Evaluation and outcomes
tumor, death, Toxicities, Tumor, Tumors, PD, Toxicity, Cancer
DISEASE PROGRESSION, TUMOR, TUMOR, DISEASE, TUMORS, CANCER
A complete medical history was obtained and a physical examination was performed before randomization, including a complete blood count (CBC), blood chemistries, and tumor assessments. Tumor measurements were obtained every 6 weeks until progression was demonstrated in both arms, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Progression-free survival (PFS) was measured from the date of randomization to radiographically-documented progressive disease (PD) or death due to any cause. The OS was measured from the date of randomization-to-date of death from any cause. Toxicities were graded according to the National Cancer Institute of Canada Common Toxicity Criteria (version 3.0). Quality of life was assessed at the same time as tumor assessments and data were collected every 3 months after disease progression using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)-C30 (version 3).