Epirubicin (Ellence) is currently being studied in combination with the taxanes, such as docetaxel(Drug information on docetaxel) (Taxotere), in patients with advanced breast cancer. As a single agent, docetaxel has proven to be a very active drug in breast cancer, so the results of these combination trials are awaited with interest. Our experience has shown epirubicin(Drug information on epirubicin)/docetaxel to be a feasible and active combination in breast cancer.
We designed a multicenter trial to evaluate response, time to progression, and toxicity outcomes of epirubicin/docetaxel in the treatment of metastatic breast cancer. Patients received epirubicin 75 mg/m² IV plus docetaxel 75 mg/m² IV on day 1, repeated every 3 weeks to the completion of six cycles. Premedication included dexamethasone(Drug information on dexamethasone) and antiemetics. Previous therapy for advanced breast cancer was not allowed. Response was evaluated after the third and sixth cycles.
From March 1998 to October 1999, 99 patients were enrolled in the trial. To date, 43 patients have been evaluated for response, toxicity, and treatment compliance. Patient characteristics were as follows: median age, 53 years (range: 3174 years); performance status < 2, all patients; no previous chemotherapy, 63%; previous chemotherapy as neoadjuvant, adjuvant, or both, 37%. Of 36 evaluable patients, the response rate was complete response, 27.8%; partial response, 47.2%; overall response, 75% (95% CI: 58%88%); no change, 13.9%; progressive disease, 11.1%. The median time to progression had not yet been reached at the time of analysis.
The main hematologic toxicity was neutropenic fever in 7% of the cycles. Nonhematologic toxicity, per cycle, all grades, was as follows: alopecia (as the main side effect), 83%; asthenia, 21% (grade 3/4, 1%); stomatitis, 24% (grade 3/4, 2%); vomiting, 12% (grade 3/4, 1%); neuromotor, 10% (grade 3/4, 2%). Compliance was as expected, with only 11% delayed cycles and 3% dose reduction.
CONCLUSION: Pending confirmation by final results, we believe that these encouraging results (75% overall response rate) indicate that further research into the epirubicin/docetaxel combination is needed.