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)

Autor: 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
Přispěvatelé: [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., This study was funded by Janssen Cilag S.A.
Jazyk: angličtina
Rok vydání: 2019
Předmět:
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
Zdroj: BMC Cancer
BMC Cancer, Vol 19, Iss 1, Pp 1-10 (2019)
ISSN: 1471-2407
Popis: 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.
Databáze: OpenAIRE