A cohort compassionate-use program with cabazitaxel plus prednisone for patients with metastatic castration-resistant prostate cancer: Interim results.

Abstract

e15112 Background: In the TROPIC trial (NCT00417079), treatment with CbzP produced a statistically significant improvement in overall survival vs mitoxantrone + prednisone (MP) in patients (pts) with mCRPC previously treated with a docetaxel (D)-containing regimen (HR 0.70; p< 0.0001). These results supported the establishment of 2 programs (based on local regulations): a compassionate use (CUP) and an early access program (EAP; NCT01254279). Methods: The aims of the CUP/EAP are to provide drug to pts with mCRPC who may benefit from CbzP prior to commercial availability and further assess CbzP safety profile. Total enrollment for both programs is estimated at 1600 pts from 250 centers globally. Eligible pts receive CbzP (25 mg/m2 Q3W + prednisone 10 mg PO QD) until disease progression, death, unacceptable toxicity or physician/pt decision. Results: Baseline characteristics and safety data are available for the first 399 pts: median age was 68 yrs (range 43–89), with 90.2% ECOG PS 0–1. The median cumulative dose of prior D was 675 mg/m2; prior therapy with MP was permitted. For pts whose disease progressed following D, median time from last dose of D to progression was 4 months; 53.3% of pts experienced disease progression either during or < 3 months after D. 61% of pts had ≥ 2 metastatic sites; the most common were bone (93.2%) and regional lymph nodes (34.4%). At the time of analysis, a median of 4 cycles of CbzP had been administered; 4 pts received ≥ 10 cycles. Median relative dose intensity was 99.2% (range 80.1–104.9). G-CSF was administered to 34.3% of pts in Cycle 1 (6.3% therapeutic, 26.6% prophylactic). Overall, 71.4% of pts had adverse events (AEs; all grades). Most common grade 3-4 AEs were neutropenia 11.3%, febrile neutropenia 6.3%, anemia 2.8%, fatigue 2%, neutropenic sepsis 1.8%, vomiting 1.3% and diarrhea 1%. Eight (2%) treatment-related deaths were reported. Conclusions: The CUP/EAP provides additional safety data for CbzP in a routine clinical practice pt population with heavily pre-treated mCRPC. Treatment with CbzP was tolerable, with a predictable and manageable toxicity profile consistent with data reported for TROPIC and the product labeling.