Contact: Leonard N. Karp
215-575-3720
lkarp@philadelphiamedicine.com
October 26, 2006
For immediate release:
In this month’s edition:
- Temple Lung Center Performs Region's First Biologic Lung Volume Reduction
- Crozer Earns Top Ranking in National Cardiac Care/Surgery Ratings
- Fox Chase Clinical Trail To Help Determine Most Appropriate Breast Cancer Treatment for Individual Women
Editors note: Research, new techniques and improved facilities by Philadelphia International Medicine hospitals and physicians may lead to new ways to treat some of our most challenging diseases. Below are just some examples from our hospitals.
Temple Lung Center Performs Region's First Biologic Lung Volume Reduction
Philadelphia - Pulmonologists at the Temple Lung Center have performed the region's first biologic lung volume reduction (BLVR), a potential new treatment for advanced emphysema that uses the application of a biodegradable gel to lung tissue-not surgery-to improve patients' breathing.
BLVR procedures take approximately 30 minutes and require a minimal hospital stay and only mild sedation of the patient. This Phase 1 clinical trial is being performed at only three hospitals in the nation.
"This potential new procedure requires only a bronchoscope to deliver treatment directly to diseased lung tissue-the source of the problem," says Gerard Criner, MD, chief of Pulmonary and Critical Care Medicine at the Temple Lung Center, as well as a principal investigator in the trial. "Temple's next phase of study is to help determine whether BLVR can be a simple, cost-effective treatment for advanced emphysema," adds Dr. Criner. "Potentially, BLVR may be the best option for patients who wish to avoid long recovery periods and the risks of complications associated with surgery."
Dr. Criner, chief of Temple Lung Center -- a U.S. News & World Report ranked program for respiratory disorders -- and one of the premier experts in the nation on emphysema treatment, is rated consistently as a Best Doctor in Philadelphia.
Emphysema is a degenerative disease affecting more than three million Americans and eight million worldwide that reduces the elasticity of lung tissue, preventing the healthy exchange of oxygen. In BLVR, physicians target diseased portions of the lung with a bronchoscope and apply a pharmaceutical-grade gel directly to small airways feeding the most diseased areas of the lung. The gel effectively collapses diseased tissue, seals it off from the rest of the lung, and causes the diseased regions to scar and shrink. BLVR, like the more invasive lung volume reduction surgery (LVRS) and endobronchial valve placement (EBV), "chokes off" the diseased lung tissue, allowing healthy tissue to perform better.
The procedure is intended to reduce lung volume over a period of weeks, as diseased lung tissue collapses. The reduction in lung-volume restores a more normal physiological relationship between the lung and chest wall, thereby improving breathing. The BLVR procedure takes approximately 20-30 minutes and patients experience only mild discomfort. Temple's first patient returned home two days after the procedure.
Temple University Hospital has been at the forefront of new emphysema treatments, having been the east coast's top recruiter for the National Emphysema Treatment Trial, which studied LVRS, as well as an active clinical site for the National Heart Lung Blood Institute's COPD Clinical Research Network and the Pennsylvania Study of COPD Exacerbations.
The BLVR trial is being developed by Aeris Therapeutics Inc. of Woburn, MA, which manufactures the gel. Dr. Criner has no financial interest in Aeris Therapeutics Inc.
Crozer Earns Top Ranking in National Cardiac Care/Surgery Ratings
Crozer-Chester Medical Center was ranked among the top 5 percent of all hospitals nationally for heart surgery and among the top 10 percent of all hospitals nationally for overall cardiac care and coronary interventions, according to a comprehensive study released by HealthGrades, the nation's leading healthcare ratings company. In addition, Crozer-Chester Medical Center is a recipient of the Specialty Excellence Award for Cardiac Care and Heart Surgery.
Crozer-Chester Medical Center also received five-star ratings for clinical excellence in Coronary Bypass Surgery, Valve Replacement Surgery, Coronary Interventions and Treatment of Heart Attack according to the 2007 HealthGrades' ratings.
"Crozer has always demonstrated a commitment to providing excellent cardiac care, and these new HealthGrades quality ratings validate that commitment," says Joan K. Richards, president and chief operating officer of Crozer-Keystone Health System. "I salute all of the physicians, nurses and other employees who have worked together to create such an excellent program."
As part of its ninth annual Hospital Quality in America Study, HealthGrades independently analyzed more than 5,000 hospitals in all 50 states and the District of Columbia for its 2007 ratings, objectively assessing their clinical outcomes and quality. The 40 million hospitalization records utilized in the assessment are publicly available and licensed from the federal government's Centers for Medicare and Medicaid Services. The HealthGrades ratings take into account varying degrees of patient severity from hospital to hospital and measure whether patient outcomes for each of more than two dozen procedures and diagnoses are better than expected (5-Star), as expected (3-Star) or worse than expected (1-Star).
The 2007 HealthGrades ratings for all hospitals nationwide are available, free of charge, on the organization's award-winning consumer Web site, located at www.healthgrades.com.
Since 1992, Crozer's dedicated heart surgery team has performed more than 3,000 surgeries with an excellent record of success. Among the surgeries performed include "off-pump" bypass surgery, repair of defective heart valves, and emergency or scheduled repairs of life-threatening conditions of the aorta.
Karl Grunewald, MD, chief of the Division of Cardiothoracic Surgery at Crozer, says, "Crozer's strong ratings from HealthGrades in cardiac surgery are a tribute to the commitment to excellence of the entire heart surgery team at Crozer. We work together to ensure patient safety and elicit good outcomes - giving our patients a chance to successfully return to the standard of living they enjoyed before surgery."
For patients suffering from blocked arteries, Crozer offers the latest procedures in the area of interventional cardiology, performed in the medical center's new cardiac catheterization labs. These procedures include cardiac catheterization, angioplasty (including emergency primary angioplasty), atherectomy, and stenting (including drug-eluting stents).
Ancil Jones, MD, chief of the Division of Cardiology at Crozer, says, "We're proud that our interventional cardiology program has again been recognized for excellence by HealthGrades. Our patients trust Crozer because of our experience. We've performed more than 17,000 cardiac catheterization procedures, more than 5,000 angioplasties and more than 1,000 primary angioplasties since we began performing these procedures in 1992."
Cardiac patients who are initially diagnosed at other Crozer-Keystone hospitals can return to those hospitals for post-procedure care and rehabilitation. In addition, cardiologists from other hospitals - such as Edward LaPorta, MD, chief of the Section of Cardiology at DCMH, and Samuel Ruby, MD, chief of the Section of Cardiology at Taylor - come to Crozer to perform procedures.
Fox Chase Clinical Trail To Help Determine Most Appropriate
Breast Cancer Treatment for Individual Women
In an effort to accelerate the reality of "personalized medicine," Fox Chase Cancer Center is participating in an international clinical trial designed to best determine the most appropriate and effective treatment for women with early-stage breast cancer.
The study, called TAILORx, Trial Assigning Individualized Options for Treatment (Rx), will determine whether genes frequently associated with a higher risk of breast cancer recurrence can be used to help determine the best course of treatment.
"We know from our research that some women with hormone receptor positive early stage breast cancer receive chemotherapy that is unnecessary, but the challenge is determining which women benefit and which do not," said Lori J. Goldstein, M.D., principal investigator TAILORx at Fox Chase Cancer Center and director of Fox Chase's Breast Evaluation Center and Breast Cancer Research Program. "TAILORx is designed to allow us to tailor a woman's treatment based on a number of genetic factors to ensure the best course of action for each woman."
The majority of women with hormone receptor positive early stage breast cancer are advised to receive chemotherapy in addition to radiation and hormonal therapy, yet research has demonstrated that chemotherapy does not benefit all women equally. TAILORx seeks to incorporate a molecular profiling test (a technique that examines many genes simultaneously) into clinical decision-making, and thus spare women unnecessary treatment if chemotherapy is not likely to substantially benefit them.
"This trial is important because it is one of the first to examine a methodology for personalizing cancer treatment," said Elias A. Zerhouni, MD, director of the National Institutes of Health.
The study will enroll over 10,000 women at 900 sites in the United States and Canada including Fox Chase Cancer Center. Women eligible for the study will be recently diagnosed with early stage breast cancer that has not spread to the lymph nodes, and who are estrogen receptor and/or progesterone receptor positive, and Her2/neu negative.
More about TAILORx
Breast cancer is the most frequently diagnosed cancer in women, with an estimated 212,920 new cases of invasive breast cancer expected in the United States in 2006. Over one-half of these women's cancer will test positive for estrogen receptors and will not have cancer in their lymph nodes.
"For 80 percent to 85 percent of those women, the current standard treatment practice is surgery followed by radiation and hormonal therapy," explained Goldstein. "The proportion of women who actually benefit substantially from chemotherapy is fairly small."
TAILORx seeks to determine the most effective approach to cancer treatment, with the fewest side effects, for women with early-stage breast cancer by using Oncotype DXT.
Oncotype DXT measures the levels of expression of 21 genes (whether they are transcribed into messenger RNA) in breast tumors. This assessment can more precisely estimate a person's risk of recurrence than standard characteristics, such as tumor size and grade.
Based on the Oncotype DXT gene expression analysis, a recurrence score from 0 to 100 is generated; the higher the score, the greater a woman's chance of having a recurrence if treated with hormonal therapy alone.
Women will be studied for 10 years, with an additional follow-up of up to 20 years after initial therapies. Based on their recurrence score, women will be assigned to three different treatment groups in the TAILORx study:
- Women with a recurrence score higher than 25 will receive chemotherapy plus hormonal therapy (the standard of care)
- Women with a recurrence score lower than 11 will receive hormonal therapy alone
- Women with a recurrence score of 11 to 25 will be randomly assigned to receive adjuvant hormonal therapy, with or without chemotherapy.
TAILORx is designed primarily to evaluate the effect of chemotherapy on those with a recurrence score of 11 to 25. Because the degree of benefit of chemotherapy for women with recurrence scores between 11 and 25 is uncertain, TAILORx seeks to determine if the Oncotype DXT test will be helpful in future treatment planning for this group.
Hormonal therapies including tamoxifen and the aromatase inhibitors anastrozole, letrozole and exemestane are assigned based on menopausal status and comorbidities. Women on the chemotherapy arm of the trial will receive one of several standard combination chemotherapy regimens considered to be the best available standard care today. It will also be possible for women participating in TAILORx to participate in other NCI-sponsored clinical trials, provided the therapy prescribed in the clinical trial is consistent with their assigned therapy in TAILORx.
TAILORx is sponsored by the National Cancer Institute and is coordinated by the Eastern Cooperative Oncology Group.