Intermittent continuous infusion of fluorouracil and low-dose oral leucovorin in pretreated breast cancer: a pilot study.

AIMS AND

BACKGROUND

There is evidence that fluorouracil (FU), when administered by protracted venous infusion, has antitumor activity in pretreated breast cancer. The aims of the study were to assess, in a population of heavily pretreated breast cancer patients (> or = 2 lines of chemotherapy previously administered), the feasibility and activity of a new combination of oral L-leucovorin and continuous FU infusion.

METHODS

Patients were treated with the following combination: oral L-leucovorin, 5 mg/m2 days 1 through 14, plus FU, 250 mg/m2 days 1 through 14, with cycles repeated every 21 days.

RESULTS

Since November 1994, 22 patients have entered the study and 20 are assessable for response and side effects. Major patient characteristics were: ECOG performance status, 0-2; median age, 56 years (range, 41-70); sites of metastasis, bone 9, lung 8, liver 2, pleura 7; 2 or more metastatic sites, 18. A total of 74 cycles has been administered (median/patient, 3 cycles). Five partial remissions (25%), 4 disease stabilizations and 11 disease progressions have been observed. Median time to progression was 3 months (range 1.6+). Grade I-II mucositis was observed in 8 patients and grade III-IV in 6 patients. Other side effects have included diarrhea and thrombocytopenia.

CONCLUSIONS

The schedule has demonstrated moderate activity in heavily pretreated breast cancer, with mucositis as the dose-limiting toxicity.