Research and reprieves

New methods of research and innovative clinical trials are changing expectations about cancer survival,
and doctors believe that a cancer diagnosis
will no longer be a death sentence.
Sunday, October 10, 2004 | 12:00 a.m. CDT; updated 8:02 p.m. CDT, Monday, July 7, 2008

New mother Kim Kremer added some unexpected medical terms to her vocabulary during her pregnancy: lymph node, biopsy and malignant.

The 30-year-old arrived at her obstetrician’s office with a swollen belly, but to her surprise, the doctor focused on a different, less visible growth in her breast.

“She said that it’s just hormones,” Kremer said of the small knot found in her right breast. “She said we’d keep our eye on it, and we all kind of blew it off.”

But later tests showed that the knot had grown, and eventually, Kremer’s worst fears were confirmed. With no genetic history or obvious risk factors, she was diagnosed with breast cancer.

“More than anything, I had a new baby, and I was scared to death for him and for my husband and for my mother,” she said.

Two weeks after her diagnosis, Kremer, a Loose Creek resident, came to Ellis Fischel Cancer Center in Columbia for a second opinion. Within a week, doctors removed her right breast and 26 lymph nodes from under her arm.

Her breast was gone, but Kremer was focusing on saving her life.

“I thought that if I have a mastectomy, I would know that it’s gone,” Kremer said. “I didn’t want my breast anymore. I wanted to do the biggest thing that I could.”

Her doctors were thinking big too.

"One of our biggest accomplishments"

Kremer may not have known it at the time, but she was becoming a player in a local revolution of breast cancer diagnosis and treatment.

With clinical trials and advances in screening technology, Columbia doctors are changing the way women talk, think and heal.

“Cancer is turning into more of a chronic disease than a death sentence. And that’s one of our biggest accomplishments,” said David Schlossman, medical oncologist with the Missouri Cancer Associates, a hematology and oncology practice.

Doctors are now able to diagnose breast cancer better before the disease spreads to other organs. This lifts cure rates — classified as a five-year survival rate — well into the 90th percentile. And for women like Kremer, there is definitely hope in numbers.

Technological advances

Over the past decade, local cancer professionals have seen a shift in diagnostic tools from traditional photographic techniques to more advanced digital imaging.

Digital mammography, now a staple at more than 40 percent of mammogram facilities nationwide, first appeared at Boone Hospital Center in early 2001.

”We were the first in the state with this equipment,” said David Pittman, chief of pathology at Boone Hospital.

The equipment allows for X-ray images to be recorded electronically and viewed on a computer screen. The examining doctor can then magnify, brighten or adjust the contrast of the image for closer inspection of certain areas.

The picture can also be transmitted easily to other doctors for second opinions and consultation.

There are even computers that help doctors find abnormalities. Computer-assisted detection and diagnosis machines analyze a mammogram image and display markers next to potentially problematic sites.

Although some studies claim that the result is similar to a second opinion, others maintain that digital imaging detects cancer at earlier stages.

Methods of screening

Most doctors agree that mammography remains the best way to screen for cancer, but its limitations are significant.

“Thirty percent of breast cancer is not detected by mammograms,” said Clay Anderson, director of clinical services at Ellis Fischel. “The sensitivity and specificity just aren’t that great.”

Anderson said that the recent use of magnetic resonance imaging on breasts allows for greater sensitivity in the image.

Doctors at Ellis Fischel began doing breast MRIs five months ago. They say the technique is helpful particularly for younger women with dense breast tissue, those at very high risk for breast cancer and for women with large amounts of scarring from previous operations.

Although a breast MRI can detect more abnormalities than a mammogram, it is less accurate in assessing what is and is not cancer.

There are other downsides too.

“Cost is a major consideration,” said Edward Sauter, an Ellis Fischel surgical oncologist who said breast MRIs are too costly to be used as a standard screening method.

“Can our health system afford the expensive MRI versus the $50 mammogram?” he asked.

Sauter is among a group of MU research pioneers who are designing and testing new methods of diagnosis.

“I try to find ways to find cancer cells before the mammogram sees it,” he said.

According to Sauter, more than 98 percent of breast cancers originate in the ducts. Since 1999, he has offered his patients a controversial diagnostic technique called a ductoscopy.

Developed in Japan in the early 1990s, a ductoscopy is a procedure in which a 0.9-millimeter endoscope is inserted into the lining of the breast through openings in the nipple.

An ongoing clinical trial at Ellis Fischel is now comparing ductoscopy findings with results from breast tissues extracted invasively through biopsy or mastectomy.

For a woman with an abnormal mammogram, a biopsy is often the next step. To determine if a lump is solid or filled with fluid, doctors extract a sample of tissue from the suspicious area and examine it under a microscope.

The procedure is now being done with smaller needles and with the help of ultrasound technology.

In Boone Hospital’s Hugh Harris Breast Screening & Diagnostic Center, radiologist Teri Elwing pushed for the

Harris Breast Screening & Diagnostic Center, radiologist Teri Elwing pushed for the ultrasound-guided biopsy more than four years ago. Now it is standard practice.

“It saves 80 percent of women that would normally go under the surgeon’s knife from having to do that,” said Pittman.

The ultrasound machine detects sound vibrations in the breast and translates them into a computer image. That picture then serves as a detailed map for the biopsy, improving the accuracy of the needle’s path.

Clinical trials and tribulations

After her surgery, Kremer sat down with her doctor to discuss her options. That’s how she became a part of a national experiment.

“Clinical trial” was a foreign term for her, Kremer said , adding she was unsure if the treatments were safe or effective. “But my doctor told me that if he had a mother or a sister with breast cancer, he would recommend this to them,” she said. “And so I did it.”

Kremer is among the 220 patients at Ellis Fischel currently receiving treatment in clinical trials. These are local, national and international trials, designed to test the safety and efficacy of new treatments. There are 19 breast cancer trials open at Ellis Fischel, four at Boone Hospital and nine at the Missouri Cancer Associates with some trials available at more than one facility.

Breast cancer clinical trials in Columbia are government-funded projects that go through several stages of testing before they are offered to patients on a broader scale.

Although most new treatments start in clinical trials, only three percent of adults with cancer participate in such studies, according to the American Cancer Society.

“All standard chemotherapy combinations that we use have come out of clinical trials,” said Schlossman, who heads several breast cancer trials through Boone Hospital and Missouri Cancer Associates. “If we don’t push forward with clinical trials, we will have the same treatments 10 years from now.”

Barbara Barrett, clinical trials research manager at Ellis Fischel, classified the clinical studies as yet another treatment option.

Participation in a trial costs the same as standard therapy with experimental agents provided by the trial administrators. Often, patients are required to visit with doctors more frequently during the study and may have extra blood work and screening tests done.

“We would like to have a clinical trial for every patient that walks through the door, but we’re not there yet.” Barrett said.

She also said that for many patients, clinical trials can offer better care than standard therapy.

At Ellis Fischel, 16 percent of patients participate in trials. Many live outside of Columbia. Barrett suggested they are willing to make the extra trip and put in a few extra days at the doctor’s office to receive innovative treatments that may not be available as standard therapy for years.

One such therapy examines the role of the anti-inflammatory drug Celebrex — more commonly used for arthritis relief — in preventing breast cancer in high-risk women.

Under the supervision of Sauter, this trial involves 47 patients at MU and is due for completion next year.

Schlossman, who is recruiting for the same trial at Boone Hospital, said he chose it because it was scientifically interesting, appropriate for his patient base and offered patients a higher level of care.

In his 25 years as a medical oncologist, Schlossman has seen the emergence of what he calls translational research.

“It’s molecular biology in the Petri dish translating into patient treatment,” he said, adding that clinical trials are experiencing this trend.

Schlossman said doctors are beginning to explore the role of genetic markers in tailoring therapies for each patient.

As with other types of medicines, a patient’s response to cancer treatment can vary. Although one chemotherapy drug may do little to stop the spread of cancer in one patient, it could be the saving grace for another.

“In 100 women with breast cancer, I can tell you how many will respond to a treatment, but I can’t tell you which ones,” Schlossman said.

Not yet, at least.

But scientists have made remarkable progress in tracing certain genes that affect the body’s response to treatment.

One such gene is called the human epidermal growth factor receptor 2, or HER-2. An estimated 25 percent of women with breast cancer have extra copies of HER-2, which is strongly associated with faster growth and spread of cancer cells.

Herceptin is a drug developed to slow the spread of cancer in women with high levels of HER-2 — women like Kremer.

As part of her treatment, Kremer’s drug regimen is a combination of Herceptin and a chemotherapy agent called Taxol. The side effects are rough, but Kremer said she’s starting to feel better.

“If people didn’t test the drugs I’m taking now, we wouldn’t know if they work,” she said. “I could be helping a neighbor, a friend or a stranger.”

Kremer’s altruism is a widely echoed sentiment, said Pittman, who emphasizes that women participating in clinical trials don’t always see direct results from treatment.

“Clinical studies are not for everybody,” Pittman said, adding that while some people in the studies receive standard care, others may be taking a risk on a yet unproven treatment.

Pittman, who for 10 years chaired Boone Hospital’s Institutional Review Board in charge of clinical trials, said community hospitals are less likely to enter into riskier trials.

Still, the number of clinical trials available in Columbia is impressive, given its size. And with the complement of academic research, new therapies are always around the corner. But the most coveted treatment against breast cancer is still prevention.

Searching for the Holy Grail

The American Cancer Society urges all women over 40 to get annual mammograms, with some at high-risk for breast cancer starting five to 10 years earlier. Clinical and self-exams should be routine for women over 20.

“Most women that we see with advanced breast cancer haven’t had a mammogram in a few years,” Pittman said. “Women should follow the guidelines.”

Patricia Blueitt is out on the streets, in pharmacies, at grocery stores and in beauty salons spreading the message of prevention. As an outreach coordinator for a statewide initiative called Show Me Healthy Women, Blueitt seeks out low-income women between 50 and 64 eligible for free mammograms and clinical exams.

More than 17,000 cases of breast cancer have been diagnosed in Missouri through the program since its 1991 start, but many women are still neglecting necessary screenings, Blueitt said.

“Maybe they’re scared to find out,” she said. “But it’s OK to be scared, I tell them. We’re all scared to find out something.”

While Blueitt concentrates her prevention efforts around known risk factors such as smoking, age and family history, some doctors in Columbia are searching for help at the molecular level.

Five years ago, Ellis Fischel began enrollment for the world’s largest prevention trial for women without breast cancer but at high risk.

The Study of Tamoxifen and Raloxifene trial involved 19,000 participants throughout North America, 150 of them from mid-Missouri.

The trial, which closed regional enrollment in July, compared the effects of Tamoxifen, the first FDA-approved drug for prevention of breast cancer in high-risk populations, with a similar drug, Raloxifene, currently used to fight osteoporosis.

“This is just the tip of the iceberg,” said Anderson. He predicted that in 20 years, women would be able to choose from a number of different synthetic and natural compounds for prevention.

Sauter is investigating several such agents that show preventive promise. He is currently studying how soy affects the breast.

“Epidemiological evidence suggests that Asians have a lower risk of cancer. Whether that’s related to soy, we don’t know,” Sauter said.

Although some oncologists warn their patients against soy consumption — and still others recommend the product — Sauter said that the area is largely unexplored. But he suspects that different amounts of soy have different effects of the breast.

Schlossman is looking even further into the future when prevention could mean rewriting the DNA code. He is hopeful that genetic research will help identify the exact origins of cancer and help doctors correct the mutations that lead to the disease.

“It may take another 100 years, but that’s the Holy Grail of cancer research,” he said.

Race makes a difference in cancer rates

In Missouri, black women with breast cancer are 30 percent more likely to die from the disease than affected women who are white, according to a new report released last month by the Missouri Department of Health and Senior Services.

Although the incidence of breast cancer is actually 5 percent higher among white females, black women are getting diagnosed with more advanced forms of the disease.

The report says that screening rates are comparable among women of both races but that black women may be less likely to receive further diagnosis and effective treatment.

Missouri findings are representative of national trends.

To order a copy of the Missouri cancer report, call Tammy Anderson, Missouri Department of Health and Senior Services, at 573 522-2840.

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