Study Shows Docetaxel Combined with Gemcitabine Is Active in Metastatic Breast Cancer

November 1, 2001

Combination chemotherapy with monthly docetaxel (Taxotere) and weekly 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

Combination chemotherapy with monthly docetaxel (Taxotere)and weekly gemcitabine (Gemzar) is highly active in patients with metastaticbreast cancer who have received prior chemotherapy, according to the results ofa 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 completeresponses and 29 partial responses. Among patients who achieved a response, 25remained responsive for more than 6 months. The median survival for the entirestudy population was 24.5 months, with no significant difference between the 30patients who received prior chemotherapy in the adjuvant setting only and the 9patients who received prior chemotherapy for metastatic disease. The 1-yearsurvival rate was 74%, and the 2-year rate survival is estimated to be53%. 

"The overall response rate is higher than any previously reported withthese drugs, either alone or in combination, and responses were seen in allpatient subgroups," said lead investigator Leslie R. Laufman, MD, presidentof Hematology Oncology Consultants, Inc, in Columbus, Ohio. "Furthermore, ahigh proportion of responses lasted more than 6 months, and this is generallyassociated with prolonged survival."

Eligibility and Results

Women aged 18 years and older with histologically confirmed breast cancerwere eligible for enrollment. All eligible patients had received priorchemotherapy in the adjuvant or metastatic setting, but they had not receivedprevious treatment with a taxane or gemcitabine. Women were also consideredeligible for enrollment if they did not exhibit peripheral neuropathy worse thangrade 2, and if they had a Southwest Oncology Group (SWOG) performance status of0, 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-hourinfusion following administration of gemcitabine on day 1. Prophylacticfilgrastim (granulocyte colony-stimulating factor, Neupogen) was permitted afterthe first treatment cycle had been completed in patients who experienced febrileneutropenia or grade 4 neutropenia that lasted for 5 or more days.

All patients were evaluable for toxicity. Hematologic toxicities includedgrade 4 neutropenia in 36 patients (46% cycles), with only a 3% (sixepisodes) incidence of febrile neutropenia, and three patients developinginfections. Most patients were treated with prophylactic oral antibiotics duringperiods of severe neutropenia. Grade 4 thrombocytopenia occurred in one patient,and three patients required red blood cell transfusions. Grade 3 fatigue wasobserved in 13 patients, and grade 3 fluid retention affected three patients.Other toxicities were mild and infrequent.