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Few types of cancers have screening tests

Dr. Madeline Pugliese at her pediatrics office in

Dr. Madeline Pugliese at her pediatrics office in Port Washington. (Jan. 18, 2011) Credit: Newsday / Alejandra Villa

Sixty years ago, scientists who had toiled for decades produced the nation's first early-detection cancer screening, fueling hope that the disease is less of a threat when spotted early.

That simple screening, the Pap test, produced in 1948, has transformed cervical cancer from the No. 1 cause of cancer deaths in women to 13th. Yet today, only three other forms of cancer - breast, prostate and colorectal - have similar screenings.

As for lung cancer, medical investigators proved two months ago that annual CT scans of smokers and former smokers can spot lung tumors early in their evolution, but it's unclear how widely used the test will become. For virtually all other cancers, including ovarian and pancreatic - two rare and deadly ones - early detection remains a dream deferred.

Efforts have been under way for years to find screenings for both, but the slow pace and high cost of scientific innovation, and the U.S. Food and Drug Administration's rigorous regulatory process, have pushed the possibility well into the future.

Doctors say deaths from ovarian cancer could sharply decline through early detection just as they plummeted with widespread testing for cervical malignancies.

"We want to screen people before they become symptomatic with ovarian cancer because 80 percent of women are diagnosed after the disease has already spread," said Dr. John Lovecchio, chief of gynecologic oncology at the North Shore-Long Island Jewish Health System.

The Office of Rare Diseases at the National Institutes of Health considers ovarian cancer a rare affliction because it affects only 25,000 women annually. And, with 16,000 deaths annually, it is one of the most lethal.

"We need a test to detect ovarian cancer in large numbers of women that would allow us to intervene in a reasonable amount of time," said Dr. Julia Smith, director of the Breast Cancer Screening and Prevention Program at the NYU Cancer Institute in Manhattan. Breast and ovarian cancers are sometimes linked to the same gene mutations.

Correlogic Systems Inc., a tiny Maryland-based biotechnology company, went into Chapter 11 proceedings six months ago, overburdened by the high cost of trying to bring an ovarian screening to market, its chief executive says.

Peter Levine, who is trying to reorganize the company, said he spent about $22 million on efforts to develop a test called Ovachek, based on protein patterns in the blood that are unique to ovarian cancer. He estimates it will take another $4 million to $5 million to complete additional FDA testing.

"It's one of the clear unmet medical needs," said Levine, a Long Island native, referring to ovarian cancer screening. "My mother died in Huntington Hospital [of ovarian cancer] so I am acutely aware of the seriousness of this disease.

Levine, however, now says the test is not for broad population testing but as an additional diagnostic for women at elevated risk. Two other tests are already available for those patients.

 

Pancreatic cancer undetected

As with ovarian cancer, pancreatic cancer is marked by vague symptoms that often go undetected. Its fatality rate is equally alarming - the one-year survival rate is only 20 percent, and the five-year survival is 4 percent.

"With breast cancer you can feel a lump, but there's nothing like that with pancreatic cancer," said Kerri Kaplan, executive director of the Lustgarten Foundation, America's largest private foundation dedicated solely to funding pancreatic cancer research. The Bethpage-based organization was founded 13 years ago for people with the disease with the help of Cablevision, which owns Newsday. "If all you've got is a stomachache, you're not going to run to the doctor for a cancer test.

She cited research under way, funded by Lustgarten, aimed at developing a screening for the disease.

Pancreatic cancer has strong genetic roots, spreading through some families over several generations. The disease also can occur without a familial link, a form called sporadic.

Pancreatic screening research has faced setbacks.

A snippet of DNA dubbed the palladin gene, hailed four years ago as a leading potential marker of hereditary forms of the disease, has turned out to be of little relevance to most familial forms and has no relevance to sporadic pancreatic cancer, the most common form.

And many medical policy analysts have begun to argue against population-based screenings for a variety of cancers because, they say, the benefits do not outweigh the risks of additional medical procedures.

 

Panel opposes some screenings

The U.S. Preventive Services Task Force, a panel of outside medical experts who advise the federal government on preventive health measures, has cautioned against screenings for ovarian and pancreatic cancers. The panel also recommends against screening for testicular and bladder cancers as well as prostate cancer after age 75. Panelists insist screening for these cancers is not in the public interest.

Dr. Ned Calonge, who chairs the task force, said in screening, "you take a person who is well or asymptomatic and do something to them" - an imaging exam, drawing blood or conducting an invasive procedure, such as a colonoscopy.

With rare cancers, he said, such screening drains health care resources because at least 100 people must be tested for every two cases that are found.

Doctors and advocates, he contends, have not done a good job of analyzing test imperfections - generating false positive and negative readings, for example - and treating slow-growing cancers that are best left alone. What's more, he said, screening doesn't always help.

"Screening simply cannot alter the course of the disease in many people," said Calonge, president and chief executive of The Colorado Trust, a health care nonprofit in Denver. " . . . Now that you have it, you can't do anything about it, but you have consumed health-care resources."

But Dr. Jill Whyte, a gynecologic oncologist at North Shore, says she believes screening is needed to give patients a fighting chance - and that tests for rare cancers must be precise. With respect to ovarian cancer, she said, "You're talking about a disease with a very low prevalence so the test has to be very sensitive to pick up cancers in so few women."

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