PMID- 35317768 OWN - NLM STAT- MEDLINE DCOM- 20220329 LR - 20220329 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 22 IP - 1 DP - 2022 Mar 22 TI - Real-world burden of adverse events for apalutamide- or enzalutamide-treated non-metastatic castration-resistant prostate cancer patients in the United States. PG - 304 LID - 10.1186/s12885-022-09364-z [doi] LID - 304 AB - BACKGROUND: Second-generation androgen receptor inhibitors (ARIs) have been associated with adverse events (AEs) such as fatigue, falls, fractures, and rash in non-metastatic castration-resistant prostate cancer (nmCRPC) patients as identified in clinical trials. The objectives of this study were to describe the incidence and management of AEs in patients receiving apalutamide and enzalutamide. METHODS: This retrospective chart review study was conducted in nmCRPC-treating sites in the United States. Patients starting apalutamide or enzalutamide between February 1, 2018 and December 31, 2018 were included and any AEs they experienced were recorded. AEs, including those considered to be of special interest as defined in the pivotal clinical trials of the second-generation ARIs, were analyzed and grouped retrospectively in this study. Detailed chart data (patient demographics, clinical characteristics, treatment history, type of AE, outcomes, and resource utilization) were then collected for a randomly selected subset among patients with >/=1 AE to characterize AEs and their management. Descriptive results were summarized. RESULTS: Forty-three sites participated in the study. A total of 699 patients were included, of whom 525 (75.1%) experienced >/=1 AE. The most common AEs were fatigue/asthenia (34.3%), hot flush (13.9%), and arthralgia (13.6%). In the subset of 250 patients randomly selected from those who experienced >/=1 AE, patients were primarily White (72.0%), the mean age was 71 years, 86.0% had an Eastern Cooperative Oncology Group score of 0-1 at nmCRPC diagnosis, and the average prostate specific antigen (PSA) value at diagnosis was 23.2 ng/mL. PSA-doubling time < 10 months was chosen as reason to initiate treatment in 40% of patients. The median duration of follow-up was 1.1 years, with 14.4% of patients progressing to metastasis by end of study period. Grade 3-4 and Grade 5 AEs occurred in 14.4 and 0.4% of patients, respectively. Actions taken to manage AEs included AE-directed treatment (38.0%), ARI discontinuation (10.4%), dose reduction (7.6%), and AE-related hospitalization (4.8%). CONCLUSIONS: This study highlights the burden of AEs among nmCRPC patients treated with apalutamide or enzalutamide, providing a relevant real-world benchmark as clinical trial evidence and the treatment landcape for nmCRPC continues to evolve. CI - (c) 2022. The Author(s). FAU - Hussain, Arif AU - Hussain A AD - University of Maryland Greenebaum Comprehensive Cancer Center, 22 S Greene St, Baltimore, MD, 21201, USA. FAU - Jiang, Shan AU - Jiang S AD - Bayer Healthcare Pharmaceuticals, 100 Bayer Blvd, Whippany, NJ, 07981, USA. FAU - Varghese, Della AU - Varghese D AD - OPEN Health, 4350 East-West Highway, Suite 1100, Bethesda, MD, 20184, USA. FAU - Appukkuttan, Sreevalsa AU - Appukkuttan S AD - Bayer Healthcare Pharmaceuticals, 100 Bayer Blvd, Whippany, NJ, 07981, USA. FAU - Kebede, Nehemiah AU - Kebede N AD - OPEN Health, 4350 East-West Highway, Suite 1100, Bethesda, MD, 20184, USA. FAU - Gnanasakthy, Kajan AU - Gnanasakthy K AD - RTI Health Solutions, 5 Sylvan Way, Parsippany, NJ, 07054, USA. FAU - Macahilig, Cynthia AU - Macahilig C AD - RTI Health Solutions, 5 Sylvan Way, Parsippany, NJ, 07054, USA. FAU - Waldeck, Reg AU - Waldeck R AD - Bayer Healthcare Pharmaceuticals, 100 Bayer Blvd, Whippany, NJ, 07981, USA. FAU - Corman, Shelby AU - Corman S AD - OPEN Health, 4350 East-West Highway, Suite 1100, Bethesda, MD, 20184, USA. shelbycorman@gmail.com. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20220322 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 0 (Androgen Receptor Antagonists) RN - 0 (Antineoplastic Agents, Hormonal) RN - 0 (Benzamides) RN - 0 (Nitriles) RN - 0 (Thiohydantoins) RN - 0 (apalutamide) RN - 2010-15-3 (Phenylthiohydantoin) RN - 93T0T9GKNU (enzalutamide) SB - IM MH - Aged MH - Androgen Receptor Antagonists/*adverse effects/therapeutic use MH - Antineoplastic Agents, Hormonal/*adverse effects/therapeutic use MH - Arthralgia/chemically induced MH - Asthenia/chemically induced MH - Benzamides/*adverse effects/therapeutic use MH - Fatigue/chemically induced MH - Flushing/chemically induced MH - Hospitalization MH - Humans MH - Male MH - Nitriles/*adverse effects/therapeutic use MH - Phenylthiohydantoin/*adverse effects/therapeutic use MH - Prostatic Neoplasms, Castration-Resistant/*drug therapy MH - Retrospective Studies MH - Thiohydantoins/*adverse effects/therapeutic use MH - United States PMC - PMC8939229 OTO - NOTNLM OT - Adverse events OT - Apalutamide OT - Chart review study OT - Enzalutamide OT - Non-metastatic castration-resistant prostate cancer OT - Retrospective study COIS- Reg Waldeck and Sreevalsa Appukkuttan are employees of Bayer Healthcare Pharmaceuticals. Shan Jiang was an employee of Bayer Healthcare Pharmaceuticals at the time the study was conducted. Shelby Corman and Nehemiah Kebede were employees of OPEN Health, which was a paid consultancy for the study, at the time the study was conducted. Kajan Gnanasakthy is an employee of RTI Health Solutions, which was a paid consultancy for the study. Cynthia Macahilig was an employee of RTI Health Solutions at the time the study was conducted. Arif Hussain has served in a consulting or advisory role for Novartis, AstraZeneca, Bayer, and Bristol-Myers Squibb, and has received research funding from Sotio, Merck, Bayer, Agensys, Clovis Oncology, and Cerulean Pharma. EDAT- 2022/03/24 06:00 MHDA- 2022/03/30 06:00 PMCR- 2022/03/22 CRDT- 2022/03/23 05:35 PHST- 2021/09/27 00:00 [received] PHST- 2022/02/11 00:00 [accepted] PHST- 2022/03/23 05:35 [entrez] PHST- 2022/03/24 06:00 [pubmed] PHST- 2022/03/30 06:00 [medline] PHST- 2022/03/22 00:00 [pmc-release] AID - 10.1186/s12885-022-09364-z [pii] AID - 9364 [pii] AID - 10.1186/s12885-022-09364-z [doi] PST - epublish SO - BMC Cancer. 2022 Mar 22;22(1):304. doi: 10.1186/s12885-022-09364-z.