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Vol. 60, No. 4, 2001
Issue release date: June 2001
Oncology 2001;60:303–307

Single-Agent Gemcitabine Is Active in Previously Treated Metastatic Breast Cancer

Spielmann M. · Llombart-Cussac A. · Kalla S. · Espié M. · Namer M. · Ferrero J.-M. · Diéras V. · Fumoleau P. · Cuvier C. · Perrocheau G. · Ponzio A. · Kayitalire L. · Pouillart P.
aInstitut Gustave Roussy, Villejuif, bInstitut Curie, Paris, cHospital Saint-Louis, Paris, dCentre Lacassagne, Nice, eCentre René Gauducheau, Nantes, et fLilly France, St-Cloud, France

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Background: This phase II study was designed to assess the efficacy and safety of gemcitabine in patients with metastatic breast cancer (MBC) previously treated with an anthracycline- or anthracenedione-containing regimen as first-line therapy for metastatic disease. Patients and Methods: Forty-seven patients with MBC were enrolled in five French centers. Patients were eligible if they had received one prior chemotherapy regimen with an anthracycline or anthracenedione for metastatic disease, if they had responded to that prior regimen, and if they had relapsed at least 6 months after the first response. Fifteen patients received more than one prior anthracycline regimen; thus, gemcitabine was third-line therapy for 30% of patients. Gemcitabine 1,200 mg/m2 was administered as a 30-min intravenous infusion on days 1, 8, and 15 of a 28-day cycle for a maximum of eight cycles after the best response was obtained. Results: Objective responses were seen in 12 of 41 assessable patients (4 complete responses and 8 partial responses), for an objective response rate of 29% (95% confidence interval, 16–46%). The median response duration was 8.1 months (range: 2.5–27.4 months). Serious hematological toxicity was minimal, with grade 4 neutropenia in 2% of the patients (no neutropenic fever), grade 3 neutropenia in 28% of the patients, and grade 3 thrombocytopenia in 6% of the patients. Among the nonhematological toxicities, asthenia was the most common. Conclusions: Gemcitabine given at this dose and schedule is a well-tolerated treatment with definitive antitumor activity in pretreated MBC patients. This result warrants future exploration of the use of gemcitabine as a single agent and in combination in patients with MBC.

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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