Long-Term Data from a Landmark Phase III Trial Show Survival Benefit at Three- and Four-Years in Patients with Glioblastoma ...( LOS ANGELES Oct. 30 /- Schering-P...),Health

LOS ANGELES, Oct. 30 /PRNewswire-FirstCall/ -- Schering-Plough Corp. and the European Organisation for the Research and Treatment of Cancer (EORTC) announced long-term follow-up results from the landmark Phase III trial conducted by the EORTC and the National Cancer Institute of Canada (NCIC) that showed the combination of TEMODAR (R) chemotherapy (temozolomide) Capsules and radiation therapy significantly prolonged survival in patients with glioblastoma multiforme (GBM) versus radiation treatment alone and that a survival benefit remains with longer follow up. These data were presented at the 49th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO).

"In 2004, the data demonstrated that temozolomide therapy, taken during and following radiation, offers significantly greater median overall survival than radiotherapy alone (14.6 versus 12.1 months, p less than 0.0001)," said Dr. Rene-Olivier Mirimanoff, professor and chairman, Department of Radiation Oncology, University Hospital, Lausanne, Switzerland. "With longer follow-up, the data continue to show patients benefit from the combined therapy with potential increased long-term survival outcomes."

In the study, the two-, three- and four-year survival rates for the combination temozolomide/radiation therapy compared to radiation therapy alone were respectively 27.2 percent versus 10.9 percent, 16.0 percent versus 4.4 percent and 12.1 percent versus 3.0 percent.

"In 2004, the addition of temozolomide to radiotherapy demonstrated a statistically significant survival benefit with an oral therapy that has very acceptable toxicity and a favorable benefit-risk profile," said Robert J. Spiegel, M.D., FACP, Chief Medical Officer and Senior Vice President, Schering-Plough Research Institute. "These follow-up survival findings should provide further hope for patients and physicians fighting this terrible disease."

In the study, 573 patients were randomized between
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