Abstract | BACKGROUND AND PURPOSE:
Chemoradiotherapy is increasingly used in the primary management of patients with loco-regionally advanced gastrointestinal (GI) cancer. Oral chemotherapy with uracil and tegafur (UFT) plus leucovorin (LV) may represent a convenient way of delivering protracted infusion of fluorouracil. Our goal was to evaluate the safety of UFT plus LV combined with radiation and determine the maximum-tolerated dose (MTD) and a recommended dose for further testing. PATIENTS AND METHODS: Patients with inextirpable GI cancer received escalating doses of UFT (starting at 300 mg/m(2)/d with 50 mg/m(2)/d increments between consecutive cohorts) and fixed doses of LV (90 mg/d). UFT and LV were given 5 days per week concurrently with radiation to 50 Gy (2 Gy/fraction). RESULTS: Twenty-five patients were treated, and 22 received the planned treatment. Three patients were withdrawn from treatment, two due to disease-progression and one due to toxicity. The MTD of UFT with radiation was 400 mg/m(2)/d with 90 mg/d of LV. Diarrhoea was the main dose limiting toxicity (DLT). Since some toxicity (3/12 DLTs) was seen in the expanded cohort at the level below, but none (0/9 DLT) at the starting level, the recommended dose chosen for further testing is 300-350 mg/m(2)/d depending upon the size of the target volume. CONCLUSION: Concomitant chemoradiation with oral UFT plus LV is feasible and well tolerated and should be further investigated since tumour responses were frequently seen.
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Authors | P Byström, J-E Frödin, A Berglund, N Wilking, B Glimelius |
Journal | Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
(Radiother Oncol)
Vol. 70
Issue 2
Pg. 171-5
(Feb 2004)
ISSN: 0167-8140 [Print] Ireland |
PMID | 15028404
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Tegafur
- Uracil
- Leucovorin
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Topics |
- Administration, Oral
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage)
- Female
- Follow-Up Studies
- Gastrointestinal Neoplasms
(drug therapy, mortality, pathology, radiotherapy)
- Humans
- Leucovorin
(administration & dosage)
- Male
- Maximum Tolerated Dose
- Middle Aged
- Neoplasm Staging
- Prospective Studies
- Radiotherapy Dosage
- Radiotherapy, Adjuvant
- Risk Assessment
- Survival Analysis
- Tegafur
(administration & dosage)
- Terminally Ill
- Treatment Outcome
- Uracil
(administration & dosage)
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