Amgen Inc, a leading biotechnology company, announced data from a phase 3 study showing that administration of Neulasta (pegfilgrastim) in the first and subsequent cycles of chemotherapy significantly lowers the rate of infection, as manifested by febrile neutropenia (low white blood cell count with fever), hospitalization and the use of intravenous anti-infectives in breast cancer patients receiving moderately myelosuppressive (strong) chemotherapy, a release from the company says.

Data from the randomized, double-blind, placebo-controlled study of 928 patients show that first and subsequent-cycle administration of Neulasta resulted in a 94 per cent reduction in the incidence of febrile neutropenia, a 93 per cent reduction in the incidence of hospitalization and an 80 per cent reduction in the incidence of intravenous anti-infective use in patients previously considered at moderate risk for neutropenic complications.

"This study provides compelling evidence that administering Neulasta in the first and subsequent cycles of moderately myelosuppressive chemotherapy can significantly reduce the risk of potentially life-threatening infections that can result in hospitalizations and require IV antibiotics," said Lee Schwartzberg, one of the study's lead investigators and medical director of The West Clinic, Memphis, Tenn. "Approximately 600,000 chemotherapy patients are at risk for developing neutropenia, which has traditionally been treated reactively. Doctors usually reserve proactive use of Neulasta for only those patients considered at very high risk of developing chemotherapy-induced neutropenia," he added.

"This study may give physicians the evidence they need to help protect cancer patients from chemotherapy-induced neutropenic complications beginning in the first cycle of chemotherapy treatment," said Schwartzberg.

Neulasta was well-tolerated in this study. Bone pain was the most frequently observed adverse event in both arms of the study (31 per cent with Neulasta versus 27 percent with placebo). A lower percentage of serious adverse events were reported for Neulasta patients compared with placebo patients (12 per cent versus 24 per cent); this difference was attributable to the lower percentage of febrile neutropenia events reported in Neulasta patients compared with placebo patients.

Neulasta was approved by the US FDA in 2002 for decreasing the incidence of infection, as manifested by chemotherapy-induced neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs with a clinically significant incidence of febrile neutropenia.

The results will be presented Schwartzberg in a plenary session at the Multinational Association of Supportive Care in Cancer (MASCC) Annual Meeting.