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| |  Single Injection Pegfilgrastim Supports Delivery of Dose-Dense Chemotherapy By Danny Kucharsky STOCKHOLM, SWEDEN -- June 7, 2005 -- A single injection of pegfilgrastim effectively supports the delivery of dose-dense chemotherapy in 14-day treatment cycles, according to an analysis of three phase 2 studies. Researchers presented these findings here June 3rd at the 10th Congress of the European Hematology Association (EHA). The results suggest that it is possible to deliver full-dose chemotherapy every 14 days with administration of pegfilgrastim once per cycle, said lead investigator Andreas Engert, MD, Senior Consultant, Department of Internal Medicine, University of Cologne, Cologne, Germany. The researchers also found that 86% of cycles were delivered on schedule at a full dose of chemotherapy and few chemotherapy cycles were delayed or reduced due to neutropaenia. The combined analysis looked at the ability of pegfilgrastim to support chemotherapy delivery in 14-day treatment cycles for six to eight cycles with pegfilgrastim 6 mg support in each cycle. The open-label, multicentre, phase 2 studies enrolled patients with three tumour types -- extensive small cell lung cancer, high-risk Hodgkin's disease and aggressive B-cell non-Hodgkin's lymphoma. Patients received different chemotherapy regimens with different therapeutic objectives. The studies shared key endpoints, that is, the proportion of patients with full chemotherapy doses on schedule, serum pegfilgrastim concentration (measured before chemotherapy administration on day 1 of each cycle) and the incidence of adverse events. Overall, 100 patients received 603 doses on schedule. Few patients delayed chemotherapy because of neutropenia. Among patients in the small cell lung cancer group, thrombocytopenia was the most common reason for delaying chemotherapy. Bone pain of any severity was reported in 33%, but the overall safety profile was similar to that already established with pegfilgrastim or expected with daily pegfilgrastim, Dr. Engert said. The combined analysis also found that 55% of patients received a full chemotherapy dose on schedule. By day 1 of cycles 2 to 6, absolute neutrophil count approximated baseline levels. This indicates that pegfilgrastim was satisfactorily cleared by cycle day 1, with no evidence of pegfilgrastim accumulation, Dr. Engert said. Dr. Engert concluded that pegfilgrastim in 14-day dose dense chemotherapy was well tolerated in the three patient groups studied, with a safety profile similar to that expected with daily pegfilgrastim.
[Presentation title: Single Injection Pegfilgrastim Effectively Supports the Delivery of Dose-Dense Chemotherapy: A Combined Analysis of Three Phase 2 Trials. Abstract 0272]
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