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 avoidab le 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 an thracycline-pretreated patients eligible: 55; median age: 51 years [range: 28-68 years]; median performance status: 0 [range: 0-3] with metastatic bre ast cancer. using two different granulocyte colony-stimulating factor and s teroid pre- and post-medication schedules. Twenty-nine patients (group A) r eceived a 5-day oral prednisone premedication, and 26 (group B) received 9- day low-dose i.m, dexamethasone; group B patients also received prophylacti c granulocyte colony-stimulating factor. All patients were evaluable for to xicity and 53 for response. Prophylactic granulocyte colony-stimulating fac tor significantly lowered the incidence of grade III-IV neutropenia and neu tropenic fever (p = 0.0001 and 0.01, respectively). The incidence of modera te-severe fluid retention syndrome was lower in patients receiving i.m. dex amethasone (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/resista nt patients. as well as in 10 paclitaxel-pretreated patients, the overall r esponse rate was 50%. Docetaxel is highly active in anthracycline- and pacl itaxel-pretreated metastatic breast cancer, with manageable toxicity. Optim al use of both granulocyte colony-stimulating factor support and steroid pr emedication deserves further investigation.