The Food and Drug Administration on Wednesday approved the first new chemotherapy for brain tumors in 20 years, a drug called Temodar designed for adults whose anaplastic astrocytomas have failed treatment.
"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 tested 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.
Temodar, known chemically as temozolomide, is an oral form of chemotherapy. Patients would take pills at home for five days a month every month until their tumors seem to stop responding.
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. These rapidly growing, hard-to-treat tumors typically kill within two to three years of diagnosis.
Temodar is one of a new class of cancer drugs. Schering-Plough Corp. tested it against anaplastic astrocytomas in patients who relapsed despite surgery, radiation and other chemotherapy.
Twelve of 54 patients -- a fairly impressive 22 percent -- had their tumors significantly shrink or temporarily disappear, the FDA said.
The study was tiny and did not compare Temodar to older chemotherapies, so it's hard to say whether the treatment will prove better than other cancer drugs that doctors now try as last-ditch efforts. But Yung said he believed that was a better response than doctors get other alternatives plus it's easier to take.
Not only can patients take the pills at home, but side effects proved milder than for many chemotherapies. The most common reactions were mild nausea and vomiting, headaches and mild immune suppression. Schering-Plough Corp. said side effects were severe in less than 10 percent of patients, and the FDA said most patients had their immune systems recover without having to delay treatment.
Even for those people Temodar helped, it's not a cure, Yung stressed.
But the median duration of Temodar's effect was 12 and 1/2 months, meaning half of patients began relapsing sooner but half lasted longer.
One of Yung's patients, 59-year-old Larry Sager of Beaumont, Texas, has seen his tumor stop growing for a full 1 and 1/2 years after surgery, radiation and a type of surgically implanted chemotherapy patch all failed.
"I wouldn't be here if it wasn't for" Temodar, Sager said Wednesday. "When I asked him (the doctor) my options, he said not to do anything, and then I'd have two months. That wasn't for me."
Other than slight constipation the five days a month that he takes Temodar, "I had no side effects whatsoever, Sager said.
Temodar, "as a lower toxicity drug, is of paramount importance to these patients," said Naomi Berkowitz, executive director of the American Brain Tumor Association.
Temodar will be available next month, Schering said. Dosage varies according to patients' size, but company figures suggest the average treatment will cost about $1,500 a month wholesale.
Written By Lauran Neergaard