Skip to main content
Top
Published in: Supportive Care in Cancer 6/2017

01-06-2017 | Original Article

Preemptive treatment with Xonrid®, a medical device to reduce radiation induced dermatitis in head and neck cancer patients receiving curative treatment: a pilot study

Authors: Nicola Alessandro Iacovelli, Simona Naimo, Francesca Bonfantini, Anna Cavallo, Paolo Bossi, Carlo Fallai, Emanuele Pignoli, Salvatore Alfieri, Cristiana Bergamini, Federica Favales, Ester Orlandi

Published in: Supportive Care in Cancer | Issue 6/2017

Login to get access

Abstract

Purpose

The purpose of this study was to investigate efficacy, safety and tolerability of Xonrid®, a new medical device, in preventing radiation dermatitis associated with head and neck cancer (HNC) radiotherapy (RT).

Methods

In this monocentric, prospective pilot study, adult consecutive HNC patients who were planned to receive curative RT with or without chemotherapy were enrolled. Patients were instructed to apply Xonrid® on the irradiated area during treatment continuing until 2 weeks after the completion of RT or the development of severe skin toxicity. Toxicity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 scale. The patient reported outcome measures included the Skindex-16 questionnaire and patient satisfaction. Skin reflectance spectra were analyzed to objectively evaluate dermatitis.

Results

In total, 41 subjects were enrolled (30 males, median age 60 years). No skin adverse events were recorded either in the skin area where the product was applied or in the nearby skin over the entire period of administration. At the end of RT, nine patients (22%) presented G1, 31 (76%) G2, and one patient (2%) G3 skin toxicity (after 5 weeks). Seven and 20 patients reached skin maximum toxicity at the fourth week and after the seventh week, respectively. An increasing trend of median spectrophotometry scores along with skin toxicity grades was observed. A correlation between Skindex-16 scores and skin toxicity grade during treatment was found.

Conclusions

Our study results suggest that Xonrid® is well tolerated, safe, and effective in minimizing and delaying high-grade radiation dermatitis in HNC patients.
Appendix
Available only for authorised users
Literature
1.
go back to reference Russi EG, Moretto F, Rampino M et al (2015) Acute skin toxicity management in head and neck cancer patients treated with radiotherapy and chemotherapy or EGFR inhibitors: literature review and consensus. Crit Rev Oncol Hematol 96(1):167–182CrossRefPubMed Russi EG, Moretto F, Rampino M et al (2015) Acute skin toxicity management in head and neck cancer patients treated with radiotherapy and chemotherapy or EGFR inhibitors: literature review and consensus. Crit Rev Oncol Hematol 96(1):167–182CrossRefPubMed
3.
go back to reference Fernando IN, Ford HT, Powles TJ et al (1996) Factors affecting acute skin toxicity in patients having breast irradiation after conservative surgery: a prospective study of treatment practice at the Royal Marsden Hospital. Clin Oncol (R Coll Radiol) 8:226–233CrossRef Fernando IN, Ford HT, Powles TJ et al (1996) Factors affecting acute skin toxicity in patients having breast irradiation after conservative surgery: a prospective study of treatment practice at the Royal Marsden Hospital. Clin Oncol (R Coll Radiol) 8:226–233CrossRef
4.
go back to reference Bernier J, Bonner J, Vermorken JB et al (2008) Consensus guidelines for the management of radiation dermatitis and coexisting acne-like rash in patients receiving radiotherapy plus EGFR inhibitors for the treatment of squamous cell carcinoma of the head and neck. Ann Oncol 19:142–149. doi:10.1093/annonc/mdm400 CrossRefPubMed Bernier J, Bonner J, Vermorken JB et al (2008) Consensus guidelines for the management of radiation dermatitis and coexisting acne-like rash in patients receiving radiotherapy plus EGFR inhibitors for the treatment of squamous cell carcinoma of the head and neck. Ann Oncol 19:142–149. doi:10.​1093/​annonc/​mdm400 CrossRefPubMed
6.
go back to reference Bray FN, Simmons BJ, Wolfson AH, Nouri K (2016) Acute and chronic cutaneous reactions to ionizing radiation therapy. Dermatol Ther (Heidelb) 6:185–206CrossRef Bray FN, Simmons BJ, Wolfson AH, Nouri K (2016) Acute and chronic cutaneous reactions to ionizing radiation therapy. Dermatol Ther (Heidelb) 6:185–206CrossRef
7.
go back to reference Hymes SR, Strom EA, Fife C (2006) Radiation dermatitis: clinical presentation, pathophysiology, and treatment 2006. J Am Acad Dermatol 54:28–46CrossRefPubMed Hymes SR, Strom EA, Fife C (2006) Radiation dermatitis: clinical presentation, pathophysiology, and treatment 2006. J Am Acad Dermatol 54:28–46CrossRefPubMed
8.
go back to reference Nyström J, Geladi P, Lindholm-Sethson B et al (2004) Objective measurements of radiotherapy-induced erythema. Skin Res Technol 10(4):242–250CrossRefPubMed Nyström J, Geladi P, Lindholm-Sethson B et al (2004) Objective measurements of radiotherapy-induced erythema. Skin Res Technol 10(4):242–250CrossRefPubMed
9.
go back to reference Salvo N, Barnes E, van Draanen J et al (2010) Prophylaxis and management of acute radiation-induced skin reactions: a systematic review of the literature. Curr Oncol 17:94–112PubMedPubMedCentral Salvo N, Barnes E, van Draanen J et al (2010) Prophylaxis and management of acute radiation-induced skin reactions: a systematic review of the literature. Curr Oncol 17:94–112PubMedPubMedCentral
13.
go back to reference Chren MM, Lasek RJ, Sahay AP et al (2001) Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg 5(2):105–110CrossRefPubMed Chren MM, Lasek RJ, Sahay AP et al (2001) Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg 5(2):105–110CrossRefPubMed
14.
go back to reference Abeni D, Picardi A, Pasquini P et al (2002) Further evidence of the validity and reliability of the Skindex-29: an Italian study on 2,242 dermatological outpatients. Dermatology 204(1):43–49CrossRefPubMed Abeni D, Picardi A, Pasquini P et al (2002) Further evidence of the validity and reliability of the Skindex-29: an Italian study on 2,242 dermatological outpatients. Dermatology 204(1):43–49CrossRefPubMed
15.
go back to reference Stamatas GN, Zmudzka BZ, Kollias N et al (2008) In vivo measurement of skin erythema and pigmentation: new means of implementation of diffuse reflectance spectroscopy with a commercial instrument. Br J Dermatol 159:683–690CrossRefPubMed Stamatas GN, Zmudzka BZ, Kollias N et al (2008) In vivo measurement of skin erythema and pigmentation: new means of implementation of diffuse reflectance spectroscopy with a commercial instrument. Br J Dermatol 159:683–690CrossRefPubMed
16.
go back to reference Palazzi M, Tomatis S, Orlandi E et al (2008) Effects of treatment intensification on acute local toxicity during radiotherapy for head and neck cancer: prospective observational study validating CTCAE, version 3.0, scoring system. Int J Radiat Oncol Biol Phys 70(2):330–337CrossRefPubMed Palazzi M, Tomatis S, Orlandi E et al (2008) Effects of treatment intensification on acute local toxicity during radiotherapy for head and neck cancer: prospective observational study validating CTCAE, version 3.0, scoring system. Int J Radiat Oncol Biol Phys 70(2):330–337CrossRefPubMed
17.
go back to reference Leonardi MC, Gariboldi S, Ivaldi GB et al (2008) A double-blind randomized, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: interim analysis. Eur J Dermatol 18:317–321PubMed Leonardi MC, Gariboldi S, Ivaldi GB et al (2008) A double-blind randomized, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: interim analysis. Eur J Dermatol 18:317–321PubMed
18.
go back to reference Primavera G, Carrera M, Berardesca E et al (2006) A double-blind, vehicle controlled clinical study to evaluate the efficacy of MAS065D (Xclair), a hyaluronic acid-based formulation, in the management of radiation-induced dermatitis. Cutan Ocul Toxicol 25:165–171CrossRefPubMed Primavera G, Carrera M, Berardesca E et al (2006) A double-blind, vehicle controlled clinical study to evaluate the efficacy of MAS065D (Xclair), a hyaluronic acid-based formulation, in the management of radiation-induced dermatitis. Cutan Ocul Toxicol 25:165–171CrossRefPubMed
19.
go back to reference Liguori V, Guillemin C, Pesce GF et al (1997) Double-blind, randomized clinical study comparing hyaluronic acid cream to placebo in patients treated with radiotherapy. Radiother Oncol 42:155–161CrossRefPubMed Liguori V, Guillemin C, Pesce GF et al (1997) Double-blind, randomized clinical study comparing hyaluronic acid cream to placebo in patients treated with radiotherapy. Radiother Oncol 42:155–161CrossRefPubMed
20.
go back to reference Higgins PD, Han EY, Yuan JL et al (2007) Evaluation of surface and superficial dose for head and neck treatments using conventional or intensity-modulated techniques. Phys Med Biol 52(4):1135–1146CrossRefPubMed Higgins PD, Han EY, Yuan JL et al (2007) Evaluation of surface and superficial dose for head and neck treatments using conventional or intensity-modulated techniques. Phys Med Biol 52(4):1135–1146CrossRefPubMed
21.
go back to reference Palazzi M, Orlandi E, Pignoli E et al (2006) Target coverage in head and neck cancer treated with intensity-modulated radiotherapy: a comparison between conventional and conformal techniques. Tumori 92:503–510PubMed Palazzi M, Orlandi E, Pignoli E et al (2006) Target coverage in head and neck cancer treated with intensity-modulated radiotherapy: a comparison between conventional and conformal techniques. Tumori 92:503–510PubMed
22.
go back to reference Orlandi E, Palazzi M, Pignoli E et al (2010) Radiobiological basis and clinical results of the simultaneous integrated boost (SIB) in intensity modulated radiotherapy (IMRT) for head and neck cancer: a review. Crit Rev Oncol Hematol 73:111–125CrossRefPubMed Orlandi E, Palazzi M, Pignoli E et al (2010) Radiobiological basis and clinical results of the simultaneous integrated boost (SIB) in intensity modulated radiotherapy (IMRT) for head and neck cancer: a review. Crit Rev Oncol Hematol 73:111–125CrossRefPubMed
23.
24.
go back to reference Atherton PJ, Burger KN, Loprinzi CL et al (2012) Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer 20:1729–1735CrossRefPubMed Atherton PJ, Burger KN, Loprinzi CL et al (2012) Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer 20:1729–1735CrossRefPubMed
25.
go back to reference Dawson JB, Barker DT, Ellis DT et al (1980) A theoretical and experimental study of light absorption and scattering by in vitro skin. Phys Med Biol 25:695–709CrossRefPubMed Dawson JB, Barker DT, Ellis DT et al (1980) A theoretical and experimental study of light absorption and scattering by in vitro skin. Phys Med Biol 25:695–709CrossRefPubMed
26.
go back to reference Turesson I, Notter G (1986) Dose-response and dose latency relationships for human skin after various fraction schedules. Br J Cancer 53:67–72 Turesson I, Notter G (1986) Dose-response and dose latency relationships for human skin after various fraction schedules. Br J Cancer 53:67–72
27.
go back to reference Wan S, Parrish JA, Jaenicke KF (1983) Quantitative evaluation of ultraviolet induced erythema. Photochem Photobiol 37:643–648CrossRefPubMed Wan S, Parrish JA, Jaenicke KF (1983) Quantitative evaluation of ultraviolet induced erythema. Photochem Photobiol 37:643–648CrossRefPubMed
28.
go back to reference Wan S, Jaenicke KF, Parrish JA (1983) Comparison of the erythemogenic effectiveness of ultraviolet-B (290–320 nm) and ultraviolet. A (320–400 nm). Radiation by skin reflectance. Photochem Photobiol 37:547–552CrossRefPubMed Wan S, Jaenicke KF, Parrish JA (1983) Comparison of the erythemogenic effectiveness of ultraviolet-B (290–320 nm) and ultraviolet. A (320–400 nm). Radiation by skin reflectance. Photochem Photobiol 37:547–552CrossRefPubMed
Metadata
Title
Preemptive treatment with Xonrid®, a medical device to reduce radiation induced dermatitis in head and neck cancer patients receiving curative treatment: a pilot study
Authors
Nicola Alessandro Iacovelli
Simona Naimo
Francesca Bonfantini
Anna Cavallo
Paolo Bossi
Carlo Fallai
Emanuele Pignoli
Salvatore Alfieri
Cristiana Bergamini
Federica Favales
Ester Orlandi
Publication date
01-06-2017
Publisher
Springer Berlin Heidelberg
Published in
Supportive Care in Cancer / Issue 6/2017
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-017-3569-z

Other articles of this Issue 6/2017

Supportive Care in Cancer 6/2017 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine