ABSTRACT
BACKGROUND: The efficacy of systemic chemotherapy for peritoneal dissemination of gastric cancer remains unclear. The efficacy of weekly paclitaxel in combination with doxifluridine (5'-DFUR) in gastric cancer patients with malignant ascites was evaluated. PATIENTS AND METHODS: Patients with histologically confirmed gastric cancer with ascites were eligible. The treatment consisted of paclitaxel intravenously (i.v.) administered at 80 mg/m(2) on days 1, 8 and 15 every 4 weeks, and doxifluridine administered orally at 533 mg/m(2) on days 1-5 every week. The response rate for patients with ascites was determined based on the Japanese Classification of Gastric Carcinoma. Also, the concentration of paclitaxel in the ascites was measured. RESULTS: Twenty-four patients were investigated. The response rate (RR) was 41.7%, including complete remission (CR) and partial remission (PR) in 4 and 6 patients, respectively. The concentration of paclitaxel in the ascites was maintained between 0.01 µM and 0.05 µM until 72 hours. The median overall survival (OS) was 215 days, and 1-year survival rate was 29.2%. No severe toxicity was noted. CONCLUSION: Weekly paclitaxel in combination with doxifluridine is effective for gastric cancer patients with malignant ascites with an acceptable toxicity profile.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Ascites/pathology , Floxuridine/administration & dosage , Paclitaxel/administration & dosage , Peritoneal Neoplasms/secondary , Stomach Neoplasms/drug therapy , Stomach Neoplasms/pathology , Adult , Aged , Ascites/drug therapy , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged , Peritoneal Neoplasms/pathology , Remission Induction , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: Paclitaxel and doxifluridine (5'-DFUR) have distinct mechanisms of action and toxicity profiles. This study evaluated the antitumor activity and toxicities of combination chemotherapy with these drugs in patients with advanced/recurrent gastric cancer (AGC). PATIENTS AND METHODS: Patients with histologically confirmed AGC, which was either unresectable or metastatic, were included in this study. The treatment consisted of 80 mg/m² paclitaxel given i.v. on days 1, 8, and 15 every 4 weeks, and 533 mg/m² doxifluridine given orally on days 1-5 every week. RESULTS: One hundred and four patients were evaluated for toxicity and 93 patients were evaluated for a therapeutic response. The overall response rate was 33.3% (1st line: 41.7%, 2nd line: 25.0%), including a complete remission in two patients, a partial remission in 29, stable disease in 39, progressive disease in 17; the response was not evaluable in six patients. The median overall survival was 287 days. Commonly observed grade 3/4 adverse events were leukopenia (13.5%), anorexia (3.8%), fatigue (3.8%) and diarrhea (2.9%). CONCLUSION: Paclitaxel and doxifluridine combination chemotherapy is a well-tolerated and convenient treatment regimen that can be given on an outpatient basis with promising efficacy for AGC.
