Abstract

5003 Background: Satraplatin is a novel oral platinum compound previously reported to reduce risk of disease progression among HRPC pts progressing after prior CT. Herein the impact of satraplatin on OS is reported. Methods: SPARC is a multinational, randomized, double blind, placebo-controlled trial comparing Satraplatin 80 mg/m2/day po x 5 q 5 weeks) + prednisone 5 mg po bid [S] vs placebo + prednisone [P] in patients with metastatic HRPC progressing after prior CT. Progression-free survival (PFS) and OS were co-primary endpoints. Secondary and exploratory endpoints included time to pain progression (TPP), pain response, duration of pain response, objective tumor response, and PSA response. Efficacy analyses were conducted on an intent-to-treat (ITT) basis. Results: 950 pts were randomized 2:1 to S (n=635) and P (n=315). Baseline characteristics were well-balanced across groups. Of all pts, 51% received prior docetaxel and 47% received post-SPARC CT. As reported, S was associated with statistically significant improvements in PFS; TPP; PSA response, objective tumor response, pain response, and duration of pain response. These improvements did not translate into an OS benefit: median OS was 61.3 weeks and 61.4 weeks in the S and P groups respectively (HR = 0.97; 95% CI: 0.83, 1.13). Trends for improved OS was observed in the subgroup of pts who received prior docetaxel (HR = 0.78; 95% CI: 0.61, 0.99; medians 66.1 vs. 62.9) as well as pts who reported a PPI score 2–5 at baseline (HR = 0.88; 95% CI: 0.67, 1.16; medians 45.7 vs. 43.0) when models were adjusted for baseline prognostic factors. In the S group; myelosuppression was the most common toxicity; grade 4 neutropenia was detected in 4% and only one patient experienced grade 4 thrombocytopenia. Grade 3/4 non- hematologic side effects in the S group included infection (4.5%), vomiting (1.6%) and diarrhea (1.9%). Conclusions: Satraplatin is well tolerated and reduces risk of disease progression for men with HRPC progressing after prior CT. Ongoing analyses are planned to define relationships between PFS, pain response, and OS, as well as to elucidate factors (including post-SPARC CT) that may have confounded the ITT survival analysis. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration GPC-Biotech GPC-Biotech GPC-Biotech

Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call