Mega Doctor News –
By Roberto Hugo Gonzalez
During his long professional career, Dr. Alvaro Restrepo has taken advantage of scientific medical research in order to fight cancer side by side with his patients. Dr. Restrepo explained, “Research is very important and is present in all aspects of the medical decisions made on a daily basis.” He explained that everything we do today is based on yesterday’s research, and tomorrow’s medical treatments will be based on today’s clinical trials.
He indicated that research is a careful study that is done to find and report new knowledge about something. “In Oncology, clinical trials are research studies that examine how patients respond to different medical approaches for various types of cancers.”
“Studies address scientific challenges and identify better ways to treat, diagnose, and prevent cancer-related diseases.” Patients who participate in clinical trials are volunteers who provide a tremendous service to advance cancer research.
According to Dr. Restrepo, there are several types of clinical trials that help physicians understand and treat their patients more effectively.
He added that prevention trials involve people who want to prevent cancer or cancer recurrence. Screening trials examine individuals who do not have symptoms of cancer and identify best methods to detect the disease; and diagnostic trials are conducted to determine how to identify cancer using new tests (X-rays, blood tests, genetic alterations, etc.)
Dr. Restrepo went on to say that treatment trials are designed to answer questions about new treatments, such as drugs (chemotherapeutic agents), surgical procedures, vaccines, or radiation therapy. These trials are conducted with patients diagnosed with cancer.
Clinical trials involving new drug therapies, combinations, or interactions are conducted in four phases, and some lead to breakthrough drugs or therapies.
Phase I trials usually involve a small number of participants (approximately 15-50) and are designed to determine the dosage safety of a drug, the delivery method and side effects. Once researchers have determined the appropriate dose amount, the therapy or technique moves on to a phase II trial.
Phase II trials generally test for response and include a slightly larger group of participants (approximately 25-100) usually with the same type of cancer. The trials examine the effectiveness of the treatment and side effects.
Phase III trials compare a new drug or intervention with current available treatments. Patients are usually randomly assigned to the current treatment group or the new treatment group. Studies are moved to this stage only after showing promise in the earlier phases, and these trials include larger numbers of patients (several hundred to several thousand).
He said that the Food and Drug Administration (FDA) is involved in every phase of research and must give final approval before a drug can be released for general physician and patient use. After a treatment has passed Phase III it is submitted for approval by the FDA. Once a treatment is FDA-approved, it is made available to the general population.
Dr. Restrepo said it can take on average 12 years and over US$350 million to get a new drug from the laboratory to the pharmacy shelf. “Only 1 in 1000 of the compounds that enter laboratory testing will ever make it to human testing.”
The Texas Oncology – McAllen research program was established 20 years ago in 1994. “We have participated in approximately 125 Phase II and Phase III studies with the enrollment of more than 550 patients from the Rio Grande Valley area.” He pointed out that half of the patients in the local research studies have had breast cancer.
Dr. Billie Marek, medical director of Texas Oncology McAllen has been the research site leader and principal investigator of most of these studies. Due to his excellent leadership, hard work, and dedication the research program in McAllen has persisted over time. Dr. Marek has now stepped down from the research program leadership and has endowed the leadership to Dr. Alvaro Restrepo.
It is important to mention that Texas Oncology-McAllen research is part of a larger research network US Oncology Research. Dr. Restrepo said that since 1999, US Oncology Research has been conducting Phase I-IV clinical trials across a large number of indications in more than 370 sites of care and 100 radiation oncology centers in 18 states. “More than 59,000 patients have enrolled in over 1300 clinical trials.”
Dr. Restrepo emphasized that Texas Oncology – McAllen research physicians in collaboration with other 900 investigators affiliated to US Oncology Research span every cancer type and stage, and are dedicated to advancing cancer care. “Together, we have contributed to some of the most important recent developments in cancer treatment, including the approval of more than 46 anticancer agents by the FDA.”
Dr. Restrepo’s area of interest is breast cancer; he is currently the Texas Oncology – McAllen research site leader and local principal investigator for six Phase II and Phase III Breast Cancer studies. He is the principal investigator in the United States for an International study soon available for enrollment in McAllen and the rest of the country. He is part of the US Oncology Breast cancer committee since 2008.
Dr. Restrepo shared with Mega Doctor News the following examples of how research studies benefit us on a daily basis. One benefit is in the decision-making in patients with breast cancer needing surgery, either a radical surgery like mastectomy (removal of the breast) or a conservative surgery like lumpectomy (removal of the tumor only in the breast).
“Since the early 1970’s more than six modern large studies with more than 8000 patients directly compared breast conservation plus radiation therapy vs. mastectomy. Patients were followed for more than 20 years and the results showed similar survival rates for both groups,” he stated.
He pointed out that studies also show that in certain low-grade tumors, radiation therapy can be avoided. Recently research studies confirmed no need for an axillary dissection of nodes if they were not involved by tumor (a surgical procedure that opens the armpit to examine and remove lymph nodes if deemed necessary). These investigations have confirmed that removal of a smaller area of bone, muscle, or tissue involved with a tumor is now acceptable without altering the risk of recurrence or survival.
Clinical studies also confirm that for large tumors greater than 4 cm, breast conservation is also possible when they are treated with chemotherapy to make the tumor smaller. A good understanding of the biology and behavior of the tumor helps tailor a more personalized treatment plan. Tests can be performed to determine the rate of recurrence and whether chemotherapy can be beneficial or avoided.
“Thanks to research studies we now understand that all breast cancer tumors are different at the molecular level but they can be grouped in categories. For the aggressive breast cancer tumors chemotherapy is the only intervention that decreases the chance of recurrence after surgery. For some other tumors, drugs must be used in combination with other chemotherapeutic agents to improve the chance of cure.” Studies also show no benefit of vitamin A, E, C, antioxidants, beta-carotene, caffeine, alkaline water, etc. in the prevention of breast cancer.
He is excited to say that thanks to prior research studies today in the U.S., trends in breast cancer are encouraging. “Data from the National Cancer Institute (NCI) show consistent declines in both new cases and deaths from breast cancer since 1990.” He added, “Further, the U.S. Centers for Disease Control and Prevention (CDC) reports that from 2001 to 2010 the incidence of breast cancer among U.S. women did not increase, while mortality decreased 2 percent annually.”
In addition, he said that what’s most notable about these data is that breast cancer mortality is decreasing faster than incidence – meaning that women with breast cancer are living longer. That trend is also confirmed by the National Cancer Institute (NCI) data: although only 75 percent of women with breast cancer survived more than five years in 1975, in 2011 more than 90 percent did.
Dr. Restrepo said, “Women with breast cancer are enjoying higher survival rates and improved quality of life due to earlier diagnosis, new technologies, improved chemotherapy treatments, and hormonal therapy. Research saves lives and helps cure cancer,” Dr. Restrepo concluded. MDN
7th Annual Walk, Run, & Ride Promotes Breast Cancer Awareness and Rallies Survivors Oct. 25 Fundraiser
The 7th edition of the event begins at 8 a.m., on Saturday, Oct. 25 at Texas Oncology–McAllen, located at 1901 South Second Street. Registration for the 5k run; 2.5 or 4.5-mile walk; or 20, 40, or 60-mile bicycle rally is now open. Proceeds from the event benefit the Texas Oncology Foundation, Comfort House, Food Bank of the RGV, Infinite Love, and Aurora House. For more information or to register, visit TXOWalkRunRide.com.
Tuesday, Oct. 25 at 10 a.m.
Texas Oncology–McAllen, 1901 South Second Street, McAllen, Texas, 78503
Alvaro Restrepo, M.D., medical oncologist at Texas Oncology–McAllen, and event chairman Veronica Vela Whitacre, McAllen city commissioner; and other Walk, Run & Ride participants