Both studies met the primary objective of demonstrating that the mean days of severe neutropenia of Neulasta®-treated patients did not exceed that of Filgrastim-treated patients by more than one day in cycle 1 of chemotherapy (see Table 1). The rates of febrile neutropenia in the two studies were comparable for Neulasta® and Filgrastim (in the range of 10% to 20%). Other secondary endpoints included days of severe neutropenia in cycles 2–4, the depth of ANC nadir in cycles 1–4, and the time to ANC recovery after nadir. In both studies, the results for the secondary endpoints were similar between the two treatment groups.

Table 1. Mean Days of Severe Neutropenia (in Cycle 1)

Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m² administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928 patients were randomized to receive a single subcutaneous injection of Neulasta® 6 mg or placebo on day 2 of each chemotherapy cycle. Study 3 met the primary objective of demonstrating that the incidence of febrile neutropenia (defined as temperature ≥ 38.2°C and ANC ≤ 0.5 x10⁹/L) was lower for Neulasta®-treated patients as compared to placebo-treated patients (1% versus 17%, p < 0.001). The incidence of hospitalizations (1% versus 14%) and IV anti- infective use (2% versus 10%) for the treatment of febrile neutropenia were also lower in the Neulasta®-treated patients compared with the placebo-treated patients.

REFERENCES

1.   Morstyn G, Dexter T, Foote M. Filgrastim (r-metHuG-CSF) in clinical practice. 2nd ed. 1998;3:51-71.

2.   Valerius T, Elsasser D, Repp R, et al. HLA Class-II antibodies recruit G-CSF activated neutrophils for treatment of B-cell malignancies. Leukemia and Lymphoma. 1997;26: 261-269.

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