1. Phase II trial with S-1 in chemotherapy-naïve patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG)
- Author
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Chollet, P., Schöffski, P., Weigang-Köhler, K., Schellens, J. H. M., Cure, H., Pavlidis, Nicholas, Grünwald, V., Boer, R. De, Wanders, J., Fumoleau, P., and Pavlidis, Nicholas [0000-0002-2195-9961]
- Subjects
Male ,Hand foot syndrome ,Reproductive toxicity ,Pyridines ,Oral fluoropyrimidines ,medicine.medical_treatment ,Gastroenterology ,Blister ,Hematoma ,Dehydration ,Multicenter study ,Pyridines/*administration & dosage/adverse effects ,Clinical trial ,Drug Combinations ,Epistaxis ,Oncology ,Vertigo ,Blood clotting disorder ,Infection ,Human ,Diarrhea ,Antimetabolites, Antineoplastic/*administration & dosage/adverse effects ,Antimetabolites, Antineoplastic ,medicine.medical_specialty ,Clinical article ,Weight reduction ,4 dihydroxypyridine plus oxonate potassium plus tegafur ,Drug fever ,Side effect ,Adenocarcinoma ,Tegafur ,Xerostomia ,Article ,Syncope ,Hypersalivation ,Pharmacokinetics ,Stomach Neoplasms ,Sepsis ,Posthitis ,Humans ,Petechia ,Stomach carcinoma ,Somnolence ,Aged ,Leukopenia ,Skin toxicity ,Gimeracil ,medicine.disease ,Oxonic Acid ,Dyspnea ,Erythema ,Asthenia ,Gastric cancer ,5 chloro 2 ,Malaise ,Drug eruption ,Cancer Research ,Palliative care ,Stomach Neoplasms/*drug therapy ,Cohort Studies ,Backache ,Hyperpigmentation ,Controlled clinical trial ,Dysesthesia ,Flatulence ,Heart palpitation ,Fatigue ,Priority journal ,Hyperbilirubinemia ,Rhinitis ,Peripheral edema ,Stomach ,Anemia ,Nausea ,Middle Aged ,Anorexia ,Treatment Outcome ,medicine.anatomical_structure ,Gastritis ,Toxicity ,Hypertension ,Female ,Hypotension ,medicine.drug ,Adult ,Abdominal pain ,Chemotherapy induced emesis ,Oteracil ,Internal medicine ,Xerophthalmia ,medicine ,Carcinoma ,Phase 2 clinical trial ,Wound healing impairment ,Oxonic Acid/*administration & dosage/adverse effects ,Chemotherapy ,Stomatitis ,business.industry ,Tegafur/*administration & dosage/adverse effects ,Cancer ,Alopecia ,Thrombocytopenia ,Surgery ,Palliative chemotherapy ,business ,Controlled study ,Constipation - Abstract
S-1 is a new oral fluorinated pyrimidine derivate, in which the oral 5-fluorouracil (5-FU) prodrug, tegafur, was combined with two 5-FU-modulating substances, 5-chloro-2,4-dihydroxypyridine (gimeracil), and potassium oxonate (oteracil), at a molar ratio of 1:0.4:1. The final mechanism of action is exerted by 5-FU. The present study is the first European phase II trial of S-1 in gastric cancer. The primary study objectives were the safety, toxicity and activity of S-1 in non-pretreated patients with gastric cancer. The secondary objective was the duration of response. Patients had to have histologically- or cytologically-verified metastatic or locally advanced, unresectable gastric cancer; S-1 was administered orally twice daily at 40, then 35 mg/m2 for 28 days every 5 weeks. The starting dose of 40 mg/m2 was found to be intolerable due to significant non-haematological toxicity, and this dose was rapidly reduced to 35 mg/m2 twice daily. Of the 7 patients enrolled at the 40 mg/m2 level, only 3 were evaluable. At 35 mg/m2, a response rate of 26.1% (95% Confidence Interval (CI) 12.0-45.1%) in 23 enrolled patients, and 31.6% (C.I. 14.7-53.0%) in 19 evaluable patients according to an independent radiology review, was found. The median duration of response at 35 mg/m2 (6 patients) was 223 days (range, 108-828 days), and of stable disease was 111 days (range 68-411 days). S-1 can be administered with an acceptable safety and toxicity in European patients at a dose of 35 mg/m2 days 1 - 28 every 5 weeks and is associated with a moderate response rate similar to the results achieved with other fluoropyrimidines. © 2003 Elsevier Science Ltd. All rights reserved. 39 9 1264 1270
- Published
- 2003