multiple-center phase II study of biweekly oxaliplatin and tegafur-uracil/leucovorin for chemonaive patients with advanced gastric cancer

• Published in: Cancer chemotherapy and pharmacology Vol. 63; no. 5; pp. 819 - 825
• Main Authors: Chen, Jen-Shi, Rau, Kun-Ming, Chen, Yen-Yang, Huang, Jen-Seng, Yang, Tsai-Shen, Lin, Yung-Chang, Liau, Chi-Ting, Lee, Kuan-Der, Su, Yu-Cheih, Kao, Ruey-Ho
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Berlin/Heidelberg : Springer-Verlag 01.04.2009; Springer-Verlag; Springer; Springer Nature B.V
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - secondary; Administration, Oral; Adolescent; Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Cancer Research; Disease Progression; Dose-Response Relationship, Drug; Female; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Leucovorin - administration & dosage; Male; Maximum Tolerated Dose; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Staging; Oncology; Organoplatinum Compounds - administration & dosage; Original Article; Pharmacology. Drug treatments; Pharmacology/Toxicology; Prognosis; Stomach Neoplasms - drug therapy; Stomach Neoplasms - pathology; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Survival Rate; Tegafur - administration & dosage; Time Factors; Treatment Outcome; Tumors; Uracil - administration & dosage; Young Adult; Chemotherapy; Leucovorin; Oxaliplatin; Gastric cancer; Tegafur–uracil; Antineoplastic agent; Human; Fluoropyrimidine derivatives; Tegafur; Patient; Calcium folinate; Malignant tumor; Prodrug; Stomach cancer; Tegafur-uracil .Leucovorin; Alkylating agent; Treatment; Antimetabolic; Phase II trial; Pyrimidine derivatives; Digestive diseases; Advanced stage; Uracil; Cancer; Gastric disease; Platinum II Complexes
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-008-0797-4

Purpose The current study assessed the efficacy and safety of biweekly oxaliplatin combining oral tegafur-uracil/leucovorin in treating chemonaive patients with advanced gastric cancer. Methods Eligible patients were 18-75 years old, had stage IV disease or post-surgery recurrence, no prior palliative chemotherapy, and an ECOG performance status of 0-2. Patients in the current study received 2-h i.v. infusion of oxaliplatin at a dose of 100 mg/m² after diluting in 500 mL 5% dextrose/water (dexan premedication), and 5-HT3 antagonist biweekly. Oral tegafur-uracil and leucovorin was given at a dose of 300 mg/m²/day and 60 mg/day three times daily from day 1 to 21, respectively, followed by a 1-week rest. Response assessment was based on the RECIST criteria and was performed every two courses. Toxicity was assessed according to NCI common toxicity criteria version 2. Results From October 2003 to April 2006, 57 patients were evaluated (55 eligible) with a median age of 61 years (range 31-75). According to the assessment of response in 48 evaluable patients, partial response rate was 24/48 (50.0%) (95% CI: 35.23-64.73%) and stable disease was observed in 11 patients (22.92%), and diseased progressed in 13 patients (27.08%). Mean number of oxaliplatin cycles was 3 (0.5-6.5). Median time to progression was 177 days. Median overall survival was 318 days. Major-grade (III/IV) toxicities were diarrhea 25.5%, vomiting 16.5%, anemia 10.9%, numbness 12.7%, thrombocytopenia 7.3%, neutropenia 3.6% and leucopenia 1.8%. Conclusions Biweekly, oxaliplatin combining oral tegafur-uracil/leucovorin in treating patients with advanced gastric cancer showed acceptable activity and manageable toxicity.