Landmark Breast Cancer Pilot Study at UAMS Examines New Breast Conservation Therapy

By todd

LITTLE ROCK – The University of Arkansas for Medical Sciences (UAMS), and RITA Medical Systems, Inc. (Nasdaq: RITA) today announced that the first patient in a planned series of 30 received a radiofrequency ablation-assisted lumpectomy procedure.


The RFA procedure, which sears a one-centimeter margin, or perimeter, of soft tissue following standard lumpectomy removal of a breast tumor, is intended to give the patient a cancer-free area around the site where the tumor has been removed so that repeat lumpectomies and/or radiation therapy are unnecessary.


V. Suzanne Klimberg, M.D., professor of surgery and pathology at UAMS, developed the procedure being used in the clinical study, “Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites with Indocyanine Green Confirmation to Decrease Re-operation.”


“Our goal is to change the way breast cancer is treated for the more than 100,000 women in the United States who undergo traditional lumpectomy for early stage breast cancer each year,” Klimberg said. “Our initial research on donor mastectomy sections in the lab told us that RFA was effective in creating negative margins around small breast tumor.”


Klimberg also is chief of the Division of Breast Surgical Oncology at UAMS, director of the Breast Cancer Program in UAMS’ Arkansas Cancer Research Center (ACRC) and staff physician the Central Arkansas Veterans Healthcare Systems (CAVHS).


“With the study we hope to prove that we can reduce the high re-operative rates associated with lumpectomy and that we can reduce the need for whole-breast radiation therapy following surgery to remove a breast tumor,” she said. 


Klimberg will treat up to 30 patients in the clinical trial. The treatments will be performed under the guidelines of the pilot study approved by the investigational review board (IRB) with educational funding support provided in part by RITA Medical Systems of Mountain View, Calif. Additional support for the study will be provided by the Tenenbaum Breast Cancer Research Program.


The researchers believe that giving patients a clear surgical margin at the time of the original lumpectomy will make unnecessary the estimated 40 percent of repeat lumpectomy procedures currently being done. The researchers also believe that the need for a standard course of five to six weeks of whole-breast radiation therapy may be reduced or eliminated for some patients who receive RFA-assisted lumpectomy.


“We are honored to partner with the University of Arkansas for Medical Sciences and its Arkansas Cancer Research Center and are pleased to support Dr. Klimberg’s efforts,” said Joseph DeVivo, president and chief executive officer of RITA Medical Systems. “We believe the procedure holds great promise for breast cancer patients, and we are proud that RITA’s current RFA offering is Dr. Klimberg’s product of choice.”


Under the IRB-approved prospective trial protocol, qualified patients will be treated with RFA at the time of initial lumpectomy. Before and after RFA is completed, fluorescence imaging will be used to ensure that no residual live cells remained in the ablation zone. Patients will be required to come in for follow-up visits at set intervals for a minimum of two years after the procedure. Although local recurrence rate is not the primary aim in this pilot study, patients still will be followed over time for local recurrence.


Each year in the United States, an estimated 120,000 women receive standard breast conservation therapy, commonly referred to as lumpectomy. Of these patients approximately 40 percent require additional surgery when pathology, typically reported two to five days following initial surgery, reveals the presence of cancer in the margin surrounding the tumor.


Also, only 10 percent to 40 percent of patients who are candidates for breast conservation therapy are receiving it, indicating the majority of women are undergoing some form of mastectomy (surgical removal of the whole breast), although several studies demonstrate equivalent outcomes for lumpectomy plus radiation therapy (RT) compared with mastectomy. Mastectomy also can result in significant psychological effects.


Whole-breast radiation therapy is recommended to most patients following lumpectomy to reduce the risk of recurrence at the surgical site. RT is associated with substantial side effects during treatment, as well as late toxic effects and significantly decreases patient quality of life.


Another motivation to develop an alternative to RT is the number of patients who refuse to be treated with RT following lumpectomy. Estimates suggest that 30 percent to 40 percent of breast cancer patients choose not to receive RT due to fear about side effects and poor cosmetic results, and concerns about consequences of travel and impacts on their job or family. Radiation is typically given five days a week for five to seven weeks. 


Breast cancer remains the leading cancer diagnosis in women in the U.S. and will affect one in seven women in a woman’s lifetime, with more than 215,000 new cases estimated to be diagnosed in 2004. About 59,000 more women will be diagnosed with a very early stage of the disease. Despite availability of breast-conserving surgery, only 10 percent to 40 percent of women in the United States who are candidates for this treatment receive it.


Approximately 185,000 women diagnosed with early-stage breast cancer undergo one of the three most common surgical treatments: lumpectomy, lumpectomy with radiation or mastectomy. Each of these treatments is associated with a range of potentially negative physical and psychological effects, including cosmetic effects, toxicity and considerable risk of recurrence. RFA-assisted lumpectomy may allow improved cosmetic results with the best opportunity to ensure negative margins in patients with early-stage breast cancer, while avoiding the adverse effects associated with radiation therapy.


RITA Medical Systems develops, manufactures and markets innovative products for cancer patients, including radiofrequency ablation (RFA) systems for treating cancerous tumors as well as percutaneous vascular and spinal access systems.  The company’s oncology product lines include implantable ports, some of which feature its proprietary Vortex® technology; tunneled central venous catheters; safety infusion sets and peripherally inserted central catheters used primarily in cancer treatment protocols.  The proprietary RITA system uses radiofrequency energy to heat tissue to a high enough temperature to ablate it or cause cell death.  In March 2000, RITA became the first RFA company to receive specific FDA clearance for unresectable liver lesions in addition to its previous general FDA clearance for the ablation of soft tissue.  In October 2002, RITA again became the first company to receive specific FDA clearance, this time, for the palliation of pain associated with metastatic lesions involving bone.


UAMS is the state’s only comprehensive academic health center, with five colleges, a graduate school, a medical center, five centers of excellence and a statewide network of regional centers. UAMS has about 2,170 students and 650 residents and is the state’s largest public employer with almost 9,000 employees. UAMS and its affiliates have an economic impact in Arkansas of about $3.8 billion a year.


UAMS centers of excellence are the Arkansas Cancer Research Center, Harvey and Bernice Jones Eye Institute, Donald W. Reynolds Center on Aging, Myeloma Institute for Research and Therapy and Jackson T. Stephens Spine and Neurosciences Institute.