Andre Goy, M.D., M.S., Deputy Director and Chief, Lymphoma and Director, Clinical and Translational Cancer Research, John Theurer Cancer Center, and colleagues analyzed data from the phase II pivotal trial of pralatrexate (known as the PROPEL study) -- which led to the FDA approval of pralatrexate in September 2009.
The goal of the study was to determine the outcome of the subset of patients with Peripheral T-Cell Lymphoma (PTCL) who had previously received and failed or relapsed after ICE chemotherapy. ICE is a combination of ifosfamide, carboplatin and etoposide, currently used as standard salvage therapy in patients with PTCL in preparation of high dose therapy followed by autologous stem cell transplantation.
PTCL is an especially aggressive cancer that attacks immune cells that protect the body from viruses. It is typically resistant to second-line treatments, such as ICE regimens.
Forty percent of study patients treated with pralatrexate showed a partial or complete response. The authors concluded that the efficacy of this medication as a standalone treatment compared favorably to ICE-based regimens.
"Given the results, we will continue to explore the role of pralatrexate in combination with other agents to build upon its single agent activity. Our investigation will include PTCL patients in relapse and in the frontline setting in an effort to improve outcomes," said Dr. Goy.
This research was presented at the annual meeting of the American Society of Hematology (ASH) taking place December 4-7, 2010 in Orlando, Florida.
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