| Phase III study shows that the oral platinum formulation satraplatin given in combination with prednisone delays progression of advanced prostate cancer When given with prednisone, the new oral platinum agent satraplatin significantly reduces risk of disease progression in men with advanced prostate cancer that was resistant to prior chemotherapy and hormone therapy, according to a presentation at the American Society of Clinical Oncology’s Prostate Cancer Symposium. Satraplatin is the first platinum-based drug designed to be taken orally. “Our findings suggest that satraplatin plus prednisone could be a valuable second-line treatment option for men with hormone-refractory prostate cancer,” said Daniel Petrylak, MD, Associate Professor of Medicine at Columbia University College of Physicians & Surgeons, Director of the Genitourinary Oncology Program at New York-Presbyterian Hospital, and lead author of the study. “This is significant because there is currently no standard second-line therapy for these patients.” In the phase III SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial, 950 men with advanced prostate cancer were randomized to prednisone with either satraplatin or placebo. Eligible patients had disease failure with one prior chemotherapy regimen. Eligible patients were men greater than 18 years with stage D2 hormone-refractory advanced prostate cancer. After stratification by Performance Status, Pain Index and type of progression (prostate-specific antigen only versus other measures), patients were randomized 2:1 to satraplatin and prednisone (5mg twice daily) or to prednisone plus placebo (same schedule). Progression was based on radiologic progression, symptomatic progression, skeletal events, or death. Men who received satraplatin plus prednisone experienced a 33 percent reduction in disease progression compared with men who received prednisone alone. Moreover, the improvement in progression-free survival increased over time: At 6 months, 30 percent of patients taking satraplatin had no evidence of disease progression compared with 17 percent of patients in the placebo group. At 12 months, 16 percent of patients taking satraplatin did not have disease progression compared with 7 percent of patients in the placebo group. Satraplatin was associated with mild to moderate side effects that included low white blood cell and platelet counts, nausea, vomiting, and diarrhea. |