Patient-reported outcome thresholds and their associations with survival, adverse events, and quality of life in a pooled analysis of breast cancer trials
- Author(s)
- Menz, BD; Modi, ND; Abuhelwa, AY; Kuderer, NM; Lyman, GH; Swain, SM; Kichenadasse, G; Shahnam, A; Haseloff, M; Vitry, A; Rammant, E; Ramsey, I; Chan, RJ; McKinnon, RA; Rowland, A; Sorich, MJ; Hopkins, AM;
- Journal Title
- International Journal of Cancer
- Publication Type
- Online publication before print
- Abstract
- Researchers at the EORTC recently recommended clinical thresholds for the QLQ-C30 to facilitate actionable insights in clinical practice. We evaluate the distribution of these thresholds and associations with outcomes in breast cancer. Data were pooled from two early-stage and six advanced-stage breast cancer trials. EORTC thresholds were applied to available QLQ-C30 data to identify clinically important PRO domains. Associations between the number of clinically important PRO domains at baseline with overall survival (OS), invasive-disease-free survival (IDFS), progression-free survival (PFS), grade ≥3 adverse events (AEs), and serious AEs were evaluated using Cox-regression. Data from 8544 breast cancer patients, of whom 2428 (41%) of the 5893 early-stage and 1486 (56%) of the 2651 advanced-stage patients reported ≥3 clinically important PRO domains. In the early-stage, each additional clinically important PRO domain was associated with worsened grade ≥3 AEs (HR, 1.03 [95%CI, 1.01-1.04], p = 0.001) and serious AEs (1.05 [1.03-1.07], p < 0.001). In the advanced-stage, each additional clinically important PRO domain was associated with worsened OS (1.05 [1.03-1.07], p < 0.001), PFS (1.03 [1.01-1.04], p = 0.002), grade ≥3 AEs (1.04 [1.02-1.06], p < 0.001), and serious AEs (1.07 [1.04-1.11], p < 0.001). A substantial proportion of breast cancer patients report clinically important PRO domains at baseline, with increasing numbers associated with worsening AEs, survival, and quality-of-life.
- Keywords
- Eortc; breast cancer; cancer; patient‐reported outcomes; survival outcomes
- Department(s)
- Medical Oncology
- Publisher's Version
- https://doi.org/10.1002/ijc.70020
- Open Access at Publisher's Site
https://doi.org/10.1002/ijc.70020- Terms of Use/Rights Notice
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Creation Date: 2025-07-31 04:18:45
Last Modified: 2025-07-31 04:18:59