Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” study

Abstract

BackgroundTo evaluate the safety and efficacy of abiraterone acetate (AA) in the “real life” clinical practice for men with chemotherapy-naïve metastatic castration-resistant prostate.MethodsA consecutive series of patients with mCRPC in 9 Italian tertiary centres treated with AA was collected. Demographics, clinical parameters, treatment outcomes and toxicity were recorded. The Brief Pain Inventory scale Q3 was tracked and patient treatment satisfaction was evaluated. Survival curves were estimated by the method of Kaplan-Meier and Cox regression and compared by the log-rank test statistic.ResultsWe included 145 patients (mean age 76.5y). All patients were on androgen deprivation therapy. Patients had prior radiotherapy, radical prostatectomy, both treatments or exclusive androgen deprivation therapy in 17%, 33%, 9% and 40%, respectively. 57% of the patients had a Gleason score higher more than 7 at diagnosis. 62% were asymptomatic patients. The median serum total PSA at AA start was 17 ng/mL (range 0,4–2100). The median exposure to AA was 10 months (range 1–35). The proportion of patients achieving a PSA decline ≥50% at 12 weeks was 49%. Distribution of patient satisfaction was 32% “greatly improved”, 38% “improved”, 24% “not changed”, 5.5% “worsened”. Grade 3 and 4 toxicity was recorded in 17/145 patients 11.7% (70% cardiovascular events, 30% critical elevation of AST/ALT levels). At the last follow-up, median progression free and overall survival were 17 and 26.5 months, respectively. Both outcomes significantly correlated with the presence of pain, patient satisfaction, PSA baseline and PSA decline.ConclusionsThe AA is effective and well tolerated in asymptomatic or slightly symptomatic mCRPC in a “real life” setting. The survival outcomes are influenced by the presence of pain, patient satisfaction, baseline PSA and PSA decline.Trial registrationThe study was retrospectively registered at ISRCTN as DOI:10.1186/ISRCTN 52513758 in date April the 30th 2016.Electronic supplementary materialThe online version of this article (10.1186/s12885-017-3755-x) contains supplementary material, which is available to authorized users.

Real‐world outcome with abiraterone acetate plus prednisone in Asian men with metastatic castrate‐resistant prostate cancer: The Singapore experience

“…To the best of our knowledge, this case series is the largest cohort of patients reported in Asia. The reported OS and PFS of patients in both the CN and PC cohorts are similar to other case series presented in Table …”

“…The shorter OS reported in the CN patients, when compared to the relevant cohort in the COU‐AA‐302 study, was attributed to the inclusion of older patients with a heavier burden of symptomatic disease . Other retrospective cohort studies have reported a poorer median OS of patients on AAP in real‐world clinical settings and have attributed their findings to patient factors, that is, age, burden of disease, ECOG status, etc …”

“…Since then, there have been several retrospective cohort studies on AAP that describe the mOS and predictors of OS as shown in Table . In a cohort study of 110 patients from Hong Kong, Poon et al.…”

Identification of key genes in prostate cancer gene expression profile by bioinformatics

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Prognostic value of platelet to lymphocyte ratio in predicting survival of patients with metastatic castration‐resistant prostate cancer receiving abiraterone acetate: An evidence‐based case report and review of literature

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