Toxicity and activity of docetaxel in anthracycline-pretreated breast cancer patients -: A phase II study

Docetaxel has proven effective in advanced breast cancer. Myelosuppression and cumulative fluid retention syndrome an troublesome, potentially avoidable toxicities. Zn this consecutive cohort study, docetaxel (100 mg/m(2) by 1 hour i.v. infusion, q3 weeks) activity and toxicity was explored in 56 anthracycline-pretreated patients eligible: 55; median age: 51 years [range: 28-68 years]; median performance status: 0 [range: 0-3] with metastatic breast cancer. using two different granulocyte colony-stimulating factor and steroid pre- and post-medication schedules. Twenty-nine patients (group A) received a 5-day oral prednisone premedication, and 26 (group B) received 9-day low-dose i.m, dexamethasone; group B patients also received prophylactic granulocyte colony-stimulating factor. All patients were evaluable for toxicity and 53 for response. Prophylactic granulocyte colony-stimulating factor significantly lowered the incidence of grade III-IV neutropenia and neutropenic fever (p = 0.0001 and 0.01, respectively). The incidence of moderate-severe fluid retention syndrome was lower in patients receiving i.m. dexamethasone (p = 0.08). Overall response rate was 53% (4 complete responses/24 partial responses, 95% confidence interval 39.4-66.2%)1 32% have stable disease and 15% progressive disease. In 21 anthracycline-refractory/resistant patients. as well as in 10 paclitaxel-pretreated patients, the overall response rate was 50%. Docetaxel is highly active in anthracycline- and paclitaxel-pretreated metastatic breast cancer, with manageable toxicity. Optimal use of both granulocyte colony-stimulating factor support and steroid premedication deserves further investigation.