Kennedy brain tumor puts spotlight on new treatment

News of Sen. Edward Kennedy's diagnosis with a malignant glioma shocked the nation. It has also raised awareness about the grim prognosis associated with this type of brain tumor. A new study conducted by the American College of Radiology's Radiation Therapy Oncology Group could bring hope to glioma patients.

Kennedy (D-MA) began undergoing surgery Monday morning at Duke University Medical Center, where he will remain for a week before returning to Massachusetts General Hospital for further treatment.

Malignant gliomas account for more than half of the nearly 20,000 new primary malignant brain tumors diagnosed each year in the U.S., according to the National Cancer Institute. Prognosis is poor, and patients with the most aggressive form die within a year. Surgical resection and radiation therapy remain the standard of care.

A study published in June 2004, however, showed that combining radiation therapy with the drug temozolomide could add a survival benefit. The drug changed the management landscape. Kennedy will likely receive temozolomide, according to news reports citing Dr. Otis Brawley, chief medical officer of the American Cancer Society.

A new study conducted by the RTOG, a clinical research component of the ACR, could establish whether high doses of temozolomide after radiotherapy can improve the outcomes for patients with newly diagnosed malignant glioma.

"Researchers, both in the U. S. and abroad, have been very enthusiastic about this study," said RTOG Chair Dr. Walter J. Curran Jr. "The rate of patient enrollment has exceeded our expectations, due in part to the strong desire of the entire oncology community to find improved treatment options for patients with this serious disease."

The trial will enroll about 1150 patients with malignant glioma at 217 sites throughout the U.S., Canada, Europe, and Israel. The study goal is to find out whether an increased dose of temozolomide each month, in comparison with the standard dosage, improves patient outcome. The study also seeks to determine the possible side effects that the longer drug schedule might have on patients. The trial is expected to close to patient accrual in mid-June, when researchers will start distilling its data, said Curran, who is also chair of the radiation oncology department at Emory School of Medicine.

Enrolled patients take a daily dose of temozolomide orally during radiotherapy. After completion of radiotherapy, patients randomly receive either the standard temozolomide treatment schedule (once a day for five days every four weeks for up to one year) or the longer schedule (once a day for 21 days every four weeks for up to one year). Patients undergo MRI or CT exams at regular intervals to assess tumor size and treatment effect.

Correlative laboratory studies have shown a link between tumor O-6-methylguanine-DNA methyltransferase (MGMT) gene expression and treatment response. The RTOG will thus also examine the relationship between methylated gene status and temozolomide dose on survival. The researchers will follow these patients for life.

The European Organisation for Research and Treatment of Cancer is a cosponsor of the four-year trial, which has been funded by the NCI.

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