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• W4206396913 abstract "51 Background: Understanding the toxicities experienced by patients treated with advanced CRC is critical when considering appropriate dose modifications, standard drug dosing, and quality of life. A workflow that makes available Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) to clinicians to inform overall toxicity assessment should be easy to use and focus on clinically relevant issues. The value of a system that not only collects PRO-CTCAE but integrates it with clinician grading to inform overall symptomatic adverse event assessment during clinical trials is unclear. Methods: Patients were simultaneously enrolled in a phase II multi-center clinical trial that evaluated a genotype-guided dosing strategy for irinotecan by prospectively analyzing efficacy in 100 mCRC patients receiving FOLFIRI (5-fluorouracil, leucovorin, irinotecan) and bevacizumab. On day 1 and day 15 of each cycle patients provided PRO-CTCAE responses on 13 symptoms (26 questions) which were made available to clinicians at the time of their toxicity assessment. Descriptive statistics were used to summarize patient demographic and clinical characteristics. Concordance was defined as both patient and clinician giving the same response (both positive or both negative). Results: 100 patients participated in the study, of which 48% were female and 83% White. Overall, 96% of both patients and providers completed at least 80% of PRO-CTCAE forms available to them, demonstrating the feasibility of an integrated workflow for patient-clinician toxicity grading. Across all symptoms, concordance was high (73%) for the patient and provider reporting severe symptoms. 39% of patient-provider pairs reported at least 1 severe symptom and 34% of pairs never reported a severe symptom. In 23% of pairs the patient reported a severe symptom and the provider never did, and in 3% of pairs, the provider reported a severe symptom, but the patient never did. On the symptom level, the concordance was highest (>90%) for dysphagia and vomiting, and lowest (74-82%) for abdominal pain, fatigue, and pain. 52 patients required dose decreases, with the first decrease most often due to hematologic toxicity (80%). In 46% of cases the patient reported at least one severe toxicity prior to or on the same day as the dose decrease, compared to 19% of cases where the provider reported at least severe toxicity prior to or on the same day as the dose decrease. Conclusions: A workflow that brings patient-reported toxicity to clinicians at the time of clinical toxicity rating is feasible. Nevertheless, discordance continues to exist between patient-reported and clinician-reported toxicity ratings, consistent with prior research. Further research could formally compare concordance when using an integrated vs a non-integrated toxicity rating workflow and could ascertain the reasons for continued discordance within an integrated workflow." @default.
• W4206396913 created "2022-01-26" @default.
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• W4206396913 date "2022-02-01" @default.
• W4206396913 modified "2023-09-24" @default.
• W4206396913 title "Integrated approach to collecting patient reported toxicities in a colorectal cancer trial." @default.
• W4206396913 doi "https://doi.org/10.1200/jco.2022.40.4_suppl.051" @default.
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