Adding the drug temozolomide (Temodar®) to radiation therapy for the treatment of a brain tumor called glioblastoma multiforme increased survival in a large randomized trial conducted in Canada and Europe. While this approach has been customary in the United States for several years, these findings are definitive and should establish this approach as the standard of care.
American Society of Clinical Oncology (ASCO) annual meeting, New Orleans, June 7, 2004.
Glioblastoma multiforme, the most common and most aggressive form of brain cancer in adults, is considered incurable. Most patients die within a year of diagnosis. In the United States, most physicians have been treating these patients with radiation followed by temozolomide, based on promising early studies of the drug.
The trial presented at ASCO included 573 patients who were randomly divided into two groups. One group received radiation following biopsy or surgery. In the other group, patients received temozolomide daily, beginning at the same time they started radiation therapy and continuing for six weeks following radiation.
Roger Stupp, M.D., of University Hospital in Lausanne, Switzerland, led the trial, which was coordinated by the European Organization for Research and Treatment of Cancer and the National Cancer Institute of Canada Clinical Trials Group.
After two years, 26 percent of patients taking temozolomide were alive compared to just 10 percent of those who had radiation only. The median survival in the radiation-plus-temozolomide group was 14.6 months compared to 12.1 months in the radiation-alone group. Progression-free survival - the amount of time before the tumor began to grow again - was 7.2 months in the temozolomide group and 5 months in the other group.
The side effects of the combined therapy were mostly mild to moderate. Fewer than 10 percent of patients experienced a severe drop in blood counts and only three developed severe infections.
This trial enrolled only those participants who were under 70 years of age and who were in good overall health, noted Michael Prados, M.D., of the University of California, San Franciso, who commented on the presentation at ASCO. This suggests, he said, that the results might not be applicable to all patients with glioblastoma multiforme.
There are a couple of questions left unanswered by this trial, according to Howard A. Fine, M.D., of the National Cancer Institute’s Center for Cancer Research. For example, he said, it is unclear whether the survival benefit arose from the low-dose temozolomide given during radiation, from the post-radiation temozolomide that was given for six months, or from both. Previous studies had found a benefit only from post-radiation chemotherapy, but this trial was not designed to answer that question.
Additionally, most other trials that have found a benefit to post-radiation temozolomide have treated patients for a year, he said; this trial treated patients for six months, so it is unknown whether longer treatment would have resulted in even greater benefit.
The trial demonstrates that temozolomide used during and/or after radiation is effective as a first-line treatment of the disease. "The findings will probably change the standard of care," said Stupp, an assessment with which Fine agrees. However, said Fine, "we have a long way to go" in developing clearly superior treatments for patients with this difficult disease.
Posted by the National Cancer Institute
June 7, 2004
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