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

BMC Cancer

Research Article

Pierluigi Bove¹  Clara Natoli²  Michele De Tursi²  Vincenzo Mirone³  Paolo Verze³  Pietro Castellan⁴  Luigi Schips⁴  Maida Bada⁴  Luca Cindolo⁵  Giuseppe Carrieri⁶  Oscar Selvaggio⁶  Salvatore Micali⁷  Mino Rizzo⁷  Eugenio Martorana⁷  Giampaolo Bianchi⁷  Cosimo De Nunzio⁸  Giuseppe Mario Ludovico⁹  Marcello Scarcia⁹  Paolo Chiodini^1,10  Silvana Giacinti^1,11  Maurizio Valeriani^1,12  Anastasia Laudisi^1,13  Pasquale Ditonno^1,14  Stefano Boccasile^1,14 

[1] Department Of Experimental Medicine and Surgery, Azienda Policlinico Tor Vergata, Rome, Italy;Department of Medical, Oral and Biotechnological Sciences, Centro Scienze dell’Invecchiamento e Medicina Traslazionale (CeSI-MeT), Chieti, Italy;Department of Neurosciences, Sciences of Reproduction and Odontostomatology, Urology Unit, University of Naples “Federico II”, Naples, Italy;Department of Urology, ASL Abruzzo2, Via dei Vestini, Chieti, Italy;Department of Urology, ASL Abruzzo2, Via dei Vestini, Chieti, Italy;Department of Urology, ASL Abruzzo2 , “S. Pio da Pietrelcina” Hospital, Via San Camillo de Lellis 1, Vasto, Italy;Department of Urology, University of Foggia, V.le L. Pinto, Foggia, Italy;Department of Urology, University of Modena & Reggio Emilia, Baggiovara Hospital, Via Giardini, 1355, Baggiovara, Italy;Department of Urology, “Sant’Andrea” Hospital , Sapienza University”, Rome, Italy;Ente Ecclesiastico Ospedale “F. Miulli”, S.P. per Santeramo Km 4.100, Acquaviva delle Fonti, Italy;Medical Statistics Unit, University of Campania “Luigi Vanvitelli”, via L. Armanni 5, Naples, Italy;Oncology Unit, “Sant’Andrea” Hospital, “Sapienza University”, Rome, Italy;Radiation therapy Unit, “Sant’Andrea” Hospital, “Sapienza University”, Rome, Italy;UOSD of Medical Oncology Azienda Policlinico Tor Vergata, Rome, Italy;Urology and Andrology Unit II, Department of Emergency and Organ Transplantation, University of Bari, Piazza G. Cesare 11, Bari, Italy;

关键词: Prostate cancer;    Androgen deprivation therapy;    Abiraterone acetate;    Castration-resistant prostate cancer;    Androgen receptor;   

DOI  :  10.1186/s12885-017-3755-x

 received in 2017-01-13, accepted in 2017-11-06,  发布年份 2017

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2017