Dose Finding Trial

Johnson et al. (33) demonstrated the clinical activity of pegfilgrastim and confirmed the unique biologic behavior of this self-regulating molecule in patients with lung cancer. It was in breast cancer, however, that further development of pegfilgrastim occurred.

Doxorubicin and docetaxel are, arguably, the most effective antineoplastic drugs currently available for breast cancer. The combination of doxorubicin 60 mg/m2 administered by bolus iv followed by docetaxel 75 mg/m2 iv over 1 h repeated every 21 d produced a response rate of nearly 70% in patients with metastatic breast cancer with limited prior therapy (28). However, grade 4 myelosuppression occurred in 70% of patients, lasting a median of 5 d (range: 1-13 d), and the incidence of FN was 38%.

Based on the American Society of Clinical Oncology (ASCO) clinical practice guidelines for the use of hematopoeitic growth factors, an incidence of FN > 40% was an indication for primary prophylaxis with granulocyte growth factors (30). A once-per-cycle granulocyte growth factor would allow patients the potential benefits of this regimen without the consequences of such a high rate of FN and without the need for daily injections of filgrastim. Thus, this regimen was chosen for the evaluation of pegfilgrastim.

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