A Phase II Trial of Gemcitabine in Patients with Metastatic Breast Cancer Previously Treated with an Anthracycline and Taxane

Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
Clinical Breast Cancer (Impact Factor: 2.11). 05/2005; 6(1):55-60. DOI: 10.3816/CBC.2005.n.009
Source: PubMed


This study was designed to evaluate the efficacy and safety of single-agent gemcitabine for the treatment of patients with anthracycline- and taxane-pretreated metastatic breast cancer (MBC). Eligible patients were required to have bidimensionally measurable MBC that had been treated with 2-4 prior chemotherapy regimens that included an anthracycline and a taxane. Gemcitabine was delivered at a dose of 800 mg/m2 on days 1, 8, and 15 of a 28-day cycle until evidence of disease progression.
Twenty-two patients were enrolled and included in the safety analysis; 18 patients were evaluable for response. The median age of patients was 54 years (range, 36-70 years). The mean number of prior chemotherapy regimens for metastatic disease was 2.3, and the mean dose of gemcitabine delivered was 911 mg/m2 (range, 600-1600 mg/m2).
Overall, gemcitabine was well tolerated with minimal grade 3 toxicities; the only grade 4 toxicity was 1 case of pulmonary embolus. Three patients had evidence of partial tumor regression (17%; 95% CI, 4%-41%), and 1 patient had a 41% decrease in tumor volume, including liver metastasis.
Gemcitabine is active and well tolerated as monotherapy given in heavily pretreated patients with MBC after anthracyclines and taxanes. The activity and safety reported in this trial are consistent with previous reports in similar patients.

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    • "Gemcitabine as a single agent has induced overall response rates of 0 – 37% in first-line treatment, whereas the response rates in the second-or third-line therapy were 26 and 13% (Brodowicz et al, 2000; Spielmann et al, 2001; Blackstein et al, 2002; Heinemann, 2003, 2005; Modi et al, 2005). In studies limited to second-or third-line therapy after anthracycline and/or taxane exposure, response rates of 0 – 29% and median time to progression of 2 – 6 months were achieved (Spielmann et al, 2001; Modi et al, 2005; Heinemann et al, 2006; Seo et al, 2007). Several considerations support the use of gemcitabine and a platinum salt in the salvage treatment of metastatic breast cancer (MBC): First, in vitro studies indicate additive or synergistic activity that was most pronounced in platinum-resistant cell lines and was found to be due to an increased formation and an impaired repair of platinum – DNA adducts (Peters et al, 1995; van Moorsel et al, 1997). "
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