VILLEJUIF, France--Salvage therapy with docetaxel(Drug information on docetaxel) (Taxotere) produced responses in more than a quarter of heavily pretreated, anthracycline-resistant breast cancer patients, said Jean-Louis Misset, MD, an oncologist at Paul Brousse Hospital, Villejuif.
The compassionate use program enrolled 241 patients at 19 French centers. The patients had received a median of four previous chemotherapy regimens. The group included 107 patients who had shown clinical resistance to anthracy-clines, and 108 who had received the maximum cumulative anthracycline dose.
"The patients all had poor prognoses, more than half with liver involvement and 80% with multisite disease, but not all had less than 3 months life expectancy," Dr. Misset said, "Some had slowly growing disease. In these patients, we are bound to find some alternative therapy. We can't just send them home."
Too Concerned With Toxicity?
Patients received docetaxel, 100 mg/m2 as a 1-hour infusion every 3 weeks, repeated six times if disease remained stable. The regimen continued for nine or more courses in patients who responded or had clinical improvement. Patients were premedicated with corticosteroids, antihistamines, or both. Growth factor support was allowed, as were diosmine and diuretics for fluid retention.
Of 217 patients evaluable for response, 40 (19%) have had partial responses, and 18 (8%) have had minor responses. The median duration of response has been 6 months. An additional 95 patients (44%) have had disease stabilization.
Grade 4 neutropenia occurred in 87% of patients and 55% of cycles. The three toxic deaths reported all involved febrile neutropenia and sepsis. "I think Americans are too concerned with the toxicity of Taxotere," Dr. Misset said in his report of the results at the San Antonio Breast Cancer Symposium. "In our experience, it can be handled."
He said that 101 patients remain in the program, indicating that, in some patients, stabilization and responses have been maintained for long durations.