376 Oral doxifluridine plus leucovorin in elderly patients with advanced breast cancer

In an ongoing phase II study, 37 elderly patients (≥ 70 year) hâve been treated with oral doxifluridine 600 mg/m 2 plus oral 1 -leucovorin 25 mg, both q 12 hours days 1–4. The courses are repeated every 12 days. A total of 230 courses have been given, with a median of 4 cycles per patient (range 1–14). The main patient characteristics are a median age of 76 years (range 70–88), median ECOG performance status 0 (range 0–2), soft tissue, viscera and bone involvement in respectively 81%, 46% and 27% of patients. Seventeen of the 37 patients have previously received chemo and/or hormonotherapy for metastatic disease. The grade 1–2 (NCI) side effects are: nausea and vomiting (37%), diarrhea (26%), mucositis (14%), gastric pain (3%), leukopenia (11%), piastrinopenia (9%), anemia (9%). Grade 3 nausea and vomiting has been observed in 1 patient and grade 3 diarrhea in 4 patients. Only 1 patient has experienced grnde 4 diarrhea. In the 32 evaluable patients, 1 CR, 8 PR (CR + PR = 28%, C.I. 95% = 28 ± 15), 11 SD and 12 PD have been recorded. The 17 previously untreated patients show a response rate of 35% (1 CR + 5 PR) with a median response duration of 4 months (1+ − 15+); the 15 pretreated patients include 3 PR (20%) with a median duration of 2 months (1+ − 4). Doxifluridine plus 1-leucovorin is a treatment with promising activity and good compliance when delivered in an out-patient setting. Data management by ITMO (Italian Trials in Medical Oncology) Scientific Service.