Several treatment options are currently available for patients with mCRPC who were treated with a docetaxel-containing regimen. As one therapeutic option, cabazitaxel (CABA) in combination with prednis(ol)one can be administered. SCOPE is the first multinational, non-interventional study to address this question prospectively.
Within the ongoing SCOPE study, data on medical history, therapeutic management and outcome of mCRPC patients starting treatment with CABA under routine conditions are assessed with a target recruitment of 900 patients. For the current interim analysis (cut-off: MAR 16, 2018) descriptive statistics were used to analyze preliminary data on treatment outcomes.
Of 551 enrolled patients, 137 patients (median age: 73 (47 to 88) years, ECOG of ≤ 1: 81.8%, median duration of CRPC at study inclusion: 20.4 (0.8 to 109.1) months) have completed CABA therapy. For 27 patients, first line therapy with an androgen-receptor targeted agent (ARTA) was documented (ARTA 1st line), of which 10 patients received an ARTA in 2nd line (ARTA post ARTA). None (0.0%) of the 10 ARTA post-ARTA patients had reductions in PSA levels ≥50% (PSA50 response) compared to baseline. Median progression-free survival (PFS) after the start of the respective therapy was longer for 1st line ARTA than for ARTA post-ARTA therapy (10.8 vs. 3.5 months, p = 0.0106). Fifty patients received docetaxel as 1st line therapy directly followed by CABA (CABA 2nd line) and for 24 patients ARTA therapy was documented after docetaxel and prior to CABA (CABA 3rd line). PSA50 response to CABA was 38.0% (CABA 2nd line) and 37.5% (CABA 3rd line), respectively. Median PFS after start of CABA therapy showed no significant differences between the CABA 2nd line and CABA 3rd line group (4.2 vs. 5.1 months, p = 0.5663).
The current results indicate that the outcome of ARTA post-ARTA is unfavourable compared to 1st line ARTA therapy and that CABA is effective in both ARTA and docetaxel refractory patients. However, interpretation of results is challenging due to the highly diverse treatment sequences administered in patients with mCRPC under routine conditions.
Clinical trial identification
BfArM data base No: 6658.
Legal entity responsible for the study
Sanofi Aventis Deutschland GmbH.
Sanofi Aventis Deutschand GmbH.
J. Gschwend: Lectures: Amgen, Astellas, Bayer, Janssen, MSD, Novartis, Roche, Sanofi; Advisor role: Bayer, BMS, Janssen, MSD, Novartis, Pfizer, Roche. C. Bokemeyer: Honoraria: Merck KGaA, Sanofi, Roche, Bayer, Brystol-Meyer Squibb, Servier/Pfizer, AstraZeneca; Consulting: Lilly/ImClone, Merck Serono, Sanofi, Mundipharma, Bayer Schering Pharma, Hexal. All other authors have declared no conflicts of interest.