Docetaxel/Gemcitabine Is Active Against Metastatic Disease.

2001 OCT 4 - (NewsRx.com & NewsRx.net) --

Combination chemotherapy with monthly docetaxel (Taxotere) and weekly gemcitabine (Gemzar) is a highly active regimen in patients with metastatic breast cancer who have received prior chemotherapy.

Results from this 39-patient, Phase II clinical trial showed a response rate of 79%, with two complete responses and 29 partial responses. Twenty-five of these patients remained responsive for more than six months.

The median survival for the entire study population is 24.5 months, with no significant difference between the 30 patients who received prior chemotherapy in the adjuvant setting only, and the nine patients with prior chemotherapy for metastatic disease. The one-year survival is 74% for the entire study population, and the two-year survival is estimated to be 53%.

The study was published in the September 2001 issue of Annals of Oncology.

"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, Hematology Oncology Consultants, Inc., Columbus, Ohio. "Furthermore, a high proportion of responses lasted more than six months, and this is generally associated with prolonged survival."

Women 18 years and older with histologically confirmed breast cancer were eligible for the trial. All eligible patients had received prior chemotherapy in the adjuvant or metastatic setting, but they had not previously received taxanes 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.