Gemcitabine and cisplatin salvage regimen in heavily pretreated metastatic breast cancer: a Brazilian experience.

Gemcitabine and cisplatin combination (Gem-Cis) is a commonly used regimen in metastatic breast cancer (MBC), with proven activity in phase II trials. It is mostly used as a salvage regimen for progressive disease refractory to anthracyclines and taxanes, and when liver dysfunction secondary to liver metastasis precludes these drugs. Retrospective review of medical charts was conducted for patients treated with Gem-Cis for MBC in a single institution in Brazil between January 2004 and July 2007. The purpose of this study was to evaluate the outcomes and toxicity of Gem-Cis in a broad indication, including patients with deteriorated performance status (PS) and liver dysfunction, which were excluded from clinical trials. Fifty-six patients were included. Median age was 52 years, 46.4% were hormone-receptor negative, 57.2% received 3 or more prior chemotherapy lines, and 34 had liver metastasis. The median overall survival (OS) was 7.6 months, the median progression-free survival was 3.3 months, and the response rate was 21.2%. In variable analysis, PS was significantly associated with OS, even after adjusting to other factors. Toxicities included grades 3 or 4 anemia in 19.3%, neutropenia in 21.1%, and thrombocytopenia in 12.3%. Gem-Cis was a relatively active combination in this population that typically carries a poor prognosis. The subgroup of patients with favorable PS experienced longer survival, even when liver metastasis and hepatic dysfunction were a concern. Toxicity was manageable and it was not correlated with PS or liver dysfunction.