Annals of Oncology 15:891-895, 2004
© 2004 European Society for Medical Oncology
Original Paper |
Phase II study of pegylated liposomal doxorubicin (Caelyx®) and docetaxel as first-line treatment in metastatic breast cancer
Received 27 November 2003; revised 28 January 2004; accepted 2 February 2004Background:
The aim of this study was to determine the activity and safety of pegylated liposomal doxorubicin (PLD; Caelyx®) and docetaxel combination as first-line treatment in patients with metastatic breast cancer (MBC).
Patients and methods:
Forty-four patients with a median age of 63 years were treated with PLD 30 mg/m2 (day 1) and docetaxel 75 mg/m2 (day 2) every 3 weeks for six cycles. Recombinant human Granulocyte Colony-Stimulating Factor (rhG-CSF) could be used in patients with grade 
3 neutropenia after the first cycle.
Results:
Forty-two of 44 patients were assessable for response. The response rate (RR) was 64.3% (95% confidence interval 49.8% to 78.8%). Six patients (14.3%) achieved complete response (complete disappearance of all measurable and assessable disease lasting at least 4 weeks, no new lesions, no disease-related symptoms), partial response was observed in 21 patients (50%) (50% decrease of measureable disease lasting at least 4 weeks, no progression of assessable disease, no new lesions, no disease-related symptoms), eight patients had stable disease and seven patients progressive disease. Median disease-free and overall survival were not reached, but were in excess of 17 months (range 6–17 months). Twenty of the patients had received previous adjuvant chemotherapy (10 with epirubicin-containing regimen with a median cumulative dose of 400 mg/m2). Grade 3 neutropenia occurred in 18.4% and neutropenic fever in 9% of patients. Palmar–plantar erythrodysesthesia was observed in four patients. Dose reduction was necessary in seven patients. Two patients discontinued treatment: one due to prolonged grade 3–4 neutropenia and one due to neurotoxicity. No treatment-related deaths occurred.
Conclusions:
The combination of PLD and docetaxel achieved high RRs with acceptable toxicity as first-line treatment in MBC.
First Department of Medical Oncology, St Savvas Anticancer-Oncologic Hospital, Athens, Greece
Key words: docetaxel, metastatic breast cancer, pegylated liposomal doxorubicin
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