ORAL DOXIFLURIDINE IN ELDERLY PATIENTS WITH METASTATIC COLORECTAL-CANCER - A MULTICENTER PHASE-II STUDY

Background: Cancer chemotherapy in elderly patients is an important an d under-researched area. Doxifluridine is a fluoropyrimidine derivativ e and is activated to 5-fluorouracil by uridine phorylase, which is mo re highly expressed in maligant cells. Because of the high bioavailabi lity and low toxicity of oral doxifluridine we conducted this phase II trial to evaluate the feasibility, toxicity and activity of a home th erapy with oral doxifluridine in elderly metastatic colorectal cancer patients. Patients and methods: Forty-three elderly metastatic colorec tal cancer patients entered the study: their median ECOG performance s tatus was 1 (0-2) and median age 74 years (69-83), the predominant sit e of metastasis was liver and all but one of the patients had received no previous chemotherapy. Doxifluridine was given orally at the initi al daily total dose of 2250 mg for 4 consecutive days every week. The daily dose was reduced to 1500 mg if toxicities greater than grade 2 ( WHO) occurred. Results: Forty-two patients are evaluable for toxicity: treatment was well tolerated, with the most common side effect being diarrhea, severe in 7 (17%) patients (6 grade 3 and 1 grade 4). Thirty -six patients are evaluable for response and 2 complete and 3 partial responses have been observed (response rate 14%; 95% confidence limit interval 5%-29%). Conclusions: This study demonstrates that a home the rapy with oral doxifluridine in elderly advanced colorectal cancer pat ients is feasible, with a relatively low rate of toxicity, and has mod erate activity, comparable to that of intravenous 5-fluorouracil. Ther efore, this treatment may be considered for the management of advanced colorectal cancer in the elderly.