Docetaxel in 253 previously treated patients with progressive locally advanced or metastatic breast cancer: Results of a compassionate use program inThe Netherlands

The aims of this study were to evaluate the efficacy and safety of docetaxe l (Taxotere(R)) in patients with progressive locally advanced or metastatic breast cancer, previously treated with at least one chemotherapy regimen, and the effect of the number of previous chemotherapy lines on response rat e, progression-free survival and overall survival. Two-hundred and fifty-th ree patients from 10 hospitals in The Netherlands received docetaxel as par t of a compassionate use program. The majority had received prior anthracyc line-containing chemotherapy (84.2%). The recommended starting dose was 100 mg/m(2) i.v. every 3 weeks. All patients received corticosteroid premedica tion. Two-hundred and thirty patients were evaluable for response. The over all response rates (ORR) to docetaxel when used as second-, third- or fourt h-line treatment were, respectively, 40.2, 26.0 and 34.6% (p value 0.30). T he median progression-free survival for this population was 4.9 months and the median overall survival of the whole group was 8.5 months, and both wer e not related to the number of previous chemotherapy regimens (p value, res pectively, 0.71 and 0.16). The toxicity of docetaxel was manageable and neu tropenia was the most frequently noted toxicity. This study confirms that d ocetaxel is an active cytotoxic agent in pretreated patients with progressi ve locally advanced or metastatic breast cancer and is still active when us ed as third- or fourth-line treatment. [(C) 2000 Lippincott Williams & Wilk ins.].