Phase II study of gemcitabine as first-line chemotherapy in patients with advanced or metastatic breast cancer

In this phase II study, the efficacy and tolerability of gemcitabine were s tudied in 42 patients with locally advanced or metastatic breast cancer who had received up to one prior chemotherapy regimen in an adjuvant setting, Ten patients had received adjuvant chemotherapy. Twenty-eight patients (67% ) had visceral disease spread at entry. Gemcitabine (1000 mg/m(2)) was admi nistered weekly on days 1, 8 and 15 of a 28-day cycle. The mean number of c ompleted cycles was 3.9 and the mean dose delivered was 942.2 mg/m(2). Nine ty-seven percent of injections were administered as assigned. No complete r esponses were observed, but there were six partial responses and 24 patient s with stable disease lasting 2-9 months. The overall response rate was 14. 3% (95% CI 5.4-28.5%). The median survival for all patients was 15.2 months . Maximum WHO grade 3 and 4 toxicities were observed in five patients for n ausea and vomiting, one patient for diarrhea, one patient for pain, seven p atients for alanine transaminase, and eight patients for segmented neutroph ils, There were no grade 3 and 4 toxicities for alopecia. These data confir m modest single-agent gemcitabine activity in advanced or metastatic breast cancer. Gemcitabine's favorable toxicity profile makes it an ideal candida te for combination chemotherapy, [(C) 1999 Lippincott Williams & Wilkins.].