A phase II open-label study of DHA-paclitaxel (Taxoprexin) by 2-h intravenous infusion in previously untreated patients with locally advanced or metastatic gastric or oesophageal adenocarcinoma
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/m2) 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 ≥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.
|Keywords||Adenocarcinoma, DHA-paclitaxel, Oesophagus, Stomach|
|Persistent URL||dx.doi.org/10.1007/s00280-007-0486-8, hdl.handle.net/1765/29637|
Jones, R.J., Hawkins, R.E., Eatock, M.M., Ferry, D.R., Eskens, F.A.L.M., Wilke, H.A.M., & Evans, T.R.J.. (2008). A phase II open-label study of DHA-paclitaxel (Taxoprexin) by 2-h intravenous infusion in previously untreated patients with locally advanced or metastatic gastric or oesophageal adenocarcinoma. Cancer Chemotherapy and Pharmacology, 61(3), 435–441. doi:10.1007/s00280-007-0486-8