99 P - Treatment of advanced breast cancer with vinorelbine (VLB), fluorouracil (FU), l-leucovorin (LLV) and human granulocyte colony-stimulating factor (GCSF)

29 women with advanced breast cancer were treated with an iv combination regimen consisting of vinorelbine (40 mg/m2 iv on days 1 and 14), FU (400 mg/m2, days 1–5), LLV (100 mg/m2, days 1–5) and GCSF (5 mcg/kg/d sc on days 6–12). Treatment cycles were repeated every 4 weeks. 27 patients (pts) are evaluable for response and toxicitiy assessment. 9 pts were refractory to first-line chemotherapy, all others were chemotherapeutically naive. 11 pts were preand 18 pts postmenopausal. The median age was 56 (29 to 75) yrs, and the median WHO performance status I (0–2), Predominant tumour sites were visceral in 23, soft-tissue and bone in 3 pts each. After a median of 5 (2–6) treatment cycles, 11/18 (61%) previously untreated PTS with metastatic disease, and 2/9 (22%) chemotherapeutically pretreated pts had objective tumour response, including 3 CR. The median time to response was only 1.8 (1.5 – 4.2) months, median duration of both response and survival have not been reached yet. WHO grade III and IV hematologic side effects occurred in 9 and 3 pts, including 2 cases with septicaemia. Severe nonhematologic side effects (WHO III/IV) requiring dose attenuations occurred in 4 pts, and included stomatitis in 2, emesis and neuropathy in 1 pt each. Other commonly encountered, though generally mild adverse reactions were nausea/vomiting (55%). constipation (31%) and local reactions at the injection site (27%). We conclude, that VLB/FU/LLV+GCSF is an effective regimen for treatment of advanced breast cancer, particularly if used for first-line therapy.