Discordance of patient- and physician-reported toxicities in two prospective trials of stereotactic body radiotherapy (SBRT) for localized prostate cancer.

• DOI: 10.1200/jco.2022.40.6_suppl.245
• Publication Date: 2022-02-16T21:35:25Z
• Authors: Akshat Patel; Rohit R Badia; Armon Amini; Christopher Kung; Samuel B. Kusin; Sarah Neufeld; Samantha Mannala; Aurelie Garant; Raquibul Hannan; Robert D. Timmerman; Michael J. Zelefsky; Michael Ryan Folkert; Neil Bipinchandra...
• Keywords: Clinical endpoint; Concordance

245 Background: SBRT for localized prostate cancer (PCa) is the focus of several ongoing and reported high-impact trials, which often on physician-reported toxicity (P-Tox) when comparing regimens. Patient-reported quality life (PR-QoL) may differ provide a more sensitive comparative metric treatment burden, especially with fewer provider interactions during than protracted RT courses. We evaluated concordance prospective genitourinary (GU) gastrointestinal (GI) P-Tox PR-QOL in men receiving PCa. Methods: Data from two concurrently-enrolled trials high-risk (Phase I Safety Endpoint, NCT01896271) low-intermediate risk II GI Toxicity NCT02353832) PCa were used. Matching standardized schedules collected PR-QoL [Expanded Prostate Cancer Index Composite (EPIC)] (CTCAE v5.0) analyzed over first 18 months follow up, where symptoms are most pronounced. assessed Grade≥2 GU/GI physician declines exceeding anchor based minimal clinically important difference (MCID) thresholds (-6 urinary -5 bowel summary scores, respectively) each patient at time point. Patients without baseline data excluded full, while points missing or individually imputation. Concordance was by Cohen’s kappa statistic. Results: From 101 patients, there 256 (64%) up observations through both point baseline. low all GU domains (mean 0.093; Table). MCID patients physicians (38% vs 17% 44% 10% GI). There little overlap reporting: PR-QoL, 54% Grade ≥2 P-Tox. Mean similarly analyzing sub-groups trial, investigator, an alternative 2xMCID threshold. Conclusions: differed dramatically studies despite primary endpoints. This reflect subjective varying intervention driving reporting, rather actual burden. These strongly support use study endpoints guidelines this rapidly evolving space. [Table: see text]