Annals of Oncology 13:286-292, 2002
© 2002 European Society for Medical Oncology
Phase II study of weekly docetaxel in patients with metastatic breast cancer
Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan
Received 17 May 2001; revised 16 August 2001; accepted 5 September 2001.
Background
This study was conducted to investigate the efficacy and toxicity of weekly docetaxel administration in patients with metastatic breast cancer.
Patients and methods
Thirty-seven women were treated with 1 h infusions of docetaxel at 40 mg/m2/week after pre-medication with 8 mg dexamethazone. Each cycle consisted of three consecutive weekly treatments followed by a 1 week rest. All patients were assessed for toxicity; five patients were not assessable for clinical response, time to progression (TTP) and overall survival (OS) because of early treatment failure, but they were included in intention-to-treat analysis.
Results
Patients received a median of four cycles (range, 1–9), with a median dose intensity of 28 mg/m2/week (range 22–30) and a median relative dose intensity of 0.95 (range 0.73–1.0). No patients showed complete response, whereas 14 had partial response, which accounted for 38% of objective response rate [95% confidence interval (CI) 22% to 53%]. In addition, three patients (8%, 95% CI 0% to 17%) had stable disease over 6 months. Clinical responses were achieved at a median of three cycles (range 1–4 cycles). The median TTP and OS were 5 and 12 months, respectively. The weekly docetaxel regimen was generally well tolerated. About half of the patients experienced grade 
1 neutropenia; only 19% had grade 3/4 neutropenia, including one case of grade 4. No febrile neutropenia was observed and fluid retention syndrome was uncommon. Non-hematologic toxicity, however, such as asthenia/fatigue, nail damage, tearing or hearing disorders, was seen with successive treatment cycles.
Conclusions
Weekly docetaxel at 40 mg/m2/week is an active and feasible regimen for patients with metastatic breast cancer.
Key words: breast cancer, chemotherapy, docetaxel, phase II
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