Abstract
152 Background: Satraplatin is an oral platinum that has demonstrated efficacy and tolerability in metastatic CRPC. Bevacizumab has revealed safety and efficacy in advanced prostate cancer, and synergy was noted between platinum based chemotherapy and B. Methods: Primary endpoint was time to progression (TTP). Latter wasdefined per RECIST 1.0 or onset of a skeletal event, or > 2 new areas of bone metastases. DP metastatic CRPC patients were eligible. S 80mg/m2 orally on days 1-5, P 5 mg twice daily, and B 10mg/kg on day 1, and 15mg/kg on day 15 were administered in 35 day cycles. Results: 31 patients enrolled (13 African American and 18 Caucasian) to complete accrual. Median age was 67 years (range 50-85 years) and 21 patients (68%) were > 65 years of age. Median pretherapy PSA was 180.7 ng/ml (range 4.7-1,433 ng/ml). 21 (68%) had bone pain, Gleason score was > 8 in 20 (65%) patients. Pretherapy 12 patients had measurable disease progression, 17 (55%) had bone scan progression, and 8 had PSA only progression. 176 cycles have been administered; median 4 cycles (range 0-12 cycles). Grade 4 toxicities noted were, pulmonary embolism in 2 patients and thrombocytopenia in 1 patient. Grade 3 toxicities observed were neutropenia and hypertension in 3, anemia in 7 and , thrombocytopenia and diarrhea in 2 patients each. No treatment related deaths. 29 patients are response evaluable to date; 10 (34%) had a ≥30% PSA decline and 3 (10%) had a > 90% PSA decline. Of 12 patients with MD, 2 had a response and 7 had stable disease. Median TTP was 7.4 months (90% CI 4.8-12.8 months) and median survival was 11.2 months (90% CI 9.1-18.3 months). 47% of patients were alive at 12 months. Genotype characterization for excision repair cross-complementation group 1 (ERCC1) polymorphism was performed in 17 patients with 9 having homozygous (CC), 3 with heterozygous, (CT) and 2 patients with absence of ERCC expression respectively. Conclusions: The combination was tolerable and revealed promising efficacy in metastatic CRPC. ERCC1 testing will be correlated with outcome endpoints. Supported in part by Genentech Inc and GPC Biotech. [Table: see text]
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