Acute radiation-induced skin toxicity in hypofractionated vs. conventional whole-breast irradiation: An objective, randomized multicenter assessment using spectrophotometry

Schmeel, Leonard Christopher; Koch, David; Schmeel, Frederic Carsten; Röhner, Fred; Schoroth, Felix; Bücheler, B.-M.; Mahlmann, Birgit; Leitzen, Christina; Schüller, Heinrich; Tschirner, Sabine; Fuhrmann, Arne; Heimann, Muriel; Brüser, Dilini; Abramian, Alina-Valik; Müdder, Thomas; Garbe, Stephan; Vornholt, Susanne; Schild, Hans H.; Baumert, Brigitta G.; Wilhelm-Buchstab, Timo

doi:10.1016/j.radonc.2020.02.018

Cited by 42 publications

(57 citation statements)

References 41 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As shown in literature the grade and severity of ARD is less important in hypofractionated regimen, probably making the use of topical devices less useful [26]. Conversely a topical product could be useful in the prevention and treatment of this side effect in the proton era, since the incidence of ARD seems to be higher as reported in a recent paper by the University of Maryland, showing a higher rate of ARD for patients treated with protons [27].…”

Section: Discussionmentioning

confidence: 93%

See 1 more Smart Citation

A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients

et al. 2020

View full text Add to dashboard Cite

Background: This study was an open-label, 2-arms, monocentric, randomized clinical trial comparing Xonrid®, a topical medical device, versus standard of care (SOC) in preventing and treating acute radiation dermatitis (ARD) in Head and Neck Cancer (HNC) and Breast Cancer (BC) patients undergoing radiotherapy (RT). Methods: Eligible HNC and BC patients were randomized 1:1 to receive Xonrid® + SOC or SOC during RT. Patients were instructed to apply Xonrid® on the irradiated area three times daily, starting on the first day of RT and until 2 weeks after RT completion or until the development of grade ≥ 3 skin toxicity. The primary endpoint was to evaluate the proportion of patients who developed an ARD grade < 2 at the 5th week in both groups. Secondary endpoints were median time to grade 2 (G2) skin toxicity onset; changes in skin erythema and pigmentation and trans-epidermal water loss (TEWL); patient-reported skin symptoms. All patients were evaluated at baseline, weekly during RT and 2 weeks after treatment completion. The evaluation included: clinical toxicity assessment; reflectance spectrometry (RS) and TEWL examination; measurement of patients' quality of life (QoL) through Skindex-16 questionnaire.

show abstract

Section: Discussionmentioning

confidence: 93%

“…As shown in literature the grade and severity of ARD is less important in hypofractionated regimen, probably making the use of topical devices less useful [ 26 ].…”

Section: Discussionmentioning

confidence: 99%

A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients

et al. 2020

View full text Add to dashboard Cite

show abstract

“…An important and frequent adverse reaction of adjuvant WBI is RID, often considerably impairing the patients’ quality of life during the course of WBI and up to weeks thereafter [ 1 , 2 ]. Generations of radiobiologists have devoted their efforts to investigate the underlying mechanisms of damage, the dose-effect relationship, and the different latencies of skin damage caused by ionizing radiation [ 12 , 13 , 14 , 15 ].…”

Section: Discussionmentioning

confidence: 99%

“…Radiation-induced dermatitis (RID) is one of the most common side effects during and following radiation therapy (RT) [ 1 ]. RID can impair the patients’ quality of life for several weeks, and may also necessitate an RT interruption to recover skin integrity [ 2 ]. Any interruption of the RT could, however, reduce the allover treatment efficacy and might thus result in higher tumor recurrence and impaired tumor control rates, as dose declines of 0.6 Gy were reported for each unexpected day of interruption [ 3 , 4 ].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Objective Evaluation of Risk Factors for Radiation Dermatitis in Whole-Breast Irradiation Using the Spectrophotometric Lab Color-Space

Böhner

Koch

Schmeel

et al. 2020

Cancers

Self Cite

View full text Add to dashboard Cite

Background: Radiation-induced dermatitis (RID) is frequent in breast cancer patients undergoing radiotherapy (RT). Spectrophotometry (SP) is an objective and reliable tool for assessing RID severity. Despite intensive research efforts during the past decades, no sustainable prophylactic and treatment strategies have been found. Estimation of new and reevaluation of established risk factors leading to severe RID is therefore of major importance. Methods: 142 early breast cancer patients underwent whole-breast irradiation following breast-conserving surgery. RID was evaluated by physician-assessed Common Terminology Criteria of Adverse Events (CTCAE v4.03). Spectrophotometers provided additional semi quantification of RID using the L*a*b color-space. A total of 24 patient- and treatment-related parameters as well as subjective patient-assessed symptoms were analyzed. Results: Values for a*max strongly correlated with the assessment of RID severity by physicians. Breast volume, initial darker skin, boost administration, and treatment technique were identified as risk factors for severe RID. RID severity positively correlated with the patients’ perception of pain, burning, and reduction of everyday activities. Conclusions: Physician-assessed RID gradings correlate with objective SP skin measurements. Treatment technique and high breast volumes were identified as objective and significant predictors of RID. Our data provide a solid benchmark for future studies on RID with objective SP.

show abstract

Photobiomodulation therapy for the prevention of acute radiation dermatitis in breast cancer patients undergoing hypofractioned whole‐breast irradiation (LABRA trial)

et al. 2021

View full text Add to dashboard Cite

Objectives: To evaluate the efficacy of photobiomodulation therapy in breast cancer patients post-lumpectomy undergoing hypofractionated whole-breast irradiation (HF-WBI) for the prevention and management of acute radiodermatitis (ARD). Materials and Methods: A randomized, multicentric clinical trial (LABRA trial, NCT03924011) was set up at the Limburg Oncology Center, including the Jessa Hospital (Hasselt, BE) and Ziekenhuis Oost-Limburg (Genk, BE). A total of 71 breast cancer patients planned to undergo HF-WBI were randomized to one of the two study arms: the control group (n = 32) or the PBM group (n = 39). The PBM group received the standard institutional skincare combined with PBM (2×/week) during the complete radiotherapy (RT) course. Patients in the control group received the standard skincare combined with placebo treatment (2x/week). Patients' skin reactions were evaluated weekly during the RT treatment by using the modified version of the Radiation Therapy Oncology Group (RTOG) criteria. Results: At week 3 of RT, one patient presented a grade 2 and one patient a grade 3 skin reaction in the control group, while in the PBM group, all patients still presented grade 1 ARD. At the final RT session 28% of the patients presenting grade 2-3 ARD, while in the PBM group 10% presented grade 2 and no grade 3 ARD. PBM reduced the incidence of severe ARD by 18%. However, the difference was not significant (p = 0.053). Conclusion: Based on the LABRA trial results, PBM seems not able to reduce the incidence of severe ARD in breast cancer patients undergoing HF-WBI. Research in a larger patient population is recommended.

show abstract

Acute radiation-induced skin toxicity in hypofractionated vs. conventional whole-breast irradiation: An objective, randomized multicenter assessment using spectrophotometry

Cited by 42 publications

References 41 publications

A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients

A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients

Objective Evaluation of Risk Factors for Radiation Dermatitis in Whole-Breast Irradiation Using the Spectrophotometric Lab Color-Space

Photobiomodulation therapy for the prevention of acute radiation dermatitis in breast cancer patients undergoing hypofractioned whole‐breast irradiation (LABRA trial)

Contact Info

Product

Resources

About

Acute radiation-induced skin toxicity in hypofractionated vs. conventional whole-breast irradiation: An objective, randomized multicenter assessment using spectrophotometry

Cited by 42 publications

References 41 publications

A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients

A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients

Objective Evaluation of Risk Factors for Radiation Dermatitis in Whole-Breast Irradiation Using the Spectrophotometric L*a*b Color-Space

Photobiomodulation therapy for the prevention of acute radiation dermatitis in breast cancer patients undergoing hypofractioned whole‐breast irradiation (LABRA trial)

Contact Info

Product

Resources

About

Objective Evaluation of Risk Factors for Radiation Dermatitis in Whole-Breast Irradiation Using the Spectrophotometric Lab Color-Space