학술논문
Longitudinal patient-reported outcomes on genotype-guided irinotecan dosing: feasibility and clinical relevance.
Document Type
Academic Journal
Author
Sorah JD; Lineberger Comprehensive Cancer Center, Chapel Hill, NC 27599, United States.; Division of Oncology, Department of Medicine, University of North Carolina, Chapel Hill, NC 27599, United States.; Deal AM; Lineberger Comprehensive Cancer Center, Chapel Hill, NC 27599, United States.; Stein SI; Lineberger Comprehensive Cancer Center, Chapel Hill, NC 27599, United States.; Jonsson M; Lineberger Comprehensive Cancer Center, Chapel Hill, NC 27599, United States.; Innocenti F; Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599, United States.; Turk A; Division of Hematology/Oncology, Indiana University, Indianapolis, IN 46202, United States.; Boles JC; UNC Rex Hematology/Oncology, Raleigh, NC 27607, United States.; Irvin W; Bon Secours Cancer Institute, Richmond, VA 23114, United States.; Basch EM; Lineberger Comprehensive Cancer Center, Chapel Hill, NC 27599, United States.; Division of Oncology, Department of Medicine, University of North Carolina, Chapel Hill, NC 27599, United States.; Sanoff HK; Lineberger Comprehensive Cancer Center, Chapel Hill, NC 27599, United States.; Division of Oncology, Department of Medicine, University of North Carolina, Chapel Hill, NC 27599, United States.; Wood WA; Lineberger Comprehensive Cancer Center, Chapel Hill, NC 27599, United States.; Division of Hematology, Department of Medicine, University of North Carolina, Chapel Hill, NC 27599, United States.
Source
Publisher: Oxford University Press Country of Publication: England NLM ID: 9607837 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-490X (Electronic) Linking ISSN: 10837159 NLM ISO Abbreviation: Oncologist Subsets: MEDLINE
Subject
Language
English
Abstract
Introduction: 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.
(Published by Oxford University Press 2024.)
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.
(Published by Oxford University Press 2024.)