Gemcitabine and carboplatin in intensively pretreated patients with metastatic breast cancer

Background: Patients with metastatic breast cancer (MBC) are
increasingly exposed to anthracyclines and taxanes either during
treatment of primary breast cancer or during initial therapy of
metastatic disease. The combination of gemcitabine and carboplatin
was therefore investigated as an anthracycline- and taxane-free
treatment option. Patients and Methods: MBC patients previously
treated with chemotherapy were enrolled in a multicenter phase II
study. Treatment consisted of gemcitabine (1,000 mg/m(2) i.v. on
days 1 and 8) and carboplatin (AUC 4 i.v. on day 1) applied every 3
weeks. Results: Thirty-nine patients were recruited, and a total of
207 treatment cycles were applied with a median of 5 cycles per
patient. One complete response and 11 partial responses were
observed for an overall response rate of 31% (95% CI: 17-48%).
Twelve patients (31%) had stable disease. Median time to
progression was 5.3 months (95% CI: 2.6-6.7 months) and median
overall survival from start of treatment was 13.2 months (95% CI:
8.7-16.7 months). Grade 3/4 hematological toxicity included
leukopenia (59%/5%), thrombo-cytopenia (26%/23%) and anemia
(10%/0%). Nonhematological toxicity was rarely severe. Conclusion:
Combination chemotherapy with gemcitabine and carboplatin is an
effective and generally well-tolerated treatment option for
intensively pretreated patients with MBC. Due to a considerable
incidence of severe thrombocytopenia it would be reasonable to
consider starting gemcitabine at the lower dose level of 800
mg/m(2). Copyright (c) 2008 S. Karger AG, Basel.