Lay Summary: I discuss the Taxotere and Gemzar combination.
Taxotere and gemcitabine in combination have been tested in phase II. Results from the first study, 39-patient, phase II clinical trial showed a response rate of 79 percent, with two complete responses and 29 partial responses. Twenty-five of these patients remained responsive for more than six months.
The median survival for the entire study population is 24.5 months, with no significant difference between the 30 patients who received prior chemotherapy in the adjuvant setting only, and the nine patients with prior chemotherapy for metastatic disease. The one-year survival is 74 percent for the entire study population, and the two-year survival is estimated to be 53 percent.
There have now been 6 studies. In phase II trials using every-2-week regimens of gemcitabine at 1,500 or 2,000 mg/m2 on day 1 and docetaxel at 50 or 65 mg/m2 on day 1 or 55 mg/m2 on day 8, response rates were 50% in pretreated patients and 66% in treatment-naive patients.
In a recent phase III trial reported by O’Shaughnessy et al 511 anthracycline- pretreated patients with metastatic breast cancer received oral capecitabine at 1,250 mg/m2 twice daily for 14 days plus docetaxel at 75 mg/m2 on day 1 every 3 weeks or docetaxel alone at100 mg/m2 every 3 weeks. The capecitabine/docetaxel doublet was associated with a significantly higher objective response rate (42% vs 30%) and significant improvements in median overall survival (14.5 vs 11.5 months) and 1-year survival rates (57% vs 47%). Analyses of delivered treatment indicated that early in the trial, capecitabine doses were reduced to approximately 1,000 mg/m2 twice daily due to poor tolerability (diarrhea and hand-foot syndrome) and were maintained at that level throughout treatment. These results suggest that the capecitabine/ docetaxel and not Taxotere alone should be considered a standard of treatment in the setting of metastatic breast cancer. Whether gemcitabine is better with Taxotere is better than Xeloda and taxotere is unknown.
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]
Lenz F, Beldermann F, Geberth M, et al. A phase II study of first-line combination chemotherapy with docetaxel and gemcitabine in anthracycline-pretreated, Her-2 negative metastatic breast cancer. Proceedings from the 12th European Conference on Clinical Oncology. Sept. 21-25, 2003. Copenhagen, Denmark.
ANDREW D. SEIDMAN, Gemcitabine and Docetaxel in Metastatic Breast Cancer ONCOLOGY December 2004 • Volume 18 Number 14 Supplement 12