Evaluating immune-related adverse events using PRO-CTCAE in a phase II study of ipilimumab for hormone-sensitive prostate cancer Journal Article
| Authors: | Vargas P. de Almeida, D.; Anderson, J. M.; Danila, D. C.; Morris, M. J.; Slovin, S. F.; Abida, W.; Cohn, E. D.; Baser, R. E.; Scher, H. I.; Autio, K. A. |
| Article 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 (j = 0.10) and highest for rash (j = 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. © 2023, Innovative Healthcare Institute. All rights reserved. |
| Keywords: | survival; adult; clinical article; middle aged; fatigue; diarrhea; drug dose reduction; follow up; anorexia; prostate specific antigen; ipilimumab; quality of life; phase 2 clinical trial; vomiting; practice guideline; abdominal pain; prostate cancer; pruritus; rash; gleason score; hospitalization; immunotherapy; radical prostatectomy; clinical decision making; patient-reported outcomes; toxicity; awareness; androgen deprivation therapy; good clinical practice; adverse event; patient-reported outcome; immune checkpoint inhibitor; human; male; article; evaluation study; tertiary care center; immune-related adverse events; castration sensitive prostate cancer |
| Journal Title: | Journal of Immunotherapy and Precision Oncology |
| Volume: | 6 |
| Issue: | 4 |
| ISSN: | 2666-2345 |
| Publisher: | Innovative Healthcare Institute |
| Date Published: | 2023-11-01 |
| Start Page: | 162 |
| End Page: | 169 |
| Language: | English |
| DOI: | 10.36401/jipo-23-9 |
| PROVIDER: | scopus |
| PMCID: | PMC10734393 |
| PUBMED: | 38143953 |
| DOI/URL: | |
| Notes: | Article -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PDF -- MSK corresponding author is Karen Autio -- Source: Scopus |
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