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• STAR Trial at Saint Barnabas Health Care System They were words every woman hopes never to hear. “How long have you had this lump?” asked Francis Ruocco’s physician after he had examined her breast during a scheduled mammogram and ultrasound. Stunned, Mrs. Ruocco felt her right breast and to her dismay found a mass in the upper section. While she had felt a tremendous itch in that breast, Mrs. Ruocco had no other symptoms and never noticed the lump in her breast self-exams. It was the week before Christmas 1996 and an excisional biopsy was immediately scheduled in the operating room for early January. “I didn’t tell my family during Christmas,” recalls Mrs. Ruocco. “I wanted as much normalcy around me as possible to spare them and myself. It was very difficult. I kept getting weepy, hoping that this wasn’t going to be the last Christmas.” On January 13, her family learned the worst; the diagnosis was breast cancer. Saint Barnabas breast surgeon Elissa J. Santoro, M.D., who treated Mrs. Ruocco, recommended a lumpectomy and radiation followed by chemotherapy since the cancer had been found in six of the lymph nodes. The procedure was performed in February and Mrs. Ruocco credits her surgeon for giving her support during those difficult days, calling Dr. Santoro her “life raft.” In the tumultuous and frightening weeks that followed, Mrs. Ruocco clung to the encouragment and optimisim shown by Dr. Santoro, who helped her to believe that surviving breast cancer was not only possible, but also probable. She also placed faith on an important discussion with her oncologist Philip Lowry, M.D., hematologist/oncologist at The Cancer Center of Saint Barnabas Medical Center. “He told me that people who survive breast cancer hit it hard and hit it early,” Mrs. Ruocco relates. It was that second phrase, Mrs. Ruocco says, that helped her decide to participate in a clinical trial at Saint Barnabas that was designed specifically for patients with localized breast cancer. Clinical trials are studies that evaluate the effectiveness of new interventions and therapies. The research was being conducted by The Cancer and Leukemia Group B (CALGB), a national clinical research group sponsored by the National Cancer Institute. CALGB completes important clinical trials in the areas of leukemia, breast cancer, lung cancer, gastrointestinal malignancies and prostate cancer using patients from 31 university medical centers and over 185 community hospitals across the country. In this particular trial, which was called CALGB #9344 and was conducted between May 1, 1994 and April 15, 1997, patients were given the drug Taxol® in combination with Adriamycin® and cyclophosphamide in addition to their regular intravenous chemotherapy treatment. The results from the very trial in which Mrs. Ruocco was enrolled, when presented at the national meeting of the American Society of Clinical Oncology last year, resulted in Taxol® now being considered part of standard therapy for women with breast cancer involving the lymph nodes. Clinical Trials Lead to Breakthroughs According to the National Cancer Institute, clinical trials for cancer include all of the following: prevention trials to keep cancer from developing; early detection trials to find cancer; treatment trials to test new therapies; quality of life studies to improve the comfort of those with cancer; and studies to evaluate cancer-causing behaviors, such as the use of tobacco. By taking part in a clinical trial, patients may reap the benefit of a new drug or procedure while helping scientists evaluate its effectiveness. Participation in a clinical trial may also directly contribute to finding better ways to prevent, detect or treat the disease. “As a mother with breast cancer, I wanted to do anything I could to help my two daughters,” Mrs. Ruocco says. “Ten years ago, the people in clinical trials received the treatment that was standard for me in 1997. I’m thrilled that through my use of Taxol® I’ve helped to improve the future for my daughters.” She adds that another benefit of her participation has been the follow-up diagnostics she continues to receive, including tests every three months done at minimal cost through the clinical trial, as researchers continue to measure the progress of the participants. Dr. Lowry affirms that the cancer treatments of today were found as a result of clinical studies done five to ten years ago, and calls Mrs. Ruocco “ahead of her time.” To complete these studies, he says, notable cancer centers nationwide join together and agree on protocols before participating with research organizations like CALGB, as well as major pharmaceutical companies which also complete clinical trials. In order to be asked to participate, the hospital must show a certain level of competence and expertise, as well as patient volume, Dr. Lowry relates. A facility must have adequate and qualified staff and be able to complete collection of data. “There is a misconception that clinical trials make patients guinea pigs, when in fact they are designed to make good treatments even better,” says Dr. Lowry. “It is an incremental process. If a series of small studies shows promising results, then a clinical trial is created on a larger scale and it is monitored very closely. We are constantly trying to measure and improve treatments which have initially proven successful.” It is important to note that those who enter clinical trials receive the same medical treatment that non-participants are given; the difference is that they are also given an additional treatment, medication or procedure through the study. Participants of clinical trials can choose to withdraw from studies at any time, and those who decide not to participate can be assured that their care is not compromised in any way, says Dr. Lowry. All patients at The Cancer Center of Saint Barnabas receive state-of-the-art medical care and comprehensive follow-up diagnostics, and all trial participants receive the same care as the non-participating patients. Now cancer-free for three years, Mrs. Ruocco credits her family, friends and physicians for their support and optimism during that difficult time and the clinical trial for keeping her at “the forefront” of cancer treatment. She hopes for continued good health and sees her life through different eyes. “You do not go through something like that without coming to the realization that you want to be around for a long time,” relates Mrs. Ruocco. “Life is much more beautiful to me now. I used to be depressed at the thought of turning 50, and then I was hit by cancer at 54. Now I’m aiming for high numbers. Age 60 and 70 sound very good to me.” For more information about The Cancer Center of Saint Barnabas Medical Center, please call (973) 322-5200.
Women at Risk and Minority Women in Particular Urged to Participate in Study Trials at Saint Barnabas Health Care System In May 1999, public announcement was made of the Saint Barnabas Health Care System’s participation in the Study of Tamoxifen and Raloxifene (STAR) at its cancer centers located at Monmouth Medical Center, Newark Beth Israel Medical Center and Saint Barnabas Medical Center. One of the largest breast cancer prevention studies ever, STAR is being conducted by research professionals who are part of the National Surgical Adjuvant Breast and Bowel Project (NSAPB) and are supported by the National Cancer Institute. Concern now lies in how to recruit minority women to participate in the study. Minority women, in particular, are less likely to participate in clinical trials of this nature compared to their Caucasian counterparts. With two of the three participating Saint Barnabas cancer centers located in urban centers, principal investigators at each site are striving to enroll a significant number of women representing minority populations. The advantage of STAR is that all study patients will be taking either tamoxifen or raloxifene, both of which are thought to prevent breast cancer. All STAR participants will be followed closely by their own physicians. Participants are asked to make a five-year commitment to the STAR study during which time they will have regular follow-up examinations. Drug therapy is provided free of charge. Women who participate in STAR must be postmenopausal, at least age 35, and have an increased risk of breast cancer as determined by age, family history of breast cancer, personal medical history, age at first menstrual period and age at first live birth. They will also go through an informed consent process. For information on STAR individuals may call: Minda Costin, R.N., M.A., STAR Project Coordinator, Newark Beth Israel Medical Center, (973) 926-7230 Lydia Kevill, R.N., B.S.N., O.C.N., STAR Site Coordinator, Monmouth Medical Center, (732) 923-6582 Jo Anne Behr R.N., B.S.N., O.C.N., STAR Site Coordinator, Saint Barnabas Medical Center, (973) 322-2992. [ top ] |
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