Combination chemotherapy with monthly docetaxel(Drug information on docetaxel) (Taxotere) and weekly gemcitabine(Drug information on gemcitabine) (Gemzar) is highly active in patients with metastatic breast cancer who have received prior chemotherapy, according to the results of a phase II study published in the September issue of the Annals of Oncology.
The response rate in this trial in 39 patients was 79%, with 2 complete responses and 29 partial responses. Among patients who achieved a response, 25 remained responsive for more than 6 months. The median survival for the entire study population was 24.5 months, with no significant difference between the 30 patients who received prior chemotherapy in the adjuvant setting only and the 9 patients who received prior chemotherapy for metastatic disease. The 1-year survival rate was 74%, and the 2-year rate survival is estimated to be 53%.
"The overall response rate is higher than any previously reported with these drugs, either alone or in combination, and responses were seen in all patient subgroups," said lead investigator Leslie R. Laufman, MD, president of Hematology Oncology Consultants, Inc, in Columbus, Ohio. "Furthermore, a high proportion of responses lasted more than 6 months, and this is generally associated with prolonged survival."
Eligibility and Results
Women aged 18 years and older with histologically confirmed breast cancer were eligible for enrollment. All eligible patients had received prior chemotherapy in the adjuvant or metastatic setting, but they had not received previous treatment with a taxane or gemcitabine. Women were also considered eligible for enrollment if they did not exhibit peripheral neuropathy worse than grade 2, and if they had a Southwest Oncology Group (SWOG) performance status of 0, 1, or 2.
All patients received gemcitabine IV at 800 mg/m² for 30 minutes on days 1, 8, and 15 of a 28-day cycle. Docetaxel at 100 mg/m² was administered via 1-hour infusion following administration of gemcitabine on day 1. Prophylactic filgrastim(Drug information on filgrastim) (granulocyte colony-stimulating factor, Neupogen) was permitted after the first treatment cycle had been completed in patients who experienced febrile neutropenia or grade 4 neutropenia that lasted for 5 or more days.
All patients were evaluable for toxicity. Hematologic toxicities included grade 4 neutropenia in 36 patients (46% cycles), with only a 3% (six episodes) incidence of febrile neutropenia, and three patients developing infections. Most patients were treated with prophylactic oral antibiotics during periods of severe neutropenia. Grade 4 thrombocytopenia occurred in one patient, and three patients required red blood cell transfusions. Grade 3 fatigue was observed in 13 patients, and grade 3 fluid retention affected three patients. Other toxicities were mild and infrequent.