Background: Limited real-world data exist on the effectiveness and safety of abiraterone acetate plus prednisone (abiraterone hereafter) in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) naive to chemotherapy. Most of the few available studies had a retrospective design and included a small number of patients. In the interim analysis of the ABItude study, abiraterone showed good clinical effectiveness and safety profile in the chemotherapy-naive setting over a median follow-up of 18 months. Patients and methods: We evaluated clinical and patient-reported outcomes (PROs) of chemotherapy-naive mCRPC patients treated with abiraterone as for clinical practice in the Italian, observational, prospective, multicentric ABItude study. mCRPC patients were enrolled at abiraterone start (February 2016-June 2017) and followed up for 3 years; clinical endpoints and PROs, including quality of life (QoL) and pain, were prospectively collected. Kaplan–Meier curves were estimated. Results: Of the 481 patients enrolled, 454 were assessable for final study analyses. At abiraterone start, the median age was 77 years, with 58.6% elderly patients and 69% having at least one comorbidity (57.5% cardiovascular diseases). Visceral metastases were present in 8.4% of patients. Over a median follow-up of 24.8 months, median progression-free survival (any progression reported by the investigators), time to abiraterone discontinuation, and overall survival were, respectively, 17.3 months [95% confidence interval (CI) 14.1-19.4 months], 16.0 months (95% CI 13.1-18.2 months), and 37.3 months (95% CI 36.5 months-not estimable); 64.2% of patients achieved ≥50% reduction in prostate-specific antigen. QoL assessed by Functional Assessment of Cancer Therapy—Prostate, the European Quality of Life 5 Dimensions 3 Level, and European Quality of Life Visual Analog Scale remained stable during treatment. Median time to pain progression according to Brief Pain Inventory data was 31.1 months (95% CI 24.8 months-not estimable). Sixty-two patients (13.1%) had at least one adverse drug reaction (ADR) and 8 (1.7%) one serious ADR. Conclusion: With longer follow-up, abiraterone therapy remains safe, well tolerated, and active in a large unselected population.

Real-world experience of abiraterone acetate plus prednisone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: long-term results of the prospective ABItude study

Paiar F.
2022

Abstract

Background: Limited real-world data exist on the effectiveness and safety of abiraterone acetate plus prednisone (abiraterone hereafter) in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) naive to chemotherapy. Most of the few available studies had a retrospective design and included a small number of patients. In the interim analysis of the ABItude study, abiraterone showed good clinical effectiveness and safety profile in the chemotherapy-naive setting over a median follow-up of 18 months. Patients and methods: We evaluated clinical and patient-reported outcomes (PROs) of chemotherapy-naive mCRPC patients treated with abiraterone as for clinical practice in the Italian, observational, prospective, multicentric ABItude study. mCRPC patients were enrolled at abiraterone start (February 2016-June 2017) and followed up for 3 years; clinical endpoints and PROs, including quality of life (QoL) and pain, were prospectively collected. Kaplan–Meier curves were estimated. Results: Of the 481 patients enrolled, 454 were assessable for final study analyses. At abiraterone start, the median age was 77 years, with 58.6% elderly patients and 69% having at least one comorbidity (57.5% cardiovascular diseases). Visceral metastases were present in 8.4% of patients. Over a median follow-up of 24.8 months, median progression-free survival (any progression reported by the investigators), time to abiraterone discontinuation, and overall survival were, respectively, 17.3 months [95% confidence interval (CI) 14.1-19.4 months], 16.0 months (95% CI 13.1-18.2 months), and 37.3 months (95% CI 36.5 months-not estimable); 64.2% of patients achieved ≥50% reduction in prostate-specific antigen. QoL assessed by Functional Assessment of Cancer Therapy—Prostate, the European Quality of Life 5 Dimensions 3 Level, and European Quality of Life Visual Analog Scale remained stable during treatment. Median time to pain progression according to Brief Pain Inventory data was 31.1 months (95% CI 24.8 months-not estimable). Sixty-two patients (13.1%) had at least one adverse drug reaction (ADR) and 8 (1.7%) one serious ADR. Conclusion: With longer follow-up, abiraterone therapy remains safe, well tolerated, and active in a large unselected population.
Procopio, G.; Chiuri, V. E.; Giordano, M.; Alitto, A. R.; Maisano, R.; Bordonaro, R.; Cinieri, S.; Rossetti, S.; De Placido, S.; Airoldi, M.; Galli, L.; Gasparro, D.; Ludovico, G. M.; Guglielmini, P. F.; Carella, C.; Nova, P.; Aglietta, M.; Schips, L.; Beccaglia, P.; Sciarra, A.; Livi, L.; Santini, D.; Procopio, G.; Chiuri, V.; Mantini, G.; Roberto Bordonaro, R. M.; Cinieri, S.; Rossetti, S.; De Placido, S.; Airoldi, M.; Galli, L.; Gasparro, D.; Ludovico, G. M.; Guglielmini, P. F.; Santini, D.; Naglieri, E.; Fagnani, D.; Aglietta, M.; Livi, L.; Schips, L.; Passalacqua, R.; Fiore, M.; D'Angelillo, R. M.; Ceresoli, G. L.; Magrini, S.; Rondonotti, D.; Mirone, V.; Ferriero, M. C.; Sciarra, A.; Acquati, M.; Boccardo, F.; Scagliotti, G. V.; Mencoboni, M.; De Giorgi, U.; Micheletti, G.; Lanzetta, G.; Sartori, D.; Carlini, P.; Soto Parra, H. J.; Battaglia, M.; Uricchio, F.; Bernardo, A.; De Lisa, A.; Carrieri, G.; Ardizzoia, A.; Aieta, M.; Pisconti, S.; Marchetti, P.; Paiar, F.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11568/1141556
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