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• W2398889174 abstract "Background: The primary objective of this study was to determine the maximum tolerated dose (MTD), the toxicity profile and the recommended dose (RD) for phase II of a combination of S-1 and weekly administration of docetaxel. Patients and Methods: Patients with histologically diagnosed recurrent or unresectable locally advanced gastric cancer were enrolled. A fixed oral dose of 80 mg/m 2 S-1 was given for 3 weeks. Docetaxel was infused intravenously on day 1, 8 and 15, repeated every 5 weeks. A pharmacokinetic study was also performed. Results: A total of 14 patients were enrolled. One dose-limiting toxicity (DLT) (grade 3 diarrhea with febrile neutropenia) occurred at level 2. DLTs occurred in 3/5 patients at level 3, (grade 3 stomatitis, with febrile neutropenia or continuous grade 4 neutropenia). The pharmacokinetic study suggested no drug interactions. Overall response and disease control rates were 20% and 80%, respectively. The response rate at the RD (level 2) was 50%. Overall survival was 9.4 months. Conclusion: RD was level 2 (80 mg/m 2 of S-1 for 3 weeks and 20 mg/m 2 of docetaxel on day 1, 8 and 15, every 5 weeks). Dose intensities of S-1 and docetaxel were 48 mg/m 2 /week and 12 mg/m 2 /week, respectively. This regimen showed promising activity for advanced gastric cancer. The incidence and mortality of gastric cancer has been declining, however, it remains one of the most common causes of cancer-related death (1). It is often diagnosed in advanced stage or recurrent disease, both of which are incurable, and carries a dismal prognosis with a short median survival. The one year survival rate is approximately 50% in stage III gastric cancer patients, and 25% in stage IV. Although gastric cancer has been regarded as a resistant tumor, several clinical trials have revealed that some chemotherapeutic agents are effective. 5-Fluorouracil (5- FU)-containing regimens are considered as standard chemotherapy because they provide survival benefit and improvement in quality of life compared with best supportive care (2-4). Hence in the 1980's, many combinations of drugs, 5-FU/doxorubicin/mitomycin (FAM) (5), 5-FU/doxorubicin/methotrexate (FAMTX) (6), etoposide/doxorubicin/cisplatin (EAP) (7), epirubicin/ cisplatin/5-FU (ECF) (8), 5-FU/doxorubicin/cisplatin (FAP) (9) and 5-FU/cisplatin (FP) (10, 11) were reported in the treatment of gastric cancer. Although response rates were improved by 40-70%, the survival advantage over single agent 5-FU alone was not significant and severe adverse effects were observed (12). To improve efficacy of chemotherapy against gastric cancer, development of novel agents and combinations which have higher antitumor activity with favorable safety profiles is crucial. S-1, a fourth-generation oral fluoropyrimidine, is a formulation of tegafur (FT), 5-chloro-2,4-dihydroxypyridine (CDHP) and potassium oxonate (Oxo) at a molar ratio of 1:0.4:1 (13). FT is the prodrug for cytotoxic fluorouracil (FU) and CDHP prevents its degradation. CDHP is a potent and competitive inhibitor of dihydropyrimidine dehydrogenase, which reduces the degradation of FU and allows efficacious concentrations to enter the anabolic pathway. The diarrheagenic property of FU is a result of its phosphorylation in the intestine, primarily by orotate phosphoribosyltransferase (OPRT). Oxo is a competitive inhibitor for OPRT. Thus, the protective effect of Oxo is due to its ability to reduce phosphorylation of FU. Thus, one component of S-1, CDHP, reduces the degradation of cytotoxic FU, and another component, Oxo, potentially reduces its GI toxicity. Phase II studies of S-1 monotherapy in patients with advanced gastric cancer showed an overall" @default.
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• W2398889174 date "2007-07-01" @default.
• W2398889174 modified "2023-10-02" @default.
• W2398889174 title "Phase I Study of Combination Therapy with S-1 and Weekly Docetaxel for Advanced Gastric Cancer" @default.
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