Weekly Docetaxel Promising Treatment for Older Patients With Advanced Breast Cancer

November 1, 2001

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

Weekly dosing of docetaxel (Taxotere) is active andwell tolerated in elderly patients with advanced breast cancer who areconsidered poor candidates for combination chemotherapy, according to theresults 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-yearactuarial survivals of 61% and 29%, respectively.

"Patients with metastatic breast cancer who are elderly or have poorperformance status are often difficult to treat," said John D. Hainsworth,MD, director of clinical research at the Sarah Cannon Cancer Center inNashville, and the study’s principal investigator. "This studydemonstrates that weekly administration of docetaxel provides an additionaltreatment option for this difficult patient subgroup."

Study Protocol

The multicenter trial enrolled 41 patients with advanced breast cancer whowere 65 years of age or older and poor candidates for combination chemotherapydue to comorbid disease or poor tolerance of previous chemotherapy. Patients whohad received previous treatment with taxanes for metastatic disease were noteligible to enroll. However, patients who were treated with taxanes as part ofadjuvant therapy and whose disease relapsed more than 6 months followingcompletion of this treatment were eligible. All patients had measurable orevaluable disease, an Eastern Cooperative Oncology Group performance status of0, 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 radiationtherapy 4 weeks prior to enrollment, and to have recovered from alltreatment-related toxicity. The median age of study participants was74 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 patientsreceived a 1-hour IV infusion of docetaxel, 36 mg/m², for six consecutive weeklydoses, followed by 2 weeks without treatment. Prophylactic corticosteroids wereadministered with each dose of docetaxel to minimize peripheral edema. Also,dexamethasone at 8 mg orally was given to patients 12 hours prior to receivingdocetaxel, at the time of docetaxel administration, and 12 hours followingtreatment.

Patients were reevaluated for response after completing 8 weeks of treatment.All patients with an objective tumor response or stable disease continued toreceive the same weekly schedule of docetaxel for a maximum of four 8-weekcourses (32 weeks). Patients with progressive disease were removed from thetrial.

Adverse Events

The treatment was well tolerated. Severe neutropenia occurred in 0.4% ofcourses. Thrombocytopenia did not occur, and anemia, requiring red blood celltransfusions, was observed in two patients. Severe leukopenia was uncommon, withtwo patients requiring omission of scheduled doses due to this side effect.Grade 3 fatigue was the most common nonhematologic toxicity, occurring in eightpatients (20%). There were no treatment-related deaths.