Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events and Quality-of-Life Linear Analogue Self-Assessment in Breast Cancer Patients Receiving Radiation Therapy: Single-Institution Prospective Registry

Abstract

We sought to investigate the impact of Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) on overall quality-of-life (QOL) employing Linear Analogue Self-Assessment (LASA) in breast cancer (BC) patients undergoing radiation therapy (RT) in a single-institution prospective registry. All patients treated with RT for BC with curative intent from 2015 to 2019 at our institution were eligible for this analysis. Breast specific PRO-CTCAE and overall LASA QOL questionnaires were administered at baseline, end-of-treatment, 3, 6, 12 months, and then annually. A patient was considered to have patient-reported treatment-related symptomatic AEs (PAE) at each time-point, if she had a score of 3 or higher (“severe” or worse) for any breast specific PRO-CTCAE item that was higher than baseline. Minimal clinical difference in overall QOL was considered to be a 10-point change in LASA score. Hypofractionation was defined as any treatment >2 Gy per fraction. Repeated measures mixed models were used to determine the effect PRO-CTCAE had on overall QOL based on LASA. Three-hundred and two (392) patients with a median follow-up of 2.3 years (range, 0.4–3.9) were included for analysis. Patient and treatment characteristics included: 8% pT0, 15% pTis, 50% pT1, 21% pT2, 6% pT3, 63% pN0, 17% pN1, 6% pN2, 3% pN3, 11% pN not reported, 81% ER+, 77% PR+, 11% HER2+, 65% ECOG 0, and median body mass index (BMI) 27.3 (range, 16.4 – 53.8). Treatment characteristics included: median dose 40.05 Gy (range, 40–50.4 Gy), 74% treated with hypofractionation, 42% received a boost (median 10 Gy, range 5.4–12 Gy), 86% treated with photons, 14% treated with proton beam therapy, 76% underwent lumpectomy, and 41% received chemotherapy. Average overall QOL LASA scores for all patients were 78.5 at baseline, 79.8 at end of treatment, 79.8 at 3 months, 77.1 at 6 months, 79.4 at 12 months, and 79.7 at 24 months. On univariate analysis, patients who reported a PAE had, on average, a 9.8-point reduction in overall LASA QOL (p<.0001). On multivariate analysis, not being treated with hypofractionation and higher BMI were predictive for worse overall LASA QOL with a 9.5-point reduction in LASA for patients who reported a PAE (p<.0001). While average overall QOL according to LASA did not change during follow-up for all patients treated with curative intend RT for BC, patients who reported a worsening breast-specific PRO-CTCAE item to “severe” or worse experienced statistically significant and clinically meaningful deterioration in overall QOL based on LASA scale. The use of hypofractionation significantly improved overall QOL while higher BMI predicted for worse QOL. These results contribute to the understanding of PRO-CTCAE for breast cancer patients and promote the value of integration of PRO-CTCAE items into future clinical trials.