Re SPPI and Satraplatin.
The data presented today showed that the median time to pain progression was 66.1 weeks for the satraplatin arm compared with 22.3 weeks for the placebo arm. The hazard ratio was 0.64 (95% CI: 0.51-0.79, p<0.001). These results were consistent across subsets, including patients treated with prior Taxotere® (docetaxel). All pain progression events were adjudicated by a blinded independent review committee. Complementing the time to pain progression data, pain response rates were 24.2 percent for the satraplatin plus prednisone arm (N=351) compared with 13.8 percent for the placebo arm (N=181) (p=0.005). Pain response rates for patients treated with prior Taxotere were 25.7 percent for the satraplatin arm compared with 13.1 percent for control (p<0.015). All of the findings presented today continue to build on the data previously presented from the SPARC trial.
Pain response was assessed by patients using a weekly present pain intensity (PPI) and analgesic score. The PPI score was defined according to the McGill-Melzack questionnaire with:
0 = no pain, 3 = distressing pain,
1 = mild pain, 4 = horrible pain, and
2 = discomforting pain, 5 = excruciating pain.
The criteria for pain response are a greater than or equal to 2 point reduction in the patients' weekly PPI score from baseline and maintenance of the two point reduction for at least five consecutive weeks in the setting of a stable or decreasing weekly analgesic score compared to baseline. Patients were evaluable for pain response if their baseline PPI score was greater than or equal to one and had completed four consecutive weekly assessments of PPI and analgesic scores during the study treatment.
Safety and Common Adverse Reactions
Safety findings in the SPARC trial were consistent with previous clinical studies involving satraplatin. The most common adverse reactions consisted of myelosuppression (bone marrow functions): 21 percent of patients in the satraplatin arm experienced Grade 3 or 4 thrombocytopenia; 14 percent had leucopenia and 21 percent had neutropenia. Eight percent of patients in the satraplatin arm experienced Grade 3 or 4 gastrointestinal toxicities, including nausea (1.3 percent), vomiting (1.6 percent), diarrhea (2.1 percent) and constipation (2.1 percent). Five percent or less of patients in the satraplatin arm experienced Grade 3 or 4 fatigue, Grade 3 or 4 infections and pulmonary/respiratory Grade 3 or 4 toxicities. |
