The trial was conducted by European Organisation for the Research and Treatment of Cancer (EORTC) and the National Cancer Institute of Canada (NCIC). Primary endpoint of the study was overall survival, with secondary endpoints of progression-free survival and quality of life.
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% versus 10.9%, 16% versus 4.4% and 12.1% versus 3%.
In the study, 573 patients were randomized between July 2000 and March 2002. Patients received either focal radiotherapy plus temozolomide at 75mg/meters squared daily continuously for 42 (up to 49) days, followed by up to six cycles of adjuvant temozolomide (150 to 200 mg/meters squared daily for five days every 28 days) or focal radiotherapy alone.
Robert Spiegel, chief medical officer and senior vice president at Schering-Plough Research Institute, said: “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. These follow-up survival findings should provide further hope for patients and physicians fighting this terrible disease.”