RESULTS OF LEUCOVORIN AND DOXIFLURIDINE ORAL REGIMEN IN THE TREATMENTOF METASTATIC COLORECTAL-CANCER

We conducted a multicentric phase II study on advanced colorectal canc er to determine the efficacy and toxicity of oral treatment with leuco vorin (LV) plus doxifluridine (5'DFUR), a novel fluoropyrimidine deriv ative with proven antitumor activity in different experimental models. Thirty-six outpatients with measurable disease entered the trial and received orally LV 20 mg in the morning and in the afternoon, and 2 h later 5'-DFUR 500 mg/m(2) every 2 days for 3 months. Thirty-four evalu able patients underwent a total of 408 weeks of treatment. The respons e rate was 35%, with two complete remissions and 10 partial responses. The median survival of patients who responded to treatment (responder s) was 17.1 months (range 4-32), which was significantly longer (p<0.0 01) than the 6.5 months (range 2-11) of the patients who did not respo nd (non-responders). Therefore, after 4-8 weeks of treatment, 14 patie nts (41%) had an improvement in their performance status and/or stabil ization of pain. General toxicity was usually mild, myelo and gastroin testinal toxicity were moderate, and there was no evidence of relevant neurological toxicity. These results show that a home therapy with or al LV-5'DFUR is a safe and effective treatment regimen for metastatic colorectal carcinoma. [(C) 1998 Lippincott Williams & Wilkins.].