Abstract 626P
Background
Docetaxel (D), cabazitaxel (C) and new hormonal therapies (H) prolong overall survival (OS) in mCRPC. CARD trial recently showed that a sequence including D, C and one H (abiraterone or enzalutamide) provides an optimal outcome in this setting (De Wit, NEJM 2019). SCOPE prospectively evaluates the activity and safety of C according to different sequences in mCRPC patients (pts) in daily practice.
Methods
SCOPE is an ongoing multinational, non-interventional study conducted in Germany, Austria and Switzerland in mCRPC pts previously treated with D in first line and starting C in daily practice. Medical history, previous therapies and outcome during C therapy are collected. Pts are followed for 24 months after start of C therapy. Primary endpoint is progression-free survival (PFS) with C according to different sequences. Here we provide interim study results at the cut-off date of Feb 20, 2020.
Results
From Oct 2015 to cut-off date, 356 pts (median age 73 yrs; bone mets 81.2%, visceral mets 25.0%, symptomatic 43.5%, ECOG 0-1 74.2%) were treated with C and completed the 24 months (mo) follow-up period. Of them, 180 (50.6%) received DCH and 176 (49.4%) received DHC. C was given at the dose of 25 mg/m2 in 93.5 % pts every 3 weeks for a median number of 5 cycles with prophylactic G-CSF in 43% of pts. Median PFS with C was 4.74 mo (95% CI 4.1-5.2) with DCH and 4.64 mo (95% CI 3.9-5.0) with DHC (p=0.52). A PSA decrease of ≥ 30% from baseline was reported by 38.3% and 33.0% of pts with DCH and DHC, respectively. Median time to PSA progression with C was 6.18 and 6.88 mo, median rPFS was 6.84 and 5.69 mo and median clinical PFS was 8.59 and 8.52 mo with DCH and DHC respectively. Percentage of pts still alive at 2 yrs from first C cycle were 15.0% and 11.4% with DCH and DHC, respectively. Most common all grade treatment emergent adverse events with C were fatigue (11.8%), anemia (8.2%), nausea (8.2%) and diarrhea (7.6%).
Conclusions
Preliminary results of SCOPE prospective study suggest that cabazitaxel administered in daily practice retains its activity after novel hormonal therapies and shows manageable safety profile. Source of funding: Sanofi.
Clinical trial identification
CABAZL07266.
Editorial acknowledgement
Legal entity responsible for the study
Sanofi.
Funding
Sanofi.
Disclosure
C. Bokemeyer: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Sanofi; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck KGaA; Advisory/Consultancy: Merck Sharp Dohme; Honoraria (self): Roche; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self): AstraZeneca; Advisory/Consultancy: Lilly; Advisory/Consultancy: Mundipharma; Advisory/Consultancy: Hexal; Advisory/Consultancy: GSO; Advisory/Consultancy: AOK Health Insurance. M-L. Amram: Advisory/Consultancy: Sanofi. F. Stoiber: Honoraria (self), Advisory/Consultancy: Sanofi. J. Gschwend: Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Sanofi.