Evaluating Immune-Related Adverse Events Using PRO-CTCAE in a Phase II Study of Ipilimumab for Hormone-Sensitive Prostate Cancer.

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.
Competing Interests: Conflict of Interest: Daniel Vargas P. de Almeida reports speaker compensation from Astellas, AstraZeneca, Bayer, Eli Lilly, Janssen-Cilag, and Sanofi-Aventis. Daniel C. Danila reports research support from US Department of Defense, American Society of Clinical Oncology, Prostate Cancer Foundation, Stand Up to Cancer, Janssen Research & Development, Agensys, Genentech, CreaTV; consultant for Angle LLT, Axiom LLT, Janssen Research & Development, AstraZeneca, BioView LTD, Clovis, Astellas, Medivation, Pfizer, and Agensys. Michael J. Morris reports travel support from Endocyte, Fujifilm; research funding (to institution) from Novartis, Bayer, Celgene, Corcept, Roche/Genentech, Janssen; is an uncompensated consultant to Bayer, Novartis, Johnson and Johnson; is a compensated consultant to Oric, Lantheus, Curium, AstraZeneca, Amgen, Daiichi, Convergent Therapeutics, Pfizer, and ITM Isotope Technologies. Wassim Abida reports speaking honoraria from Roche, Medscape, Aptitude Health, Clinical Education Alliance, MJH Life Sciences and touchIME, consulting fees from Clovis Oncology, Janssen, ORIC Pharmaceuticals, Daiichi Sankyo and AstraZeneca UK, and research funding (to institution) from AstraZeneca, Zenith Epigenetics, Clovis Oncology, Glaxo-Smith Kline, and ORIC Pharmaceuticals. Howard I. Scher reports compensated consultant/advisor to Ambry Genetics Corp, Konica Minolta Inc, Bayer, Pfizer Inc, Sun Pharmaceuticals, WCG Oncology; uncompensated consultant/advisory to Amgen, Janssen Research & Development, LLC, Janssen Biotech, Inc,; honoraria from Arsenal Capital; has received research funding (to institution) from AIQ Solutions, Epic Sciences, Illumina, Inc, Janssen, Menarini Silicon Biosystems, Prostate Cancer Foundation and ThermoFisher; supported in part by NIH/NCI grant P50 CA092629 (MSK SPORE in Prostate Cancer); intellectual property rights BioNTech, Elucida Oncology, MaBVAX, Y-mAbs Therapeutics, Inc.; non-financial support from Amgen, Bayer, Epic Sciences, Promontory Therapeutics (formerly Phosplatin), Pfizer Inc, Prostate Cancer Foundation, and WCG Oncology. Karen A. Autio reports research funding (to institution) from Pfizer, Amgen, Trishula, CytomX, Astra-Zeneca, Eli Lilly, Glaxo-Smith Kline, and Parker Institute for Cancer Immunotherapy. The remaining authors have no disclosures
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