By Kevin O. Hwang, MD
December 9, 2004 — In patients with HER2-overexpressing metastatic breast cancer, the combination of gemcitabine and trastuzumab induces a high response rate with acceptable toxicity, according to data from Brufsky and colleagues presented at the 27th San Antonio Breast Cancer Symposium.
Trastuzumab, an antibody against HER2, is effective when used as monotherapy or in combination with chemotherapy in the treatment of metastatic breast cancer. Preclinical studies indicate that the combination of gemcitabine and trastuzumab may be effective in HER2-overexpressing metastatic breast cancer. Brufsky and colleagues conducted a study to determine the response rate and toxicity of the combination of gemcitabine and trastuzumab in patients with HER2-overexpressing metastatic breast cancer. Results of the first stage were reported.
The first stage of the study enrolled 25 patients (median age, 55 years) with HER2-overexpressing metastatic breast cancer who had not received chemotherapy in the metastatic setting. All patients had adequate end-organ function. Gemcitabine was given on Days 1 and 8 and trastuzumab was given on Day 1 of the 21-day cycles. The primary endpoint was response rate, and secondary endpoints were time to progression, overall survival, and toxicity.
A total of 152 cycles were given, with a median of 5 cycles per patient. The overall response rate was 64%. Roughly 4 out of 5 respondes were partial responses while one fifth were complete responses. Subgroup analysis revealed that combination therapy was most effective in patients who had never received chemotherapy (90% response rate) and in those who had nonvisceral metastases (88% response rate). The Kaplan-Meier estimate of median time to progression was 4.4 months. Median overall survival was 16.3 months.
Treatment was associated with fatigue or nausea and vomiting in 24% to 28% of patients. The most common hematologic toxicity was neutropenia. Grade 4 neutropenia was observed in 11.8% of all cycles given, with grade 3 neutropenia observed in 3.9% of cycles. No patients in this first stage of the study dropped out due to adverse events.
The investigators concluded that the combination of gemcitabine and trastuzumab is effective and reasonably tolerable for first-line treatment of HER2-overexpressing metastatic breast cancer.
http://clinicaloptions.com/onco/news...SABCS_3047.asp
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