Weekly high-dose 5-fluorouracil as a 24-h infusion and sodium folinic acid (AIO regimen) plus irinotecan in patients with locally advanced nonresectable and metastatic adenocarcinoma or squamous cell carcinoma of the oesophagus: a phase II trial

In the majority of patients with oesophageal carcinoma, curative treatment proves to be impossible when diagnosis was established; therefore, most of the patients are candidates for palliative chemotherapy. The aim of this phase II study was to evaluate the efficacy and safety of 5-fluorouracil/folinic acid (AIO regimen) plus irinotecan in patients with locally advanced or metastatic carcinoma of the oesophagus. The methods used a prospective phase H trial, start: November 2002; patients: n = 25; chemotherapy: irinotecan (80 mg/m(2)) as a 1-h infusion and 5-fluorouracil (2000 mg/m(2)) with sodium folinic acid (500 mg/m(2)) as a 24-h infusion on days 1, 8, 15, 22, 29 and 36, repeated on day 57 Last date of evaluation: 28 February 2007; n = 24; adenocarcinoma: n = 13, squamous cell carcinoma (SCC): n = 11;UICC III/IV: 3/21; grading G1/G2/G3/G4: 0/8/12/4; median age: 58 years (range 44-75); men/women: 19/5; Eastern Cooperative Oncology Group index 0/1/2: 3/17/4; applications: 460. Higher-grade toxicity: grade 3 diarrhoea: n = 2, grade 4 diarrhoea: n = 1, grade 4 vomiting: n = 1 grade 4 nausea: n = 1, grade 3 fatigue: n = 1, grade 3 hyponatraemia: n = 2, grade 4 elevation of creatinine: n = 1, thrombosis of the vena subclavia: n=1, ischaemic lesion of the brain stem: n = 1. Three patients died after two chemotherapeutic applications because of high tumour burden. Evaluable for response: n = 19. Partial response: n=8 (33%), stable disease: n = 9 (38%), progressive disease: n = 2 (8%), not evaluable: n = 5 (21%). Time-to-progression: 6.6 months (range 1.6-24.6). Total median survival: 13.6 months (median survival of adenocarcinoma: 20.3 months, median survival of SCC: 10.0 months). Secondary resection (R0): n = 3. In oesophageal carcinomas, the AIO regimen plus irinotecan is excellently manageable as an outpatient treatment and shows efficacy in adenocarcinomas and SCCs of the oesophagus. Anti-Cancer Drugs 20:165-173 (C) 2009 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.