Patients
tumour, arrhythmia, trachea-oesophageal fistula
UNCONTROLLED HYPERTENSION, ARRHYTHMIA, BRAIN METASTASES, EVENT, THIRD-DEGREE HEART BLOCK, TUMOUR
For both stages, A1 and A2, eligible patients were ≥16 years of age, with ECOG performance score 0–1 and life expectancy of at least 12 weeks with adequate bone marrow, liver and kidney function, with previous chemotherapy completed at least 28 days before first study dose. Additionally, for Stage A1, eligible patients required histologically confirmed ACA or SCC of the oesophagus, suitable for palliative RT, tumour length 15 cm or less, no oesophageal stent in situ. For Stage A2, eligible patients required histologically confirmed solid metastatic or unresectable tumour where cisplatin-capecitabine treatment was deemed appropriate.Key exclusion criteria included patients with multiple or untreated brain metastases, significant cardiovascular event within 6 months before study entry, symptomatic arrhythmia or requiring treatment, uncontrolled hypertension, second or third-degree heart block or prolonged QTc interval on ECG (>450 ms in males, >470 ms in females), presence of trachea-oesophageal fistula or invasion of the tracheo-bronchial tree, and use of strong CYP3A inhibitors and inducers or haemopoetic growth factors within 14 days before start of treatment. For Stage A2, patients with dihydropyrimidine dehydrogenase were excluded.