PURPOSE: Combination chemotherapy regimens can improve survival in patients with advanced gastric and oesophageal adenocarcinoma. Docosahexaenoic acid (DHA)-paclitaxel is a novel conjugate formed by the covalent linkage of the fatty acid DHA to paclitaxel and may result in increased tumour exposure to paclitaxel without increased toxicity. PATIENTS AND METHODS: In this single arm, phase II study of DHA-paclitaxel, eligible patients with previously untreated, inoperable locally advanced or metastatic adenocarcinoma of the oesophagus, oesophago-gastric junction or stomach were treated with DHA-paclitaxel (1,100 mg/m(2)) administered by 2-h intravenous infusion every 21 days. RESULTS: Fifty-four patients were recruited of whom 53 were evaluable for toxicity, and 48 for response. There were five confirmed partial responses (9.4%) by the RECIST criteria. The median duration of response was 87 days (range 49-97 days), the median time to progression was 84 days (95% CI 78-124 days), and median overall survival was 262 days (95% CI 205-357 days). Grade >or=3 neutropaenia occurred in 93% of patients, and febrile neutropaenia in 17% of patients. CONCLUSIONS: DHA-paclitaxel has modest activity in patients with oesophago-gastric cancer and with haematological toxicity that is comparable to paclitaxel and docetaxel.
PURPOSE: Combination chemotherapy regimens can improve survival in patients with advanced gastric and oesophageal adenocarcinoma. Docosahexaenoic acid (DHA)-paclitaxel is a novel conjugate formed by the covalent linkage of the fatty acidDHA to paclitaxel and may result in increased tumour exposure to paclitaxel without increased toxicity. PATIENTS AND METHODS: In this single arm, phase II study of DHA-paclitaxel, eligible patients with previously untreated, inoperable locally advanced or metastatic adenocarcinoma of the oesophagus, oesophago-gastric junction or stomach were treated with DHA-paclitaxel (1,100 mg/m(2)) administered by 2-h intravenous infusion every 21 days. RESULTS: Fifty-four patients were recruited of whom 53 were evaluable for toxicity, and 48 for response. There were five confirmed partial responses (9.4%) by the RECIST criteria. The median duration of response was 87 days (range 49-97 days), the median time to progression was 84 days (95% CI 78-124 days), and median overall survival was 262 days (95% CI 205-357 days). Grade >or=3 neutropaenia occurred in 93% of patients, and febrile neutropaenia in 17% of patients. CONCLUSIONS:DHA-paclitaxel has modest activity in patients with oesophago-gastric cancer and with haematological toxicity that is comparable to paclitaxel and docetaxel.
Authors: Aditya G Kohli; Paul H Kierstead; Vincent J Venditto; Colin L Walsh; Francis C Szoka Journal: J Control Release Date: 2014-05-06 Impact factor: 9.776