Docetaxel/Gemcitabine Administered Every Other Week as First-Line Treatment for Metastatic Breast Cancer: Final Results of a Phase II Trial

Background The purpose of this study was to assess the toxicity and efficacy of the combination of docetaxel and gemcitabine every 2 weeks as first-line therapy in metastatic breast cancer. Patients and Methods We selected patients between the ages of 18 years and 70 years with a Karnofsky performance status of ≥ 60 to receive docetaxel 65 mg/m 2 followed by gemcitabine 2500 mg/m 2 on day 1 every 14 days for 10 cycles. Patients could receive more cycles at the discretion of investigator. Results Of the 52 patients entered, 48 were evaluable for efficacy and toxicity. The overall response rate was 75% (95% confidence interval, 60%–86%), with 8 patients (17%) exhibiting a complete response. The median time to progression was 10.7 months, and the median survival was 32.2 months. The predominant grade 3/4 hematologic toxicity was neutropenia (44% of patients), and the predominant grade 3/4 nonhematologic toxicity was asthenia (15% of patients). Other grade 3/4 toxicities, such as anemia, nausea/vomiting, and diarrhea, were present but infrequent (≤ 10% of patients). The relative dose intensities of both drugs were > 88%. Conclusion The combination of docetaxel/gemcitabine once every 2 weeks is active and well tolerated in patients with untreated advanced breast carcinoma. This chemotherapy regimen might be useful in advanced breast cancer when anthracycline combinations are not preferred, such as cases previously treated with adjuvant anthracycline chemotherapy.