DNAprint Genomics (DNAG)

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Striking on our turf????

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http://www.newsday.com/business/printedition/ny-bzmed094296546jun09,0,5491341.story?coll=ny-business....

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An RX just for you
Personalized tests and drugs, instead of one-size-fits-all treatment, is wave of the future, experts say

BY KATHLEEN KERR
STAFF WRITER

June 9, 2005

When Donna Delfyett-White, a Queens assistant high school principal, found a cancerous lump in her breast last year, she started researching treatment options.

After doctors diagnosed Delfyett-White, 48, with Stage 2 breast cancer, tests showed it was a type that would not respond to Tamoxifen, a drug that can help prevent reoccurrences of the disease.

The feisty educator had a mastectomy to remove two tumors at North Shore University Hospital in Manhasset and soon became acquainted with the complicated world of personalized medicine - the use of blood and tissue tests to find gene mutations that will help match patients to the drugs most likely to work for them.

In years to come, personalized medicine is expected to spur important changes in the pharmaceutical industry.

Tests of Delfyett-White's tumors revealed a genetic mutation that put her in a small group of women - 20 to 30 percent - whose breast tumors produce high levels of a protein, HER2, associated with metastatic breast cancer.

The kind of cancer Delfyett-White has responds to Herceptin, a drug approved by the Food and Drug Administration in 1998 and made by California-based Genentech.

"I had no idea there was more than one kind of breast cancer," said Delfyett-White, who lives in Bayside with her husband and two children.

"I thought everybody got Tamoxifen," she said, silver bracelets jangling, in her office at The Newcomers High School in Long Island City, where she oversees health, physical education and guidance.

Delfyett-White enrolled in a clinical trial at North Shore and after traditional chemotherapy began receiving Taxol and Herceptin, a cutting-edge drug that fits the personalized medicine mold.

Personalized medicine is the wave of the future, experts say. It is also referred to as pharmacogenomics or pharmacogenetics.

"It's the way medicine is going," says Dr. Roy Herbst, chief of thoracic oncology at the M.D. Anderson Cancer Center in Houston. "If we're really going to be effective in cancer the way everyone wants, my feeling is the only way to do it is to use these targeted approaches."

Increasingly, pharmaceutical houses are focusing on drugs tailored to work in smaller groups of patients rather than widely prescribed blockbusters. One-size-fits-all drugs may lose their luster, especially for cancer patients with tumors that resist certain medications. And it is hoped new tests will help spare patients from drugs that may cause side effects while doing little to defeat their diseases.

"It's a much more rational way of treating cancer," says Dr. Lora Weiselberg, Delfyett-White's oncologist and chief of North Shore's breast cancer service. "We didn't appreciate the differences [between tumor types] in the past."

The need for tests that predict which drugs will benefit individual patients could also spur new diagnostic businesses and help older ones grow.

And such tests could mean important changes in medical care, said Dr. Lawrence Lesko, director of the Food and Drug Administration's Office of Clinical Pharmacology and Biopharmaceutics.

For example, Lesko said, the FDA recently approved a test that can tell whether some drug dosages for certain patients should be higher or lower, depending on their metabolic rates.

One company, Perlegen Sciences of Mountain View, Calif., is searching for genetic mutations that affect patients' responses to drugs.

"This is where the future's going," said Perlegen senior vice president Paul Cusenza.

Dr. Pam Klein, senior director of oncology for Genentech, said there are already two tests to check women's responsiveness to Herceptin. But Klein warned that developing such tests is difficult and the research can be tedious.

"Herceptin is the gold standard that is so beautiful, but when you look at the whole story, it's not going to be that easy," Klein said.

The drug Tarceva, developed by Long Island's OSI Pharmaceuticals in cooperation with Genentech, is a case in point.

In November, the Food and Drug Administration approved Tarceva for treatment of nonsmall-cell lung cancer in those who have undergone chemotherapy to no avail. Clinical trials showed Tarceva's median increase in life extension was about two months.

A test would be useful to tell exactly which patients would respond best to Tarceva.But right now, there is no approved test.

"I think there's going to be a lot of progress down this road," said Colin Goddard, OSI's chief executive. "With Tarceva, although it's a target therapy, it appears to be a lot more complicated."

Goddard says targeting subsets of a disease in small groups of people could help streamline research and speed up the process of bringing drugs to market. Later, broader uses may be found for the same drugs.

Tarceva has proven effective where a similar lung cancer drug, AstraZeneca's Iressa, failed to extend life. But despite fears that AstraZeneca's investment in Iressa would be lost, the company hopes to find a new market. In some cancer patients of Asian descent with genetic mutations and in people who have never smoked, data suggests Iressa can extend life.

The Iressa experience illustrates one hope for personalized medicine - that some people will benefit from drugs that don't work in others.

Still, Dr. Roman Perez-Soler, chairman of the oncology department at Montefiore Medical Center in the Bronx, predicts slow growth for personalized medicine.

"I think at this point we have a vision," Perez-Soler said. "It's a vision that tells you more or less where we are going but it's hard to define exactly where."

Personalized medicine offers no guarantees, at least not yet.

About a month ago, Delfyett-White, the Queens school principal, developed heart failure, an expected result in about 4 percent of Herceptin users, and was forced to stop using the drug.

A June 2 heart scan showed Delfyett-White's heart has improved but is not back to normal. She can't resume Herceptin for now but is grateful for the 31 weekly infusions she had.

"I'm putting things in perspective and thankful for what I had," Delfyett-White said.
Copyright 2005 Newsday Inc.

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