The side effect profile of ZD4054 in this study included headache, edema and nasal congestion.
The OS results were as follows:
Intent-to-treat population ZD4054 15mg ZD4054 10mg Placebo
Number of patients 98 107 107
Number of deaths 34 33 51
Median overall survival (months) 23.5 24.5 17.3
Hazard ratio versus placebo 0.65 0.55 -
80% CI 0.49, 0.86 0.41, 0.73 -
"It is usual to use PFS as an endpoint in Phase II studies, however it can be difficult to measure accurately in patients with metastatic HRPC. Overall survival is an unambiguous endpoint and clearly an important outcome for patients," commented Professor Nick James.
PFS in this study was measured through clinical or radiological evidence of disease worsening, or worsening of disease-related pain. However, patients with metastatic HRPC can typically have multiple bone metastases, making assessments of further changes in bone metastases difficult.
The Phase II EPOC study design:
This study recruited a total of 312 asymptomatic or mildly symptomatic HRPC patients with bone metastases who were randomized into one of three treatment arms: 15 mg ZD4054 once daily; 10 mg ZD4054 once daily or a placebo tablet once daily. In addition to study treatment, all men randomized into the study received best supportive care.
Mode of action -- specific ETA receptor antagonism:
ZD4054 targets the ETA receptor. In
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