Linking the European Organisation for Research and Treatment of Cancer Item Library to the Common Terminology Criteria for Adverse Events

Overview

Journal J Clin Oncol

Specialty Oncology

Date 2022 Aug 16

PMID 35973158

Authors

Alexandra Gilbert

Claire Piccinin

Galina Velikova

Mogens Groenvold

Dagmara Kulis

Jane M Blazeby

Andrew Bottomley

Affiliations

Soon will be listed here.

Abstract

Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Item Library is an interactive online platform currently composed of 950 unique items (questions) derived from 67 patient-reported outcome (PRO) questionnaires. PROs complement clinician adverse event (AE) reporting classifications like the Common Terminology Criteria for Adverse Events (CTCAE). This work aims to create a standardized framework using the CTCAE to systematically classify symptomatic AEs from the EORTC Item Library through linking individual items to corresponding AEs.

Methods: The EORTC Item Library items were searched for within the CTCAE (v5.0) and linked to an AE if they were described within the AE's title, description, or grading. Symptoms described in EORTC items but not located in the CTCAE were coded as missing symptoms. Other nonsymptom EORTC items, not described within the CTCAE were assigned a non-CTCAE descriptive classification. Further descriptive codes (eg, multiple issues) were allocated to enable descriptive analysis. Two raters independently coded 26.2% (n = 249) of the items. The remaining 701 items were coded by one rater and verified by the second, followed by discussion with two additional raters to reach consensus.

Results: Overall, 625 (65.8%) EORTC items were linked to 208 different AEs. Three hundred sixty-nine items provide information about non-CTCAE cancer-related issues and were categorized into seven descriptive classifications, including body image; emotional impact of a symptom, diagnosis, or treatment; global health and quality of life; and impact on life and daily activities. Inter-rater agreement for independent coding was 79.1%. Bowel urgency and tenesmus were identified as missing symptoms in CTCAEv5.0.

Conclusion: The EORTC Item Library provides considerable coverage of CTCAE toxicities, along with other complementary issues important to patients with cancer. Using the CTCAE clinical framework to classify symptomatic PRO items may facilitate PRO selection and use in clinical trials and routine care.

Citing Articles

Mapping immune checkpoint inhibitor side effects to item libraries for use in real-time side effect monitoring systems.

Lai-Kwon J, Jefford M, Best S, Zhang I, Cella D, Piccinin C J Patient Rep Outcomes. 2025; 9(1):27.

PMID: 40048089 PMC: 11885683. DOI: 10.1186/s41687-025-00855-8.

Development and validation of the systemic nutrition/inflammation index for improving perioperative management of non-small cell lung cancer.

Wang P, Wang S, Huang Q, Chen X, Yu Y, Zhang R BMC Med. 2025; 23(1):113.

PMID: 39988705 PMC: 11849302. DOI: 10.1186/s12916-025-03925-2.

Survival outcomes, multidimensional prediction and subsequent therapy in patients with hormone receptor-positive advanced breast cancer receiving palbociclib: a real-world analysis.

Ma J, Wu Z, Xu Y, Wang Y, Lin Y, Zhou L Gland Surg. 2025; 13(12):2313-2324.

PMID: 39822368 PMC: 11733649. DOI: 10.21037/gs-24-362.

Assessing tolerability with the Functional Assessment of Cancer Therapy item GP5: psychometric evidence from LIBRETTO-531, a phase 3 trial of selpercatinib in medullary thyroid cancer.

Regnault A, Bunod L, Loubert A, Brose M, Hess L, Maeda P J Patient Rep Outcomes. 2024; 8(1):149.

PMID: 39694978 PMC: 11655800. DOI: 10.1186/s41687-024-00823-8.

Efficacy and safety of avatrombopag in the treatment of chemotherapy-induced thrombocytopenia in children with acute lymphoblastic leukemia: a single-center retrospective study.

Yang H, Gao J, Ruan Y, Chen Z, Fang R, Zhang L Ther Adv Hematol. 2024; 15:20406207241304300.

PMID: 39649520 PMC: 11622298. DOI: 10.1177/20406207241304300.

References

Taarnhoj G, Kennedy F, Absolom K, Baeksted C, Vogelius I, Johansen C . Comparison of EORTC QLQ-C30 and PRO-CTCAE™ Questionnaires on Six Symptom Items. J Pain Symptom Manage. 2018; 56(3):421-429. DOI: 10.1016/j.jpainsymman.2018.05.017. View

Nout R, van de Poll-Franse L, Lybeert M, Warlam-Rodenhuis C, Jobsen J, Mens J . Long-term outcome and quality of life of patients with endometrial carcinoma treated with or without pelvic radiotherapy in the post operative radiation therapy in endometrial carcinoma 1 (PORTEC-1) trial. J Clin Oncol. 2011; 29(13):1692-700. DOI: 10.1200/JCO.2010.32.4590. View

Cieza A, Fayed N, Bickenbach J, Prodinger B . Refinements of the ICF Linking Rules to strengthen their potential for establishing comparability of health information. Disabil Rehabil. 2016; 41(5):574-583. DOI: 10.3109/09638288.2016.1145258. View

Kluetz P, Kanapuru B, Lemery S, Johnson L, Fiero M, Arscott K . Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop. Value Health. 2018; 21(6):742-747. DOI: 10.1016/j.jval.2017.09.009. View

Froeding L, Greimel E, Lanceley A, Oberguggenberger A, Schmalz C, Radisic V . Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review. Int J Gynecol Cancer. 2018; 28(4):808-817. DOI: 10.1097/IGC.0000000000001211. View

Quinten C, Maringwa J, Gotay C, Martinelli F, Coens C, Reeve B . Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. J Natl Cancer Inst. 2011; 103(24):1851-8. PMC: 3243678. DOI: 10.1093/jnci/djr485. View

Kluetz P, Slagle A, Papadopoulos E, Johnson L, Donoghue M, Kwitkowski V . Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms. Clin Cancer Res. 2016; 22(7):1553-8. DOI: 10.1158/1078-0432.CCR-15-2035. View

Tucker C, Escorpizo R, Cieza A, Lai J, Stucki G, Ustun T . Mapping the content of the Patient-Reported Outcomes Measurement Information System (PROMIS®) using the International Classification of Functioning, Health and Disability. Qual Life Res. 2014; 23(9):2431-8. PMC: 4189969. DOI: 10.1007/s11136-014-0691-y. View

Henson C, Anandadas C, Barraclough L, Swindell R, West C, Davidson S . The case for including bowel urgency in toxicity reporting after pelvic cancer treatment. J Natl Compr Canc Netw. 2013; 11(7):827-33. DOI: 10.6004/jnccn.2013.0103. View

10.

Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson L . Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections. Clin Cancer Res. 2017; 24(8):1780-1784. DOI: 10.1158/1078-0432.CCR-17-2555. View

11.

Atkinson T, Ryan S, Bennett A, Stover A, Saracino R, Rogak L . The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review. Support Care Cancer. 2016; 24(8):3669-76. PMC: 4919215. DOI: 10.1007/s00520-016-3297-9. View

12.

Kyte D, Retzer A, Ahmed K, Keeley T, Armes J, Brown J . Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials. J Natl Cancer Inst. 2019; 111(11):1170-1178. PMC: 6855977. DOI: 10.1093/jnci/djz038. View

13.

Cieza A, Brockow T, Ewert T, Amman E, Kollerits B, Chatterji S . Linking health-status measurements to the international classification of functioning, disability and health. J Rehabil Med. 2002; 34(5):205-10. DOI: 10.1080/165019702760279189. View

14.

Atkinson T, Rogak L, Heon N, Ryan S, Shaw M, Stark L . Exploring differences in adverse symptom event grading thresholds between clinicians and patients in the clinical trial setting. J Cancer Res Clin Oncol. 2017; 143(4):735-743. PMC: 5354957. DOI: 10.1007/s00432-016-2335-9. View

15.

Coens C, Pe M, Dueck A, Sloan J, Basch E, Calvert M . International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium. Lancet Oncol. 2020; 21(2):e83-e96. DOI: 10.1016/S1470-2045(19)30790-9. View

16.

Basch E, Reeve B, Mitchell S, Clauser S, Minasian L, Dueck A . Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014; 106(9). PMC: 4200059. DOI: 10.1093/jnci/dju244. View

17.

Hay J, Atkinson T, Reeve B, Mitchell S, Mendoza T, Willis G . Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Qual Life Res. 2013; 23(1):257-69. PMC: 3896507. DOI: 10.1007/s11136-013-0470-1. View

18.

Petersen M, Aaronson N, Arraras J, Chie W, Conroy T, Costantini A . The EORTC CAT Core-The computer adaptive version of the EORTC QLQ-C30 questionnaire. Eur J Cancer. 2018; 100:8-16. DOI: 10.1016/j.ejca.2018.04.016. View

19.

Petersen M, Aaronson N, Conroy T, Costantini A, Giesinger J, Hammerlid E . International validation of the EORTC CAT Core: a new adaptive instrument for measuring core quality of life domains in cancer. Qual Life Res. 2020; 29(5):1405-1417. DOI: 10.1007/s11136-020-02421-9. View

20.

McFatrich M, Brondon J, Lucas N, Hinds P, Maurer S, Mack J . Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research. Cancer. 2019; 126(1):140-147. PMC: 6906242. DOI: 10.1002/cncr.32525. View