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News Article | November 16, 2016
Site: www.biosciencetechnology.com

This might be the ultimate do-it-yourself project: Doctors are testing a device that would let women do part of their own breast reconstruction at home. It's aimed at not only making treatment more comfortable and convenient, but also giving women a sense of control - something cancer often takes away. More than 100,000 women each year in the United States have surgery to remove a cancerous breast, and many of them choose reconstruction with an implant. To make room for a permanent one, many of them get a tissue expander, a temporary pouch that is gradually enlarged with saline to stretch the remaining skin and muscle. This means trips to the doctor every week or two for several months for injections of saline into the pouch, which can be a painful ordeal. "We would put as much saline as we could until basically the patient would say, 'I can't stand it anymore,'" said Dr. Daniel Jacobs, a Kaiser Permanente plastic surgeon in San Jose, California. While biking home one day, Jacobs had an idea: Why couldn't a tiny can of compressed gas, like the one he carries to fix a flat tire, be used to let women inflate their own tissue expanders, a little each day so there is less stretching at a time and less pain? He helped found a company - AirXpanders Inc. of Palo Alto, California - to develop the device, called AeroForm. It's sold in Australia, approved in Europe and under review by the U.S. Food and Drug Administration. Its use requires no special training, wires or tubes - just a palm-sized remote control that activates a tiny cartridge inside the pouch to pump gas, up to three times a day according to how the woman feels. In a company-sponsored study of 150 women, AeroForm patients finished tissue expansion in half the time and were able to get implants a month sooner than others who had the usual saline treatments, said the study leader, Dr. Jeffrey Ascherman, a plastic surgeon at Columbia University Presbyterian Medical Center in New York. "My patients love it," he said. When some women who agreed to be in the study learned they had been assigned to get the saline device for comparison, "I had one who started crying, and other women said, 'please Dr. Ascherman, can't you change it?'" he said. There was no difference in rates of side-effects such as infections, but seven of the air expanders malfunctioned versus only one saline one, Ascherman said. The device was tweaked to fix the problem, he said. "It's a really interesting concept," said one outside expert, Dr. Deanna Attai, a University of California at Los Angeles surgeon who is a past president of the American Society of Breast Surgeons. "Giving the patient a sense of control is very psychologically important," because many women feel robbed of that, Attai said. "To a patient that's going through cancer treatment that could be a big deal." Dr. Susan E. Downey, a Los Angeles plastic surgeon who used the AeroForm on two patients in the study, said: "I think it will make life easier for a lot of people." It did for 35-year-old Luincys Fernandez, a high school chemistry teacher who lives in Bogota, New Jersey, and teaches in New York. She was diagnosed with breast cancer a year ago, when pregnant with her second son, and used the AeroForm as part of the study. "I really, really liked it," she said. She carried the remote control in her purse and completed the tissue expansion in just 18 days. "It did not interrupt any of my daily activities. I could go back to normal. I could see the results right away and I could see where I wanted it to go" in terms of size and appearance, she said. The device comes in three sizes. Women can choose the amount of inflation up to a point, limited by how much tissue is left and how far the device can expand. Once fully expanded, the device is removed and replaced with a breast implant. In Australia, AeroForm costs more than saline expanders but requires fewer office visits, so costs are not directly comparable. In the U.S., tissue expansion generally is reimbursed at a flat rate that is part of breast reconstruction, and AeroForm's impact on this cost - if the device wins FDA approval - is not clear.


News Article | November 16, 2016
Site: www.rdmag.com

This might be the ultimate do-it-yourself project: Doctors are testing a device that would let women do part of their own breast reconstruction at home. It's aimed at not only making treatment more comfortable and convenient, but also giving women a sense of control — something cancer often takes away. More than 100,000 women each year in the United States have surgery to remove a cancerous breast, and many of them choose reconstruction with an implant. To make room for a permanent one, many of them get a tissue expander, a temporary pouch that is gradually enlarged with saline to stretch the remaining skin and muscle. This means trips to the doctor every week or two for several months for injections of saline into the pouch, which can be a painful ordeal. "We would put as much saline as we could until basically the patient would say, 'I can't stand it anymore,'" said Dr. Daniel Jacobs, a Kaiser Permanente plastic surgeon in San Jose, California. While biking home one day, Jacobs had an idea: Why couldn't a tiny can of compressed gas, like the one he carries to fix a flat tire, be used to let women inflate their own tissue expanders, a little each day so there is less stretching at a time and less pain? He helped found a company — AirXpanders Inc. of Palo Alto, California — to develop the device, called AeroForm. It's sold in Australia, approved in Europe and under review by the U.S. Food and Drug Administration. Its use requires no special training, wires or tubes — just a palm-sized remote control that activates a tiny cartridge inside the pouch to pump gas, up to three times a day according to how the woman feels. In a company-sponsored study of 150 women, AeroForm patients finished tissue expansion in half the time and were able to get implants a month sooner than others who had the usual saline treatments, said the study leader, Dr. Jeffrey Ascherman, a plastic surgeon at Columbia University Presbyterian Medical Center in New York. "My patients love it," he said. When some women who agreed to be in the study learned they had been assigned to get the saline device for comparison, "I had one who started crying, and other women said, 'please Dr. Ascherman, can't you change it?'" he said. There was no difference in rates of side-effects such as infections, but seven of the air expanders malfunctioned versus only one saline one, Ascherman said. The device was tweaked to fix the problem, he said. "It's a really interesting concept," said one outside expert, Dr. Deanna Attai, a University of California at Los Angeles surgeon who is a past president of the American Society of Breast Surgeons. "Giving the patient a sense of control is very psychologically important," because many women feel robbed of that, Attai said. "To a patient that's going through cancer treatment that could be a big deal." Dr. Susan E. Downey, a Los Angeles plastic surgeon who used the AeroForm on two patients in the study, said: "I think it will make life easier for a lot of people." It did for 35-year-old Luincys Fernandez, a high school chemistry teacher who lives in Bogota, New Jersey, and teaches in New York. She was diagnosed with breast cancer a year ago, when pregnant with her second son, and used the AeroForm as part of the study. "I really, really liked it," she said. She carried the remote control in her purse and completed the tissue expansion in just 18 days. "It did not interrupt any of my daily activities. I could go back to normal. I could see the results right away and I could see where I wanted it to go" in terms of size and appearance, she said. The device comes in three sizes. Women can choose the amount of inflation up to a point, limited by how much tissue is left and how far the device can expand. Once fully expanded, the device is removed and replaced with a breast implant. In Australia, AeroForm costs more than saline expanders but requires fewer office visits, so costs are not directly comparable. In the U.S., tissue expansion generally is reimbursed at a flat rate that is part of breast reconstruction, and AeroForm's impact on this cost — if the device wins FDA approval — is not clear.


News Article | March 1, 2017
Site: www.prweb.com

Breast Surgeon, Dr. Dennis Holmes of 90210 Surgery Medical Center will review minimally invasive cryoablation for the treatment of early stage breast cancer and where it fits in the treatment paradigm at Susan G. Komen San Diego’s Annual Dinner Symposium, “Screens, Genes & The Choices We Make.” The event brings together leading cancer and wellness experts to share the latest innovations in breast cancer research, treatment and holistic well-being. The symposium will take place on Thursday, March 16, 2017 at the San Diego Del Mar Marriott. Dr. Holmes is an internationally renowned breast surgeon and cancer researcher currently serving as Interim Director of the Margie Petersen Breast Center at Providence St. John’s Health Center and Interim Director, John Wayne Cancer Institute Breast Surgery Fellowship Program. Formerly, Dr. Holmes held the positions of Chief Breast Surgeon and Medical Director of the Los Angeles Center for Women’s Health, and Chief Breast Cancer Surgeon, and Breast Cancer Research Committee Co-Chair at the University of Southern California Kenneth Norris Comprehensive Cancer Center. Dr. Holmes has been a pioneer in the field of minimally invasive breast surgery, including intraoperative radiotherapy, lymph node-sparing surgery and cryoablation “I am thrilled to partner with Komen San Diego, as we share similar goals - to save lives and pursue the best breast cancer treatments,” said Dr. Holmes. Currently, the standard of care for early stage breast cancer is surgery (e.g. lumpectomy, mastectomy) and sentinel node biopsy followed by breast radiotherapy and adjuvant endocrine and/or chemotherapy. Although surgery offers tumor removal and margin verification, a major drawback of surgery is the cosmetic and functional impairment of the breast resulting from volume changes, scar formation, nipple displacement, sensation changes, skin/scar retraction, and re-excision rate. Dr. Holmes was an investigator in the National Cancer Institute Z1072 Clinical Trial sponsored by the Alliance for Clinical Trials in Oncology. The trial examined cryoablation for the treatment of early stage breast cancer. In a 5-year multicenter study, cryoablation was shown to be 92% effective for complete ablation of invasive breast tumors ≤2 cm and 100% effective for complete ablation of invasive ductal breast cancer tumors <1.0 cm. Results from this breast cancer study (ACOSOG Z1072), which included a 5-year follow-up, were published in the Annals of Surgical Oncology. The Visica® 2 Treatment System developed by Sanarus Technologies, was the exclusive device used in the Z1072 study. “Cryoablation is a very promising alternative to traditional surgery for early stage breast cancer. Cryoablation minimizes changes in breast volume and nipple position, and avoids prominent scars,” explained Dr. Holmes. “The outstanding results of Z0172 inspired me to start the FROST Clinical Study, for which I now serve as Principal Investigator.” The FROST Clinical Study is the evolution of data from Z1072, which examines the rate of successful tumor ablation in patients treated with cryoablation of the primary tumor instead of surgical removal of early stage breast cancer. The FROST Clinical Study is currently enrolling women age 50 and older with core needle biopsy proven clinical stage I, T1, (≤1.5 cm) clinically node negative (N0), unifocal, hormone receptor positive and HER2/neu-negative invasive ductal carcinoma. Cryoablation with the Visica 2 Treatment System is a nonsurgical option for patients that have been diagnosed with early stage breast cancer, is visible on sonogram, and has been confirmed with a biopsy. This procedure has many benefits including: under 30-minutes, local anesthesia, in-office, excellent cosmesis, cost efficient, and quick patient recovery. Cryoablation is a viable option to surgery that results in complete early stage tumor ablation. About Dr. Holmes Dr. Holmes serves in the leadership of several national surgical societies and is a frequent lecturer at national conferences. He is a member of the education committee of the American Society of Breast Surgeons. Dr. Holmes is a Fellow of the American College of Surgeons and was also recently selected as Board Chair and President of the TARGIT Collaborative Group, a national research and education organization. Widely respected by colleagues for his innovative approach to breast cancer care, Dr. Holmes has gained worldwide acclaim for his pioneering research in targeted intraoperative radiotherapy. Dr. Holmes believes wholeheartedly that, with proper treatment, most women diagnosed with breast cancer will live a long, fulfilling life—a life both richer and more meaningful than they could have ever imagined. Find out more at http://www.drholmesmd.com About Sanarus Technologies In 2001, the Visica® 2 Treatment System was the first device available for cryoablation of fibroadenomas. Since then, our system has been used to successfully treat thousands of patients. The Visica 2 Treatment System is FDA-cleared for the ablation of cancerous or malignant tissue and benign tumors. At Sanarus, we develop innovative solutions for the nonsurgical treatment of breast tumors. We are headquartered in Pleasanton, CA, and all our products are manufactured in the USA. Find out more at http://www.sanarus.com ABOUT SUSAN G. KOMEN SAN DIEGO®: Since its inception in 1995, Komen San Diego has granted more than $18 million to research and local non-profits who provide everything from free diagnostic mammograms, meal delivery, temporary financial aid, transportation and more. Seventy-five percent of every dollar raised in San Diego stays in San Diego County to fund breast health services for uninsured and underinsured women and their families. The remaining 25 percent funds international breast cancer research. In fact, next to the U.S. government, Susan G. Komen® is the largest funder of breast cancer research in the world. For more information, please visit http://www.komensandiego.org. Connect with us on Facebook and Twitter and Instagram.


News Article | November 3, 2016
Site: www.prweb.com

Cancer Surgery of Mobile announced today that it has acquired the Visica® 2 Treatment System, a cryoablation device that uses extreme cold (cryo) to destroy tissue (ablation). Developed by Sanarus Technologies, the Visica 2 Treatment System destroys the tumor by freezing it with liquid nitrogen and damaging the adjacent vasculature that fuels tumor growth. Dr. Patterson is the first breast surgeon in Alabama to use this advanced technology for the treatment of certain breast cancers as an alternative to lumpectomy. Sharla Gayle Patterson, M.D., FACS is fellowship-trained in breast surgery oncology and specializes in oncoplastic surgery. She is certified by the American Society of Breast Surgeons and was the first surgeon in the area to receive certification in Hidden Scar Breast Cancer Surgery. Cryoablation—also referred to as tumor freezing—is a minimally invasive procedure done under ultrasound guidance in the doctors’ office or radiology suite. After injection of local anesthesia, a thin probe is inserted through the skin directly into the tumor. Liquid nitrogen is pumped into the probe to form an “ice ball” around the lesion. Freezing destroys the tumor cells, which are then reabsorbed by the body over time. The procedure can be done in under an hour with most patients reporting minimal discomfort and a resumption of normal activity right away. Little, if any, visible scarring occurs. Because no breast tissue is removed during the procedure, the natural shape of the breast is maintained. “At Cancer Surgery of Mobile, we take a proactive approach to women’s health and well-being. Our patients are encouraged to understand their options and make informed treatment decisions. Cryoablation is a great addition to the practice because we see positive outcomes from a virtually painless in-office procedure,” said Dr. Patterson. “It’s a safe and effective treatment that increases patient satisfaction and underscores our commitment to providing the highest level of patient care.” In a 5-year multicenter study funded by the National Cancer Institute and sponsored by the Alliance for Clinical Trials in Oncology, cryoablation with the Visica 2 Treatment System was shown to be 100% effective for complete ablation of invasive ductal breast cancer tumors <1.0 cm. The Visica 2 Treatment System was the exclusive device used in the Z1072 study and showed cryoablation effective in 92% of the targeted lesions. Results from this phase II trial (ACOSOG Z1072) and an introduction to the current FROST Trial for early stage breast cancer will be presented at the Synergy 2016 annual symposium, Friday November 4 at the Eden Roc, Miami Beach. The panel discussion, "Minimally Invasive Cryoablation For Early Stage Breast Cancer," features insights from Dennis R. Holmes, MD, FACS, Kamilia Kozlowski, MD and Bing Han, MD, PhD. “The breast is an ideal location for ablative therapy because there are no organs between it and the skin to get in the way of tumor access,” said Dr. Patterson. “With cryoablation, I’m able to effectively treat the target lesion and offer the patient an excellent cosmetic result.” Cryoablation with the Visica 2 Treatment System is an option for patients whose breast tumor is less than 4 cm in diameter, visible on sonogram and has been confirmed with a biopsy. About Cancer Surgery of Mobile Cancer Surgery of Mobile is a multi-specialty group consisting of surgical oncologist Dr. Lee Thompson; general surgeon Dr. Gerhard Boehm; breast surgeon Dr. Sharla Patterson; and orthopedic oncologist Dr. Zhiqing Xing. Cancer Surgery of Mobile was the first in the area to implement a High Risk Breast Cancer Clinic. Patients at the clinic receive a risk assessment, breast exam and evaluation by Dr. Patterson with recommendations for genetic testing and counseling, if needed. Consultations with a dietician, an exercise physiologist and a breast cancer nurse navigator are also available. Dr. Patterson is accepting new patients for all services, including cryoablation with the Visica 2 Treatment System. Learn more about Cancer Surgery of Mobile by visiting our website or call 251.433.5557. About Sanarus Technologies In 2001, the Visica 2 Treatment System was the first system available for cryoablation of fibroadenomas. Since then, our system has been used to successfully treat thousands of patients. The System is FDA-cleared for the ablation of cancerous or malignant tissue and benign tumors. At Sanarus, we develop innovative solutions for the nonsurgical treatment of breast tumors. We are headquartered in Pleasanton, CA, and all of our products are manufactured in the USA. Find out more at sanarus.com.


News Article | November 16, 2016
Site: www.chromatographytechniques.com

This might be the ultimate do-it-yourself project: Doctors are testing a device that would let women do part of their own breast reconstruction at home. It's aimed at not only making treatment more comfortable and convenient, but also giving women a sense of control — something cancer often takes away. More than 100,000 women each year in the United States have surgery to remove a cancerous breast, and many of them choose reconstruction with an implant. To make room for a permanent one, many of them get a tissue expander, a temporary pouch that is gradually enlarged with saline to stretch the remaining skin and muscle. This means trips to the doctor every week or two for several months for injections of saline into the pouch, which can be a painful ordeal. "We would put as much saline as we could until basically the patient would say, 'I can't stand it anymore,'" said Dr. Daniel Jacobs, a Kaiser Permanente plastic surgeon in San Jose, California. While biking home one day, Jacobs had an idea: Why couldn't a tiny can of compressed gas, like the one he carries to fix a flat tire, be used to let women inflate their own tissue expanders, a little each day so there is less stretching at a time and less pain? He helped found a company — AirXpanders Inc. of Palo Alto, California — to develop the device, called AeroForm. It's sold in Australia, approved in Europe and under review by the U.S. Food and Drug Administration. Its use requires no special training, wires or tubes — just a palm-sized remote control that activates a tiny cartridge inside the pouch to pump gas, up to three times a day according to how the woman feels. In a company-sponsored study of 150 women, AeroForm patients finished tissue expansion in half the time and were able to get implants a month sooner than others who had the usual saline treatments, said the study leader, Dr. Jeffrey Ascherman, a plastic surgeon at New York-Presbyterian/Columbia Medical Center in New York. "My patients love it," he said. When some women who agreed to be in the study learned they had been assigned to get the saline device for comparison, "I had one who started crying, and other women said, 'please Dr. Ascherman, can't you change it?'" he said. There was no difference in rates of side-effects such as infections, but seven of the air expanders malfunctioned versus only one saline one, Ascherman said. The device was tweaked to fix the problem, he said. "It's a really interesting concept," said one outside expert, Dr. Deanna Attai, a University of California, Los Angeles, surgeon who is a past president of the American Society of Breast Surgeons. "Giving the patient a sense of control is very psychologically important," because many women feel robbed of that, Attai said. "To a patient that's going through cancer treatment that could be a big deal." Dr. Susan E. Downey, a Los Angeles plastic surgeon who used the AeroForm on two patients in the study, said: "I think it will make life easier for a lot of people." It did for 35-year-old Luincys Fernandez, a high school chemistry teacher who lives in Bogota, New Jersey, and teaches in New York. She was diagnosed with breast cancer a year ago, when pregnant with her second son, and used the AeroForm as part of the study. "I really, really liked it," she said. She carried the remote control in her purse and completed the tissue expansion in just 18 days. "It did not interrupt any of my daily activities. I could go back to normal. I could see the results right away and I could see where I wanted it to go" in terms of size and appearance, she said. The device comes in three sizes. Women can choose the amount of inflation up to a point, limited by how much tissue is left and how far the device can expand. Once fully expanded, the device is removed and replaced with a breast implant. In Australia, AeroForm costs more than saline expanders but requires fewer office visits, so costs are not directly comparable. In the U.S., tissue expansion generally is reimbursed at a flat rate that is part of breast reconstruction, and AeroForm's impact on this cost — if the device wins FDA approval — is not clear.


SAN FRANCISCO--(BUSINESS WIRE)--Invitae Corporation (NYSE:NVTA), a genetic information company, and TME Research, LLC today announced the initiation of a new clinical collaboration to evaluate the benefits of universal genetic testing of breast cancer patients. TME Research represents more than 300 breast care practices around the country whose core mission is to improve the quality and access to targeted breast cancer care. The collaboration, called the Universal Breast Cancer Genetic Testing Registry, will enroll 1,000 breast cancer patients across 20-25 TME practices in the United States. The enrollees will be tested with Invitae’s multi-cancer panel, an 80-gene hereditary cancer test that includes genes associated with hereditary cancers in eight major organ systems. Any patient with a current or previous diagnosis of breast cancer will be asked to consent to be enrolled in the study and receive genetic testing regardless of whether they meet established testing criteria. The goal of the study is to gather clinical and genetic information on every patient to better clarify the prevalence of gene alterations associated with breast cancer, the relationship of specific alterations with clinical presentation, and the impact of genetic information on clinical care and genetic counseling of the family. “The biggest revolution in medicine will be in genetic testing, and it is starting in the cancer realm with breast cancer patients. Universal genetic testing of breast cancer patients will reveal the true component that genetics has in breast cancer development,” said Peter Beitsch, MD, TME principal and former president of the American Society of Breast Surgeons. “This will not only benefit patients but also entire families – both male and female relatives – since deleterious genetic mutations associated with breast cancer can lead to many different cancers including prostate cancer.” Emerging research suggests current guidelines may be too narrow in their recommendations for genetic testing for breast cancer patients and their family members. Under current guidelines, those who do not meet specified criteria but may benefit from genetic information rarely receive testing. Genetic information can inform cancer treatment decisions and can help patients’ families better understand their risk for developing breast and a variety of cancers. “This Universal Registry will be a landmark trial that we hope will help lead to the revision or removal of restrictive guidelines that were developed when genetic testing was considerably more expensive,” noted Dr. Beitsch. Study enrollment is expected to begin in the first quarter of 2017. “Genetic information can help guide surgical and other treatment decisions for all breast cancer patients. As testing becomes more affordable and accessible, more patients should have the opportunity to benefit from understanding their genetic information,” said Robert Nussbaum, MD, chief medical officer of Invitae. “Invitae is pleased to partner with TME Research on this important study to better understand how frequently germline mutations occur in breast cancer and how that knowledge can be used to improve clinical management for all breast cancer patients and their families.” This study represents the second clinical collaboration between Invitae and TME Research focused on increasing access to hereditary cancer testing for patients with breast cancer and improved clinical support models for healthcare practitioners. Invitae Corporation's (NYSE: NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Invitae’s goal is to aggregate most of the world’s genetic tests into a single service with higher quality, faster turnaround time, and lower price than many single-gene and panel tests today. The company currently provides a diagnostic service comprising hundreds of genes for a variety of genetic disorders associated with oncology, cardiology, neurology, pediatrics, and other rare disease areas. For more information, visit our website at invitae.com. TME is a network of clinicians, researchers and educators comprising over 300 clinical practices whose core mission is to improve the quality and access to targeted breast cancer care by fostering high quality and comprehensive educational programs and resources. TME research is an extension of the TME mission and designs, executes and optimizes accrual in breast cancer and breast health studies with a focus on performing these studies with community leaders. TME is headquartered in Allentown, PA. For more information, visit http://www.tmeded.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to that genetic testing will benefit cancer patients and their entire families; that genetic information can inform and guide cancer treatment decisions and help patients’ families understand their risk for developing breast and a variety of cancers; that the Universal Registry will be a landmark trial that will help lead to the revision or removal of restrictive guidelines regarding genetic testing recommendations; and that study enrollment is expected to begin in the first quarter of 2017. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the company’s ability to use rapidly changing genetic data to interpret test results accurately, consistently, and quickly; the company’s history of losses; the company’s need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company’s ability to develop and commercialize new tests and expand into new markets; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; laws and regulations applicable to the company’s business, including state licensing requirements and potential regulation by the Food and Drug Administration; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements. NOTE: Invitae and the Invitae logo are trademarks of Invitae Corporation. All other trademarks and service marks are the property of their respective owners.


What happens when doctors encourage patients to decide for themselves what kind of cancer treatment they should receive — and then the patients make the wrong choice? That is the dilemma facing a growing number of surgeons who care for women with early-stage breast cancer, new research suggests. Survey results from 2,402 women with the disease reveal that misconceptions about the value of surgery lead many patients to remove a healthy breast when there is no medical reason to do so. Patients were more likely to make this decision when their surgeons failed to make clear that the procedure would not reduce the risk that their cancer would come back, or prolong their life. “When patients participate more in their breast cancer surgical decisions, they more often receive aggressive treatment,” researchers wrote in a study published Wednesday in JAMA Surgery. “Ironically, a physician’s desire to support patient autonomy may result in excessive surgery if patients are misinformed, as our results suggest is common.” The surgery in question is called contralateral prophylactic mastectomy, or CPM. This is when doctors find cancer in one breast and then remove not just the affected breast but the other one too. It sounds like a logical way to reduce the risk of breast cancer, but in most cases, it isn’t. Unless a woman has a genetic mutation that increases her risk for the disease, the chance that a patient with early-stage cancer in one breast will later develop it in the other breast is very low — too low, doctors say, to justify the risks that come with surgery. That’s why the American Society of Breast Surgeons advises doctors to steer most women away from CPM. This wasn’t always the case, but treatments like chemotherapy, immunotherapy and hormone therapy have become so effective that in addition to reducing the risk that the known breast cancer will return, they also make it unlikely that a second breast cancer will develop, the study authors explained. “No compelling evidence suggests a survival advantage,” they wrote. And yet, “rates of this aggressive, costly, morbid, and burdensome procedure are increasing over time … even among patients without a high genetic risk of a secondary primary breast cancer.” To understand why this is happening, Dr. Reshma Jagsi, a radiation oncologist at the University of Michigan, and her colleagues sent surveys to 3,880 women in Los Angeles County and Georgia who were diagnosed with stage 0, stage 1 or stage 2 breast cancer between July 2013 and September 2014. The women were identified through registries maintained by the National Cancer Institute. Among the eligible women, 71% responded. Overall, 44% of the women said they considered removing their healthy breast, including the 24.8% of women who considered it “strongly” or “very strongly,” the researchers found. Women with high-risk mutations were more likely to think about CPM, but even among those with an average risk for breast cancer, 21% gave it strong or very strong consideration and an additional 20% considered it “moderately” or “weakly.” Among the women who at least contemplated CPM, 38% said they knew the procedure didn’t “improve survival for all women with breast cancer,” according to the study. An additional 24% were under the false impression that it did, and 38% said they didn’t know. Similarly, 43.5% of these women said they knew that removing a healthy breast “does not prevent cancer from recurring for all women with breast cancer,” while 17% thought it did and 39.5% said they didn’t know, according to the study. Ultimately, 14% of women with an average risk of breast cancer went through with the surgery, along with 26% of high-risk women. Nearly all (96%) of the women who removed a healthy breast cited “peace of mind” as a reason for doing so — even though many of them had acknowledged that CPM would not reduce the risk that cancer would return or extend their life. This finding suggests that women “do believe — whether rationally or emotionally — that there is a meaningful effect of more aggressive surgery on the ultimate risk of recurrence or survival,” the study authors wrote. Surgeons should emphasize to patients that they can get the same peace of mind with less drastic types of therapy, they added. In this study, women were more likely to opt for CPM if they were younger, white, had attended at least some college, had a mother, sister or daughter with breast cancer, had private insurance (instead of Medicaid) or had larger breasts. Also, women in Georgia were more likely to have CPM than women in Los Angeles. When the researchers used statistical methods to control for each patient’s age and family history of breast cancer, they found that women with a high-risk mutation were only slightly more likely to have the surgery than were average-risk women. In fact, the difference between the two groups was too small to be statistically significant. A minority of women (37%) said their surgeons recommended against the procedure, and these patients took that advice to heart — only 2% of them got the surgery anyway, the researchers found. On the flip side, 11% of women said their surgeons recommended CPM, and 59% of these patients followed that advice. An additional 46% of women said their surgeons neither recommended nor discouraged CPM; among this group, 21% had the surgery, according to the study. The researchers called the results “sobering.” But they also suggest a straightforward way to confront the problem. “Our findings should motivate surgeons to broach these difficult conversations with their patients, to make their recommendations clear, and to promote patients’ peace of mind by emphasizing” the effectiveness of other treatments, they wrote. Follow me on Twitter @LATkarenkaplan and "like" Los Angeles Times Science & Health on Facebook.


News Article | February 15, 2017
Site: www.prweb.com

Global Breast Health & Wellness Center, founded by Dr. April Speed, announced it has expanded its cryoablation treatment of fibroadenoma to include early stage breast cancer with the Visica® 2 Treatment System. Developed by Sanarus Technologies, the Visica 2 Treatment System is a cryoablation device that uses extreme cold liquid nitrogen (cryo) to destroy tissue (ablation). The device destroys the tumor by freezing and damaging the adjacent vasculature that fuels tumor growth. Dr. April L. Speed is board-certified by the American College of Surgeons and is a member of the American Society of Breast Surgeons, the Society of Surgical Oncology and the American Society of Clinical Oncology (ASCO). Dr. Speed was recognized by her peers and awarded the ASCO National Diversity in Oncology Award in 2009. Cryoablation—also referred to as tumor freezing—is a minimally invasive procedure done under ultrasound guidance in the doctor’s office or radiology suite. After injection of local anesthesia, a thin probe is inserted through the skin directly into the tumor. Liquid nitrogen is pumped into the probe to form an “ice ball” around the lesion. Freezing destroys the tumor cells, which are then reabsorbed by the body over time. The procedure can be done in less than an hour with most patients reporting minimal discomfort and a resumption of normal activity right away. Little, if any, visible scarring occurs. Because no breast tissue is removed during the procedure, the natural shape of the breast is maintained. ”I’ve been providing cryoablation for the treatment of fibroadenomas since 2015 and have obtained very good results” said Dr. Speed. “Those results coupled with the publication of the National Cancer Institute Z1072 Trial have truly encouraged me to expand my practice to offer cryoablation for early stage breast cancer tumors.” In a 5-year multicenter study funded by the National Cancer Institute and sponsored by the Alliance for Clinical Trials in Oncology, cryoablation with the Visica 2 Treatment System was shown to be 100% effective for complete ablation of invasive ductal breast cancer tumors <1.0 cm. The Visica 2 Treatment System was the exclusive device used in the Z1072 study and showed cryoablation to be effective in 92% of the targeted lesions. Results from this breast cancer study (ACOSOG Z1072), which included a 5-year follow-up, were published in the Annals of Surgical Oncology. Dr. Speed further explained that “In November 2016, I opened my new state of the art facility located in Buckhead to provide Greater Atlanta with a comprehensive, 100% dedicated, breast surgery practice. Cryoablation is one of our primary treatment options for our patients because it provides an opportunity for women to have cutting edge therapy with dignity and detail performed in a serene, patient-centered environment. It also gives women the benefit of a minimally invasive procedure with little to no scarring, downtime, or discomfort.” Dr. Speed recently discussed cryoablation and other breast cancer related topics on Atlanta Business RadioX. She discussed the technology of cryoablation, who would qualify as a patient, and why she has chosen to offer cryoablation for the treatment of early stage breast cancer lesions. She has also been featured on CentricTV. Cryoablation with the Visica 2 Treatment System is a nonsurgical option for patients that have been diagnosed early stage breast tumor that is less than 4 cm in diameter, is visible on sonogram and has been confirmed with a biopsy. About Global Breast Health & Wellness Center Dr. Speed serves on several boards, the Susan G. Komen for the Cure Greater Atlanta Affiliate, and the Georgia Perimeter College. She's a highly sought-after speaker, author, consultant and lecturer on breast cancer and breast health. Dr. Speed has recently embarked upon an exciting venture of private practice in two convenient locations, Buckhead and Conyers, and welcomes all of her previous patients and new patients alike to continue to be a part of this amazing journey of transformation from your Breast Health to your Best Health℠. Let's treat it, beat it, move on!℠ To contact Dr. Speed go http://www.draprilspeed.com or call 678.210.2846 About Sanarus Technologies In 2001, the Visica® 2 Treatment System was the first available for cryoablation of fibroadenomas. Since then, our system has been used to successfully treat thousands of patients. The Visica 2 Treatment System is FDA-cleared for the ablation of cancerous or malignant tissue and benign tumors. At Sanarus, we develop innovative solutions for the nonsurgical treatment of breast tumors. We are headquartered in Pleasanton, CA, and all of our products are manufactured in the USA. Find out more at http://www.sanarus.com


Khan A.J.,Johnson University | Vicini F.A.,American Society of Breast Surgeons | Beitsch P.,American Society of Breast Surgeons | Goyal S.,Johnson University | And 11 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2012

Purpose: The American Society of Breast Surgeons enrolled women in a registry trial to prospectively study patients treated with the MammoSite Radiation Therapy System breast brachytherapy device. The present report examined the outcomes in women aged >70 years enrolled in the trial. Methods and Materials: A total of 1,449 primary early stage breast cancers were treated in 1,440 women. Of these, 537 occurred in women >70 years old. Fisher's exact test was performed to correlate age (≤70 vs. >70 years) with toxicity and with cosmesis. The association of age with local recurrence (LR) failure times was investigated by fitting a parametric model. Results: Older women were less likely to develop telangiectasias than younger women (7.9% vs. 12.4%, p = 0.0083). The incidence of other toxicities was similar. Cosmesis was good or excellent in 92% of the women >70 years old. No significant difference was found in LR as a function of age. The 5-year actuarial LR rate with invasive disease for the older vs. younger population was 2.79% and 2.92%, respectively (p = 0.5780). In women >70 years with hormone-sensitive tumors ≤2 cm who received hormonal therapy (n = 195), the 5-year actuarial rate of LR, overall survival, disease-free survival, and cause-specific survival was 2.06%, 89.3%, 87%, and 97.5%, respectively. These outcomes were similar in women who did not receive hormonal therapy. Women with small, estrogen receptor-negative disease had worse LR, overall survival, and disease-free survival compared with receptor-positive patients. Conclusions: Accelerated partial breast irradiation with the MammoSite radiation therapy system resulted in low toxicity and produced similar cosmesis and local control at 5 years in women >70 years compared with younger women. This treatment should be considered as an alternative to omitting adjuvant radiotherapy for older women with small-volume, early-stage breast cancer. © 2012 Elsevier Inc.

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