Docetaxel in patients with anthracycline-resistant advanced breast cancer

Objective: To better determine docetaxel activity in patients with well-def ined anthracycline-resistant breast cancer. Methods: From October 1996, we carried out a phase II trial in 69 heavily pretreated patients with advance d breast cancer with docetaxel 100 mg/m(2) by a 1-hour infusion on day 1, w ith cycles repeated every 3 weeks. Patients were classified as having prima ry anthracycline resistance (n = 32), secondary anthracycline resistance (n = 7), anthracycline pretreatment (n = 22) or no anthracycline pretreatment (n = 8). Results:Among 68 evaluable patients, we observed 6 (9%) complete r esponses and 27 (40%) partial responses, for an overall response rate of 49 % (95% confidence interval 37-61%); the disease remained stable in 17 patie nts (25%). Responses according to the above subgroups were as follows: prim ary anthracycline resistance 41%, secondary anthracycline resistance 43%, a nthracycline pretreatment 64% and no anthracycline pretreatment 43%. The me dian time to response, median time to progression and median overall surviv al were 2, 7 and 10 months, respectively. Myelosuppression was the dose-lim iting toxicity, with grade 4 neutropenia occurring in 47% of the patients a nd neutropenic fever in 12%. G-CSF was added in the case of grade 4 febrile neutropenia; a 25% reduction in the dose of docetaxel was required in 4 pa tients. Other side effects were mild. Conclusions: The results of the prese nt trial confirm the high activity of docetaxel in heavily pretreated patie nts with advanced breast cancer, including those with strictly defined anth racycline resistance. Copyright (C) 2001 S. Karger AG, Basel.