Characterization of Objective Skin Color Changes during and after Breast and Chest Wall Radiotherapy and Correlation with Radiation-Induced Skin Toxicity in Breast Cancer Patients, Including Patients with Skin of Color

Abstract

Radiation dermatitis (RD) is common among women undergoing breast and chest wall radiotherapy (RT); however, existing scales to assess the severity of RD are subjective and do not account for variability in skin of color (SOC). For instance, the Common Terminology Criteria for Adverse Events (CTCAE) criteria do not include hyperpigmentation in the grading scale. There is data indicating worse RD in African American and Hispanic patients; however, the rate and severity in SOC remains unknown given the lack of data using objective measures of RD. Spectrophotometry is one method to quantify the appearance of color by measuring spectral characteristics without the bias associated with subjective clinical scoring. We present a phase I prospective non-therapeutic clinical trial to objectively define SOC at baseline and evaluate spectrophotometric skin changes during and after breast or chest wall RT in parallel with physician-graded RD using CTCAE criteria. We hypothesize that there will be greater discrepancy between physician graded RD and objective measures of RD in patients with SOC in whom hyperpigmentation will be undercaptured by physician-grading. This is the first study intending to correlate SOC with objective changes after RT as a reliable indicator of RD. We offer a novel system for evaluating RD that is applicable to SOC. A total of 60 patients with localized breast cancer (stage 0-III) undergoing conventional whole breast or chest wall RT (50Gy/ 25 fx), hypofractionated whole breast RT (40.5Gy/15 fx) or ultrahypofractionated partial breast RT (6Gy x5), with or without regional nodal RT were enrolled. 3 skin color readouts using the Commission International de l'Eclairage 3D color system (l*, a*, b*) were measured within the radiation field using a spectrophotometer at baseline, once weekly during RT, 10 days post RT, 4 weeks and 12 months post RT. The spectrophotometer is a non-invasive, hand-held device that is used in the clinic room with no additional equipment or setup requirements. Data is automatically exported to a spreadsheet organized by timepoint and patient. The l* axis is a gray scale (0 = black, 100 = white) correlating with skin pigmentation and the a* axis describes red and green values correlating with erythema. The primary objective is to evaluate the changes from baseline in skin color readouts in the quadrant of tumor location during and after RT based on fractionation. The secondary objective is to evaluate changes within and across groups defined by baseline skin color. Exploratory objectives include evaluating the association of baseline color readouts and changes after RT with acute and late grade > 2 clinician-rated skin and subcutaneous tissue effects according to the CTCAE, v5.0, physician graded cosmesis and clinical interventions to treat RD, such as use of topical steroids and oral analgesics. As of January 2023, we have enrolled 100% of the planned patients. To be determined. To be determined. Clinical Study Identifier: S22-00192.