Eligible study designs included phase II and III clinical trials, expanded access programs, and prospective clinical trials. Eligible trials were of patients with cancer assigned to treatment with sorafenib or sunitinib, with safety data available for arterial thromboembolic events. Phase I trials were excluded.
Adverse outcomes considered as arterial thromboembolic events included arterial thrombosis, cerebral infarct, cerebral ischaemia, cerebrovascular accident, myocardial infarction, and myocardial ischaemia.
In all included trials, patients had adequate organ function, coagulation and haematological function. Patients with uncontrolled hypertension or clinically significant cardiovascular or cerebrovascular events or disease during the preceding 12 months were generally excluded from the trials. Patient malignancies assessed included renal cell cancer, hepatocellular cancer, gastrointestinal stromal tumour, non–small cell lung cancer, and neuroendocrine tumour; the median progression-free survival ranged between 2.8 to 10.2 months. Most of the trials reported cardiac ischaemia or infarction as an adverse outcome. The median age of included patients ranged between 56 and 69 years (where reported).
Drug doses and schedules were: sunitinib, 50 mg orally once daily on a four-weeks-on/two-weeks-off schedule; sorafenib, 400 mg orally twice daily. The median treatment duration ranged between 1.7 to 10.1 months (where reported).
Reviewers independently selected studies for inclusion; the authors did not state how disagreements were resolved.