ADVANCED BREAST-CANCER - A PHASE-II TRIAL WITH GEMCITABINE

Purpose: In this phase II study, the efficacy and tolerability of gemc itabine were studied in 44 patients with locally advanced or metastati c breast cancer.Patients and Methods: Of 40 patients assessable for re sponse, 14 were chemotherapy-naive, seven had received adjuvant chemot herapy, and 19 had received one prior chemotherapy regimen for metasta tic disease. Gemcitabine was administered as a 30-minute intravenous i nfusion once a week for 3 weeks followed by a 1-week rest every 4 week s. The mean number of completed cycles administered was 2.7 and the me an dosage delivered was 725 mg/m(2) per injection. Eighty-one percent of doses were delivered as scheduled. Results: There were three comple te responses and seven partial responses, for an overall response rate of 25.0% (95% confidence interval [CI], 12.7% to 41.2%). Four patient s were not assessable for efficacy (one had insufficient therapy, two had no bidimensionally measurable disease, and one had neither). All r esponses were independently validated by an external oncology review b oard. Responses were observed early in treatment, with a median time t o response of 1.9 months. The median survival duration for all 40 asse ssable patients was 11.5 months. Hematologic toxicity was generally mi ld, with World Health Organization (WHO) grade 3 and 4 leukopenia occu rring in 6.8% and 2.3% of patients and neutropenia in 23.3% and 7.0%, of patients, respectively. The only other grade 4 toxicities were infe ction and nausea and vomiting in one patient each. One patient was wit hdrawn due to shortness of breath, possibly drug-related. Flu-like sym ptoms, which were mild, transient, and treatable with acetominophen, w ere reported in 6.8% of patients. Only one patient developed alopecia of severity greater than WHO grade 2. Conclusion: In view of the singl e-agent activity seen in advanced breast cancer, modest toxicity profi le, and novel mechanism of action, gemcitabine deserves evaluation in breast cancer and is an ideal candidate for combination therapy. (C) 1 995 by American Society of Clinical Oncology.