Satraplatin:
With Spectrum diluting today need some good news to help :). This is from the upcoming Urology Meeting
[1014] SATRAPLATIN SIGNIFICANTLY IMPROVES PROGRESSION FREE SURVIVAL (PFS) AND PAIN CONTROL IN PATIENTS WITH ADVANCED HORMONE-REFRACTORY PROSTATE CANCER (HRPC): PRELIMINARY RESULTS FROM THE PHASE III SPARC TRIAL
Oliver Sartor, Cora Sternberg, J Alfred Witjes, Gurkamal Chatta, David Vaughn, William Berry, Primo Lara, Jr, Faith E Nathan, Tom McKearn, Daniel P Petrylak. Dana-Farber Cancer Institute, Boston, MA; San Camillo Forlanini, Rome, Italy; Academisch Ziekenhuis Nijmegen, Nijmegen, The Netherlands; University of Pittsburgh, Pittsburgh, PA; University of Pennsylvania, Philadelphia, PA; US Oncology, Cary, NC; University California-Davis, Sacramento, CA; GPC-Biotech, Princeton, NJ; Columbia Presbyterian Medical Center, New York, NY
Introduction and Objective: Pain control constitutes a major clinical challenge in the treatment of metastatic HRPC and is a relevant therapeutic goal in this population. Satraplatin (S) is a novel oral platinum compound with demonstrated antitumor activity in a variety of tumors, including HRPC. The SPARC trial is a large, double-blind, placebo-controlled phase III study, evaluating S in combination with prednisone (P) for the treatment of HRPC patients who have failed one prior chemotherapy regimen. Methods: The SPARC trial enrolled patients with stage D2 metastatic HRPC who had failed 1 prior chemotherapy regimen. After stratification by performance status, Present Pain Intensity (PPI) and type of progression (PSA only vs radiographic), pts were randomized 2:1 to S (80 mg/m2 qd x 5 q5wk)/antiemetic + P (5 mg bid qd) or to placebo/antiemetic placebo + P (same schedule). Pain and analgesic use were recorded by patients in pain diaries during the entire observation period. Pain scores were evaluated using a PPI score, and pain response was defined by a reduction in weekly PPI score (≥ 2 points from BL over ≥ 5 consecutive weeks) in the setting of stable/decreasing weekly analgesic score (≤ 25% from BL). Disease progression was defined as a composite of radiologic progression, symptomatic progression, skeletal events, or death. Progression events were evaluated by a blinded independent expert review committee on an intent-to-treat basis. Results: 950 pts were accrued to the study over 28 months. Treatment with S resulted in a 40% reduction in the risk of disease progression over placebo (HR = 0.6; 95% CI: 0.5-0.7;P <.001). The effect of S on PFS increased over time. At median PFS, the improvement was 13% (11 vs 9.7 weeks), reaching 89% at the 75th PFS percentile (36 vs 19 weeks). S was equally effective regardless of whether or not patients received prior docetaxel treatment. Pain response rate was significantly higher in patients receiving S (24.2% vs 13.8%, P < .005), as was PSA response rate (25.4% vs 12.4%, P < .001), and median time to pain progression (66.1 vs 22.3 weeks, P <.001). The most common toxicities were myelosuppression (thrombocytopenia, neutropenia) and GI toxicities (nausea/vomiting, diarrhea), which were generally mild to moderate. Conclusions: Oral satraplatin is well tolerated and has clinically relevant activity in patients with metastatic HRPC.
