe S, Baumert BG, Schild HH, Wilhelm-Buchstab TM (2019) Hydrofilm polyurethane films reduce radiation dermatitis severity in hypofractionated whole-breast irradiation: an objective, intra-patient randomized dual-center assessment. Polymers 11:2112CrossRefPubMedPubMedCentral

Titel: Mepitel Film for the prevention of acute radiation dermatitis in head and neck cancer: a systematic review and meta-analysis of randomized controlled trials
verfasst von: Shing Fung Lee
Henry C. Y. Wong
Adrian Wai Chan
Saverio Caini
Saba Shariati
Dirk Rades
Raymond J. Chan
Samantha K. F. Kennedy
Julie Ryan Wolf
Corina van den Hurk
Tara Behroozian
Pierluigi Bonomo
Francis C. H. Ho
Edward Chow
Patries Herst
Publikationsdatum: 01.09.2023
Verlag: Springer Berlin Heidelberg
Erschienen in: Supportive Care in Cancer / Ausgabe 9/2023
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-023-07988-w

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Mepitel Film for the prevention of acute radiation dermatitis in head and neck cancer: a systematic review and meta-analysis of randomized controlled trials