Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” study
Abstract Background To evaluate the safety and efficacy of abiraterone acetate (AA) in the “real life” clinical practice for men with chemotherapy-naïve metastatic castration-resistant prostate. Methods A consecutive series of patients with mCRPC in 9 Italian tertiary centres treated with AA was col...
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2017-11-01
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Online Access: | http://link.springer.com/article/10.1186/s12885-017-3755-x |
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Article |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Luca Cindolo Clara Natoli Cosimo De Nunzio Michele De Tursi Maurizio Valeriani Silvana Giacinti Salvatore Micali Mino Rizzo Giampaolo Bianchi Eugenio Martorana Marcello Scarcia Giuseppe Mario Ludovico Pierluigi Bove Anastasia Laudisi Oscar Selvaggio Giuseppe Carrieri Maida Bada Pietro Castellan Stefano Boccasile Pasquale Ditonno Paolo Chiodini Paolo Verze Vincenzo Mirone Luigi Schips |
spellingShingle |
Luca Cindolo Clara Natoli Cosimo De Nunzio Michele De Tursi Maurizio Valeriani Silvana Giacinti Salvatore Micali Mino Rizzo Giampaolo Bianchi Eugenio Martorana Marcello Scarcia Giuseppe Mario Ludovico Pierluigi Bove Anastasia Laudisi Oscar Selvaggio Giuseppe Carrieri Maida Bada Pietro Castellan Stefano Boccasile Pasquale Ditonno Paolo Chiodini Paolo Verze Vincenzo Mirone Luigi Schips Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” study BMC Cancer Prostate cancer Androgen deprivation therapy Abiraterone acetate Castration-resistant prostate cancer Androgen receptor |
author_facet |
Luca Cindolo Clara Natoli Cosimo De Nunzio Michele De Tursi Maurizio Valeriani Silvana Giacinti Salvatore Micali Mino Rizzo Giampaolo Bianchi Eugenio Martorana Marcello Scarcia Giuseppe Mario Ludovico Pierluigi Bove Anastasia Laudisi Oscar Selvaggio Giuseppe Carrieri Maida Bada Pietro Castellan Stefano Boccasile Pasquale Ditonno Paolo Chiodini Paolo Verze Vincenzo Mirone Luigi Schips |
author_sort |
Luca Cindolo |
title |
Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” study |
title_short |
Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” study |
title_full |
Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” study |
title_fullStr |
Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” study |
title_full_unstemmed |
Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” study |
title_sort |
safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an italian multicenter “real life” study |
publisher |
BMC |
series |
BMC Cancer |
issn |
1471-2407 |
publishDate |
2017-11-01 |
description |
Abstract Background To evaluate the safety and efficacy of abiraterone acetate (AA) in the “real life” clinical practice for men with chemotherapy-naïve metastatic castration-resistant prostate. Methods A consecutive series of patients with mCRPC in 9 Italian tertiary centres treated with AA was collected. Demographics, clinical parameters, treatment outcomes and toxicity were recorded. The Brief Pain Inventory scale Q3 was tracked and patient treatment satisfaction was evaluated. Survival curves were estimated by the method of Kaplan-Meier and Cox regression and compared by the log-rank test statistic. Results 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. 57% of the patients had a Gleason score higher more than 7 at diagnosis. 62% were asymptomatic patients. The median serum total PSA at AA start was 17 ng/mL (range 0,4–2100). The median exposure to AA was 10 months (range 1–35). The proportion of patients achieving a PSA decline ≥50% at 12 weeks was 49%. Distribution of patient satisfaction was 32% “greatly improved”, 38% “improved”, 24% “not changed”, 5.5% “worsened”. Grade 3 and 4 toxicity was recorded in 17/145 patients 11.7% (70% cardiovascular events, 30% critical elevation of AST/ALT levels). At the last follow-up, median progression free and overall survival were 17 and 26.5 months, respectively. Both outcomes significantly correlated with the presence of pain, patient satisfaction, PSA baseline and PSA decline. Conclusions The AA is effective and well tolerated in asymptomatic or slightly symptomatic mCRPC in a “real life” setting. The survival outcomes are influenced by the presence of pain, patient satisfaction, baseline PSA and PSA decline. Trial registration The study was retrospectively registered at ISRCTN as DOI: 10.1186/ISRCTN 52513758 in date April the 30th 2016. |
topic |
Prostate cancer Androgen deprivation therapy Abiraterone acetate Castration-resistant prostate cancer Androgen receptor |
url |
http://link.springer.com/article/10.1186/s12885-017-3755-x |
work_keys_str_mv |
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doaj-981184a786e2492083d7bce0054f6fa32020-11-25T00:29:48ZengBMCBMC Cancer1471-24072017-11-011711810.1186/s12885-017-3755-xSafety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” studyLuca Cindolo0Clara Natoli1Cosimo De Nunzio2Michele De Tursi3Maurizio Valeriani4Silvana Giacinti5Salvatore Micali6Mino Rizzo7Giampaolo Bianchi8Eugenio Martorana9Marcello Scarcia10Giuseppe Mario Ludovico11Pierluigi Bove12Anastasia Laudisi13Oscar Selvaggio14Giuseppe Carrieri15Maida Bada16Pietro Castellan17Stefano Boccasile18Pasquale Ditonno19Paolo Chiodini20Paolo Verze21Vincenzo Mirone22Luigi Schips23Department of Urology, ASL Abruzzo2Department of Medical, Oral and Biotechnological Sciences, Centro Scienze dell’Invecchiamento e Medicina Traslazionale (CeSI-MeT)Department of Urology, “Sant’Andrea” Hospital , Sapienza University”Department of Medical, Oral and Biotechnological Sciences, Centro Scienze dell’Invecchiamento e Medicina Traslazionale (CeSI-MeT)Radiation therapy Unit, “Sant’Andrea” Hospital, “Sapienza University”Oncology Unit, “Sant’Andrea” Hospital, “Sapienza University”Department of Urology, University of Modena & Reggio Emilia, Baggiovara HospitalDepartment of Urology, University of Modena & Reggio Emilia, Baggiovara HospitalDepartment of Urology, University of Modena & Reggio Emilia, Baggiovara HospitalDepartment of Urology, University of Modena & Reggio Emilia, Baggiovara HospitalEnte Ecclesiastico Ospedale “F. Miulli”Ente Ecclesiastico Ospedale “F. Miulli”Department Of Experimental Medicine and Surgery, Azienda Policlinico Tor VergataUOSD of Medical Oncology Azienda Policlinico Tor VergataDepartment of Urology, University of FoggiaDepartment of Urology, University of FoggiaDepartment of Urology, ASL Abruzzo2Department of Urology, ASL Abruzzo2Urology and Andrology Unit II, Department of Emergency and Organ Transplantation, University of BariUrology and Andrology Unit II, Department of Emergency and Organ Transplantation, University of BariMedical Statistics Unit, University of Campania “Luigi Vanvitelli”Department of Neurosciences, Sciences of Reproduction and Odontostomatology, Urology Unit, University of Naples “Federico II”Department of Neurosciences, Sciences of Reproduction and Odontostomatology, Urology Unit, University of Naples “Federico II”Department of Urology, ASL Abruzzo2Abstract Background To evaluate the safety and efficacy of abiraterone acetate (AA) in the “real life” clinical practice for men with chemotherapy-naïve metastatic castration-resistant prostate. Methods A consecutive series of patients with mCRPC in 9 Italian tertiary centres treated with AA was collected. Demographics, clinical parameters, treatment outcomes and toxicity were recorded. The Brief Pain Inventory scale Q3 was tracked and patient treatment satisfaction was evaluated. Survival curves were estimated by the method of Kaplan-Meier and Cox regression and compared by the log-rank test statistic. Results 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. 57% of the patients had a Gleason score higher more than 7 at diagnosis. 62% were asymptomatic patients. The median serum total PSA at AA start was 17 ng/mL (range 0,4–2100). The median exposure to AA was 10 months (range 1–35). The proportion of patients achieving a PSA decline ≥50% at 12 weeks was 49%. Distribution of patient satisfaction was 32% “greatly improved”, 38% “improved”, 24% “not changed”, 5.5% “worsened”. Grade 3 and 4 toxicity was recorded in 17/145 patients 11.7% (70% cardiovascular events, 30% critical elevation of AST/ALT levels). At the last follow-up, median progression free and overall survival were 17 and 26.5 months, respectively. Both outcomes significantly correlated with the presence of pain, patient satisfaction, PSA baseline and PSA decline. Conclusions The AA is effective and well tolerated in asymptomatic or slightly symptomatic mCRPC in a “real life” setting. The survival outcomes are influenced by the presence of pain, patient satisfaction, baseline PSA and PSA decline. Trial registration The study was retrospectively registered at ISRCTN as DOI: 10.1186/ISRCTN 52513758 in date April the 30th 2016.http://link.springer.com/article/10.1186/s12885-017-3755-xProstate cancerAndrogen deprivation therapyAbiraterone acetateCastration-resistant prostate cancerAndrogen receptor |