Humane Cancer Treatments:
Impressive..., Revolutionary..., The Future of Cancer Treatment... (Views of Doctors)
RadioFrequency Ablation (RFA) is a new, innovative, minimally invasive treatment for cancer. An alternative to the conventional treatments, the procedure can be done with only an over-night hospital stay or sometimes on an out-patient basis. There are virtually no significant side effects. RFA leaves no dis-figuring scars and requires only a local anesthetic. According to Dr.Damian Dupuy of Rhode Island Hospital, the treatment is less traumatic than surgery and unlike radiation, RFA does not adversely affect the immune system.
There have been highly successful clinical trials (over 90%) for several types of cancer, including liver, lung and breast. The Food & Drug Administration (FDA) has approved RFA's use for liver cancer and for treating the pain of bone cancer.
There are numerous articles in the medical literature on the striking results of this rather simple procedure and doctors using the treatment give it glowing reports. However, it has had practically no coverage in the national news media and is not yet widely known.
PRESS RELEASE: 11/11/04 A study has begun to determine whether radiofrequency ablation treatment for women who undergo traditional lumpectomy for breast cancer can reduce re-operative rates and the need for additional therapy (typically radiation) following the lumpectomy. "Our goal is to change the way breast cancer is treated for the more than 100,000 women in the United States who undergo a lumpectomy for early stage breast cancer each year," said Dr. Suzanne Klimberg, Director of the Breast Cancer Program at The University of Arkansas for Medical Sciences. (See full press release below)
92% Survival Rate in Stage 1 Non-Small Cell Lung Cancer Patients at One Year Using RFA (Rita Medical Products) as the Sole Anti-Cancer Treatment. (See article below)
Views of Doctors
Ernest L Rosato, MD, Assistant Professor of Surgery at Jefferson Medical College (JMC) says radiofrequency ablation is "revolutionary in terms of minimizing patient risk, loss of ability to work, and expense." He is amazed at how well patients have done to date. "What's striking is that every patient we've had wakes up and asks if they can go home. It is extraordinary how patients are tolerating this treatment."
"This really is the future of cancer treatment," according to Dr. Jeffrey Cadeddu, an assistant professor of urology at the University of Texas, Southwestern, who performs the RFA procedure.
"These results are very impressive," states Professor Lencioni, who has conducted clinical trails on RFA. "The data presented here clearly show that RITA (an RFA device) can offer a new approach in the treatment of lung cancer for the majority of patients who cannot have surgery."
"In the 20 years I've been treating cancer, this procedure has the potential for being the greatest thing that's ever come about," said Dr. Ralph Vance, an oncologist participating in an RFA trial for treating lung cancer.
Physicians & Hospitals Using RFA (liver & bone cancers mainly)
Makers of RFA devices
Breast Cancer Pilot Study Examines New Radiofrequency Ablation-Assisted Lumpectomy Breast Conservation Therapy
November 11, 2004
Study to Determine Whether Procedure Can Reduce Re-Operative Rates and Need for Additional Therapy Following Lumpectomy
The University of Arkansas for Medical Sciences (UAMS) and RITA Medical Systems, Inc. (Nasdaq:RITA - News) today announced that the first patient in a planned series of 30 received a radiofrequency ablation-assisted lumpectomy procedure.
The procedure is intended to give the patient a cancer-free area around the site where the tumor has been removed so that repeat lumpectomies are unnecessary. The procedure may also offer similar protection against recurrence provided by the use of partial or whole breast radiation, the current standard of care following lumpectomy.
The clinical study, "Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites with Indocyanine Green Confirmation to Decrease Re-operation," is designed to determine the patient benefits of using radiofrequency ablation (RFA) to ablate, or sear, a one-centimeter margin or perimeter of soft tissue following standard lumpectomy removal of a breast tumor.
V. Suzanne Klimberg, M.D., Professor of Surgery and Pathology at the University of Arkansas for Medical Sciences (UAMS) and the Central Arkansas Veterans Healthcare Systems (CAVHS), Chief of the Division of Breast Surgical Oncology at UAMS, and Director of the Breast Cancer Program at UAMS' Arkansas Cancer Research Center (ACRC), will treat up to 30 patients in the Phase I clinical trial.
The treatments will be performed under the guidelines of the investigational review board (IRB)-approved pilot study with educational funding support provided in part by RITA Medical Systems of Mountain View, California. Additional support for the study will be provided by the Tenebaum Breast Cancer Research Program.
"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. With the study we hope to prove that we can reduce the high re-operative rates associated with lumpectomy and offer added assurance that the cancer will not recur in these patients."
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 RFA-assisted lumpectomy procedure may offer similar protection against cancer recurring for some patients to the standard course of partial or whole-breast radiation therapy.
Joseph DeVivo, President and Chief Executive Officer of RITA Medical Systems, commented, "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. 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 patients will be treated with RFA at the time of initial lumpectomy. The success of the trial will be used to determine the feasibility of conducting a Phase II multicenter trial to evaluate the ability of RFA-assisted lumpectomy to decrease the rates of re-operation associated with standard lumpectomy. Qualified patients with operable breast cancer will be treated with a combination of two available and reliable treatments -- lumpectomy and RFA.
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. Long-term effects of the surgery and subjective cosmetic results will be recorded at each follow-up point. Initial endpoints of the study will be the number of excisions avoided for focally positive margins and the accuracy of ablation of the area around the tumor bed.
An additional objective of the planned multicenter trial will be to show that the local recurrence rate will be reduced by using RFA-assisted lumpectomy. Because RFA will be administered in addition to procedures of demonstrated efficacy, it is expected the local recurrence rate will decrease. Although local recurrence rate is not the primary aim in this pilot study, patients still will be followed over time for local recurrence.
The large number of women treated for breast cancer each year supports the need for advances in treatment. 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 surgical treatment when pathology, typically reported two to five days following initial surgery, reveals the presence of cancer in the margins, the area 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 currently recommended to most patients following lumpectomy to reduce the risk of recurrence at the surgical site. Radiation therapy is associated with substantial side effects during treatment, as well as late toxic effects and significantly decreases patient quality of life. The study will assist in the process of determining if RFA-assisted lumpectomy may be an option to reduce the risk of recurrence without the adverse physical and psychological effects of RT.
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.
Jeanne Hite, 66, was diagnosed by breast biopsy in September 2003 with a small breast cancer tumor. She elected to receive RFA-assisted lumpectomy in March of 2004, prior to the start of the pilot study. Ms. Hite was reluctant to undergo the recommended six weeks of whole-breast radiation therapy, and at the suggestion of two consulting physicians contacted Dr. Klimberg to inquire about surgical options for her planned breast conservation procedure.
Ms. Hite commented, "I felt immediately comfortable with Dr. Klimberg's explanation of the procedure, and I am very pleased with the results. It was almost unbelievable how easy the treatment was: I went in early in the morning and by that afternoon I felt that I was cancer free. I was able to travel to California within two weeks of the procedure to help support my daughter while she was giving birth to her second child. I would have missed that experience completely had I needed to stay at home for the radiation treatments."
Ms. Hite continued, "I hoped that by adding radiofrequency ablation to my lumpectomy procedure I would be spared the possibility of having to undergo a second procedure and the need for radiation treatments. My follow up visits since March have shown no recurrence of the cancer and I am very thankful that I have not needed additional treatments."
"Jeanne's experience is exactly what we are hoping to repeat as well as capture and analyze in the controlled study," Klimberg said. "Many women are understandably anxious about possibly needing a second procedure to remove all of the cancer. We were able to confirm Jeanne's diagnosis and treat her on the same day."
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.
According to recent statistics, 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.
Worldwide one in eight women will get breast cancer. Women with early-stage disease could potentially benefit from RFA-assisted lumpectomy. In 2002, more than 4.4 million women worldwide had some form of breast cancer with 1.2 million new cases diagnosed. Breast cancer was the cause of death for more than 410,000 women worldwide in 2002.
UAMS and its Arkansas Cancer Research Center are recognized nationally and regionally for their commitment to advancing healthcare and cancer treatment for patients.
About University of Arkansas for Medical Sciences (UAMS)
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.
NEW: From the American Roentgen Ray Society, 8/2/04
RADIOFREQUENCY ABLATION SAFE AND FEASIBLE FOR ERADICATING LUNG TUMORS
Radiofrequency ablation (RFA), the use of electrodes to heat and destroy abnormal tissue, is a promising technique to safely and effectively treat patients with inoperable lung tumors, say researchers from the IRCCS Hospital of Oncology in Bari, Italy.
In a study that focused on 18 patients with lung tumors ineligible for surgery, forty nodules were treated by lung RFA. Upon regular follow-up, no relapse was detected in 94% of the patients.
According to Cosmo Gadaleta, MD, lead author of the study, most lung tumors are inoperable due to serious coexisting health conditions or poor respiratory function in the patient. Certain of these types of inoperable tumors have been treated using radiotherapy, which can cause serious toxicity in a patient, and chemotherapy, which is not tolerable by all patients.
"Lung RFA can get around all those problems. It is minimally invasive, with only a small needle being inserted into the patient. It is also advantageous because of potentially low costs, short hospitalization times, and good patient tolerance without mortality," said Dr. Gadaleta.
Complications from the lung RFA performed were minor and included pneumothorax , the abnormal presence of air in the pleural cavity resulting in the collapse of the lung, which occurred in three of the patients. "Pneumothorax occurred in a small percentage of cases, and each occurrence was treated successfully with pleural drainage. The risk is small when compared to the benefits of lung RFA, and, since the radiology team anticipates the possibility of pneumothorax developing as a result of the procedure, they carefully monitor the patient so they can quickly treat any complications."
Dr. Gadaleta also expressed optimism for using lung RFA for treating patients with certain operable lung tumors, as well. "We feel that lung RFA could become more prevalent, first for patients who are not candidates for surgery, but also as an alternative to surgery for operable primary lung tumors, as long as the tumor is not too large."
The article appears in the August 2004 issue of the American Journal of Roentgenology.
Web Address: http://www.sciencedaily.com/releases/2004/08/040801231157.htm ,br>
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