Weekly dosing of docetaxel (Taxotere) is active and
well tolerated in elderly patients with advanced breast cancer who are
considered poor candidates for combination chemotherapy, according to the
results of a phase II study published in the Journal of Clinical Oncology
Among the 41 study patients, 13 (36%) had objective responses to treatment.
An additional 13 (36%) achieved stable disease or a minor response to treatment.
The median time to progression for responding and stable patients was 7 months.
Median survival for the entire patient group was 13 months, with 1- and 2-year
actuarial survivals of 61% and 29%, respectively.
"Patients with metastatic breast cancer who are elderly or have poor
performance status are often difficult to treat," said John D. Hainsworth,
MD, director of clinical research at the Sarah Cannon Cancer Center in
Nashville, and the study’s principal investigator. "This study
demonstrates that weekly administration of docetaxel provides an additional
treatment option for this difficult patient subgroup."
The multicenter trial enrolled 41 patients with advanced breast cancer who
were 65 years of age or older and poor candidates for combination chemotherapy
due to comorbid disease or poor tolerance of previous chemotherapy. Patients who
had received previous treatment with taxanes for metastatic disease were not
eligible to enroll. However, patients who were treated with taxanes as part of
adjuvant therapy and whose disease relapsed more than 6 months following
completion of this treatment were eligible. All patients had measurable or
evaluable disease, an Eastern Cooperative Oncology Group performance status of
0, 1, or 2, normal liver function, and a serum creatinine level of 1.5 mg/dL or less. Patients were also required to have completed radiation
therapy 4 weeks prior to enrollment, and to have recovered from all
treatment-related toxicity. The median age of study participants was
Weekly docetaxel as first-line treatment was administered to 75% of patients,
while the other 25% were given docetaxel as second-line treatment. All patients
received a 1-hour IV infusion of docetaxel, 36 mg/m², for six consecutive weekly
doses, followed by 2 weeks without treatment. Prophylactic corticosteroids were
administered with each dose of docetaxel to minimize peripheral edema. Also,
dexamethasone at 8 mg orally was given to patients 12 hours prior to receiving
docetaxel, at the time of docetaxel administration, and 12 hours following
Patients were reevaluated for response after completing 8 weeks of treatment.
All patients with an objective tumor response or stable disease continued to
receive the same weekly schedule of docetaxel for a maximum of four 8-week
courses (32 weeks). Patients with progressive disease were removed from the