Real-world evidence of patients with metastatic castration-resistant prostate cancer treated with cabazitaxel: comparison with the randomized clinical study CARD

Abstract

Background The CARD study demonstrated superiority of cabazitaxel over abiraterone/enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who received prior docetaxel and progressed ≤12 months on the alternative androgen-receptor-targeted agent (ARTA). The objective was to compare characteristics and treatment patterns of patients from a real-world dataset with the CARD population. Methods Real-world data were collected from Medimix Live TrackerTM, a retrospective, global oncology database of healthcare professional-reported electronic patient medical forms (2001–2019), with data from patients from Europe, USA, Brazil and Japan. The database contained patient, tumor and treatment information for 12,140 patients who received ≥1 line of treatment for mCRPC. A CARD-like cohort included patients treated with docetaxel, prior abiraterone/enzalutamide and cabazitaxel. Results A large proportion of patients received ≥2 lines of ARTA (35.1%) with 42% of patients who received a first-line ARTA receiving another ARTA in second line. Of the total patients, 452 were eligible for the CARD-like cohort. Median age of the CARD-like cohort was comparable to CARD (73 vs 70 years). The CARD-like cohort had unfavorable disease characteristics vs CARD: ECOG PS ≥ 2 (45% vs 4.7%); metastasis at diagnosis (46% vs 38%) and Gleason 8–10 (65% vs 57%). More patients in the CARD-like cohort received ARTA before docetaxel (48% vs 39%) and received the first ARTA for >12 months (30% vs 17%) compared with CARD. Despite more patients in the CARD-like cohort receiving the lower 20 mg/m2 dose of cabazitaxel (55% vs 21%), cabazitaxel treatment duration was similar (21.9 vs 22.0 weeks). Conclusions Sequential use of ARTA was frequent. Results indicate the CARD population is reflective of routine clinical practice and duration of response to cabazitaxel was similar in a real-world population.

Real-world effectiveness of third-line cabazitaxel in patients with metastatic castration-resistant prostate cancer: CARD-like analysis of data from a post-marketing surveillance in Japan

“…In this analysis, more than half of the CARD-like cohort received sequential ARAT, consistent with recent global real-world studies showing frequent sequential use of ARAT [9,10]. Our study suggests that patients who progress within 1 year on their rst ARAT treatment may be more likely to respond to cabazitaxel than to a second alternative ARAT in a subsequent treatment, con rming the ndings of the CARD clinical trial in a realworld Japanese patient population.…”

“…Sequential use of ARATs for the treatment of mCRPC is frequent in clinical practice [9,10], despite guidance in Europe and the US cautioning against such use [11,12].…”

“…Subsequently, de Wit et al have applied these ndings to a real-world data analysis of a CARD-like cohort using a global oncology database and found that the results from the CARD trial re ect the characteristics of patients in real-world clinical practice [9]. Given that the CARD trial suggested that cabazitaxel is more effective than an alternative ARAT, this study aims to con rm its effectiveness in real-world patients and whether the results from de Wit's real-world analysis [9] also apply to Japanese patients.…”

“…Subsequently, de Wit et al have applied these ndings to a real-world data analysis of a CARD-like cohort using a global oncology database and found that the results from the CARD trial re ect the characteristics of patients in real-world clinical practice [9]. Given that the CARD trial suggested that cabazitaxel is more effective than an alternative ARAT, this study aims to con rm its effectiveness in real-world patients and whether the results from de Wit's real-world analysis [9] also apply to Japanese patients. This study also aims to identify any patterns of cross-resistance to treatment arising from sequential use of ARATs or taxane-based chemotherapies in a realworld population, by applying the analysis from the CARD trial to a real-world dataset from a Japanese postmarketing surveillance (PMS) of cabazitaxel [17].…”

Review on the Increasing Role for PSMA-Based Radioligand Therapy in Prostate Cancer

“…Patients given cabazitaxel (CABA) lived longer than those given a second ARPI: median 13 months versus 11 months, respectively. Real-world studies of third-line treatment confirmed that CABA gives a better outcome than a second ARPI [10,11].…”