PMID- 37251681 OWN - NLM STAT- MEDLINE DCOM- 20230601 LR - 20230602 IS - 1664-2392 (Print) IS - 1664-2392 (Electronic) IS - 1664-2392 (Linking) VI - 14 DP - 2023 TI - Abiraterone acetate and prednisone in metastatic castration-resistant prostate cancer: a real-world retrospective study in China. PG - 1158949 LID - 10.3389/fendo.2023.1158949 [doi] LID - 1158949 AB - BACKGROUND: This research work was aimed at evaluating the incidence and risk factors of adverse events (AEs) occurring in patients treated with abiraterone acetate (AA) and prednisone (PDN) outside clinical trials. These associations were assessed regarding the survival outcomes. METHODS: The study included 191 patients aged >/=18 years of confirmed metastatic castration-resistant prostate cancer (mCRPC) between March 2017 and April 2022. AE incidences were descriptively summarized from the whole cohort. Baseline characteristics, safety (treatment-emergent AEs and severe AEs), and efficacy [progression-free survival (PFS)] were analyzed. Multi-variable Cox proportional hazards models were employed to assess the factors linked with PFS. RESULTS: Overall, the median PFS was 17.16 months (range, 0.5-57.58). Patient baseline prostate-specific antigen (PSA) >==ΜΈ10 ng/ml (p = 0.000), multiple organ metastasis (p = 0.007), hypertension (p = 0.004), and coronary heart disease (p = 0.004) were associated with worse PFS; however, radiotherapy (p = 0.028) was linked to better PFS at univariate analysis in the overall cohort. Baseline multiple organ metastasis, hypertension, and radiotherapy remained statistically significant in multivariable models (p = 0.007, p= 0.005, and p = 0.011, respectively).Incidence of AEs showed increased bilirubin (BIL) (55/191 patients, 28.8%) followed by increased alanine aminotransferase/aspartate aminotransferase (ALT/AST) (48/191 patients, 25.09%). The most common grade 3 AEs were increased ALT (3/191, 1.57%) followed by elevated BIL, hypercholesterolemia, and hypokalemia. Anemia had shorter PFS. There were no unexpected AEs in any patient. CONCLUSION: AA is effective and tolerated in asymptomatic or slightly symptomatic mCRPC in "real-life" setting. The survival outcomes are influenced by multiple organ metastasis, hypertension, and radiotherapy. CI - Copyright (c) 2023 Liu, Yan, Le, Li, Xing and Li. FAU - Liu, Min AU - Liu M AD - Department of Pharmacy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Yan, Jiaqing AU - Yan J AD - Department of Pharmacy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Le, Kaidi AU - Le K AD - Department of Pharmacy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Li, Ying AU - Li Y AD - Department of Pharmacy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Xing, Nianzeng AU - Xing N AD - Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Li, Guohui AU - Li G AD - Department of Pharmacy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. LA - eng PT - Journal Article DEP - 20230512 PL - Switzerland TA - Front Endocrinol (Lausanne) JT - Frontiers in endocrinology JID - 101555782 RN - EM5OCB9YJ6 (Abiraterone Acetate) RN - VB0R961HZT (Prednisone) SB - IM MH - Male MH - Humans MH - Adolescent MH - Adult MH - Abiraterone Acetate/adverse effects MH - Prednisone/adverse effects MH - *Prostatic Neoplasms, Castration-Resistant/drug therapy/pathology MH - Retrospective Studies MH - *Hypertension/drug therapy PMC - PMC10213513 OTO - NOTNLM OT - PSA OT - abiraterone OT - castration-resistant prostate cancer OT - outcome OT - progression COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/05/30 13:07 MHDA- 2023/06/01 06:42 PMCR- 2023/01/01 CRDT- 2023/05/30 11:42 PHST- 2023/02/04 00:00 [received] PHST- 2023/04/21 00:00 [accepted] PHST- 2023/06/01 06:42 [medline] PHST- 2023/05/30 13:07 [pubmed] PHST- 2023/05/30 11:42 [entrez] PHST- 2023/01/01 00:00 [pmc-release] AID - 10.3389/fendo.2023.1158949 [doi] PST - epublish SO - Front Endocrinol (Lausanne). 2023 May 12;14:1158949. doi: 10.3389/fendo.2023.1158949. eCollection 2023.