Monday, June 2, 2008

Pee in a Cup! New Non-invasive Early Detection Test for Breast Cancer

Two years ago, every three minutes a woman in the United States was diagnosed with breast cancer. Now, a woman in the US receives this blunt diagnosis every two minutes. In 2006, an estimated 212,920 new cases of invasive breast cancer are expected to be diagnosed, along with 61,980 new cases of non-invasive breast cancer. And 43,000 women are expected to die this year from this disease. Breast cancer is the leading cancer among white and African American women, the second leading cause of death in this country, and the leading cause of death in women aged 40-55 years. African American women are more likely to die from this disease. And finally, breast cancer incidence in women has increased from one in twenty in 1960 to one in eight today. Grim statistics!

There have been some interesting bits in the news lately about potential new cancer treatments, and I can't help but think that in the end, we'll find the cure from the most inane source--frog liver, macadamia nuts, Dramamine, or some other OTC drug that everyone has in his or her medicine cabinet. Some friends of mine were hoping that the cure might be found in the worm at the bottom of a Tequila bottle, but so far, the WWRFC has not been able to prove it to be the cure-all we had all hoped it would be (it does still melt cotton, however). No thanks to the Bush administration, cancer research makes tremendous leaps every year--but imagine the advances that would be made if it were a fully funded enterprise (and while I'm at it, I like to imagine what life could be like for stem cell researchers, too).

But there are exciting discoveries being made, and in this era of depleted (demolished? ransacked? decimated?) public funding, such discoveries seem more triumphant and important than ever. A good friend of my mother's sent the article below, heralding a new urine test that can be used as an early indicator of breast cancer as well as its recurrence. This is exciting stuff! The test can also be used to monitor how well a woman's breast cancer treatment is working, which would bring the ever-elusive peace of mind, or a well-informed decision to change treatment plans. This kind of test holds much promise for other cancers as well. It is amazing to me that I haven't heard anything about this on the news--but I promise you, it is legit. And it is even more amazing to think of how many lives this will save, not to mention the unnecessary surgical biopsies it will minimize. There are so many women who are faced with iffy mammograms, and have to make the decision to go forward with intrusive procedures (stereotactic biopsy, needle localization) and invasive surgeries in order to biopsy the questionable tissue. With this new test, instead of facing the pain and anxiety of surgery, they'd be able to simply pee in a cup. Of course, many biopsies end up being primary lumpectomies, as mine was, but many do not--most biopsied tissue ends up being benign. In fact, 8 out of 10 breast lumps are NOT cancerous. And currently, 70% of all breast cancers are diagnosed by breast self-exams. Since mammography can detect breast cancer up to two years before a cancer is large enough to be palpable, (like mine was), early detection is incredibly important. Breast cancer that is detected and treated early has a five-year survival rate greater than 96%. That's heartening. I am counting on being included in that survival rate, and joining the over 2 million women in the U.S. alone that are breast cancer survivors. Let's hope the gov moves on this and awards it full approval soon.

There has been a lot of hoopla in the news about VITAMIN D as well, and I'll be writing more about that later, but for now, know that research points to incredible results with vitamin D3 supplementation--cutting cancer risk across the board by 20%. As well, a recent study linked Vitamin D deficiency (and if you live in the north, and do not take at least 1,000 iu in daily supplementation, you are most likely deficient, as I was, last September--September! at the end of summer!) to a much higher risk of breast cancer (and MS, among other things) and to a much higher chance of dying from the disease if deficient at the time of diagnosis. So, for now, take your vitamin D3, get your sunshine, do your self-exams, get your mammos done, pee in the cup as soon as the gov approves the new test, and be well (dammit). Here 'tis:

BOSTON - A new and accurate urine test that warns of a woman's breast cancer risk should soon help doctors treat tumors earlier and save more lives, scientists report.

In a study of 148 women - 68 known to have very early signs of cancer, compared to 80 healthy women - the enzyme tests spotted more than 95 percent of those at risk for tumor growth, with no "false positives" among the control patients, the researchers said.

The main goal is to develop simple, painless and inexpensive tests that can warn women that breast cancer may be starting, well before their tumors become detectable by other means. What the researchers look for are two enzymes in urine samples that point to cancer risk.
"This is the outcome from many years of trying to discover non-invasive biomarkers" for early detection of tumors, said biochemist Marsha Moses, a Harvard Medical School professor at Children's Hospital Boston. "We first wanted to see if we could predict the presence of established cancer. We did that."

In the latest work, she added, "we wanted to see if these same 'biomarkers' could predict that a woman was at risk for breast cancer. We did that, too."

According to Dr. Kevin Camphausen, "This is great work. And what I think is most important is that it's a non-invasive biomarker" for use against cancer. He said Moses "is really at the cutting edge of this" new technology.

Camphausen, a senior investigator, is chief of the Radiation Oncology Branch of the National Institutes of Health, in Bethesda, MD. He said that finding "bio-markers" that can warn when cancer is beginning "is a Holy Grail of this disease."

In fact, the new research confirms that the enzyme-based tests of urine do detect tumors at least as early as standard methods - mammograms and breast palpation - and probably even earlier.

During the study, to avoid bias, the urine samples were "blinded" so the researchers didn't know which samples came from cancer patients and which came from women enrolled as controls.
Such promising results are important because there is great need for early detection. Breast tumors are the most widely reported cancer in women, and spotting them early so treatment can begin is vital in the battle for survival. According to the American Cancer Society, about 178,000 American women will discover they have breast cancer this year. Worse, about 40,000 of them will die because of tumor growth and metastasis. Breast cancer is currently the second-most deadly form of cancer.

Also, large amounts of data from patients with other types of tumors - bladder, prostate, brain and ovarian cancer - plus a small amount of data from animal studies, indicates that other cancers are similarly detectable via urinalysis, looking for the same two telltale enzymes.
Now that an early detection system has been shown to work, the next step is to test it in far larger populations, Moses said. The goal is to win U.S. Food And Drug Administration approval so it can be commercialized for widespread diagnostic use. A new company meant to develop such diagnostic tests, Predictive BioSciences Inc., was recently established in Waltham, Mass., to bring the new test system to market.

"Risk assessment is so critically important" for women facing the threat of breast cancer, Moses explained. "We were able to detect breast cancer risk. We did find a difference" between patients at risk and healthy women, a difference "that did predict their risk."

Equally important, in addition to spotting tumors very early, the same urine test can track the progress of a tumor: how fast it's growing. Too, it also monitors how well anti-cancer treatments are working, with enzyme levels going down as treatment succeeds.

The new test system is also "non-invasive," meaning it requires no blood tests, tissue sampling or other painful medical procedures. Moses expects the test kits to be cheap and easy-to-use once they reach the market.

A full report on their achievement appeared recently in the journal Epidemiology, Biomarkers and Prevention, published by the American Association for Cancer Research.

"Our goal is not to replace mammograms, magnetic resonance imaging (MRI) and other tests," Moses explained. "We want to provide people with additional information that can precisely predict risk, and/or disease status."

The test system is based on years of research into blood vessel biology led by the late Dr. Judah Folkman, also at Children's Hospital. He had been avidly seeking natural molecules, bio-markers, which can warn that cancer has begun.

Camphausen added that government agencies - the NIH, the National Cancer Institute and the FDA - are now debating how to use such biomarkers, their value in the clinic, and how to set benchmarks for approval of their use.

Moses and her 16 research colleagues work at Children's Hospital, the Beth Isreal-Deaconess Medical Center, Mount Auburn Hospital in Cambridge, Brigham and Women's Hospital, the Dana-Farber Harvard Cancer Institute, and the University of Copenhagen, Denmark. The lead author is Susan Pories at Beth-Israel and Mt. Auburn. Moses is the senior author.

Their work focussed on identifying and analyzing a group of special tissue-dissolving enzymes called MMPs. One, called MMP-9, and the other, ADAM-12, both show up very early in cancer patients' urine, but not in samples from persons without cancer. Also, the amounts of the enzymes detected in urine reliably correlate with the severity of disease, going up as the tumor gets worse.

"Our data show that urinary ADAM-12 and MMP-9 are highly significant predictors of breast cancer risk" in patients already known to have risk-related breast tissue changes, known as "atypical hyperplasia" and "lobular carcinoma in situ," Moses and her colleagues wrote. Urine samples were obtained from all 148 women, and the existence of tumors in the cancer patients had already been confirmed with tissue biopsies.

Once the new urine test wins government approval, the researchers think it will be widely used to detect small tumors, as well as monitor the effectiveness of treatment, and watch for recurrence of tumor growth.

According to Camphausen, it has been "incredibly difficult to fund" the search for biomarkers. "So it's been done with a lot of private money so far," money from donating individuals, foundations and other non-government sources.

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