Single-agent gemcitabine as second- and third-line treatment in metastaticbreast cancer

In the present study, 25 patients with breast cancer pretreated with one or two anthracycline-based regimens for visceral metastases were enrolled. Pa tients were treated with gemcitabine 1250 mg/m(2) on days 1, 8 and 15, q28d . Nine patients received gemcitabine as second-line treatment, whereas 16 p atients received gemcitabine as third-line cytotoxic treatment, respectivel y. In the second-line setting, two (22%) patients gained PR (RR 22%) and four (44%) patients experienced SD (P = 0.2), respectively. In the third-line-se tting, one (6%) patient gained CR, one patient PR(6%) and four patients (25 %) SD, respectively, resulting in a response rate (RR) of 12%. In the second-line-setting, median time to progression was 5.1 +/- 4.0 mont hs (range: 1.6-13.9) versus 3.5-2.5 months (range: 1.3-10.4) in the third-l ine-setting. Median overall survival was 12.6 +/- 9.1 months (range: 3.9-30 .8) versus 7.5 +/- 6.7 months (range: 2.0-26.0), respectively. Overall, no patient experienced treatment limiting toxicities. We conclude from the present study that gemcitabine induced an overall RR o f 16% following prior treatment with anthracyclines. However, median time t o progression and median overall survival were limited. In the search for e fficacious treatment of patients with metastatic breast cancer, gemcitabine constitutes a valid tool in anthracycline-resistant disease and thus might represent a valuable option for combination chemotherapy in controlled tri als in this condition. (C) 2000 Harcourt Publishers Ltd.