Docetaxel and Continuous-Infusion Fluorouracil Versus Epirubicin, Cisplatin, and Fluorouracil for Advanced Gastric Adenocarcinoma: A Randomized Phase II Study

A combination of docetaxel and fluorouracil (DF) was evaluated in an outpatient setting and compared with epirubicin, cisplatin, and fluorouracil (ECF), which served as an internal control arm to avoid selection bias. Patients with metastatic or locally advanced gastric adenocarcinoma without prior...

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Published in:	Journal of clinical oncology Vol. 23; no. 3; pp. 494 - 501
Main Authors:	THUSS-PATIENCE, Peter C, KRETZSCHMAR, Albrecht, REPP, Michael, KINGREEN, Dorothea, HENNESSER, Dirk, MICHEEL, Simone, PINK, Daniel, SCHOLZ, Christian, DÖRKEN, Bernd, REICHARDT, Peter
Format:	Journal Article
Language:	English
Published:	Baltimore, MD American Society of Clinical Oncology 20-01-2005 Lippincott Williams & Wilkins
Subjects:	Adenocarcinoma - drug therapy Adenocarcinoma - pathology Adult Aged Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Cisplatin - administration & dosage Disease Progression Epirubicin - administration & dosage Female Fluorouracil - administration & dosage Humans Infusions, Intravenous Male Medical sciences Middle Aged Stomach Neoplasms - drug therapy Stomach Neoplasms - pathology Survival Analysis Taxoids - administration & dosage Treatment Outcome Tumors Antineoplastic agent Randomization Cancerology Taxane derivatives Phase II trial Epirubicin Antimitotic Gastric disease Platinum II Complexes Fluorouracil Enzyme Fluoropyrimidine derivatives Transferases Docetaxel Enzyme inhibitor Gastric adenocarcinoma Malignant tumor Stomach adenocarcinoma Thymidylate synthase Cisplatin Alkylating agent Treatment Antimetabolic Methyltransferases Perfusion Digestive diseases Pyrimidine derivatives Anthracyclins Comparative study
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Summary:	A combination of docetaxel and fluorouracil (DF) was evaluated in an outpatient setting and compared with epirubicin, cisplatin, and fluorouracil (ECF), which served as an internal control arm to avoid selection bias. Patients with metastatic or locally advanced gastric adenocarcinoma without prior chemotherapy were randomly assigned to receive either ECF (epirubicin 50 mg/m(2) day 1, cisplatin 60 mg/m(2) day 1, and fluorouracil 200 mg/m(2) days 1 through 21, every 3 weeks) or DF (docetaxel 75 mg/m(2) day 1, and fluorouracil 200 mg/m(2) days 1 through 21, every 3 weeks). Ninety patients were randomly assigned. Toxicity was rarely severe. Major toxic effects included diarrhea, stomatitis, and leukopenia in the DF arm and nausea, vomiting, and leukopenia in the ECF arm. Forty-three of 45 patients in each arm were assessable. In the DF arm, two patients (4.4%, intent to treat) experienced a confirmed complete tumor remission as best response, and 15 patients (33.3%) experienced a confirmed partial remission (overall response rate [ORR], 37.8%; 95% CI, 25.9% to 51.9%). Two patients (4.4%) in the ECF arm showed confirmed complete remission, and 14 (31.1%) showed confirmed partial remission (ORR, 35.6%; 95% CI, 24.8% to 48.7%). For the DF and ECF arms, the median survival was 9.5 and 9.7 months, and the median time to tumor progression 5.5 and 5.3 months, respectively. DF can be safely given in an ambulant setting. Compared with ECF, the dual combination of DF shows promising efficacy and may be an alternative treatment option that avoids cisplatin.
ISSN:	0732-183X 1527-7755
DOI:	10.1200/JCO.2005.02.163