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      Clinician and Patient Reporting of Symptomatic Adverse Events in Cancer Clinical Trials: Using CTCAE and PRO-CTCAE ® to Provide Two Distinct and Complementary Perspectives

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          Abstract

          Inclusion of the patient perspective in the reporting of symptomatic adverse events provides different and complementary information to clinician reporting using the Common Terminology Criteria for Adverse Events (CTCAE). The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE ®) is designed for patients to self-report their symptomatic adverse events in a manner that complements CTCAE reporting. Using CTCAE and PRO-CTCAE together offers the potential to refine our understanding of the prevalence and trajectory of lower grade AEs that can lead to elective discontinuation of therapy and diminished quality of life. This review addresses the development of PRO-CTCAE with an emphasis on the differences between PRO-CTCAE scores and CTCAE severity grades. This distinction is important when evaluating, grading and reporting toxicity and tolerability in cancer clinical trials.

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          Most cited references54

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          Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer

          Tony Mok, Yi-Long Wu, Myung-Ju Ahn … (2017)
          Background Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer. The efficacy of osimertinib as compared with platinum-based therapy plus pemetrexed in such patients is unknown. Methods In this randomized, international, open-label, phase 3 trial, we assigned 419 patients with T790M-positive advanced non-small-cell lung cancer, who had disease progression after first-line EGFR-TKI therapy, in a 2:1 ratio to receive either oral osimertinib (at a dose of 80 mg once daily) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles; maintenance pemetrexed was allowed. In all the patients, disease had progressed during receipt of first-line EGFR-TKI therapy. The primary end point was investigator-assessed progression-free survival. Results The median duration of progression-free survival was significantly longer with osimertinib than with platinum therapy plus pemetrexed (10.1 months vs. 4.4 months; hazard ratio; 0.30; 95% confidence interval [CI], 0.23 to 0.41; P<0.001). The objective response rate was significantly better with osimertinib (71%; 95% CI, 65 to 76) than with platinum therapy plus pemetrexed (31%; 95% CI, 24 to 40) (odds ratio for objective response, 5.39; 95% CI, 3.47 to 8.48; P<0.001). Among 144 patients with metastases to the central nervous system (CNS), the median duration of progression-free survival was longer among patients receiving osimertinib than among those receiving platinum therapy plus pemetrexed (8.5 months vs. 4.2 months; hazard ratio, 0.32; 95% CI, 0.21 to 0.49). The proportion of patients with adverse events of grade 3 or higher was lower with osimertinib (23%) than with platinum therapy plus pemetrexed (47%). Conclusions Osimertinib had significantly greater efficacy than platinum therapy plus pemetrexed in patients with T790M-positive advanced non-small-cell lung cancer (including those with CNS metastases) in whom disease had progressed during first-line EGFR-TKI therapy. (Funded by AstraZeneca; AURA3 ClinicalTrials.gov number, NCT02151981 .).
          Article 0 comments Cited 1013 times – based on 0 reviews     Review now
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            Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes.

            I B Wilson, P D Cleary (1995)
            Our model proposes a taxonomy or classification scheme for different measures of health outcome. We divide these outcomes into five levels: biological and physiological factors, symptoms, functioning, general health perceptions, and overall quality of life. In addition to classifying these outcome measures, we propose specific causal relationships between them that link traditional clinical variables to measures of HRQL. As one moves from left to right in the model, one moves outward from the cell to the individual to the interaction of the individual as a member of society. The concepts at each level are increasingly integrated and increasingly difficult to define and measure. AT each level, there are an increasing number of inputs that cannot be controlled by clinicians or the health care system as it is traditionally defined.
            Article 0 comments Cited 603 times – based on 0 reviews     Review now
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              Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

              Ethan Basch, Bryce B Reeve, Sandra A. Mitchell … (2014)
              The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research.
              Article 0 comments Cited 278 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Patient Relat Outcome Meas
                Journal ID (iso-abbrev): Patient Relat Outcome Meas
                Journal ID (publisher-id): prom
                Title: Patient Related Outcome Measures
                Publisher: Dove
                ISSN (Electronic): 1179-271X
                Publication date (Electronic): 08 December 2022
                Publication date Collection: 2022
                Volume: 13
                Pages: 249-258
                Affiliations
                [1 ]Division of Cancer Prevention, National Cancer Institute , Bethesda, MD, USA
                [2 ]Consultant, ICF , Fairfax, VA, USA
                [3 ]Consultant to Division of Cancer Prevention, National Cancer Institute , Bethesda, MD, USA
                [4 ]Division of Cancer Control and Population Sciences, National Cancer Institute , Bethesda, MD, USA
                Author notes
                Correspondence: Lori M Minasian, Division of Cancer Prevention, National Cancer Institute , 9609 Medical Center Drive, 5E-342, MSC-9784, Bethesda, MD, 20892-9784, USA, Tel +11 240 276 7053, Fax +11 240 276 7846, Email minasilo@mail.nih.gov
                Author information
                http://orcid.org/0000-0002-0472-4079
                http://orcid.org/0000-0002-4153-9972
                Article
                Publisher ID: 256567
                DOI: 10.2147/PROM.S256567
                PMC ID: 9744864
                PubMed ID: 36524232
                SO-VID: bb97fef8-ec89-4ed7-b17b-9edf0631e864
                Copyright © © 2022 Minasian et al.
                License:

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                Date received : 04 May 2022
                Date accepted : 12 November 2022
                Page count
                Figures: 1, Tables: 1, References: 58, Pages: 10
                Categories
                Subject: Review

                ScienceOpen disciplines: Medicine
                Keywords: patient-reported outcomes version of the common terminology criteria for adverse events,pro-ctcae,patient-reported outcomes,cancer therapy,toxicity,tolerability
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: patient-reported outcomes version of the common terminology criteria for adverse events, pro-ctcae, patient-reported outcomes, cancer therapy, toxicity, tolerability

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