Effectiveness of abiraterone acetate plus prednisone in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer in a large prospective real-world cohort: the ABItude study.

Real-world data on chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone plus prednisone are limited, largely deriving from small retrospective studies.

ABitude is an Italian, observational, prospective, multicenter study of mCRPC patients receiving abiraterone plus prednisone in clinical practice. Chemotherapy-naïve mCRPC patients were consecutively enrolled at abiraterone start (February 2016 to June 2017) and are being followed for 3 years, with evaluation approximately every 6 months. Several clinical and patients reported outcomes were examined.

In this second interim analysis, among 481 enrolled patients, 453 were evaluable for analyses. At baseline, the median age was 77 years and ~69% of patients had comorbidities (mainly cardiovascular diseases). Metastases were located mainly at bones and lymph nodes; 8.4% of patients had visceral metastases. During a median follow-up of 18 months, 1- and 2-year probability of radiographic progression-free survival were 73.9% and 56.2%, respectively; the corresponding rates for overall survival were 87.3% and 70.4%. In multivariable analyses, the number of bone metastases significantly affected radiographic progression-free survival and overall survival. During abiraterone plus prednisone treatment, 65% of patients had a ⩾50% prostate-specific antigen decline, and quality of life remained appreciably high. Among symptomatic patients according to the Brief Pain Inventory) (32%), scores significantly declined after 6 months of treatment. Overall, eight patients (1.7%) had serious adverse reactions to abiraterone.

Abiraterone plus prednisone is effective and safe for chemotherapy-naïve mCRPC patients in clinical practice.

Therapeutic advances in medical oncology. 2020 Oct 29*** epublish ***

Giuseppe Procopio, Vincenzo Emanuele Chiuri, Monica Giordano, Giovanna Mantini, Roberto Maisano, Roberto Bordonaro, Nicola Calvani, Gaetano Facchini, Sabino De Placido, Mario Airoldi, Andrea Sbrana, Donatello Gasparro, Giuseppe Mario Ludovico, Pamela Guglielmini, Emanuele Naglieri, Daniele Fagnani, Massimo Aglietta, Luigi Schips, Patrizia Beccaglia, Alessandro Sciarra, Lorenzo Livi, Daniele Santini

Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, via Venezian 1, Milan, 20133, Italy., Medical Oncology Department, Ospedale Vito Fazzi, Lecce, Puglia, Italy., Medical Oncology Division, ASST-Lariana, Como, Lombardia, Italy., Radiochemotherapy Unit, Department of Diagnostics for Imaging, Oncological Radiotherapy and Hematology, Fondazione Policlinico A. Gemelli IRCCS, Rome - University Department of Radiological and Hematological Sciences, Università Cattolica Sacro Cuore, Italy., Department of Oncology, A.O. Bianchi-Melacrino-Morelli, Reggio Calabria, Calabria, Italy., MD - ARNAS Garibaldi, Catania, Sicilia, Italy., Medical Oncology Unit, Antonio Perrino Hospital, Brindisi, Puglia, Italy., Departmental Unit of Experimental Uro-Andrological Clinical Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Naples, Italy., Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Campania, Italy., Oncology Unit 2 - Città della Salute e della Scienza di Torino, Turin, Piemonte, Italy., Medical Oncology Unit 2, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy., Medical Oncology Unit, Department of General and Specialistic Medicine, University Hospital of Parma, Parma, Italy., Department of Urology, Ospedale F. Miulli, Acquaviva delle Fonti, Bari, Italy., Oncology Unit, SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy., Medical Oncology Unit, IRCCS Giovanni Paolo II, Bari, Italy., Medical Oncology Division, ASST Vimercate, Vimercate, Italy., Department of Oncology, University of Turin; Candiolo Cancer Institute - FPO- IRCCS, Candiolo, Italy., Department of Medical, Oral and Biotechnological Sciences, G. d'Annunzio University of Chieti, Urology unit, "SS. Annunziata Hospital", Chieti, Italy., Janssen SpA, Cologno Monzese, Italy., Department of Urology, Sapienza Rome University Policlinico Umberto I, Rome, Italy., Department of Radiation Oncology, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Florence, Italy., Department of Medical Oncology, University Campus Biomedico, Rome, Italy.