Hospital, Lab Receive OK for New Cancer Treatment

A Newport Beach hospital and medical laboratory have jointly received federal approval to offer an expensive and experimental cancer treatment previously available only through research hospitals, officials said Tuesday.

Hoag Memorial Hospital Presbyterian and Pacific Coast Biotherapeutics said they are planning to accept their first patient Thursday for LAK-cell therapy. According to recent medical journal reports, the treatment, which involves the use of fortified cancer-fighting cells or LAK cells, has proven effective against melanoma and kidney cancers, both considered fatal and virtually untreatable by conventional methods.

Dr. Neil Barth, medical director of the laboratory and of the hospital’s oncology program, said the LAK-cell treatment will cost “close to $50,000” per patient. He said about half of that is for hospital costs, which insurance companies have been willing to shoulder. But the rest is for laboratory work, and only about 30% of that is being paid by insurance, Barth said.

He said both the laboratory and the hospital have established endowment funds to help those who cannot afford the cost.

The treatment, which can have serious side effects, provokes the body into awakening its own cancer-fighting apparatus, then artificially intensifies it.

Barth explained that an artificially produced form of interleukin-2, a naturally occurring substance in many mammals’ immune systems, is injected into a patient’s bloodstream over a period of time.

The body responds by rapidly sending “natural killer cells,” part of the normal immune system, into the bloodstream. These cells are in the body all along, but their temporary concentration in the bloodstream allows them to be filtered out with a dialysis-type machine.

These cells are taken to a laboratory where they are cultured and “activated to very high degree of cancer-killing capability,” Barth said. These are the so-called lymphokine-activated killer cells, or LAK cells. They, along with more interleukin-2, are injected back into the patient so they can attack the cancer.

Repeated in a Month

This process, which requires a two-week hospital stay, is repeated after a month’s rest. Then interleukin-2 is injected every three weeks for an additional three to four months.

The goal, Barth said, is complete remission of the cancerous tumor, and studies show that that happens in about 20% to 40% of the cases. Some degree of remission resulted in 50% to 80% of the cases, he said.

Barth added that techniques have improved since the latest studies were conducted, making him certain that remission rates now are considerably higher.

Serious side effects have been reported in earlier LAK-cell treatment--death, in a few cases--but Barth said the interleukin-2 now is introduced much more gradually into the body to reduce unwanted reactions. He said virtually all patients experience symptoms similar to a bacterial, viral or fungus infection--fever, weakness, occasional drops in blood pressure, sometimes mental confusion. He said these effects are temporary.

Death has resulted only when a patient was already suffering from an infection that went undetected during the treatment. He said the interleukin-2 can rapidly intensify the effects of an existing infection, which can become dangerous if not recognized and treated promptly.

Until this week, the only place in California to offer LAK-cell treatment was the City of Hope in Duarte, Barth said.

Hoag and Pacific Biotherapeutics, which began seeking approval from the Food and Drug Administration for their own program last January, received it last Friday.

Proof of Safety Wanted

Barth said FDA has approved only treatment of melanoma and kidney cancer patients. The program will accept only patients considered strong enough to undergo the treatment, he said.

He said LAK-cell therapy is believed to be effective against other types of cancer as well. The FDA has declared that it wants proof of safety and effectiveness against melanoma and kidney cancers before allowing other types to be treated, he said.