Large community-based clinical trial in older cancer patients suggests benefits of Neulasta®

05/16/05

ORLANDO, Fla., (May 15, 2005) – Amgen Inc., (NASDAQ: AMGN) the world's largest biotechnology company, today announced that an initial report from a study of 701 older cancer patients with solid tumors demonstrates Neulasta® (pegfilgrastim) administered beginning in the first cycle of myelosuppressive chemotherapy resulted in reductions in febrile neutropenia (low white blood cell count with fever) and related complications, compared to those who received Neulasta in later chemotherapy cycles after developing a low white blood cell count. The study results were presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). [Abstract #8111]

"Despite the fact that more than 60 percent of cancers are diagnosed in patients 65 years or older, these patients may be under-represented in clinical trials and may also be under-treated, partly due to concern over treatment side effects, such as neutropenia, which may lead to hospitalizations and dose delays or reductions," said Lodovico Balducci, M.D., professor of medicine and oncology, University of South Florida College of Medicine, and division chief of the Senior Adult Oncology Program at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla. "This is the largest, prospective study of older patients demonstrating the feasibility of community-based clinical trials in these patients, as well as the ability of these patients to undergo myelosuppressive chemotherapy."

The study showed a decrease of approximately 60 percent in the incidence of febrile neutropenia across all cycles (4 percent versus 10 percent, respectively), as well as a 50 percent decrease in chemotherapy dose reductions (7 percent versus 14 percent) in patients receiving Neulasta beginning in the first cycle of chemotherapy compared to those who received Neulasta in later cycles. Febrile neutropenia, the primary endpoint of the study, was defined as an absolute neutrophil count (ANC) < 1 x 109/L and temperature = 38°C. Further, patients receiving Neulasta in the first cycle of chemotherapy experienced almost half the number of neutropenia-related hospitalizations (5 percent versus 9 percent) and a decrease in antibiotic use due to neutropenia compared to those who received Neulasta in later cycles.

The 701 older patients (65 years and older) with lung, breast or ovarian cancer in this study were randomized to receive Neulasta in the first cycle of myelosuppressive chemotherapy (n=349) or Neulasta in second and subsequent chemotherapy cycles at the physician's discretion (n=352).

In this study, serious adverse events were reported less frequently in patients receiving Neulasta in the first and subsequent cycles of chemotherapy than in the group receiving second and subsequent cycle Neulasta. The most frequently reported serious adverse events were febrile neutropenia, neutropenia, pneumonia and dehydration.

Source: Eurekalert & others

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