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

To evaluate the safety and efficacy of abiraterone acetate (AA) in the "real life" clinical practice for men with chemotherapy-naïve metastatic castration-resistant prostate.

A 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.

We 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.

The 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.

The study was retrospectively registered at ISRCTN as DOI: 10.1186/ISRCTN 52513758 in date April the 30th 2016.

BMC cancer. 2017 Nov 10*** epublish ***

Luca Cindolo, Clara Natoli, Cosimo De Nunzio, Michele De Tursi, Maurizio Valeriani, Silvana Giacinti, Salvatore Micali, Mino Rizzo, Giampaolo Bianchi, Eugenio Martorana, Marcello Scarcia, Giuseppe Mario Ludovico, Pierluigi Bove, Anastasia Laudisi, Oscar Selvaggio, Giuseppe Carrieri, Maida Bada, Pietro Castellan, Stefano Boccasile, Pasquale Ditonno, Paolo Chiodini, Paolo Verze, Vincenzo Mirone, Luigi Schips

Department of Urology, ASL Abruzzo2, Via dei Vestini, Chieti, Italy. ., Department of Medical, Oral and Biotechnological Sciences, Centro Scienze dell'Invecchiamento e Medicina Traslazionale (CeSI-MeT), Chieti, Italy., Department of Urology, "Sant'Andrea" Hospital , Sapienza University", Rome, Italy., Radiation therapy Unit, "Sant'Andrea" Hospital, "Sapienza University", Rome, Italy., Oncology Unit, "Sant'Andrea" Hospital, "Sapienza University", Rome, Italy., Department of Urology, University of Modena & Reggio Emilia, Baggiovara Hospital, Via Giardini, 1355, Baggiovara, Italy., Ente Ecclesiastico Ospedale "F. Miulli", S.P. per Santeramo Km 4.100, Acquaviva delle Fonti, Italy., Department Of Experimental Medicine and Surgery, Azienda Policlinico Tor Vergata, Rome, Italy., UOSD of Medical Oncology Azienda Policlinico Tor Vergata, Rome, Italy., Department of Urology, University of Foggia, V.le L. Pinto, Foggia, Italy., Department of Urology, ASL Abruzzo2, Via dei Vestini, Chieti, Italy., Urology and Andrology Unit II, Department of Emergency and Organ Transplantation, University of Bari, Piazza G. Cesare 11, Bari, Italy., Medical Statistics Unit, University of Campania "Luigi Vanvitelli", via L. Armanni 5, Naples, Italy., Department of Neurosciences, Sciences of Reproduction and Odontostomatology, Urology Unit, University of Naples "Federico II", Naples, Italy.