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
Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:7 |
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| Enthalten in: |
ESMO open - 7(2022), 2 vom: 15. Apr., Seite 100431 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Procopio, G [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 03.05.2022 Date Revised 16.07.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.esmoop.2022.100431 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM339350458 |
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| 245 | 1 | 0 | |a Real-world experience of abiraterone acetate plus prednisone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer |b long-term results of the prospective ABItude study |
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| 500 | |a Date Revised 16.07.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSION: With longer follow-up, abiraterone therapy remains safe, well tolerated, and active in a large unselected population | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a abiraterone acetate | |
| 650 | 4 | |a metastatic castration-resistant prostate cancer | |
| 650 | 4 | |a prospective study | |
| 650 | 4 | |a real-world evidence | |
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| 650 | 7 | |a Prednisone |2 NLM | |
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| 700 | 1 | |a Gasparro, D |e verfasserin |4 aut | |
| 700 | 1 | |a Ludovico, G M |e verfasserin |4 aut | |
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| 700 | 1 | |a Chiuri, Vincenzo |e investigator |4 oth | |
| 700 | 1 | |a Mantini, Giovanna |e investigator |4 oth | |
| 700 | 1 | |a Roberto Bordonaro, Roberto Maisano |e investigator |4 oth | |
| 700 | 1 | |a Cinieri, Saverio |e investigator |4 oth | |
| 700 | 1 | |a Rossetti, Sabrina |e investigator |4 oth | |
| 700 | 1 | |a De Placido, Sabino |e investigator |4 oth | |
| 700 | 1 | |a Airoldi, Mario |e investigator |4 oth | |
| 700 | 1 | |a Galli, Luca |e investigator |4 oth | |
| 700 | 1 | |a Gasparro, Donatello |e investigator |4 oth | |
| 700 | 1 | |a Ludovico, Giuseppe Mario |e investigator |4 oth | |
| 700 | 1 | |a Guglielmini, Pamela Francesca |e investigator |4 oth | |
| 700 | 1 | |a Santini, Daniele |e investigator |4 oth | |
| 700 | 1 | |a Naglieri, Emanuele |e investigator |4 oth | |
| 700 | 1 | |a Fagnani, Daniele |e investigator |4 oth | |
| 700 | 1 | |a Aglietta, Massimo |e investigator |4 oth | |
| 700 | 1 | |a Livi, Lorenzo |e investigator |4 oth | |
| 700 | 1 | |a Schips, Luigi |e investigator |4 oth | |
| 700 | 1 | |a Passalacqua, Rodolfo |e investigator |4 oth | |
| 700 | 1 | |a Fiore, Michele |e investigator |4 oth | |
| 700 | 1 | |a D'Angelillo, Rolando Maria |e investigator |4 oth | |
| 700 | 1 | |a Ceresoli, Giovanni Luca |e investigator |4 oth | |
| 700 | 1 | |a Magrini, Stefano |e investigator |4 oth | |
| 700 | 1 | |a Rondonotti, David |e investigator |4 oth | |
| 700 | 1 | |a Mirone, Vincenzo |e investigator |4 oth | |
| 700 | 1 | |a Ferriero, Maria Consiglia |e investigator |4 oth | |
| 700 | 1 | |a Sciarra, Alessandro |e investigator |4 oth | |
| 700 | 1 | |a Acquati, Mirko |e investigator |4 oth | |
| 700 | 1 | |a Boccardo, Francesco |e investigator |4 oth | |
| 700 | 1 | |a Scagliotti, Giorgio Vittorio |e investigator |4 oth | |
| 700 | 1 | |a Mencoboni, Manlio |e investigator |4 oth | |
| 700 | 1 | |a De Giorgi, Ugo |e investigator |4 oth | |
| 700 | 1 | |a Micheletti, Gennaro |e investigator |4 oth | |
| 700 | 1 | |a Lanzetta, Gaetano |e investigator |4 oth | |
| 700 | 1 | |a Sartori, Donata |e investigator |4 oth | |
| 700 | 1 | |a Carlini, Paolo |e investigator |4 oth | |
| 700 | 1 | |a Soto Parra, Hector Josè |e investigator |4 oth | |
| 700 | 1 | |a Battaglia, Michele |e investigator |4 oth | |
| 700 | 1 | |a Uricchio, Francesco |e investigator |4 oth | |
| 700 | 1 | |a Bernardo, Antonio |e investigator |4 oth | |
| 700 | 1 | |a De Lisa, Antonello |e investigator |4 oth | |
| 700 | 1 | |a Carrieri, Giuseppe |e investigator |4 oth | |
| 700 | 1 | |a Ardizzoia, Antonio |e investigator |4 oth | |
| 700 | 1 | |a Aieta, Michele |e investigator |4 oth | |
| 700 | 1 | |a Pisconti, Salvatore |e investigator |4 oth | |
| 700 | 1 | |a Marchetti, Paolo |e investigator |4 oth | |
| 700 | 1 | |a Paiar, Fabiola |e investigator |4 oth | |
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