Efficacy and safety of abiraterone acetate plus prednisone vs. cabazitaxel as a subsequent treatment after first-line docetaxel in metastatic castration-resistant prostate cancer: results from a prospective observational study (CAPRO)

Abstract Background To describe the patterns of second-line treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel treatment in a Spanish population, to identify the factors associated with those patterns, and to compare the efficacy and safety of the trea...

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Main Authors: Javier Puente, Aranzazu González-del-Alba, Núria Sala-Gonzalez, María José Méndez-Vidal, Alvaro Pinto, Ángel Rodríguez, José Miguel Cuevas Sanz, Jacobo Rodrigo Muñoz del Toro, Eduardo Useros Rodríguez, Ángela García García-Porrero, Sergio Vázquez
Format: Article
Language:English
Published: BMC 2019-08-01
Series:BMC Cancer
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Online Access:http://link.springer.com/article/10.1186/s12885-019-5974-9
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author Javier Puente
Aranzazu González-del-Alba
Núria Sala-Gonzalez
María José Méndez-Vidal
Alvaro Pinto
Ángel Rodríguez
José Miguel Cuevas Sanz
Jacobo Rodrigo Muñoz del Toro
Eduardo Useros Rodríguez
Ángela García García-Porrero
Sergio Vázquez
author_facet Javier Puente
Aranzazu González-del-Alba
Núria Sala-Gonzalez
María José Méndez-Vidal
Alvaro Pinto
Ángel Rodríguez
José Miguel Cuevas Sanz
Jacobo Rodrigo Muñoz del Toro
Eduardo Useros Rodríguez
Ángela García García-Porrero
Sergio Vázquez
author_sort Javier Puente
collection DOAJ
description Abstract Background To describe the patterns of second-line treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel treatment in a Spanish population, to identify the factors associated with those patterns, and to compare the efficacy and safety of the treatments most frequently administered. Methods Observational, prospective study conducted in patients with histologically or cytologically confirmed prostate adenocarcinoma; documented metastatic castration-resistant disease; progression after first-line, docetaxel-based chemotherapy with or without other agents. Results Of the 150 patients recruited into the study, 100 patients were prescribed abiraterone acetate plus prednisone (AAP), 44 patients received cabazitaxel plus prednisone (CP), and 6 patients received other treatments. Age (odds ratio [OR] 1.06, 95% [confidence interval] CI 1.01 to 1.11) and not elevated lactate dehydrogenase (LDH) levels (OR 0.33, 95% CI 0.14 to 0.76) were independently associated with the administration of AAP. Treatment with AAP was associated with significantly longer clinical/radiographic progression-free survival (hazard ratio [HR] 0.57, 95% CI 0.38 to 0.85) and overall survival (OS; HR 0.40, 95% CI 0.21 to 0.76) compared to CP, while no significant differences between the treatments were found regarding biochemical progression-free survival (PFS; HR 0.78 [95% CI 0.49 to 1.24]). However, in a post-hoc Cox regression analysis adjusted for potential confounders there were not differences between AAP and CP in any of the time-to-event outcomes, including overall survival. We observed no new safety signals related to either regimen. Conclusion Second-line AAP for patients with mCRPC is the most common treatment strategy after progression with a docetaxel-based regimen. When controlling for potential confounders, patients receiving this treatment showed no differences in PFS and OS in comparison to those receiving CP, although these latter results should be confirmed in randomized controlled trials.
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spelling doaj.art-7a49a1a1be274ce3b87d79bfb68cdf6a2022-12-22T00:01:44ZengBMCBMC Cancer1471-24072019-08-0119111010.1186/s12885-019-5974-9Efficacy and safety of abiraterone acetate plus prednisone vs. cabazitaxel as a subsequent treatment after first-line docetaxel in metastatic castration-resistant prostate cancer: results from a prospective observational study (CAPRO)Javier Puente0Aranzazu González-del-Alba1Núria Sala-Gonzalez2María José Méndez-Vidal3Alvaro Pinto4Ángel Rodríguez5José Miguel Cuevas Sanz6Jacobo Rodrigo Muñoz del Toro7Eduardo Useros Rodríguez8Ángela García García-Porrero9Sergio Vázquez10Medical Oncology, Hospital Clínico San Carlos. Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), CIBERONCMedical Oncology, Hospital Universitario Puerta de Hierro-MajadahondaMedical Oncology, ICO Girona, Hospital Josep TruetaOncology Department, Maimonides Institute of Biomedical Research (IMIBIC). Reina Sofía Hospital. University of CórdobaMedical Oncology, University Hospital La Paz – IdiPAZMedical Oncology, Hospital Universitario de LeónMedical Oncology, Hospital Universitario de la RiberaMedical Department, Janssen-Cilag S.A.Medical Department, Janssen-Cilag S.A.Medical Department, Janssen-Cilag S.A.Medical Oncology, Hospital Universitario Lucus AugustiAbstract Background To describe the patterns of second-line treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel treatment in a Spanish population, to identify the factors associated with those patterns, and to compare the efficacy and safety of the treatments most frequently administered. Methods Observational, prospective study conducted in patients with histologically or cytologically confirmed prostate adenocarcinoma; documented metastatic castration-resistant disease; progression after first-line, docetaxel-based chemotherapy with or without other agents. Results Of the 150 patients recruited into the study, 100 patients were prescribed abiraterone acetate plus prednisone (AAP), 44 patients received cabazitaxel plus prednisone (CP), and 6 patients received other treatments. Age (odds ratio [OR] 1.06, 95% [confidence interval] CI 1.01 to 1.11) and not elevated lactate dehydrogenase (LDH) levels (OR 0.33, 95% CI 0.14 to 0.76) were independently associated with the administration of AAP. Treatment with AAP was associated with significantly longer clinical/radiographic progression-free survival (hazard ratio [HR] 0.57, 95% CI 0.38 to 0.85) and overall survival (OS; HR 0.40, 95% CI 0.21 to 0.76) compared to CP, while no significant differences between the treatments were found regarding biochemical progression-free survival (PFS; HR 0.78 [95% CI 0.49 to 1.24]). However, in a post-hoc Cox regression analysis adjusted for potential confounders there were not differences between AAP and CP in any of the time-to-event outcomes, including overall survival. We observed no new safety signals related to either regimen. Conclusion Second-line AAP for patients with mCRPC is the most common treatment strategy after progression with a docetaxel-based regimen. When controlling for potential confounders, patients receiving this treatment showed no differences in PFS and OS in comparison to those receiving CP, although these latter results should be confirmed in randomized controlled trials.http://link.springer.com/article/10.1186/s12885-019-5974-9Metastatic castration-resistant prostate cancerAbiraterone acetateCabazitaxelChemotherapySequence
spellingShingle Javier Puente
Aranzazu González-del-Alba
Núria Sala-Gonzalez
María José Méndez-Vidal
Alvaro Pinto
Ángel Rodríguez
José Miguel Cuevas Sanz
Jacobo Rodrigo Muñoz del Toro
Eduardo Useros Rodríguez
Ángela García García-Porrero
Sergio Vázquez
Efficacy and safety of abiraterone acetate plus prednisone vs. cabazitaxel as a subsequent treatment after first-line docetaxel in metastatic castration-resistant prostate cancer: results from a prospective observational study (CAPRO)
BMC Cancer
Metastatic castration-resistant prostate cancer
Abiraterone acetate
Cabazitaxel
Chemotherapy
Sequence
title Efficacy and safety of abiraterone acetate plus prednisone vs. cabazitaxel as a subsequent treatment after first-line docetaxel in metastatic castration-resistant prostate cancer: results from a prospective observational study (CAPRO)
title_full Efficacy and safety of abiraterone acetate plus prednisone vs. cabazitaxel as a subsequent treatment after first-line docetaxel in metastatic castration-resistant prostate cancer: results from a prospective observational study (CAPRO)
title_fullStr Efficacy and safety of abiraterone acetate plus prednisone vs. cabazitaxel as a subsequent treatment after first-line docetaxel in metastatic castration-resistant prostate cancer: results from a prospective observational study (CAPRO)
title_full_unstemmed Efficacy and safety of abiraterone acetate plus prednisone vs. cabazitaxel as a subsequent treatment after first-line docetaxel in metastatic castration-resistant prostate cancer: results from a prospective observational study (CAPRO)
title_short Efficacy and safety of abiraterone acetate plus prednisone vs. cabazitaxel as a subsequent treatment after first-line docetaxel in metastatic castration-resistant prostate cancer: results from a prospective observational study (CAPRO)
title_sort efficacy and safety of abiraterone acetate plus prednisone vs cabazitaxel as a subsequent treatment after first line docetaxel in metastatic castration resistant prostate cancer results from a prospective observational study capro
topic Metastatic castration-resistant prostate cancer
Abiraterone acetate
Cabazitaxel
Chemotherapy
Sequence
url http://link.springer.com/article/10.1186/s12885-019-5974-9
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