818PPost hoc analysis of the effect of baseline characteristics on treatment duration in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel in the compassionate use (CUP)/expanded access programs (EAP) and CAPRISTANA registry

Background: Cabazitaxel is approved for patients with mCRPC, post docetaxel. The CUP (CABAZ_C_05005) and EAP (NCT01254279) provided access to cabazitaxel before commercial availability and assessed real-world safety. CAPRISTANA (CABAZC 06092), a prospective, observational study, evaluated the routine clinical use of cabazitaxel. In this analysis we examined factors associated with cabazitaxel treatment duration in a real-life setting. Methods: Patients ≥18 years of age with mCRPC previously treated with docetaxel, received cabazitaxel 25 mg/m2 intravenously every 3 weeks until disease progression, death, unacceptable toxicity or physician/patient decision. Of note, treatment was capped at 10 cycles in some countries. Results: The CUP/EAP/CAPRISTANA studies combined included 1,621 patients (CUP/EAP, N = 1,432; CAPRISTANA, N = 189). The median number of cabazitaxel cycles received was 6. Overall, 708 patients (43.7%) received >6 cycles (Table); 211 (13.0%) received >10 cycles. For patients receiving >10 cycles, the median number of cabazitaxel cycles received was 14. Patients receiving more cabazitaxel cycles tended to have better ECOG performance status of 0–1 (Table; P = 0.0017 for ≤6 vs > 6 cycles). In total, 348 patients (21.5%) were ≥75 years of age, of which 40% (n = 139) received >6 cabazitaxel cycles. Further analysis into the patient subgroups and reasons for treatment discontinuation are ongoing. Conclusions: Cabazitaxel was well tolerated by patients across these global studies, including elderly patients. Many patients derived benefit from cabazitaxel and went on to receive a greater number of cycles. Further analyses may identify prognostic factors that could indicate which patients are likely to receive >6 cabazitaxel cycles and derive greater benefit. Funding: Sanofi.Table: 818PCUP/EAP/CAPRISTANA N = 1,621Cabazitaxel cycles received≤6 N = 913>6 N = 708Median age, years (range)68.0 (42–89)68.0 (43–89)Age, n (%) <65 years 65–75 years ≥75 years271 (29.7) 433 (47.4) 209 (22.9)230 (32.5) 339 (47.9) 139 (19.6)ECOG PS, n (%) 0–1 2*Includes one patient with ECOG PS 3 receiving ≤6 cabazitaxel cycles.N = 912 816 (89.5) 96 (10.5)N = 708 665 (93.9) 43 (6.1)Median cabazitaxel cycles, n (range)4 (1–6)10 (7–49)Median duration of cabazitaxel exposure, months (range)2.8 (1–6)6.9 (5–35)Median time from prostate cancer diagnosis, years (range)4.5 (0–22)4.7 (0–20)Median time from mCRPC diagnosis, years (range)1.7 (0–14)1.8 (0–12)Median docetaxel cycles at last administration, n (range)7 (1–69)8 (1–58)Metastatic sites, n (%) Bone Visceral Regional lymph nodesN = 912 829 (90.8) 47 (5.1) 282 (30.9)N = 707 630 (89.0) 23 (3.2) 214 (30.2)G-CSF during Cycle 1, n (%) Prophylactic Therapeutic BothN = 499 385 (42.2) 69 (7.6) 45 (4.9)N = 380 314 (44.4) 33 (4.7) 33 (4.7)Pain at baseline (CAPRISTANA study only), n (%) None Moderate SevereN = 86 15 (17.4) 63 (73.3) 8 (9.3)N = 68 18 (26.5) 47 (69.1) 3 (4.4)* Includes one patient with ECOG PS 3 receiving ≤6 cabazitaxel cycles. Open table in a new tab Clinical trial identification: Compassionate Use Program (CUP): CABAZ_C_05005. Expanded Access Program (EAP): NCT01254279. CAPRISTANA Registry Study: CABAZC 06092. Editorial acknowledgement: Editorial assistance was provided by Danielle Lindley of Meditech Media Ltd, funded by Sanofi. Legal entity responsible for the study: Sanofi. Funding: Sanofi. Disclosure: Z. Malik: Advisory boards, speaker meetings: Sanofi. U. De Giorgi: Consultancy fees: Sanofi, Astellas, Janssen, Bristol-Myers Squibb, Ipsen, Novartis, Pfizer. S. Hitier, E. Ecstein-Fraisse, A. Ozatilgan: Employee: Sanofi. J. Carles: Consultancy, advisory role: Johnson & Johnson, Astellas Pharma, Bayer, Amgen, Pfizer, Bristol-Myers Squibb, Sanofi; Speakers' bureau: Bayer, Johnson & Johnson. All other authors have declared no conflicts of interest.