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

• Published in: Journal of patient-reported outcomes Vol. 6; no. 1; p. 3
• Main Authors: Thorpe, C. S., DeWees, T. A., Golafshar, M. A., Bhangoo, R. S., Vern-Gross, T. Z., McGee, L. A., Wong, W. W., Halyard, M. Y., Keole, S. R., Vargas, C. E.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 10.01.2022; Springer Nature B.V; SpringerOpen
• Subjects: Breast cancer; Medicine; Medicine & Public Health; Patients; Quality of Life Research; Radiation therapy; Self evaluation
• ISSN: 2509-8020; 2509-8020
• DOI: 10.1186/s41687-021-00408-9

Purpose/objectives 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). Materials/methods All patients treated with RT for BC with curative intent from 2015 to 2019 at our institution were included. Breast specific PRO-CTCAE and overall QOL LASA questionnaires were administered at baseline, end-of-treatment, 3, 6, 12 months, and then annually. Minimal clinically important difference in overall QOL was a 10-point change in LASA. Hypofractionation was any treatment > 2 Gy per fraction. Mixed models for repeated measures were used to determine the association of PRO-CTCAE and overall QOL LASA. Results Three hundred thirty-one (331) patients with a median follow-up of 3.1 years (range 0.4–4.9) were included. Average overall QOL LASA scores 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 reporting a grade ≥ 3 PRO-CTCAE had, on average, a 10.4-point reduction in overall LASA QOL (p < 0.0001). On multivariate analysis, not being treated with hypofractionation and higher BMI were predictive for worse overall LASA QOL with a 10-point reduction in LASA for patients reporting a grade ≥ 3 PRO-CTCAE (p < 0.0001). Conclusions Patients reporting a grade ≥ 3 PRO-CTCAE experienced statistically significant and clinically meaningful deterioration in overall QOL LASA. Hypofractionation improved QOL while higher BMI predicted for worse QOL. PRO-CTCAE should be integrated into future clinical trials.