{"doi":"10.36401/jipo-23-9","title":"Evaluating Immune-Related Adverse Events Using PRO-CTCAE in a Phase II Study of Ipilimumab for Hormone-Sensitive Prostate Cancer","abstract":"Introduction: Use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) during chemotherapy is associated with decreased hospitalization rates, improved quality of life, and longer survival. Limited data exist on the benefit of this symptom assessment tool for monitoring immune-related adverse events (irAEs). Methods: We incorporated irAE-related items from the National Cancer Institute's (NCI) PRO-CTCAE in a trial evaluating ipilimumab in combination with androgen deprivation therapy in 16 patients with hormone-sensitive prostate cancer. For comparison, NCI's CTCAE version 4.0 was used by clinicians. Results: IrAE-related PRO-CTCAE surveys and matched CTCAEs (184 pairs) reporting abdominal pain, diarrhea, fatigue, anorexia, nausea, vomiting, rash, and pruritus were collected at each treatment administration and during follow-up. Fatigue, diarrhea, rash, and pruritus were the symptoms most frequently reported by both patients and clinicians. Agreement was lowest for pruritus (κ = 0.10) and highest for rash (κ = 0.64). IrAEs were more commonly reported and of higher grade with PRO-CTCAE scores compared with CTCAE grades. Conclusion: PRO-CTCAEs focused on irAEs capture the patient's immunotherapy experience while complementing the clinician's toxicity assessment measures. Further study is needed to assess PRO-CTCAE's utility in identifying and managing irAEs.","journal":"Journal of Immunotherapy and Precision Oncology","year":2023,"id":367698,"datarank":0.26876392038420827,"base_score":1.791759469228055,"endowment":1.791759469228055,"self_citation_contribution":0.26876392038420827,"citation_network_contribution":0.0,"self_endowment_contribution":0.26876392038420827,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":5,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9499,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1125293,"name":"Justine Anderson","orcid":"0000-0002-5333-2012","position":1,"is_corresponding":false},{"id":311740,"name":"Daniel C. Danila","orcid":"0000-0002-7647-0741","position":2,"is_corresponding":false},{"id":311748,"name":"Michael J. Morris","orcid":"0000-0002-9454-0096","position":3,"is_corresponding":false},{"id":311736,"name":"Susan F. Slovin","orcid":"0000-0002-9074-9191","position":4,"is_corresponding":false},{"id":50783,"name":"Wassim Abida","orcid":"0000-0002-9006-7043","position":5,"is_corresponding":false},{"id":725477,"name":"Erica Simone Dayan","orcid":"0000-0001-7965-5090","position":6,"is_corresponding":false},{"id":316495,"name":"Raymond E. Baser","orcid":"0000-0002-1644-4090","position":7,"is_corresponding":false},{"id":90756,"name":"Howard I. Scher","orcid":"0000-0002-6791-9324","position":8,"is_corresponding":false},{"id":311732,"name":"Karen A. Autio","orcid":"0000-0003-0720-0390","position":9,"is_corresponding":false},{"id":1125292,"name":"Daniel Vargas Pivato de Almeida","orcid":"0000-0001-9467-5049","position":0,"is_corresponding":true}],"reference_count":19,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-19T01:15:16.306414Z","pmid":"38143953","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}