On May 19, 2004, the FDA approved gemcitabine HCl for injection (Gemzar®, made by Eli Lilly and Company) in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.

Safety and efficacy were demonstrated in one multicenter, multinational, randomized trial in 529 patients comparing the combination of Gemzar and paclitaxel with paclitaxel alone. Gemzar 1250 mg/m2 (intravenous infusion over 30 minutes) was administered on Days 1 and 8 of a 21day cycle with paclitaxel 175 mg/m2 (intravenous infusion over 3 hours) administered prior to Gemzar on Day 1 of each cycle. Singleagent paclitaxel 175 mg/m2 (intravenous infusion over 3 hours) was administered on Day 1 of each 21day cycle as the control arm.

The primary endpoint of the study was overall survival. Time to documented progressive disease was a co-primary endpoint. Gemzar in combination with paclitaxel resulted in statistically significant improvement in time to documented disease progression (median TtDPD 5.2 months versus 2.9 months, p<0.0001), and overall response rate (RR 40.6 percent versus 22.1 percent, p<0.0001) compared to monotherapy with paclitaxel. The combination of Gemzar plus paclitaxel also showed a strong trend toward improved survival in an interim survival analysis.

The principal Grade 3 and 4 adverse effects of the Gemzar plus paclitaxel regimen were hematologic (neutropenia, anemia and thrombocytopenia). Grade 3 and 4 liver enzyme elevation was also more common with Gemzar plus paclitaxel treatment. Grade 3 and 4 non-laboratory toxicities associated with Gemzar plus paclitaxel therapy included fatigue, neuropathy and myalgias.

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

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