The primary end point was overall survival, which was defined as the time from randomization to
death from any cause. Secondary end points included progression-free survival (the time from randomization to the first radiologic confirmation of disease progression or death from any cause), response rate (the proportion of patients
whose best response was a complete or partial response), rate of disease control (the proportion of patients with a best response of complete or partial response or stable disease, with the assessment of stable disease made at least 6 weeks after randomization), and safety.