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Drug boosts survival in major skin cancer study

CHICAGO — Researchers have scored the first big win against melanoma, the deadliest form of skin cancer. An experimental drug significantly improved survival in a major study of people with very advanced disease.

The results, reported Saturday at a cancer conference, left doctors elated.

"We have not had any therapy that has prolonged survival" until now, said Dr. Lynn Schuchter of the Abramson Cancer Center at the University of Pennsylvania, a skin cancer specialist with no role in the study or ties to the drug's maker.

The drug, ipilimumab, (ip-ee-LIM-uh-mab), works by helping the immune system fight tumors. The federal Food and Drug Administration has pledged a quick review, and doctors think the drug could be available by the end of this year.

"People are going to have a lot of hope and want this drug, and it's not on their doctors' shelves," although some may be able to get it through special programs directly from its maker, Bristol-Myers Squibb Co., Schuchter said.

Melanoma is the most serious form of skin cancer. Last year in the United States, there were about 68,720 new cases and 8,650 deaths from the disease. Worldwide, more than 50,000 people die of melanoma each year.

"The incidence is rising faster than any other cancer," said one of the study's leaders, Dr. Stephen Hodi of Dana-Farber Cancer Institute in Boston. "When it spreads to vital organs, it's almost always fatal."

The study involved 676 people around the world with advanced, inoperable melanoma who had already tried other treatments — a very grim situation. They were given one of three treatments: ipilimumab by itself, with another immune-stimulating treatment, or the immune-stimulating treatment alone.

After two years, 24 percent of those given the drug alone or in combination were alive, compared with 14 percent of those given just the immune-stimulating treatment.

Average survival was 10 months with ipilimumab and just over six months for the others, which worked out to a 67 percent improvement in survival for those on the drug, said one of the study's leaders, Dr. Steven O'Day of the Angeles Clinic and Research Institute in Los Angeles.

Doctors hope the drug can provide more benefit if given earlier in the course of the disease and to less sick patients.

Ten percent to 15 percent of patients on ipilimumab had serious side effects related to the drug's actions on the immune system. Most were treatable with high doses of steroids, but 14 deaths were thought to be related to the treatment. That's still far fewer than the number of deaths due to the cancer.

A spokeswoman said Bristol-Myers has not yet set a price for the drug, but similar treatments for other cancers cost several thousand dollars a month or more.

Lung cancer drug tested

An experimental drug for lung cancer patients with a certain gene showed extraordinary promise in early testing, doctors reported at a cancer conference on Saturday. More than 90 percent of the 82 patients in a study saw their tumors shrink after two months on the drug, Pfizer Inc.'s crizotinib, (crih-ZAH-tin-ib), researchers reported. Doctors expected only about 10 percent of these very sick patients to respond to the drug, according to one study leader, Dr. Yung-Jue Bang of the Seoul National University College of Medicine in South Korea. Pfizer sponsored the study. The company hopes to seek federal Food and Drug Administration approval for the drug next year.

Midlife suicides increase

A troubling and unexpected rise in suicides among middle-aged Americans has continued to increase, according to new figures from the federal Centers for Disease Control and Prevention. Historically, people 80 and older had the highest rates of suicide in the United States. Starting in 2006, however, the suicide rate among men and women between the ages of 45 and 54 was the highest of any age group — a suicide rate of 17.6 per every 100,000 people. The 75-to-84 age range had a rate of 16.4, followed by those between 35 and 44, with a 16.3 percent rate. Researchers are puzzled by the increase. Men are more than three times as likely to commit suicide as women.

Drug boosts survival in major skin cancer study 06/05/10 [Last modified: Saturday, June 5, 2010 10:07pm]

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