Changing the Practice of Medicine

The Southwest Oncology Group

It takes a lot of money to design, conduct and analyze results from large-scale clinical trials of experimental cancer treatments and prevention regimens. Laurence Baker, D.O., professor of internal medicine and pharmacology, wants to make sure it’s money well-spent. So every year, he asks the clinical researchers who attend Southwest Oncology Group meetings the same question: “Is the public getting $45 million worth of work out of you?”

Baker chairs the Southwest Oncology Group, or SWOG—the largest cancer clinical research cooperative in the United States. With an annual budget of $45 million, SWOG has more than 500 institutions and nearly 5,000 research investigators in its cancer trials network. Much of its research funding comes from the National Cancer Institute.

Evidently, the federal government believes it’s getting its money’s worth, because NCI just renewed SWOG’s funding for the next six years with a package of grants expected to exceed $120 million. The principal grant totals more than $63 million and will be administered through the U-M Medical School where SWOG’s administrative offices have been located since 2005 when Baker became chair. It is the largest single research grant ever awarded to the Medical School.

“SWOG conducts phase III trials involving hundreds or thousands of patients,” explains Baker. “It’s the evidence from phase III trials that changes the practice of medicine.”

Baker has been an investigator with the Southwest Oncology Group since 1970. Over the years, he has seen many SWOG-tested experimental treatments become accepted as the standard of care for adult cancers. More recently, SWOG has begun a new initiative in comparative effectiveness research—studies designed to help physicians select the most effective therapy by determining which patients actually benefit from a test or treatment and which patients do not.

“We’ve been funded by NIH to evaluate a genetic test called Oncotype DX in women with node-positive breast cancer,” says Baker. “The study’s goal is to determine if this genetic test predicts whether chemotherapy improves cure rates in women with breast cancer. SWOG investigators also have just been funded for a study to determine whether cancer patients actually benefit from widely used drugs that stimulate the body’s bone marrow to make more white blood cells.”

There are about 1,500 Michigan patients currently enrolled in SWOG trials at 41 hospitals and medical centers in the state, including the U-M Comprehensive Cancer Center. About 70 Medical School faculty members are active SWOG investigators and 10 serve in leadership positions within the group. —SALLY POBOJEWSKI

 

The Gift of Speech

For the first three and one-half years of her life, Ayonna Green never said a word. She was born prematurely with a damaged airway, and surgeons had to insert a tracheotomy tube in her neck so she could breathe. The surgery saved her life, but left her unable to speak and facing a lifetime of limitations, daily tracheotomy care and future medical complications.

But then her mother, Ra’mona Russell, brought Ayonna to U-M’s C.S. Mott Children’s Hospital where surgeons had developed a new procedure to reconstruct the airway and close tracheotomies in children.

“We pioneered a way to get the tracheotomy tube out and allow children to breathe and talk normally,” says Glenn E. Green (M.D. 1991), an assistant professor of otolaryngology who performed Ayonna’s airway reconstruction surgery. “For these children and their families, this is life-changing.”

In the two-part procedure, called a cricotracheal resection with a hilar release, surgeons remove the damaged sections of the airway and then move the lower trachea up from inside the chest to connect it to the voice box. So far, the procedure has been 100 percent successful.

Today Ayonna’s an active, engaging 6-year-old who’s looking forward to first grade, loves to swim and is extremely fond of Dr. Green.

Like all the children who underwent the procedure, it took awhile for Ayonna to learn how to talk afterwards. Her voice is soft and still a bit raspy, but she’s taking voice lessons and singing in her church choir. After all those years of silence, Ayonna Green has a lot to say. —SP

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Statins for Cancer?

More than 25 million people take cholesterol-lowering drugs called statins to reduce their risk of cardiovascular disease. In 2005, U-M researchers found that taking statins also can cut the risk of colorectal cancer by as much as 50 percent.

The catch is that statins work much better for some people than others—both to lower cholesterol and to prevent colorectal cancer—and doctors had no way of knowing which patients should receive statin therapy. Now an international team of scientists, including researchers at the U-M Comprehensive Cancer Center, have discovered that a genetic test can predict who is most likely to benefit from long-term use of statins.

The study compared 2,138 people in northern Israel who were diagnosed with colon cancer and 2,049 similar people without colon cancer. Blood samples from study participants were analyzed to detect small individual variations in the genetic code for an enzyme called HMGCR—the same enzyme that controls how fast the body synthesizes cholesterol.

Some people have a long version of the enzyme; some people have a short version. The study found that people with the long version of HMGCR benefited the most from taking statins to reduce the risk of colorectal cancer and cardiovascular disease.

“The test by itself cannot predict whether you have an increased risk of colon cancer; but it can predict whether taking statins will reduce the risk,” says Stephen Gruber, M.D., Ph.D., the H. Marvin Pollard Professor of Internal Medicine and a co-leader of the study.

Currently, there is no commercially available genetic test for HMGCR variants, and statins are not approved by the U.S. Food and Drug Administration for colorectal cancer prevention. The researchers hope the study’s results will encourage pharmaceutical companies to develop a test and conduct the clinical trials required for FDA approval, so physicians can prescribe statins for patients at risk for colorectal cancer. —SP

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Patient information on colorectal cancer

 

Health Briefs

The U-M’s new C.S. Mott Chidren’s Hospital and Von Voigtlander Women’s Hospital will open for business in the fall of 2011—one year ahead of schedule. Located adjacent to the current University Hospital, the state-of-the-art complex includes a nine-story tower for clinic space and a 12-story tower devoted to inpatient care, diagnostic, procedural and treatment services. Planning is under way for the big move and a grand opening celebration.

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Reusing pacemakers may be a safe and effective way to provide these life-saving medical devices to people in Third World countries who cannot afford them. A study by U-M Cardiovascular Center researchers found that implantable pacemakers can be removed prior to burial or cremation, sterilized and reused with no significant increase in complications. A large prospective clinical trial is being planned.

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Black men with chronic pain have a higher risk of depression and disability than white men with chronic pain, according to a new study by U-M researchers. The comprehensive study, which included 1,600 men, was the first to examine the impact of chronic pain on the overall health of black men. —SP

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Planning Ahead

If you want to decide what kind of medical care you’ll receive at the end of your life, write it down and tell your family now. Because when the time comes, they may have to decide for you. A U-M study found that more than one in four elderly Americans lacked the capacity to make their own medical care decisions at the end of life. Those with advance directives—including living wills or durable powers of attorney for health care—were more likely to receive the care they wanted. —SP

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Partners in Caring

Nearly 40 percent of chronically ill older Americans live alone, relying on family and friends to help manage their health care, according to a new U-M study. Adult children and other family members want to help, but they often live far away and may not have the information needed to make a difference, says Ann-Marie Rosland, M.D., a clinical lecturer in internal medicine. To help solve this problem, U-M physicians developed a telephone monitoring system, CarePartners, that uses e-mail alerts and automated phone calls to involve family members in the care of a chronically ill relative. The program is now being tested in clinical trials. —SP

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More information on the CarePartners program