Phase II trial with S-1 in chemotherapy-naive patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG)
Φόρτωση...
Ημερομηνία
Συγγραφείς
Chollet, P.
Schoffski, P.
Weigang-Kohler, K.
Schellens, J. H.
Cure, H.
Pavlidis, N.
Grunwald, V.
De Boer, R.
Wanders, J.
Fumoleau, P.
Τίτλος Εφημερίδας
Περιοδικό ISSN
Τίτλος τόμου
Εκδότης
Περίληψη
Τύπος
Είδος δημοσίευσης σε συνέδριο
Είδος περιοδικού
peer-reviewed
Είδος εκπαιδευτικού υλικού
Όνομα συνεδρίου
Όνομα περιοδικού
Eur J Cancer
Όνομα βιβλίου
Σειρά βιβλίου
Έκδοση βιβλίου
Συμπληρωματικός/δευτερεύων τίτλος
Περιγραφή
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/m(2) for 28 days every 5 weeks. The starting dose of 40 mg/m(2) was found to be intolerable due to significant non-haematological toxicity, and this dose was rapidly reduced to 35 mg/m(2) twice daily. Of the 7 patients enrolled at the 40 mg/m(2) level, only 3 were evaluable. At 35 mg/m(2), 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/m(2) (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/m(2) days 1 - 28 every 5 weeks and is associated with a moderate response rate similar to the results achieved with other fluoropyrimidines.
Περιγραφή
Λέξεις-κλειδιά
Adult, Aged, Antimetabolites, Antineoplastic/*administration & dosage/adverse effects, Cohort Studies, Drug Combinations, Female, Humans, Male, Middle Aged, Oxonic Acid/*administration & dosage/adverse effects, Pyridines/*administration & dosage/adverse effects, Stomach Neoplasms/*drug therapy, Tegafur/*administration & dosage/adverse effects, Treatment Outcome
Θεματική κατηγορία
Παραπομπή
Σύνδεσμος
http://www.ncbi.nlm.nih.gov/pubmed/12763215
http://ac.els-cdn.com/S0959804903002375/1-s2.0-S0959804903002375-main.pdf?_tid=7b046b7a08281e239de9dd6f90363c5d&acdnat=1333610886_65346a474687ae0a0922e74db168396c
http://ac.els-cdn.com/S0959804903002375/1-s2.0-S0959804903002375-main.pdf?_tid=7b046b7a08281e239de9dd6f90363c5d&acdnat=1333610886_65346a474687ae0a0922e74db168396c
Γλώσσα
en
Εκδίδον τμήμα/τομέας
Όνομα επιβλέποντος
Εξεταστική επιτροπή
Γενική Περιγραφή / Σχόλια
Ίδρυμα και Σχολή/Τμήμα του υποβάλλοντος
Πανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικής