Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 3608
© 2005 American Society of Clinical Oncology

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Abstract

A phase II study of orzel (UFT+leucovorin) in elderly (75 years old) patients with colorectal cancer: Results of ECOG 1299

NYU Cancer Institute, New York, NY; Dana-Farber Cancer Inst, Boston, MA; Capitol District Hematology/Oncology, Latham, NY; Northwestern Univ, Chicago, IL; Meriter Hosp, Madison, WI

3608

Background: UFT, an oral fluoropyrimidine consisting of Tegafur plus uracil (1:4 molar ratio), constitutes a readily absorbed combination agent inhibiting DPD and is reliably converted to 5FU. LV has been added to each dose in order to potentiate 5FU activity (Orzel). Phase III trials in metastatic colorectal cancer showed activity comparable to intravenous 5-FU/LV with reduced gastrointestinal and dermatologic toxicity (tox). In this study we evaluate the response rate (RR) and tox profile in the elderly defined as those 75 years of age. Methods: Elderly pts 75 years, with measurable disease, PS2 and no prior chemotherapy for metastatic disease were enrolled. Adjuvant therapy if completed 6 months prior was permitted. Treatment was administered as UFT 100 mg/m² plus leucovorin 30 mg q8 hours for 28 days with 7 days of rest. CT scans were performed every two cycles. Results: 58 pts were enrolled between June 2000 and July 2001. Twenty-seven (46%) were women; median age was 81 (range 75–89) yrs, with PS 0 =14, 1=31, 2=13. Median number of cycles given was 4. 57 pts are evaluable for tox with Grade 3–4 tox as follows: gastrointestinal 20 (34%), neutropenia 4 (7%), no hand-foot syndrome. There was only one grade 4 diarrhea reported. Six (10%) required dose reductions for GI toxicity. There were 2 fatalities with GI bleed and CVA. RR is as follows: CR: 2 (3.5%), PR: 9 (15.5%), SD: 20 (34%), PD: 13 (23%) and 14 (24%) not evaluable (7 withdrew, 3 deaths, 1 tox, 1 no rx, 2 no data available). Median time to progression was 19 weeks and overall survival 11.8 months. Conclusions: UFT +LV is well tolerated in the elderly with an incidence of grade 3–4 toxicity similar to phase III reports in younger patients. Activity in this study was comparable to intravenous 5FU/LV. This oral fluoropyrimidine is well tolerated and very active in elderly patients. It is an excellent alternative to intravenous 5FU/LV. Supported by NIH grants CA23318, 66636, 21115, 11083, 17145, 21076, 16087.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb

Abstract presentation from the 2005 ASCO Annual Meeting