Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer

This phase II trial assessed the toxicity and efficacy of irinotecan plus docetaxel in cisplatin-pretreated oesophageal cancer. Irinotecan 160 mg m(−2) plus docetaxel 65 mg m(−2) once every 3 weeks led to severe myelosuppression in four patients, all of whom experienced neutropenic fever. After amendment of this regimen, 24 patients (male/female=18/6; median age=58.5 years; ECOG performance status 0/1/2=9/11/4) with advanced oesophageal cancer (adenocarcinoma/epidermoid carcinoma=13/11) received irinotecan 55 mg m(−2) plus docetaxel 25 mg m(−2) on days 1, 8 and 15 of a 28-day cycle. Serious adverse events occurred in five patients, one with lethal outcome (pneumonia). Haematological toxicity ⩾3° was rare, whereas nonhaematological toxicity ⩾3° was noted in nine out of 24 patients (asthenia in five patients, diarrhoea in three patients, nausea/emesis in two patients, constipation in one patient). Median survival time was 26 (range 2–70) weeks. Response rate, assessed according to the WHO criteria, was 12.5% (95% CI 2.7–32.4%); rate of disease stabilisation (partial remission and stable disease) was 33.3% (95% CI 15.6–55.3%) with a median duration of 18.5 (range 16–51) weeks. Although the nonhaematological toxicity proved to be considerable, weekly irinotecan plus docetaxel is feasible and shows some activity in extensively pretreated patients with oesophageal cancer.