Weekly dosing of docetaxel(Drug information on 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 (19:3500-3505, 2001).
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."
Study Protocol
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 74 years.
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(Drug information on 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 treatment.
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 trial.
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