Phase II study of docetaxel in combination with oxaliplatin in patients with metastatic or locally advanced esophagogastric cancer previously untreated with chemotherapy for advanced disease. Results of the CECOG-Study ESGAS.1.2.001

4527 Background: A phase II trial was performed to determine the antitumor efficacy and tolerance of combined docetaxel and oxaliplatin in previously untreated, advanced patients with gastroesophageal adenocarcinoma. Methods: Thirty-six patients with histologically confirmed advanced gastroesophageal adenocarcinoma were entered in this trial. Treatment consisted of 3-weekly courses of docetaxel 80 mg/m2 and oxaliplatin 100 mg/m2 both given on day 1. A 5-day course of human granulocyte colony stimulating factor (G-CSF) 5 μg/kg/day was given subcutaneously to prevent neutropenia; in addition, if haemoglobin was &lt;12.0 mg/dl, erythropoietin 10,000 IU was administered subcutaneously 3 times per week. Primary objective was to evaluate the time to progression. Results: The confirmed overall response rate was 36%, including 3 complete responses (8.3%) and 10 partial responses (27.7%). Fifteen patients (41.7%) had stable disease and 8 (22.3%) progressed while on treatment. The median time to response was 2.5 months, the median time to progression was 5.3 (1- 33+) months and the median overall survival time was 9.8 (2.5–35+) months with 8 (22%) patients currently alive. Hematologic toxicity was common, though WHO grade 3/4 neutropenia occurred only in 6 (17%) patients and anaemia also in 6 (17%) patients, respectively. Nonhematologic adverse reactions were usually mild to moderate; grade 3 toxicities included emesis, diarrhoea and mucositis each in 1 patient (3%). Conclusion: Our data suggest that the combination of docetaxel and oxaliplatin with G-CSF and erythropoietin has a promising therapeutic index in patients with advanced gastroesophageal adenocarcinoma. No significant financial relationships to disclose. </jats:p