PMID- 29383035 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220311 IS - 1758-8340 (Print) IS - 1758-8359 (Electronic) IS - 1758-8340 (Linking) VI - 10 DP - 2018 TI - Abiraterone acetate and prednisone in the pre- and post-docetaxel setting for metastatic castration-resistant prostate cancer: a mono-institutional experience focused on cardiovascular events and their impact on clinical outcomes. PG - 1758834017745819 LID - 10.1177/1758834017745819 [doi] LID - 1758834017745819 AB - BACKGROUND: The aim of this work was to to evaluate the incidence and risk factors of adverse events (AEs), focusing on cardiovascular events (CVEs) and hypokalemia, in patients treated with abiraterone acetate (AA) and prednisone (PDN) outside clinical trials, and their association with survival outcomes. METHODS: This was a retrospective cohort study of 105 patients treated from 2011 to 2016. Incidence of AEs was descriptively summarized in the whole cohort and by subgroup (pre- versus post-docetaxel). Multivariable Cox proportional hazards models assessed factors associated with progression-free survival (PFS) and overall survival (OS). RESULTS: Overall, median PFS and OS were 14.9 and 24.6 months, respectively. Prostate-specific antigen (PSA) ⩾ 10 ng/ml (p = 0.007), Gleason Score >7 (p = 0.008), Eastern Cooperative Oncology Group (ECOG) performance status (PS)1-2 (p = 0.002), duration of androgen deprivation therapy (ADT) ⩽ 43.2 months (p = 0.01), and body mass index (BMI) > 25 (p = 0.03) were associated with worse PFS; presence of pain (p = 0.01), ECOG PS1-2 (p = 0.004), duration of ADT ⩽ 43.2 (p = 0.05), and BMI > 25 (p = 0.042) were associated with worse OS. Incidence of CVEs was as follows: hypertension 17.1%, fluid retention 4.8%, cardiac disorders 8.6%. 16.2% of patients developed hypokalemia. Age ⩾ 75 years was associated with higher probability of cardiac disorders (p = 0.001) and fluid retention (p = 0.03). CVEs did not impact on PFS or OS. Hypokalemia was associated with better median OS (p = 0.036). Similar associations were observed after stratification by subgroup. CONCLUSIONS: Median PFS and OS estimates and incidence of CVEs and hypokalemia in our series are consistent with those of pivotal trials of AA plus PDN, confirming the efficacy and safety of this regimen also in the real-world setting. Elderly patients have higher odds of developing/worsening CVEs. However, regardless of age, CVEs were not associated with worse outcomes. Treatment-related hypokalemia seemed to be associated with longer OS, albeit this finding needs confirmation within larger, prospective series. FAU - Cavo, Alessia AU - Cavo A AUID- ORCID: 0000-0003-2157-3740 AD - Academic Unit of Medical Oncology, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Rubagotti, Alessandra AU - Rubagotti A AD - Academic Unit of Medical Oncology, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Zanardi, Elisa AU - Zanardi E AD - Academic Unit of Medical Oncology, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Fabbroni, Chiara AU - Fabbroni C AD - Academic Unit of Medical Oncology, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Zinoli, Linda AU - Zinoli L AD - Academic Unit of Medical Oncology, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Di Meglio, Antonio AU - Di Meglio A AD - Academic Unit of Medical Oncology, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Arboscello, Eleonora AU - Arboscello E AD - Academic Unit of Internal Medicine 3, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Bellodi, Andrea AU - Bellodi A AD - Academic Unit of Internal Medicine 3, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Spallarossa, Paolo AU - Spallarossa P AD - Clinic of Cardiovascular Disease, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Cattrini, Carlo AU - Cattrini C AD - Academic Unit of Medical Oncology, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Messina, Carlo AU - Messina C AD - Academic Unit of Medical Oncology, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, Genoa, Italy. FAU - Boccardo, Francesco AU - Boccardo F AD - Academic Unit of Medical Oncology, San Martino Polyclinic Hospital, Institute for Cancer Research and Treatment, L.go R. Benzi 10, 16132, Genoa, Italy. LA - eng PT - Journal Article DEP - 20180109 PL - England TA - Ther Adv Med Oncol JT - Therapeutic advances in medical oncology JID - 101510808 PMC - PMC5784574 OTO - NOTNLM OT - abiraterone acetate OT - cardiovascular adverse events OT - hypokalemia OT - metastatic castration-resistant prostate cancer OT - obesity OT - safety COIS- Conflict of interest statement: The authors declare that there is no conflict of interest. EDAT- 2018/02/01 06:00 MHDA- 2018/02/01 06:01 PMCR- 2018/01/09 CRDT- 2018/02/01 06:00 PHST- 2017/05/04 00:00 [received] PHST- 2017/10/05 00:00 [accepted] PHST- 2018/02/01 06:00 [entrez] PHST- 2018/02/01 06:00 [pubmed] PHST- 2018/02/01 06:01 [medline] PHST- 2018/01/09 00:00 [pmc-release] AID - 10.1177_1758834017745819 [pii] AID - 10.1177/1758834017745819 [doi] PST - epublish SO - Ther Adv Med Oncol. 2018 Jan 9;10:1758834017745819. doi: 10.1177/1758834017745819. eCollection 2018.