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Title: Satraplatin Shows Benefit in Prostate Cancer Patients After Docetaxel Failure: Presented at EAU
URL: http://www.pslgroup.com/dg/21EE2A.htm
Doctor's Guide
March 30, 2008


By Jill Stein

MILAN, Italy -- March 30, 2008 -- The oral platinum satraplatin cuts the risk of disease progression and time-to-pain progression in patients with hormone-refractory prostate cancer (HRPC) who had progressed after prior treatment with docetaxel, according to results reported here March 27 at the 23rd Annual European Association of Urology (EAU) Congress.

Cora Sternberg, MD, Chief, Medical Oncology Division, San Camillo Forlanini Hospital, Rome, Italy, reported findings that compared the effects of satraplatin plus prednisone to placebo plus prednisone in patients who had progressive metastatic HRPC with tumour or prostate-specific antigen (PSA) progression after failure of at least 2 courses of 1 prior chemotherapy regimen.

Docetaxel plus prednisone became the standard for initial treatment of patients with HRPC in the United States and several European countries during the enrolment period for this trial. A posthoc, subgroup analysis of this phase 3 trial therefore was performed to compare the efficacy of satraplatin in the subset of patients (51.3%) who had received prior docetaxel.

In the intent-to-treat population (ITT), 950 patients were randomised to satraplatin (80 mg/m2 daily for 5 days, once every 5 weeks) plus prednisone (5 mg twice daily) or to placebo plus prednisone. Approximately half the patients in both groups had received prior docetaxel.

As previously reported, in the ITT group, satraplatin was associated with a 33% decrease in the risk of disease progression versus placebo (hazard ratio [HR] 0.67; P < .001) and a 36% decrease in the time-to-pain progression (HR 0.64; P < .001).

In the subgroup of patients who had received prior docetaxel, satraplatin reduced the likelihood of disease progression by 33% versus placebo (HR 0.67, 0.83; P < .001) and postponed time-to-pain progression by a median of 20.9 weeks versus placebo (HR 0.66; P = .007).

In the same subgroup, higher pain-response rates were observed in the satraplatin group compared with the placebo group (26% versus 13%). In the ITT population, results were similar: 24% versus 14%; P = .005.

Satraplatin was generally well tolerated, and incidences of myelosuppression
and neuropathy were not increased in patients who had progressed after prior docetaxel.

[Presentation title: Satraplatin Increases Progression-Free Survival and Delays Time-to-Pain Progression (TTP) in Patients With Hormone-Refractory Prostate Cancer Who Have Progressed After Prior Docetaxel. Abstract 638]

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