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 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
"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 (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.