U.S. approves new brain chemotherapy

WASHINGTON -- Patients who fail therapy for a particularly deadly brain tumor are about to get a new option that may extend their life a few more months. The government yesterday approved the first new chemotherapy for brain tumors in 20 years.

Temodar, known chemically as temozolomide, is an oral form of chemotherapy for adults with anaplastic astrocytomas, giving patients the ability to be treated by taking pills at home.

"Temodar is not a wonder drug . . . not the cure drug that we're looking for," cautioned Dr. Alred Yung, oncology chairman at M.D. Anderson Cancer Center, who helped test the drug.

"But it's better than what we have had," because patients can take Temodar at home with fewer side effects than many alternatives, he said.

Some patients can experience mild nausea and vomiting, headaches and immune suppression. But manufacturer Schering-Plough Corp. said side effects were severe in less than 10 percent of patients, and the FDA said most patients had their immune system recover without needing treatment delays.

About 18,000 brain tumors are diagnosed in the United States each year. Anaplastic astrocytomas are one of the worst kinds, accounting for 2,000 to 3,000 new cases a year. They are rapidly growing tumors that are hard to treat, and patients typically live two to three years after diagnosis.

When initial surgery, radiation or chemotherapy failed, these patients have had few options, Yung said.

Temodar is one of a new class of cancer drugs, and can pass through the blood-brain barrier fairly easily. So Schering tested it against anaplastic astrocytomas in patients who had relapsed.

Twelve of 54 patients -- a fairly impressive 22 percent -- had their tumors significantly shrink or temporarily disappear, the Food and Drug Administration said.

The study was tiny and did not compare Temodar to older chemotherapies, so it's hard to say just how effective it is vs. alternatives. But Yung said he believed that was a better response than doctors get from other, older drugs.

Even for those people Temodar helped, it's not a cure, he stressed. But the median duration of Temodar's effect was 12.5 months.

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