Precision weapons 

At the age of 58, John Allen is battling advanced colorectal cancer.

But Allen is by no means ready to give up hope. A new type of treatment called Erbitux is killing the cancer cells in his body.

“I went to the doctor in the last part of May,” Allen says. “I had lost my appetite and didn’t know what was wrong.”

Allen began to lose weight -- a lot of weight. “I was down to 127 pounds, down from 175 pounds,” he says.

Diagnostic surgery was performed and the cancer was discovered. It had already metastasized, or spread, to his liver. Allen’s oncologist, Dr. Mark Taylor, says his other doctors had little hope to save his life.

The cancer was so bad that for a time, hospice care was considered rather than treatment. “They told me I had it in four places,” Allen says.

Instead, Taylor enrolled Allen in a clinical trial at Summit Cancer Care. “He’s still living, first of all,” Taylor says. “The site of the tumor has shrunk, and over time as we scan it, it has gotten even smaller and smaller. He has lived a normal life during treatment. He took a trip way across state and began taking advantage of life.”

Allen is a carpenter by trade. “I’m not able to work yet,” he says. “Going back to work depends on how I get.”

At one time, Allen would not have had a future to consider. But thanks to Erbitux and other targeted treatments with “smart” drugs, there are more care options available to patients today.

Metastatic disease isn’t considered curable, but can sometimes be brought into remission and treated as a chronic disease rather than a fatal one. “As long as it’s in remission, the patient is living with cancer instead of dying of it,” Taylor says.

Smart drugs are more precise in targeting cancer cells, meaning treatment is not just more effective, it results in fewer side effects. Some of the treatments are taken by mouth, while others are given intravenously or in conjunction with chemotherapy.

Erbitux, which is the brand name for cetuximab, makes cancer cells go haywire, blocking tumor growth. “It’s the Martha Stewart drug,” Allen says.

Erbitux was developed by ImClone System Inc., which gained notoriety when Martha Stewart was convicted of obstructing justice and lying to the government in a case stemming from the sale of nearly 4,000 ImClone shares in 2001.

Although targeted treatments are not as hard on the body as standard multidisciplinary treatment (which can involve surgery, chemotherapy and radiation) there are side effects. “It affected me at first,” Allen says. “When I took it, it made me sick.”

But those symptoms can be treated and generally don’t last beyond the first part of the treatment. Recovering from chemotherapy takes at least a year.

“Standard chemotherapy doesn’t know the difference between cancer cells and normal cells,” Taylor says. “It attacks all cells. When there are side effects, you hope the chemotherapy does more damage to the cancer than the body.”

That’s why patients on chemo lose their hair. Their blood counts also fall, and they can develop a number of side effects, including mouth sores and stomach problems.

Different types of cancer respond to different smart drugs. “They’re engineered to specifically attack cancer cells -- Gleevec for leukemia, Herceptin for breast cancer,” Taylor says. “They’re very disease specific. Compared to standard chemo, there are much fewer side effects.”

Most targeted treatments are available only in large cities at major medical research centers. But patients can receive treatment locally at both Memorial Health University Medical Center and St. Joseph’s/Candler Health Systems through Summit Cancer Care.

Taylor not only is an oncologist at Summer Cancer Care, he is the local principle investigator for the H. Lee Moffitt Cancer Center at the University of South Florida.

“We have dozens and dozens of trials open,” Taylor says. “That’s one reason we do what we do. Patients don’t have to go all the way to Emory in Atlanta to receive treatment.”

Dr. Harvey C. Lebos also is an oncologist at Summit Cancer Care and is the local principle investigator for the Southeast Cancer Control Consortium. The consortium sponsors National Cancer Institute approved trials to bring state-of-the-art cancer care to the community.

As a principal investigator, Lebos speaks to local community groups and meets with other medical specialists to inform them of clinical trials that are available at Summit Cancer Care.

“Our goal has always been to give our patients access to the same clinical trials that they would find at large research institutions,” Lebos says.

Summit Cancer Care was founded in 1977 as the first practice dedicated to oncology and hematology in Southeast Georgia. In addition to its Savannah office, Summit serves patients at its offices in Statesboro, Vidalia and Rincon.

Summit was a guiding force behind the establishment of the cancer programs at Memorial Health and St. Joseph’s Candler, and its six physicians continue to staff those programs. They also go to hospitals throughout the region, including the East Georgia Regional Medical Center in Statesboro and the Meadows Regional Medical Center in Vidalia.

Both prevention and treatment clinical research trials are conducted at Summit. Prevention trials concentrate on patients who are predisposed to certain types of cancer, but who have not been diagnosed with cancer.

Treatment trials are for patients who have been diagnosed with cancer and currently are undergoing treatment. Trials involve both new drugs and standard drugs, which are used in a new way to evaluate their effectiveness.

Some trials are conducted to compare one treatment to another to see which works better with fewer side effects. Trials also are used to evaluate quality of life issues, including not only length of life, but whether a treatment can keep the patient disease-free longer.

Most of the trials at Summit are Phase Two, Three and Four trials, in which the drug has gone through an earlier phase that has determined it is not harmful. By Phase Three, the drug is being tested to see if if is more effective than current treatment.

The clinical trials that are being conducted at Summit Cancer Care are provided through programs that are extensions of the National Cancer Institute. “Most of these drugs are already on the market, but their use is being looked at in other diseases,” says Lynn Davis, Summit’s research coordinator.

Herceptin, which is already on the market for treatment of metastatic breast cancer, is being evaluated at Summit for its effectiveness in adjuvant treatment of breast cancer. Adjuvant treatment is given to women with early stage breast cancer to keep the cancer from reoccurring.

“We’re looking at the advantages of Herceptin for women whose cancer was HER2 positive,” Davis says. “We’re collecting data.”

Herceptin works only against breast cancers that make too much of the HER2/neu, or HER2, protein. These cancers are called “HER2 positive,” and about one of every four breast cancers is HER2 positive.

Gleevec also is being evaluated at Summit. “It’s marketed for chronic myeloid leukemia,” Davis says. “We’re looking at its effectiveness is treating advanced lung cancer,”

Trials also are being conducted to determine the effectiveness of Gleevec on GIST, or Gastrointestinal Stromal Tumors. “It’s being used in settings where the disease has reoccurred,” Davis says.

Its effectiveness on Merkel cell carcinoma, in which malignant cells are found on or just beneath the skin and in hair follicles, also is being tested.

Avastin is an angiogenesis inhibitor. Cancer cells need blood in order to grow, and angiogenesis inhibitors block chemical signals from tumors that stimulate the growth of new blood vessels supplying blood to tumors.

Already approved for treatment of colorectal cancer that has spread to other parts of the body, Avastin is being evaluated in clinical trials to see if it will affect other types of cancers, including breast cancer.

“Avastin is on the market for colorectal cancer,” Davis says. “We’re looking at its effectiveness in treating gastric cancer. We did have an Avastin trial for lung cancer, but it’s now closed.”

Erbitux interferes in the growth of tumors by targeting a natural protein called EGFT -- epidermal growth factor receptor -- on the surface of cancer cells. Erbitux, which is also referred to as a monoclonal antibody, has been approved in the treatment of colon cancer and is being evaluated in trials at Summit for head and neck, pancreatic and esophageal cancer treatment.

Tarceva, an oral medication, is already on the market for treatment of advanced non-small cell lung cancer. At Summit, it is being given to newly diagnosed patients, as well.

“There’s a study for its effectiveness in treating renal cancer, but it’s on hold,” Davis says.

Trials of Irissa are being conducted to see if it is effective in patients with early lung cancer that has been removed by surgery to keep the cancer from coming back. Mylotarg is being used in the treatment of acute myeloid leukemia. Some of the newer drugs being tested still have numbers instead of names.

Patients who participate in clinical trials receive the benefit not only of the latest developments in treatment, they also receive first-rate care by experts in the field. “This may be one more treatment option for them,” Davis says. “In certain settings, this is the only way they can get the drug. It’s an opportunity they otherwise wouldn’t have.”

In some clinical trials, the drugs are free, although patients are responsible for medical care during treatment.

“Many insurance companies have agreed to allow patients to participate in clinical trials,” Davis says.

“You don’t know who will do well and who won’t,” she says. “NCI will continue to provide the drug as long as it is needed, as long as the patient is improving.”

Patients in studies also are watched more closely for a longer period of time. “We have people we’ve been following 12 years out from treatment,” Davis says.

“More people have become interested in clinical trials,” she says. “The NCI a couple of years ago wanted to make the public more aware of clinical trials. People are calling and looking for clinics that participate in trials.”

For more information on cancer and clinical trials, Davis recommends the NCI’s website at www.cancer.gov or the toll-free number, 1-800-4-CANCER.

In addition to the benefits to themselves, patients also benefit society by helping advance knowledge about cancer treatments. The current approach to cancer management most often consists of surgery, radiation therapy and chemotherapy. While these treatments have been proven to kill cancer cells, they also harm healthy, normal cells, sometimes throughout the entire body.

Some types of smart drugs target only cancer cells and leave healthy cells alone. Others may effect healthy cells, but not as drastically as chemotherapy, so the healthy cells recover more quickly.

Targeted therapy also offers hope to patients whose cancer keeps coming back after standard treatment. Studies have shown that smart drugs often shrink the tumors in these patients, offering them a longer time of disease-free living, and in some cases, remission.

For some patients, the results of targeted treatments have been dramatic.

“Since the development of Gleevec, there have been some patients who have been put into long-term remission,” Taylor says. “Before, the only cure was to have a bone marrow transplant.”

While the use of targeted drugs shows exciting promise, there also is good news in the fact that major advances have been made in standard treatments such as chemo to make them work better with fewer side effects.

There also are advances in treating side effects when they do occur. “One of the biggest is that we can reverse the anemia that occurs with chemotherapy,” Taylor says. “Chemotherapy is safer because we can boost the white counts.”

Research is resulting in other promising treatments, including vaccine treatments.

“The idea behind it is to take a sample of a tumor and develop immune system cells that would be put back in the body to seek out the tumor elsewhere and attack it,” Taylor says.

So far, statistics don’t reflect that cancer survival rates have improved. But Taylor points out that it might take five to 10 years to accurately reflect the results he is seeing in his patients.

“Ten years ago, the survival rate for metastatic colon cancer was eight to 10 months, average,” Taylor says. “Now we’re pushing two to two and a half years. It may not seem like much, but you can do a lot of two years.”

For more information about Summit Cancer Care, visit summitcancercare.com or call the 24-hour information line at 877-HOPE-999.

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Linda Sickler

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