A phase I/II study of oxaliplatin and paclitaxel in patients with non-resectable cancer of the oesophagus and adenocarcinoma of the gastro-oesophageal junction: a study of the Arbeitsgemeinschaft Internistische Onkologie.

Purpose: To assess the efficacy and toxicity of paclitaxel and oxaliplatin in patients with non-resectable cancer of the oesophagus and adenocarcinoma of the gastro-oesophageal junction.

Methods: Treatment consisted of oxaliplatin 85 mg/m(2) and paclitaxel 90 mg/m(2) on days 1, 15 and 29 every 6 weeks. Patients with a non-resectable cancer of the oesophagus and/or adenocarcinoma of the gastro-oesophageal junction were eligible.

Results: Twenty-six chemotherapy-naive patients were enrolled who had the following characteristics: median age 59.5 years (range 46-81); ECOG scores of 0/1/2 for 7/16/3 patients, respectively, and 23 (88%) patients had metastatic disease. There were 5 patients (19%) with adenocarcinoma of the gastro-oesophageal junction and 21 patients (81%) with oesophageal cancer; 19 (73%) had a squamous cell cancer and 7 (27%) had an adenocarcinoma. NCI grade 4 toxicity (neutropenia) was observed in one patient. Non-haematological toxicity consisted mainly of grade 1/2 neurosensory toxicity. The overall response rate by the intention-to-treat analysis was 15% with 4 patients having confirmed partial response. Overall tumour control rate was 73%. Median overall survival was 12.3 months (range 1.5-66) and median time to progression was 4.5 months (range 0.8-19.3).

Conclusion: This regimen is well tolerated and demonstrates a modest response rate with a favourable disease control rate.