Epirubicin-based chemotherapy improves survival of breast cancer patients when used alone or with docetaxel, according to a presentation at the 27th annual San Antonio (USA) Breast Cancer symposium.

The study, which compared a sequential regimen of FEC 100 (fluorouracil 500 mg/m², epirubicin 100 mg/m², cyclophosphamide 500 mg/m²) followed by docetaxel 100mg/m² with the combination regimen alone, builds upon an existing body of survival and safety evidence for epirubicin that includes previously reported 10-year disease free and overall survival data. In both arms of the study, patients achieved disease-free and overall survival outcomes that set a new survival standard for the drug.

“These results reaffirm that ELLENCE (epirubicin) is an integral component of treatment of patients with node-positive breast cancer,” said William Gradishar, MD. “Patients stand to benefit from the significant outcome advantages delivered from these two ELLENCE-based regimens.”

The data from this large phase III randomized, multi-center clinical trial that evaluated nearly 2,000 patients were presented by Dr. Henri Roche on behalf of a consortium of French and Belgian oncologists.

Between June 1997 and March 2000, 1,999 patents were recruited in 83 French and Belgian locations to participate in the phase III randomized, multi-center clinical trial. Women with node-positive breast cancer were randomly assigned to receive either an adjuvant chemotherapy regimen containing six cycles of only epirubicin-based chemotherapy or three cycles of combination chemotherapy followed by three cycles of docetaxel. G-CSF was not administered prophylactically but was added in cases of febrile neutropenia or delayed neutrophil recovery. Radiotherapy was mandatory for all patients and tamoxifen was given after completion of chemotherapy for 5 years if tumors were hormone receptor positive.

Patient characteristics were well balanced between the two arms: median age was 50 years, conservative surgery was performed in 52 percent of patients, 39 percent of tumors were grade III, 79 percent were hormone receptor positive, 21 percent of patients were hormone receptor negative, and 62 percent of patients had one to three positive lymph nodes.

The prescribed treatment was completed in 98 percent of patients in the combination chemotherapy plus docetaxel arm and 99 percent of patients in the combination only arm. In addition, the relative dose intensity was maintained in 96 percent of the combination only arm and 98 percent in the combination chemotherapy plus docetaxel arm.

At a median follow-up of 60 months, data show that combination chemotherapy followed by docetaxel was superior to epirubicin-based combination chemotherapy only, with disease-free survival rates of 78.3 percent versus 73.2 percent, a 17 percent reduction in risk for relapse. In addition, overall survival was 90.7 percent in the sequential arm versus 86.7 percent in the combination chemotherapy only arm, representing a 23 percent reduction in the risk of death.

In addition to the positive survival data, very few patients experienced serious side effects such as heart damage or neutropenia. The most frequent toxicities reported in the study were hematologic. Four patients (0.4 percent) developed congestive heart failure in the combination chemotherapy only arm, a recognized potential complication of this type of treatment.

Epirubicin is an anthracycline cytotoxic anti-cancer agent and is the first chemotherapy approved by the FDA for use as a component of adjuvant therapy in the treatment of early-stage resectable breast cancer that has spread to the lymph nodes.