Sorah, Jonathan D.Deal, Allison M.Stein, Sophia I.Jonsson, MattiasInnocenti, FedericoTurk, AnitaBoles, Jeremiah C.Irvin, WilliamBasch, Ethan M.Sanoff, Hanna K.Wood, William A.2024-10-292024-10-292024Sorah JD, Deal AM, Stein SI, et al. Longitudinal patient-reported outcomes on genotype-guided irinotecan dosing: feasibility and clinical relevance. Oncologist. 2024;29(9):780-785. doi:10.1093/oncolo/oyae121https://hdl.handle.net/1805/44326Introduction: Standard investigator-based adverse events (AE) assessment is via CTCAE for clinical trials. However, including the patient perspective through PRO (patient-reported outcomes) enhances clinicians' understanding of patient toxicity and fosters early detection of AEs. We assessed longitudinal integration of PRO-CTCAE within clinical workflow in a phase II trial. Materials and methods: As a sub-study in a phase II trial of genotype-directed irinotecan dosing evaluating efficacy in patients with metastatic colorectal cancer receiving FOLFIRI and bevacizumab, patients reported on 13 AEs generating a PRO-CTCAE form. The primary objective was to estimate forms completed by patients and clinicians at least 80% of time. Secondary objectives were estimating concordance and time to first score of specific symptoms between patient and clinician pairs. Results: Feasibility of longitudinal PRO-CTCAE integration was met as 96% of patients and clinician-patient pairs completed at least 80% of PRO-CTCAE forms available to them with 79% achieving 100% completion. Concordance between patient and clinician reporting a severe symptom was 73% with 24 disconcordant pairs, 21 involved patients who reported a severe symptom that the clinician did not. Although protocol-mandated dose reductions were guided by CTCAE not PRO-CTCAE responses, the median time to dose reduction of 2.53 months, and the time-to-event curve closely approximated time to patient-reported toxicity. Conclusion: Longitudinal integration of PRO-CTCAE paired CTCAE proved feasible. Compared to clinicians, patients reported severe symptoms more frequently and earlier. Patient-reported toxicity more closely aligned with dose decreases indicating incorporation into routine clinical practice may enhance early detection of toxicity improving patient safety and quality of life.en-USCC0 1.0 UniversalPatient-reported outcomesCommon terminology criteria for adverse eventsComparative and optimal drug safetyEarly toxicity detectionQuality of lifeColorectal cancerArticle