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To screen or not to screen?


RandyW

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For Smokers, a Tough Call

Despite New Study, Experts Are Split on Whether the Benefits Of Early CT Screening for Lung Cancer Outweigh the Potential Risks

By Sandra G. Boodman

Washington Post Staff Writer

Tuesday, November 14, 2006; HE01

To screen or not to screen?

That is the question patients -- most of them current or former smokers -- are asking doctors following the publication of a large international study that found that spiral CT scans can detect lung cancer at its earliest and most curable stage.

The results, published last month in the New England Journal of Medicine, have fueled hope that the technology can lead to early treatment of the most common cause of cancer death, as mammography has done for breast cancer.

But the study involving more than 31,000 current and former smokers headed by researchers at Weill Medical College at Cornell University failed to answer a fundamental question: Does screening extend lives or merely find cancer earlier? Because the study did not use a control group, there is no way to tell whether the risks of screening, which include repeated radiation exposure and the possibility of aggressive follow-up treatment, outweigh the benefits of early detection, experts from the American Cancer Society and other groups say.

Therein lies the rub -- and the reason doctors are sharply divided about testing people who don't have symptoms, even for a cancer that kills 85 percent of the 174,000 Americans found to have the disease annually within five years of diagnosis.

Interest in lung cancer screening is growing, experts agree. Some hospitals and radiology clinics in the Washington area offer tests that range from $175 to $800 and are rarely covered by insurance. About 60 percent of hospitals and clinics own CT scanners, which were developed in the 1990s and can detect tumors as small as a grain of rice.

"I think the answer is pretty clear: no," said Ned Patz, a professor of radiology, cancer biology and pharmacology at Duke University Medical Center, when asked about screening. "I'm not saying it won't work, just that there's no solid proof yet that it does."

That's what Patz told his 74-year-old father, a former smoker who has no symptoms but worries about the consequences of his 20-year pack-a-day habit. A more definitive answer, Patz said, must await the outcome of a National Cancer Institute study involving 53,000 current and former smokers. That study, launched in the mid-1990s, is comparing the death rates of patients who received spiral CT scans with those screened with chest X-rays. Results are expected by about 2010.

Radiologist Alex Kladakis says he thinks there's no need to wait. One of 22 physicians at Washington Radiology Associates, among the area's largest radiology practices, Kladakis said that the recent study shows "the proof is really there" and that people over 40 who have smoked the equivalent of a half-pack a day for 15 years should consider being screened. Washington Radiology charges $686 for the non-invasive test, which takes about 30 seconds; a physician's order is required.

To Kladakis, the most persuasive finding in the study, dubbed I-ELCAP (International Early Lung Cancer Action Project), is the survival data. Of the 412 people in the study found to have Stage 1 cancer who underwent surgery, 85 percent were alive five years later; the eight patients who declined treatment were dead. The average five-year survival rate for Stage 1 lung cancer is about 70 percent, according to federal statistics.

"It seems to me those eight are kind of a mini-control group," Kladakis said, adding that requests for lung screenings have increased since the study was published. "Lung cancer is a very, very bad disease," he said. And by the time a patient has symptoms, such as a persistent cough, it usually means the disease is advanced, Kladakis said, citing the example of ABC anchorman Peter Jennings, who died of lung cancer last year.

Wide Interest

Claudia I. Henschke, the researcher who headed the I-ELCAP study, said the study shows that early diagnosis means that a cure is possible. She has said she does not think that a randomized controlled trial, the gold standard in medicine, is necessary to prove the effectiveness of lung CT scans, as do officials at the National Cancer Institute and the American Cancer Society.

Some doctors apparently agree with her. Last week, Nebraska officials announced the nation's first free statewide screening for patients at high risk: those who have smoked for 35 years or two packs a day for 15 years.

"If our effort succeeds, we could help shape lung cancer screening programs across America," said Kenneth H. Cowan, director of the Eppley Institute for Research in Cancer and Allied Diseases at the University of Nebraska Medical Center.

The potential cost of mass screening is enormous. A 2003 study by researchers at Johns Hopkins University estimated that 50 million Americans ages 45 to 75 are current or former smokers. Screening half of them with periodic lung CT scans would cost about $115 billion, the researchers said.

Consumers currently don't have enough information to decide whether screening is a wise choice, said Arthur Levin, director of the New York-based Center for Medical Consumers. "One study is not sufficient. The problem is that in this country we let the marketplace decide this. And because lung cancer is such a major killer, there's going to be a lot of interest in moving this down the road" and many people who say they want the test but may not understand the pitfalls.

CT scans, which are routinely used to stage lung cancer once it has been diagnosed, often pick up nodules, clumps of potentially cancerous tissue, during screening. Their size matters: Smaller nodules are less likely to be malignant than larger ones, experts say. Thoracic experts estimate that as many as 60 percent of smokers and former smokers have lung nodules, Patz said, but people who never smoked also can have them.

Finding a nodule usually triggers a cascade of interventions, starting with a biopsy, which can cause infection, scarring and a collapsed lung. A cancer diagnosis typically results in surgery, often followed by chemotherapy or radiation or both. Doctors have no accurate way of determining which tumors are fast-growing and aggressive and which grow so slowly that patients are likely to die with and not of them, as with some types of prostate cancer.

One Man's Story

Dennis Barry, 51, said he was stunned to learn last year that the scan he underwent as part of the I-ELCAP study at Holy Cross Hospital in Silver Spring turned up a suspicious nodule. Barry, an executive vice president of Donohoe Construction Co., said he enrolled in the study at the suggestion of a relative who works at the hospital. He said he smoked a pack a day from age 15 to age 40, when he quit.

Barry, whose father died of lung cancer at 65 after years of smoking, is one of three people out of approximately 500 screened during the Holy Cross study who were found to have Stage 1 lung cancer, according to oncologist Kashif Firozvi.

Last summer, weeks after the scan, Barry had part of his lung removed, followed by chemotherapy.

"I'm a lucky guy," Barry said. "I think this test saved my life." Two weeks ago, he said, tests showed he was cancer-free.

Laurie Fenton, president of the Lung Cancer Alliance, a Washington-based advocacy group, said that good news like Barry's has been all too rare when it comes to lung cancer.

She said that the findings of the study, which she called "a watershed moment," are so persuasive that her group is advocating screening scans for patients at high risk similar to those in the I-ELCAP study: people older than 50 who are current smokers or who smoked the equivalent of a pack a day for 10 years, and those with significant exposure to secondhand smoke because they grew up in a home with smokers or who were exposed to high levels of radon gas or other known lung carcinogens.

"We have to educate doctors" about the benefits of screening, Fenton said.

Lung cancer screening, she said, is being held to a higher standard than mammography or colonoscopy, which were widely used and covered by insurance while studies were underway to determine their effectiveness. "For us, it's so frustrating," Fenton said.

Firozvi agreed. "There has never been a randomized controlled trial of Pap smears," he said. "I think this test is comparable to mammography."

Fenton said she thinks stigma has colored attitudes toward lung cancer, which in about 85 percent of cases results from smoking. "The attitude is it's your problem. You deal with it."

But to Duke's Patz, the overarching issue is the strength of scientific evidence. Earlier studies of technology initially regarded as promising, such as chest X-rays, found the technology was ineffective in reducing the lung cancer death rate.

"Just because we haven't done the right thing in the past doesn't mean we shouldn't do it now," Patz said. "If we'd done the right studies to begin with, we'd have the answer now."

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A very balanced and comprehensive article (although they gave the nay sayer the last word).

But the item that Patz doesn't get is, he has told his father not to do the test AFTER weighing the pros and cons...most at risk people don't know there is a pro or con to weigh.

My mother didn't know. My mother wasn't given the option. My mother is now dead at age 56. Would she still be dead with early detection...maybe, but there is a POSSIBILITY that she wouldn't be.

She was never given the opportunity at the possibility!

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Nick I understand ya man. My wife was 49 when she passed away. Circumstances where different but end result is the same. Both gone to this disease. We were 3 weeks away from 9 years together and 9 weeks shy of fighting for 3 years. Guess why I miss her the most!?!? sending prayers from under the Carolina Blue sky.

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Finding a nodule usually triggers a cascade of interventions, starting with a biopsy, which can cause infection, scarring and a collapsed lung. A cancer diagnosis typically results in surgery, often followed by chemotherapy or radiation or both. Doctors have no accurate way of determining which tumors are fast-growing and aggressive and which grow so slowly that patients are likely to die with and not of them, as with some types of prostate cancer.

This paragraph of apparent "Cons" mystifies me.

Are there many people with nodules that wish they didn't know about them?

The second sentence is simply a statement of fact.

Third, I don't think that there are many lung cancers that are growing so slowly that they're irrelevant.

It's a no-brainer for me.

I believe my wife is alive today as a direct result of Dr. Claudia Henschke's pioneering.

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Hi Randy, I would like to see more screening for non-smokers too. Also education for GP's.

I had lots of symptoms that my GP's should have picked up on, but because I never smoked and was only in my 40's, Neither bothered to order CT scan as the probability was low. They'd rather believe I was some lonely whiny middle-aged menopausal hypochondriac groupie who had sob because she was out of condition. :D

Barb

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I'll stick with my previous post that the argument is so circular that it makes me not even want to read about screening. I really don't comprehend why screening for lung cancer is being treated so much differently than screening for other types. Now the statement "does screening save or merely find cancers earlier". It has been drummed into the public that finding cancer early "saves lives" so why is lung cancer any different. Colonoscopy detects nodes that may or may not be cancerous yet doctors and insurers harp on getting them done all the time whether you are at risk or not (and even PAY for them). Same with mammograms. Now talk about an aggressive approach. Women are having mastectomies to PREVENT breast cancer when they feel at risk. They only study smokers and ex-smokers which right there is enough to bias any study. As we know from the posts here and my own experience with mom NEVER SMOKING non smokers can get lung cancer, too. If all they look for is smoking as a "cause" of lung cancer then that's all they're going to find. I have to agree with PS, it's a no-brainer. With all of the different types of cancer and all of the years and money on research I have to wonder why there is screening for only 3 types of cancer that I know of anyway: breast, prostate, and colon.

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would you rather have a mammogram, colonoscopy, PSA or this one in the works?

Scientists Developing Lung Cancer Breath Test

11.12.06, 12:00 AM ET

SUNDAY, Nov. 12 (HealthDay News) -- A simple breath test could someday help predict who's at highest risk of getting lung cancer.

In preliminary research, the breath test was successful in finding cancer "markers," said senior researcher Dr. Simon D. Spivack, a pulmonologist at the Wadsworth Center, the public health laboratory of the New York State Department of Health.

That's important, he added, because "lung cancer [typically] exists for a decade or two before it is diagnosed."

His team was expected to present the results Sunday at the American Association for Cancer Research meeting in Boston.

Lung cancer remains the No. 1 cancer killer of both men and women in the United States. According to the American Lung Association, over 160,000 Americans die of the disease each year.

One reason for the high death toll: About 70 percent of lung cancers are diagnosed in the late stages, according to the Lung Cancer Alliance, a national advocacy organization based in Washington, D.C. However, one recent study found that, if diagnosed early, 92 percent of patients could expect to live 10 years.

Doctors have long sought a reliable early detection method. Even when something that looks like a predictor of cancer is found -- such as a nodule on the lung during a CT scan -- it's still not a foolproof way to determine who will get cancer, Spivack said.

"What we find in middle-age smokers is that 20 to 80 percent of these people have nodules," he said. "But 95 percent of the nodules are not cancer and are not going to be."

Enter the new test, in which people are asked to breathe for 10 minutes into a commercially available device which cools the air and forms a condensed vapor. Next, the researchers apply an assay that detects chemical changes -- specifically, a DNA methylated form of a tumor-suppressor genes.

In the test, "exhaled breath DNA could be measured for methylation, a known cancer marker," Spivack said.

DNA methylation is a kind of chemical modification of the cell's DNA, a process known to be associated with lung and other cancers.

To date, Spivack's team has used the tool on 28 people, predominately cancer-free smokers, and they are still analyzing the results for 21. Spivack currently has results for 7 people. He found that "in one gene, smokers were methylated and nonsmokers were not." He is looking at six genes in all and is still analyzing the results.

"This tool may or may not be helpful in diagnosing disease at the present time," Spivack said. "This tool aims to assess risk, so we know how to follow these people." For instance, someone deemed at high risk could be scheduled for more frequent check-ups.

Nicholas Broffman, executive director of the Pine Street Foundation, a San Francisco area-based nonprofit charity that helps people with cancer make informed decisions about treatment, said the study was "interesting."

The Foundation made news earlier this year with its study on how dogs could pick up chemical differences lingering in the breath of persons with cancer. That work was published in the journal Integrative Cancer Therapies

When the dogs sniffed the breath of 55 patients with lung cancer, 31 with breast cancer, and 83 healthy people, the animals were 88 percent to 97 percent accurate in identifying early- and late-stage breast and lung cancers.

"We are just scratching the surface of breath diagnostics," Broffman said. Worldwide, he said, the number of researchers investigating breath analysis for cancer is not as large as it could be. "I would hope more people would get into the game," he said.

Broffman said Spivack's method "is a really interesting technique because it is not invasive."

More information

To learn more about lung cancer, visit the Lung Cancer Alliance.

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Breath test of course would be the easiest. But, and playing the advocate here, how is that more accurate than the existing sputum test, mammogram-geez no, use of radiation when not at risk, colonoscopy, and risk infection and finding nodes, PSA, and risk a false positive, heck no. Get my drift. There is a down side to each of these screening procedures yet they are in full use. Should someone get these test who are not at risk, just because they're there and be denied screening for early detection for a disease that they are at risk for?

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Ohhh I can just imagine the medical malpractice lawsuits now. Your dog was poorly trained, or had a cold that day, in heat, etc, and therefore it missed my lc diagnosis causing tremendous delay in my treatment. :?

Unlike the scans, dog sniffing leaves no paper trail or scans for legal purposes. Would my lung doc have to review video of the sniffing and be trained in black lab "tells"? :D

Barb

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