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A Phase II Study of Three-Weekly Docetaxel and Weekly Trastuzumab in HER2-Overexpressing Advanced Breast Cancer

2004; Karger Publishers; Volume: 66; Issue: 1 Linguagem: Inglês

10.1159/000076333

1423-0232

Filippo Montemurro, Gabriella Choa, R. Faggiuolo, Michela Donadio, Monica Minischetti, Antonio Durando, Antonio Capaldi, Guido Vietti-Ramus, Oscar Alabiso, Massimo Aglietta,

Breast Cancer Treatment Studies

<i>Background:</i> To test safety and activity of 3-weekly doses of docetaxel and a weekly dose of trastuzumab in women with HER2-overexpressing advanced breast cancer. <i>Patients and Methods:</i> Forty-two women, median age 53 years (range 36–73 years), with HER2-overexpressing advanced breast cancer were enrolled in a study of docetaxel, 75 mg/m² q3w for 6 cycles, and trastuzumab, 4 mg/kg loading dose, 2 mg/kg weekly thereafter. Thirty-four patients (81%) had visceral metastatic involvement. Thirty-five patients had received prior chemotherapy as part of their treatment: adjuvant/neoadjuvant (26), metastatic (2) and both (7). Thirty-one patients had been previously exposed to an anthracycline and 11 to paclitaxel. Four patients had previously received high-dose chemotherapy followed by autologous stem cell transplant. <i>Results:</i> 226 cycles (median 6, range 1–6) were administered. The median delivered dose intensity for docetaxel was 24 mg/m²/week (range 16–25 mg/m²/week). The intent to treat overall response rate was 67% (95% confidence interval, 52–79%). Median progression-free survival, time to treatment failure, and duration of response were 9, 8 and 12 months, respectively. Symptomatic cardiotoxicity (grade 3) occurred in 1 patient. The most common grade 3/4 toxicity was neutropenia (76% of the patients), although febrile neutropenia did not occur. <i>Conclusions:</i> Three-weekly doses of docetaxel and a weekly dose of trastuzumab is an active and safe combination in patients with HER2-overexpressing advanced breast cancer.