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. Therapeutic advances in medical oncology

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 SciarraLorenzo Livi, Daniele Santini

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Abiraterone plus prednisone is effective and safe for chemotherapy-naïve mCRPC patients in clinical practice.
Original languageEnglish
Pages (from-to)1758835920968725
JournalTher. Adv. Med. Oncol.
Volume12
DOIs
Publication statusPublished - 2020

Keywords

  • prospective study
  • abiraterone acetate
  • effectiveness
  • metastatic castration-resistant prostate cancer
  • real-world study

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