Cancer Research Lab

The investigational oral platinum drug satraplatin, in combination with prednisone, prolongs progression-free survival of patients with hormone-refractory prostate cancer who have failed either docetaxel or non-docetaxel-containing chemotherapeutic regimens.

The findings are based on phase III data reported Friday in Orlando at The Prostate Cancer Symposium, co-sponsored by the American Society of Clinical Oncology, the American Society of Therapeutic Radiology and Oncology, and the Society of Urologic Oncology.

“Our findings suggest that satraplatin plus prednisone could be a valuable second-line treatment option for men with hormone-refractory prostate cancer,” Dr. Daniel Petrylak from Columbia University College of Physicians and Surgeons in New York said in a statement. “This is significant, because there is currently no standard second-line therapy for these patients.”

Following at least one failed chemotherapy regimen, 950 men with advanced prostate cancer received prednisone with either oral satraplatin or matching placebo.

Men treated with satraplatin plus prednisone experienced a 33% reduction in disease progression, Dr. Petrylak reported.

Specifically, at 6 months, progression-free rates were 30% among patients in the satraplatin arm compared with 17% in patients in the placebo arm. At 12 months, the rates were 16% in satraplatin-treated patients and 7% in placebo-treated patients.

The median time to progression in the combination arm was 11.1 weeks versus 9.7 weeks with placebo, a 13% improvement with satraplatin. “Most importantly,” Dr. Petrylak said at a press briefing, “it didn’t matter what prior chemotherapy patients had received.” The benefit with satraplatin was the same.

“Consistent with the phase I and phase II data, satraplatin was very well tolerated,” he also noted. “Myelosuppression was the most common toxicity; there was no significant degradation of renal function or peripheral neuropathy. Less than 5% of patients had grade 3 or grade 4 non-hematologic toxicities and about 20% developed neutropenia but only 0.6% developed neutropenic fevers.”

Patients continue to be followed for the overall endpoint of the trial, which is survival.