Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer in chemotherapy-naive patients: an Italian multicentre “real life” 1 year study

Luca Cindolo1, Clara Natoli2, Cosimo De nunzio3, Michele De Tursi2, Maurizio Valeriani4, Silvana Giacinti5, Salvatore Micali6, Mino Rizzo7, Giampaolo Bianchi7, Eugenio Martorana7, Marcello Scarcia8, Giuseppe Mario Ludovico 8, Pierluigi Bove9, Anastasia Laudisi10, Oscar Selvaggio11, Giuseppe Carrieri11, Maida Bada1, Pietro Castellan1, Stefano Boccasile12, Pasquale Ditonno12, Paolo Chiodini13, Paolo Verze14, Vincenzo Mirone14, Luigi Schips1
  • 1 ASL Abruzzo 2, Unità di Urologia (Chieti)
  • 2 Università degli Studi "G. D'Annunzio", Dipartimento di Scienze mediche, orali e biotecnologiche (Chieti)
  • 3 Ospedale Sant'Andrea, Unità di Urologia (Roma)
  • 4 Ospedale Sant'Andrea, Unità di Radioterapia (Roma)
  • 5 Ospedale Sant'Andrea, Unità di Oncologia (Roma)
  • 6 Ospedale Baggiovara, Unità di Urologia (Baggiovara)
  • 7 Università degli Studi di Modena e Reggio Emilia, Dipartimento di Urologia (Baggiovara)
  • 8 Ente Ecclesiastico Ospedale Generale Regionale "F. Miulli" (Acquaviva delle Fonti)
  • 9 Policlinico Tor Vergata, Dipartimento di Medicina Sperimentale e Chirurgia (Roma)
  • 10 Policlinico Torvergata, U.O.S.D. di Oncologia Medica (Roma)
  • 11 Università degli Studi di Foggia, Dipartimento di Urologia (Foggia)
  • 12 Policlinico di Bari, Unità II di Urologia e Andrologia, Dipartimento Emergenza e Trapianti di Organi (Bari)
  • 13 Seconda Università degli Studi di Napoli, Unità di Statistica Medica (Napoli)
  • 14 Università Federico II di Napoli, Dipartimento di Neuroscienze, Scienze Riproduttive e Odontostomatologiche (Napoli)


To better understand the “real life” experience with abiraterone acetate (AA) in men with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), we present an Italian multicentre real life analysis with a mid-term follow-up.

Materials and Methods

A consecutive series of patients with mCRPC in 8 Italian tertiary centres treated with AA was collected. Demographics, clinical parameters, treatment outcomes and toxicity were recorded. The Brief Pain Inventory scale Q2 was recorded and patient treatment satisfaction was evaluated. Univariate and multivariate analyses were performed to identify factors for treatment satisfaction. Kaplan-Meier curves were estimated.


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. The Gleason score >7 at diagnosis was 57%. Asymptomatic patients were 62%. The median serum total PSA at AA start was 17ng/mL (range 0,4-2100). Overall the median exposure to AA was 10m (range 1-35). Among the patients that had ≥ 3 months of AA the proportion of patients achieving a ≥50% PSA decline was 49%. Patient satisfaction was 31% “greatly improved”, 37% “improved”, 24% “not changed”, 7% “worsened”; and significantly correlated at multivariable analysis with baseline PSA (OR 1.43 95%CI 1.03-1.98 p0.033), pain (OR 9.3 95%CI 3.33-26.09 p<0.0001), duration of ADT>12months (OR 5.5 95%CI 1.43-21.57 p0.014). With a median follow-up of 13months, median progression free and overall survival were 17 and 26.5months, respectively, and correlated with patient satisfaction, pain, PSA decline (all p <0.001).


we study an Italian real life esperience to evaluate which parameters can influence patients' satisfation.


The AA is effective and well tolerated in asymptomatic or slightly symptomatic mCRPC in a real life setting. These preliminary data should be confirmed after longer follow-up, nevertheless the baseline PSA, the presence of pain and the duration of ADT are predictors of patient satisfaction. The survival outcomes depend on patient satisfaction, pain, and PSA decline.