In the CCTG trial, more than 560 patients aged 65 and older with advanced glioblastoma were randomly assigned to receive either short-course radiation alone or radiation plus temozolomide, given both at the same time (concurrent) and for an additional 12 rounds after radiation (adjuvant).Median overall survival in patients treated with both radiation and temozolomide was 9.3 months, compared with 7.6 months in patients who received radiation therapy alone.
The researchers also identified a group of patients for whom the addition of temozolomide was especially beneficial: Patients whose tumors have an alteration of the gene, known as promoter methylation, had an overall survival of 13.5 months compared with 7.7 months in patients with the alteration who received only radiation therapy. The trial enrolled only patients whose tumors lack the 1p/19q co-deletion, a molecular alteration in chromosomes 1 and 19 that is commonly seen in patients with some low-grade gliomas, named anaplastic oligodendroglioma.
Patients whose tumors have the 1p/19q co-deletion have a better prognosis and respond better to chemotherapy than patients whose tumors lack the alteration, explained the trial’s lead investigator, Martin van den Bent, M.
The trial, led by the Canadian Cancer Trials Group (CCTG), focused on patients over the age of 65. Perry explained, and overall incidence of the disease has been creeping up in recent years.
This is an important group of patients, said the trial’s leader, James Perry, M. A pivotal 2005 trial showed that temozolomide can improve how long patients with glioblastoma live.
In addition to improving survival, both trials resolved important questions about whether specific groups of patients benefit from receiving temozolomide, said Mark Gilbert, M. “These are important studies in the brain cancer field,” he said.
Improved Survival in Older Patients with Glioblastoma One of the trials tested the regimen in patients with glioblastoma, one of the most aggressive types of brain cancer.
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Both trials showed that administering the chemotherapy drug temozolomide (Temodar®) in addition to radiation therapy increased how long patients lived overall and without their disease progressing.
The trial investigators and other leading brain cancer researchers agreed that the results of the two trials will change the standard of care.
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