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.
OBJECTIVE
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.


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.
Jones
Robert J
RJ
Centre for Oncology and Applied Pharmacology, Beatson Oncology Centre, Western Infirmary, University of Glasgow, UK.
Hawkins
Robert E
RE
Eatock
Martin M
MM
Ferry
David R
DR
Eskens
Ferry A L M
FA
Wilke
HansJochen
H
Evans
T R Jeffry
TR
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed
D000972:Antineoplastic Agents, Phytogenic; C528070:docosahexaenoyl-paclitaxel; D017239:Paclitaxel