A Phase II Study of Infusional 5-Fluorouracil and Low-Dose Leucovorin with Docetaxel for Advanced Gastric Cancer

• Published in: Oncology Vol. 70; no. 1; pp. 63 - 70
• Main Authors: Jeung, H.-C., Rha, Sun Young, Kim, Yong Tae, Noh, Sung Hoon, Roh, Jae Kyung, Chung, Hyun Cheol
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland Karger 01.01.2006; S. Karger AG
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - secondary; Adult; Aged; Antimetabolites, Antineoplastic - administration & dosage; Antineoplastic Agents - therapeutic use; Antineoplastic Agents, Phytogenic - administration & dosage; Biological and medical sciences; Cancer; Chemotherapy; Clinical Study; Female; Fluorouracil - administration & dosage; Gastroenterology. Liver. Pancreas. Abdomen; Gastrointestinal diseases; Humans; Infusions, Intravenous; Leucovorin - administration & dosage; Male; Medical sciences; Middle Aged; Stomach Neoplasms - drug therapy; Stomach Neoplasms - pathology; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Survival Analysis; Taxoids - administration & dosage; Toxicity; Treatment Outcome; Tumors; Leucovorin; 5-Fluorouracil; Gastric cancer; Docetaxel; Antineoplastic agent; Calcium folinate; Stomach cancer; Cancerology; Taxane derivatives; Phase II trial; Advanced stage; Antimitotic; Gastric disease; Fluorouracil; Enzyme; Fluoropyrimidine derivatives; Transferases; Low dose; Enzyme inhibitor; Malignant tumor; Thymidylate synthase; Treatment; Antimetabolic; Methyltransferases; Digestive diseases; Pyrimidine derivatives
• ISSN: 0030-2414; 1423-0232
• DOI: 10.1159/000091186

Background: The standard chemotherapy regimen for advanced gastric cancer has not yet been established. We investigated the efficacy and the safety of the combination of docetaxel with infusional 5-fluorouracil (5-FU) and leucovorin (FLT) in advanced gastric cancer. Methods: Patients received docetaxel 75 mg/m 2 (1-hour infusion) followed by a leucovorin bolus 20 mg/m 2 and a 24-hour infusion of 5-FU 1,000 mg/m 2 (day 1–3) every 3 weeks. The response was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and the toxicity was evaluated by National Cancer Institute common toxicity criteria (NCI-CTC). Results: Sixty-six patients were enrolled. Median relative dose intensity was 86%. Of 57 evaluable patients, the overall response rate was 25.7%. The response rate was 34.2% in chemonaïve patients and 14.2% in the patients who had previously received treatment. Median time to progression and overall survival duration were 5.2 and 9.7 months, respectively. The most frequent grade 3–4 toxicity was neutropenia, which was the major cause of treatment delay. Other hematological and nonhematological toxicities were rare. Conclusions: The FLT regimen showed a comparable efficacy with other second-generation regimens. Because of the low nonhematological toxicity, this could be a potential alternative to the cisplatin-containing regimens in gastric cancer.