Phase II trial with S-1 in chemotherapy-naïve patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG)
dc.contributor.author | Chollet, P. | en |
dc.contributor.author | Schöffski, P. | en |
dc.contributor.author | Weigang-Köhler, K. | en |
dc.contributor.author | Schellens, J. H. M. | en |
dc.contributor.author | Cure, H. | en |
dc.contributor.author | Pavlidis, Nicholas | en |
dc.contributor.author | Grünwald, V. | en |
dc.contributor.author | Boer, R. De | en |
dc.contributor.author | Wanders, J. | en |
dc.contributor.author | Fumoleau, P. | en |
dc.creator | Chollet, P. | en |
dc.creator | Schöffski, P. | en |
dc.creator | Weigang-Köhler, K. | en |
dc.creator | Schellens, J. H. M. | en |
dc.creator | Cure, H. | en |
dc.creator | Pavlidis, Nicholas | en |
dc.creator | Grünwald, V. | en |
dc.creator | Boer, R. De | en |
dc.creator | Wanders, J. | en |
dc.creator | Fumoleau, P. | en |
dc.date.accessioned | 2018-06-22T09:52:48Z | |
dc.date.available | 2018-06-22T09:52:48Z | |
dc.date.issued | 2003 | |
dc.identifier.uri | https://gnosis.library.ucy.ac.cy/handle/7/41513 | |
dc.description.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. | en |
dc.language.iso | eng | en |
dc.source | European journal of cancer | en |
dc.subject | Article | en |
dc.subject | Human | en |
dc.subject | Adenocarcinoma | en |
dc.subject | Adult | en |
dc.subject | Aged | en |
dc.subject | Controlled study | en |
dc.subject | Female | en |
dc.subject | Priority journal | en |
dc.subject | Abdominal pain | en |
dc.subject | Alopecia | en |
dc.subject | Anemia | en |
dc.subject | Anorexia | en |
dc.subject | Clinical article | en |
dc.subject | Clinical trial | en |
dc.subject | Constipation | en |
dc.subject | Controlled clinical trial | en |
dc.subject | Diarrhea | en |
dc.subject | Fatigue | en |
dc.subject | Infection | en |
dc.subject | Leukopenia | en |
dc.subject | Multicenter study | en |
dc.subject | Phase 2 clinical trial | en |
dc.subject | Stomatitis | en |
dc.subject | Thrombocytopenia | en |
dc.subject | Vertigo | en |
dc.subject | Malaise | en |
dc.subject | Male | en |
dc.subject | Sepsis | en |
dc.subject | Hypertension | en |
dc.subject | Side effect | en |
dc.subject | Gastric cancer | en |
dc.subject | Stomach carcinoma | en |
dc.subject | 4 dihydroxypyridine plus oxonate potassium plus tegafur | en |
dc.subject | 5 chloro 2 | en |
dc.subject | Nausea | en |
dc.subject | Chemotherapy induced emesis | en |
dc.subject | Hypotension | en |
dc.subject | Backache | en |
dc.subject | Dyspnea | en |
dc.subject | Weight reduction | en |
dc.subject | Gastritis | en |
dc.subject | Hyperbilirubinemia | en |
dc.subject | Xerostomia | en |
dc.subject | Epistaxis | en |
dc.subject | Drug eruption | en |
dc.subject | Hand foot syndrome | en |
dc.subject | Skin toxicity | en |
dc.subject | Asthenia | en |
dc.subject | Blister | en |
dc.subject | Blood clotting disorder | en |
dc.subject | Dehydration | en |
dc.subject | Drug fever | en |
dc.subject | Dysesthesia | en |
dc.subject | Erythema | en |
dc.subject | Flatulence | en |
dc.subject | Gimeracil | en |
dc.subject | Heart palpitation | en |
dc.subject | Hematoma | en |
dc.subject | Hyperpigmentation | en |
dc.subject | Hypersalivation | en |
dc.subject | Oral fluoropyrimidines | en |
dc.subject | Oteracil | en |
dc.subject | Palliative chemotherapy | en |
dc.subject | Peripheral edema | en |
dc.subject | Petechia | en |
dc.subject | Posthitis | en |
dc.subject | Reproductive toxicity | en |
dc.subject | Rhinitis | en |
dc.subject | Somnolence | en |
dc.subject | Syncope | en |
dc.subject | Tegafur | en |
dc.subject | Wound healing impairment | en |
dc.subject | Xerophthalmia | en |
dc.title | Phase II trial with S-1 in chemotherapy-naïve patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG) | en |
dc.type | info:eu-repo/semantics/article | |
dc.identifier.doi | 10.1016/S0959-8049(03)00237-5 | |
dc.description.volume | 39 | |
dc.description.issue | 9 | |
dc.description.startingpage | 1264 | |
dc.description.endingpage | 1270 | |
dc.author.faculty | Ιατρική Σχολή / Medical School | |
dc.author.department | Ιατρική Σχολή / Medical School | |
dc.type.uhtype | Article | en |
dc.contributor.orcid | Pavlidis, Nicholas [0000-0002-2195-9961] | |
dc.gnosis.orcid | 0000-0002-2195-9961 |
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