send us feedback
download journals| Life on Trial Local Patient Successful in Clinical Trial by Page E. Bishop. Published: June 2005 One year ago, Janet* was an active, healthy, 46 year old single mom with a successful career and no family history of cancer. A self-described workaholic, Janet was happy in her job, but her real passion was seeing the world. She loved traveling—she took several trips each year. That was before doctors told Janet that a hormone-fed tumor had developed inside her left breast. Doctors wanted to remove the growth before it spread. After surgery, months of chemotherapy would then follow. For Janet, this was no vacation. Among her options was the possibility of enrolling in a clinical trial for a new drug called Herceptin. When combined with chemotherapy, the drug had so far shown positive results in women with early stage breast cancers like Janet’s. Herceptin carried a low risk of side effects and, more importantly, a low risk of recurrence; however, it was only available to women in the late stages of breast cancer, after it has spread to other parts of the body. Realizing the clinical trial was her only way to gain access to Herceptin, Janet looked her doctor in the eye and said, “Give me everything you’ve got.”
Herceptin, a targeted therapy drug, works like this: Normal breast tissue cells contain the Her-2 gene that regulates protein receptors on the cell surface. These Her-2 protein receptors send signals to the cell nucleus instructing the cell to replicate and divide accordingly. When too many protein receptors form on the cell surface, the cell divides and multiplies at a higher rate than it normally would, and a tumor develops within the breast tissue. When a cell over-expresses Her-2 proteins it's called Her-2 positive. Herceptin detects the excess protein receptors on Her-2 positive cells and interrupts their signals to the cell nucleus. The tumor is contained and has a reduced risk of relapsing, or returning. Because Her-2 positive tumors grow at a much faster rate than other tumors, they have a higher chance of returning after removal; and when doctors remove a Her-2 positive tumor it is difficult to detect exactly how far the cancer may have spread, says Dr. David Powell, an oncologist with VOA. “These are microscopic diseases, and we have no tests, no scanning devices to find microscopic disease. We first studied Herceptin as a single agent for late disease and we said, ‘if the results are so good here, let’s see what happens when we take it to the early stage…let’s keep the cancer from ever reaching the [advanced] stage.’” Herceptin was originally developed to be a last line of defense for patients who had already been through the full treatment cycle of surgery, radiation, chemotherapy, and hormonal therapy. “Now,” says Powell, “our last line of defense is quickly becoming our first.” Studies of women with late stage breast cancers show those who are given a combination of Herceptin and chemotherapy drugs are at increased risk for serious heart complications such as stroke, cardiac failure, and death. One particular class of chemotherapy drugs, taxanes, works well with Herceptin and carries a low risk of heart damage. One drug in this class, Taxol, was the primary chemotherapy treatment administered in the clinical trials, and it was the same agent Janet received. Even though Herceptin delivers comparatively few side effects, Janet endured numerous mental and physical challenges while under treatment. The most common side effects women experience from Herceptin are fever, chills, and weakness, but because Janet received a combination of therapies, she had difficulty in distinguishing which drug was
In Janet’s case, the most difficult part of treatment wasn’t the physical pain; it was the severe depression that was a result of her restricted lifestyle. She had never struggled with depression before, she says. When bad things happened to her, she had dealt with the pain and moved on. During her treatment, she could not shake the feeling that something was not right for her emotionally. She turned to her family, her doctors, and to her faith for support. She took anti-depressants for a while. To others who may be struggling with the effects of cancer treatment, she says: “Get strong and stay strong. Stay strong in whatever belief you have. Believe in your family; believe in your doctors; believe in yourself. Stay positive and don’t give up, no matter what.” It’s been one month since Janet finished her last chemotherapy cycle, and she is still trying to get back to her former self, physically and emotionally. Even though Janet still feels down at times, she says the most difficult days are behind her. Now, she must focus on adapting to life after cancer—life as a survivor. She’s taking things one day at a time. Right now that means going to physical therapy and receiving pain management several times a week. She wants to go back to work and be able to travel again like she used to. She wants her life to be like it was before her diagnosis, but that may never happen. “I cry more easily now,” she admits,“ and I never did that before. Now it just comes right out.” The local trial that Janet participated in was part of five years of research proving that Herceptin decreases a tumor’s chance of recurrence by more than 50%. Dr. Powell of Virginia Oncology says the local results correspond with national findings—that a regimen of Herceptin and chemotherapy creates a significantly reduced risk of recurrence. “Based on four years of data, we can now say a patient’s chance of recurrence is more than halved, and that’s pretty good!” According to the American Cancer Society, thousands of women will be diagnosed with breast cancer this year, and roughly one third of them will have tumors with excessive Her-2 proteins, making them eligible for this new targeted therapy. These statistics lead Dr. Powell to believe Herceptin will “rewrite how we treat [breast] cancers.” And breast cancer is just the beginning. Scientists want to apply a targeted therapy approach to other types of cancers as well including lung, bladder, colon…the list goes on. Powell’s associate, Dr. Paschold, says he predicts targeted therapy drugs will play a key role in treating cancer in the future. “For a long time we have known that Herceptin worked best with chemotherapy once breast cancer spread,” he says, “but this trial proves that the drug prevents the actual spread itself, and soon [Herceptin] may be applied to other cancers as doctors use it with chemotherapies to investigate a broader range of cancers. Hopefully we will start to see more drugs like Herceptin that target specific cancers with fewer side effects and fewer toxins.” Janet’s family is relieved to see her feeling better and they are glad her treatment is completed. They believe she is cured. Dr. Pashold and Dr. Powell say they will continue to monitor her for signs of recurrence. She will most likely be monitored for the rest of her life. Despite the mental and physical toll this whole experience took on her mind and body, Janet never once wavered. “From day one,” she says, “even my first day of chemo, I felt like I was a survivor.” Now that the most difficult part of her treatment is through, Janet looks forward to what lies ahead. When she regains her strength, she expects she’ll be able to once again do the things she enjoyed most before her diagnosis. Although there is still a chance her cancer could return, Janet is optimistic about the future: “I feel wonderful. I am just so happy. I feel like things are going to get so much better. Like nothing else can go wrong.” *This is not the patient’s real name. The patient requested to remain anonymous. |
|
|
Williamsburg Health Journal
4808 Courthouse Street, Suite 204 Williamsburg, VA 23188 757-645-4475 © 2007 RIAN ENTERPRISES, LLC |