A phase III trial of front-line therapy with gemcitabine plus paclitaxel compared with paclitaxel alone for the treatment of women with metastatic breast cancer revealed that the combination is superior for overall survival as well as prevention of disease progression. The one-year survival rate for gemcitabine plus paclitaxel was 70.7% compared with 60.9% for paclitaxel (P = .019). The adjusted hazard ratio for combined therapy was 0.74 (P = .006). The U.S. Food and Drug Administration approved gemcitabine (Gemzar) for use in metastatic breast cancer on May 19, 2004 based on this study. Gemzar (gemcitabine hcl) in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. It is guideline recommended after first line as a single agent.
This regimen would be appropriate for first line and may be considered appropriate for subsequent lines, when taxanes have not been previously used. The combination of the three drugs is in a phase II study: A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast Cancer,
NCT00618826 (This study has been suspended. Pending Modification )
National Institute for Health and Clinical Excellence (NICE). Gemcitabine for the treatment of metastatic breast cancer. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Jan. 24 p. (Technology appraisal guidance; no. 116).
Dent S, Messersmith H, Trudeau M, Breast Cancer Disease Site Group. The role of gemcitabine in the management of metastatic breast cancer: a clinical practice guideline. Toronto (ON): Cancer Care Ontario (CCO); 2007 Jan 22. 5 p. (Evidence-based series; no. 1-12). [11 references]
Carlos Delfino at al, Gemcitabine plus Paclitaxel as First-Line Chemotherapy for Patients with Advanced Breast Cancer Oncology Vol. 66, No. 1, 2004