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)

• Published in: BMC cancer 2019-08, Vol.19 (1), p.766-10, Article 766
• Main Authors: Puente, Javier, González-Del-Alba, Aranzazu, Sala-Gonzalez, Núria, Méndez-Vidal, María José, Pinto, Alvaro, Rodríguez, Ángel, Cuevas Sanz, José Miguel, Muñoz Del Toro, Jacobo Rodrigo, Useros Rodríguez, Eduardo, García García-Porrero, Ángela, Vázquez, Sergio
• Format: Article
• Language: English
• Subjects: Abiraterone; Abiraterone acetate; Abiraterone Acetate - adverse effects; Abiraterone Acetate - therapeutic use; Adenocarcinoma; Adenocarcinoma - drug therapy; Age Factors; Aged; Aged, 80 and over; Anemia - etiology; Antineoplastic Agents, Hormonal - adverse effects; Antineoplastic Agents, Hormonal - therapeutic use; Antineoplastic Combined Chemotherapy Protocols; Asthenia - etiology; Cabazitaxel; Cancer metastasis; Cancer research; Chemotherapy; Clinical trials; Complications and side effects; Docetaxel - therapeutic use; Dosage and administration; Drug therapy; Enzalutamide; Glucocorticoids; Humans; Kaplan-Meier Estimate; L-Lactate Dehydrogenase - analysis; Male; Metastatic castration-resistant prostate cancer; Middle Aged; Multivariate Analysis; Pain - etiology; Prednisone; Prednisone - adverse effects; Prednisone - therapeutic use; Progression-Free Survival; Proportional Hazards Models; Prospective Studies; Prostate cancer; Prostatic Neoplasms, Castration-Resistant - drug therapy; Regression analysis; Sequence; Spain; Taxoids - adverse effects; Taxoids - therapeutic use; Treatment Outcome
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-019-5974-9

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. 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. 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. 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.