1. 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)
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Sergio Vázquez, Jose Miguel Cuevas Sanz, A. González-del-Alba, Alvaro Pinto, Jacobo Muñoz del Toro, Ángela García García-Porrero, Ángel Francisco Zazo Rodríguez, Javier Puente, Eduardo Useros Rodríguez, Núria Sala-González, María José Méndez-Vidal, [Puente,J] Medical Oncology, Hospital Clínico San Carlos. Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), CIBERONC. Madrid, Spain. [González-del-Alba,A] Medical Oncology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain. [Sala-Gonzalez,N] Medical Oncology, ICO Girona, Hospital Josep Trueta, Girona, Spain. [Méndez-Vidal,MJ] Oncology Department, Maimonides Institute of Biomedical Research (IMIBIC). Reina Sofía Hospital. University of Córdoba, Cordoba, Spain. [Pinto,A] Medical Oncology, University Hospital La Paz - IdiPAZ, Madrid, Spain. [Rodríguez,A] Medical Oncology, Hospital Universitario de León, León, Spain. [Cuevas Sanz,JM] Medical Oncology, Hospital Universitario de la Ribera, Alcira, Spain. [Muñoz del Toro,JR, Useros Rodríguez,E, García García-Porrero,A] Medical Department, Janssen-Cilag S.A., Madrid, Spain. [Vázquez,S] Medical Oncology, Hospital Universitario Lucus Augusti, Lugo, Spain., and This study was funded by Janssen Cilag S.A.
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Oncology ,Male ,Neoplasias de la próstata ,astenia ,medicine.medical_treatment ,Docetaxel ,law.invention ,Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] ,0302 clinical medicine ,estudios prospectivos ,Antineoplastic Combined Chemotherapy Protocols ,dolor ,Prospective Studies ,mediana edad ,Aged, 80 and over ,anciano ,Cabazitaxel ,protocolos de quimioterapia antineoplásica combinada ,Hazard ratio ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Progression-Free Survival ,Prostatic Neoplasms, Castration-Resistant ,030220 oncology & carcinogenesis ,Taxoids ,Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Asthenia [Medical Subject Headings] ,medicine.medical_specialty ,Antineoplastic Agents, Hormonal ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Analysis of Variance::Multivariate Analysis [Medical Subject Headings] ,Antineoplastic Agents ,Adenocarcinoma ,lcsh:RC254-282 ,03 medical and health sciences ,Sequence ,Genetics ,Humans ,Aged ,Diseases::Male Urogenital Diseases::Genital Diseases, Male::Genital Neoplasms, Male [Medical Subject Headings] ,Persons::Persons::Age Groups::Adult::Middle Aged [Medical Subject Headings] ,Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Pain [Medical Subject Headings] ,medicine.disease ,Chemicals and Drugs::Polycyclic Compounds::Steroids::Pregnanes::Pregnadienes::Pregnadienediols::Prednisone [Medical Subject Headings] ,Regimen ,030104 developmental biology ,chemistry ,Persons::Persons::Age Groups::Adult::Aged::Aged, 80 and over [Medical Subject Headings] ,Asthenia ,Quimioterapia ,l-lactato deshidrogenasa ,0301 basic medicine ,Cancer Research ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Models, Statistical::Proportional Hazards Models [Medical Subject Headings] ,modelos de riesgos proporcionales ,humanos ,Abiraterone Acetate ,Kaplan-Meier Estimate ,Diseases::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Male::Prostatic Neoplasms::Prostatic Neoplasms, Castration-Resistant [Medical Subject Headings] ,Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Oxidoreductases::Alcohol Oxidoreductases::Lactate Dehydrogenases::L-Lactate Dehydrogenase [Medical Subject Headings] ,Prostate cancer ,chemistry.chemical_compound ,Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons, Cyclic::Hydrocarbons, Alicyclic::Cycloparaffins::Cyclodecanes::Taxoids [Medical Subject Headings] ,Randomized controlled trial ,law ,Diseases::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Adenocarcinoma [Medical Subject Headings] ,antineoplásicos ,Persons::Persons::Age Groups::Adult::Aged [Medical Subject Headings] ,resultado del tratamiento ,Abiraterone acetate ,Age Factors ,Anemia ,Middle Aged ,Treatment Outcome ,Drug therapy ,Prostatic neoplasms ,Health Care::Environment and Public Health::Public Health::Epidemiologic Factors::Age Factors [Medical Subject Headings] ,Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Anemia [Medical Subject Headings] ,taxoides ,medicine.drug ,Research Article ,estimación de Kaplan-Meier ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Prospective Studies [Medical Subject Headings] ,Pain ,Acetato de abiraterona ,Internal medicine ,medicine ,Chemotherapy ,análisis multifactorial ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings] ,Proportional Hazards Models ,Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings] ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Survival Analysis::Kaplan-Meier Estimate [Medical Subject Headings] ,L-Lactate Dehydrogenase ,business.industry ,Prostatic Neoplasms ,Metastatic castration-resistant prostate cancer ,Spain ,Multivariate Analysis ,neoplasias de la próstata ,Prednisone ,prednisona ,business - 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., This study was funded by Janssen Cilag S.A. Janssen-Cilag S.A. was involved in the design of the study, interpretation of data, and in writing the manuscript. Quality control and statistical analyses were performed by a contract research organization that was funded by Janssen-Cilag S.A.
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- 2019