Twenty-four patients with metastatic
breast cancer that had progressed after high-dose
chemotherapy with peripheral blood progenitor cell (PBPC) support were given intramuscular
methotrexate in combination with oral UFT (
tegafur and
uracil) and oral
leucovorin (the MUL regimen). Of the total treated, 21 patients are currently evaluable for response and toxicity. All patients had received extensive prior
chemotherapy, including a high-dose regimen with PBPC support. Of the 21 assessable patients, 8 obtained either a complete response (1) or partial response (7), for an overall objective response rate of 38%. Another 7 patients had stable disease for 3 or more months. Therefore, the MUL regimen was able to stop
disease progression for 3 or more months in nearly 75% of patients. The median time to progression and median overall survival from the start of MUL were 6 and 9 months, respectively. The toxicity was mainly gastrointestinal; 6 patients (29%) had World Health Organization grade 2/3
diarrhea, leading to a UFT
dose reduction.
Emesis was mild and easily manageable with
thiethylperazine. In conclusion, MUL
chemotherapy is active and well tolerated in patients with metastatic
breast cancer in progression after high-dose
chemotherapy. Further studies with this regimen, either as salvage
chemotherapy or as
maintenance chemotherapy after high-dose
chemotherapy with PBPC, are warranted.