Cary S. Kaufman

Cryoablation of early-stage breast cancer: Work-in-progress report of a multi-institutional trial

BackgroundWith recent improvements in breast imaging, our ability to identify small breast tumors has markedly improved, prompting significant interest in the use of ablation without surgical excision to treat early-stage breast cancer. We conducted a multi-institutional pilot safety study of cryoablation in the treatment of primary breast carcinomas.MethodsTwenty-nine patients with ultrasound-visible primary invasive breast cancer ≤2.0 cm were enrolled. Twenty-seven (93%) successfully underwent ultrasound-guided cryoablation with a tabletop argon gas-based cryoablation system with a double freeze/thaw cycle. Standard surgical resection was performed 1 to 4 weeks after cryoablation. Patients were monitored for complications, and pathology data were used to assess efficacy.ResultsCryoablation was successfully performed in an office-based setting with only local anesthesia. There were no complications to the procedure or postprocedural pain requiring narcotic pain medications. Cryoablation successfully destroyed 100% of cancers <1.0 cm. For tumors between 1.0 and 1.5 cm, this success rate was achieved only in patients with invasive ductal carcinoma without a significant ductal carcinoma-in-situ (DCIS) component. For unselected tumors >1.5 cm, cryoablation was not reliable with this technique. Patients with noncalcified DCIS were the cause of most cryoablation failures.ConclusionsCryoablation is a safe and well-tolerated office-based procedure for the ablation of early-stage breast cancer. At this time, cryoablation should be limited to patients with invasive ductal carcinoma ≤1.5 cm and with <25% DCIS in the core biopsy. A multicenter phase II clinical trial is planned.

Excising the Reexcision: Stereotactic Core-Needle Biopsy Decreases Need for Reexcision of Breast Cancer

Abstract. There is debate regarding use of the stereotactic core-needle biopsy (SCNB) for highly suspicious mammographic lesions. This study compares a serial group of mammography-detected breast cancer patients treated before and after the use of SCNB. We studied 113 consecutive nonpalpable breast cancers between 1994 and 1996. Altogether 47 patients were diagnosed by wire-localized breast biopsy (wire group) and the next 66 consecutive breast cancer patients by SCNB (stereo group). Negative margins were found more often in the stereo group than in the wire group (77% vs. 38%,p < 0.001). Reexcision was required more frequently in the wire group than in the stereo group (68% vs. 21%,p < 0.001), and one-staged surgical procedures were done more often in the stereo group than the wire group (79% vs. 21%,p < 0.001). The volume of the initial wide excision was much larger in the stereo group than in the wire group (p= 0.002). Those in the wire group required 50% more operations per patient (1.8 vs. 1.2) than the stereo group. A significant cost savings can be estimated in the stereo group compared with the wire group. The use of SCNB was associated with breast excisions of larger volume, negative margins, and decreased need for reexcision. Simultaneous adjunct procedures resulted in one-stage operations, improving cost savings. The use of SCNB for nonpalpable breast cancer benefits the patient, the surgeon, and the payor. It should be undertaken prior to the first surgical procedure.

Office-based cryoablation of breast fibroadenomas with long-term follow-up.

Abstract:  Approximately 10% of women will experience a breast fibroadenoma in their lifetime. Cryoablation is a new treatment that combines the better attributes of the current standards: surveillance and surgery. It is a minimally invasive office‐based procedure that is administered without the use of general anesthesia, involving minimal patient discomfort and little to no scarring. This work aimed to establish the long‐term (2–3 years) efficacy, safety, and satisfaction of the procedure, as well as the impact of cryoablation on mammogram and ultrasound images. Thirty‐seven treated fibroadenomas were available for assessment with an average follow‐up period of 2.6 years. Of the original 84% that were palpable prior to treatment, only 16% remained palpable to the patient as of this writing. Of those fibroadenomas that were initially ≤2.0 cm in size, only 6% remained palpable. A median volume reduction of 99% was observed with ultrasound. Ninety‐seven percent of patients and 100% of physicians were satisfied with the long‐term treatment results. Mammograms and ultrasounds showed cryoablation produced no artifact that would adversely affect interpretation. Cryoablation for breast fibroadenomas has previously been reported as safe and effective both acutely and at the 1‐year follow‐up mark, and thus has been implemented as a treatment option. At long‐term follow‐up, cryoablation as a primary therapy for breast fibroadenomas demonstrates progressive resolution of the treated area, durable safety, and excellent patient and physician satisfaction. The treatment is performed in an office setting rather than an operating room, resulting in a cost‐effective and patient‐friendly procedure. Cryoablation should be considered a preferred option for those patients desiring definitive therapy for their fibroadenomas without surgical intervention. 

Intraoperative ultrasonography guidance is accurate and efficient according to results in 100 breast cancer patients.

BACKGROUND The frequency of nonpalpable breast cancer has doubled in the last 10 years. Surgical use of high quality portable ultrasound units has made it possible to evaluate the time-saving method of intraoperative ultrasonography localization. METHODS Ultrasonography localization in the operating room immediately prior to definitive surgery was performed by the surgeon. All tissue underwent specimen mammography and ink orientation. The presence of negative margins, the closest margins, the need for reexcision, and the cosmetic result were examined for each patient. RESULTS Ultrasonography correctly localized all breast cancers at surgery (100% sensitivity). Negative margins for invasive carcinoma were found in 90% of patients. Negative margins were at least 10 mm in 27%, at least 5 mm in 62%, and at least 1 mm in 90%. Positive margins were due to the presence of noncalcified ductal carcinoma in-situ (4 of 10) or multifocal invasive disease (6 of 10) noted at final histology. Reexcisions were performed in 9% of patients. CONCLUSIONS Surgical use of intraoperative ultrasonography for localization of breast cancer is accurate and efficient. Ultrasonography localization is easier on the patient, is time and cost efficient, and convenient to schedule. Surgeons should embrace this new skill and utilize this tool whenever a nonpalpable breast cancer can be seen with ultrasonography.

Toolbox to Reduce Lumpectomy Reoperations and Improve Cosmetic Outcome in Breast Cancer Patients: The American Society of Breast Surgeons Consensus Conference

BackgroundMultiple recent reports have documented significant variability of reoperation rates after initial lumpectomy for breast cancer. To address this issue, a multidisciplinary consensus conference was convened during the American Society of Breast Surgeons 2015 annual meeting.MethodsThe conference mission statement was to “reduce the national reoperation rate in patients undergoing breast conserving surgery for cancer, without increasing mastectomy rates or adversely affecting cosmetic outcome, thereby improving value of care.” The goal was to develop a toolbox of recommendations to reduce the variability of reoperation rates and improve cosmetic outcomes. Conference participants included providers from multiple disciplines involved with breast cancer care, as well as a patient representative. Updated systematic reviews of the literature and invited presentations were sent to participants in advance. After topic presentations, voting occurred for choice of tools, level of evidence, and strength of recommendation.ResultsThe following tools were recommended with varied levels of evidence and strength of recommendation: compliance with the SSO-ASTRO Margin Guideline; needle biopsy for diagnosis before surgical excision of breast cancer; full-field digital diagnostic mammography with ultrasound as needed; use of oncoplastic techniques; image-guided lesion localization; specimen imaging for nonpalpable cancers; use of specialized techniques for intraoperative management, including excisional cavity shave biopsies and intraoperative pathology assessment; formal pre- and postoperative planning strategies; and patient-reported outcome measurement.ConclusionsA practical approach to performance improvement was used by the American Society of Breast Surgeons to create a toolbox of options to reduce lumpectomy reoperations and improve cosmetic outcomes.

Intraoperative ultrasound facilitates surgery for early breast cancer.

BackgroundMammogram-directed wire localization for nonpalpable cancer requires surgeon’s time and coordination and some patient discomfort. Up to half of these nonpalpable lesions can be visualized by ultrasound. Use of intraoperative ultrasound streamlines the process of image-guided surgery.MethodsWe prospectively visualized 69 nonpalpable breast cancers between January 1998 and July 2001. Ultrasound localization was performed in the operating room immediately before definitive surgery. Breast cancers were localized using either blue dye or a guide wire.ResultsUltrasound correctly localized all lesions at surgery. Negative margins for invasive carcinoma were found in 97% (67 of 69) of patients. Re-excisions were performed in only 6% (4 of 69) of patients. Overall negative margins were found in 90% (62 of 69) of patients. Most positive margins (71%) were due to the presence of noncalcified ductal carcinoma in situ. Mastectomy was necessary in 4% of patients, usually due to multifocal invasive carcinoma.ConclusionsIncreased familiarity with ultrasound has allowed the surgeon to localize breast cancer in the operating room, improving the process of image-guided surgery. Ultrasound localization is accurate, time efficient, technically feasible, and easier for the patient. The re-excision rate is very low and is similar to that for mammographic localization. Intraoperative ultrasound localization should be considered whenever a breast cancer needs image-guided excision.

Quality measures, standards, and accreditation for breast centers in the United States.

*Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT; yDepartment of Radiation Therapy, The William W. Backus Hospital, Norwich, CT; zThe Cancer Institute of New Jersey, University of Medicine & Dentistry of New Jersey– Robert Wood Johnson Medical School, New Brunswick, NJ; xBellingham Breast Center, University of Washington, Bellingham, WA; and kThe American College of Surgeons, Chicago, IL

Intraoperative Digital Specimen Mammography: Rapid, Accurate Results Expedite Surgery

IntroductionSpecimen mammography during image guided breast surgery is a daily occurrence. The process of specimen travel, imaging and reporting may take 20–30 minutes. An intraoperative method to obtain digital specimen mammograms may expedite the process. We compared intraoperative digital specimen mammography (IDSM) as well as standard specimen mammography (SSM) on 121 consecutive image guided lumpectomies.MethodsEach lumpectomy specimen had IDSM obtained followed by travel to radiology for SSM. Surgical decisions were based on all imaging obtained. Data included 1) the ability of each imaging method to identify the target lesion, 2) degree of concordance of surgical interpretation of IDSM compared to radiologist interpretation of SSM, 3) the time required from lumpectomy to surgical review of images from each method, and 4) potential operative time savings.ResultsIntraoperative digital specimen mammography (IDSM) was equally as accurate as standard x-ray film specimen mammography. There was no significant difference between 1) the frequency of identification of the target lesion by surgeon or radiologist, 2) lack of identification of any lesion, or 3) frequency of involved margins using imaging criteria. However, there was a marked difference in 1) the time needed to obtain images ready to read, 2) the ability to re-excise tissue promptly, and 3) the overall operating room time with an average decrease of 19 minutes.ConclusionsIntraoperative digital specimen mammography (IDSM) was equally accurate as SSM obtained in this study. Use of this new technology allows surgeons to quickly view specimen images which translate into shorter more efficient operations.

Yes, Breast Surgeons May Provide Breast Cancer Genetic Assessment and Testing

There is underutilization ofgenetic testing and counseling to identify breast cancermutation carriers before they develop breast cancer; thenext generation of genetic testing has arrived with theability to test for multiple mutations simultaneously; somepayers have instituted severe restrictions on any genetictesting unless the payer’s genetics professionals haveapproved the test; and although there are no standard cre-dentialing criteria for the various providers of breast cancergenetic testing and counseling, there are defined guidelinesfrom credible national societies.The limited availability of risk assessment, genetic testingand counseling services has several causes. Certified geneticcounselors can provide these services, but there are notenough genetic counselors to service the existing populationof breast cancer patients, let alone the high-risk undiagnosedpatients. There are about 3,000 certified genetics counselorswho provide services across the county.The article by Beitsch and Whitworth is particularly timely for several reasons. There is underutilization of genetic testing and counseling to identify breast cancer mutation carriers before they develop breast cancer; the next generation of genetic testing has arrived with the ability to test for multiple mutations simultaneously; some payers have instituted severe restrictions on any genetic testing unless the payer’s genetics professionals have approved the test; and although there are no standard credentialing criteria for the various providers of breast cancer genetic testing and counseling, there are defined guidelines from credible national societies. The limited availability of risk assessment, genetic testing and counseling services has several causes. Certified genetic counselors can provide these services, but there are not enough genetic counselors to service the existing population of breast cancer patients, let alone the high-risk undiagnosed patients. There are about 3,000 certified genetics counselors who provide services across the county. Many are in populated states and big cities (e.g., 46 in Pennsylvania who deal with cancer, 12 located within 2 miles of each other in Philadelphia), with many cities and some states left without face-to-face access with a certified genetics counselor (e.g., only three in the State of Alaska, all three located in Anchorage, and none in the entire state of Wyoming). Most patients who are identified with breast cancer mutations are identified only after they have developed cancer. The most common mutation is the hereditary breast cancer and ovarian cancer syndrome (HBOC). The goal should be to identify mutation carriers before they develop breast cancer. Such a screening system is present in some breast centers with an integrated risk assessment questionnaire within the registration papers for routine screening mammography. As mentioned by Beitsch and Whitworth, there is inadequate identification of women before their breast cancer diagnosis, underscoring the need for risk assessment by clinicians. This is a unique time in the field of genetics and the identification of cancer causing genetic mutations. The next generation mutation identification technology has afforded the ability to test for multiple genetic mutations beyond HBOC syndrome simultaneously. This provides the patient a better opportunity to be identified as a mutation carrier and appropriately counseled. The expense of single site genetic testing has prohibited many patients with strong breast cancer family histories and negative results HBOC from affording a second site genetic mutation test. With the new technology, test panels for multiple breast cancer mutations can be processed simultaneously providing a comprehensive assessment for the presence of a breast cancer genetic mutation. Early studies using a 25-gene mutation panel have shown the number of pathologic gene mutations identified can be increased by as much as 51 %. Guidelines for risk assessment and genetic counseling and testing are well established and have been documented by national organizations. Beitsch and Whitworth comment that the National Comprehensive Cancer Network (NCCN) guidelines provide criteria to identify candidates for genetic counseling and mutation testing. The guidelines also describe the health care provider who would offer such counseling and testing: ‘‘A genetic counselor, medical geneticist, oncologist, surgeon, oncology nurse, or other health professional with expertise and experience in cancer genetics should be involved early in counseling patients who potentially meet criteria for an inherited syndrome.’’ 7 The NCCN guidelines do not identify the specific health care degree required or the specific education and experience for this individual. Society of Surgical Oncology 2014

Can We Measure the Quality of Breast Surgical Care

Many studies have demonstrated gaps in healthcare quality for all medical and surgical specialties including breast surgical care. How to optimally measure and improve quality has generated debate at the local, state, and national level. Attempts to judge medical performance by private companies using non-risk-adjusted administrative databases may not be accurate and may unfairly penalize surgical care. An overview of concepts to measure and improve quality of breast cancer care is presented with specific examples relevant to breast surgeons. Breast surgeons and their professional organizations need to take ownership of quality measure programs because others will surely do so if we do not. Participation in one or more of these programs is beneficial because peer performance comparison allows identification of potential areas for individual or institutional improvement and demonstrates the commitment of breast surgeons to quality improvement. This commitment may gain even greater importance if trends continue toward performance-based physician payment, patient steerage, licensure, and board certification.Many studies have demonstrated gaps in healthcare quality for all medical and surgical specialties including breast surgical care. How to optimally measure and improve quality has generated debate at the local, state, and national level. Attempts to judge medical performance by private companies using non-risk-adjusted administrative databases may not be accurate and may unfairly penalize surgical care. An overview of concepts to measure and improve quality of breast cancer care is presented with specific examples relevant to breast surgeons. Breast surgeons and their professional organizations need to take ownership of quality measure programs because others will surely do so if we do not. Participation in one or more of these programs is beneficial because peer performance comparison allows identification of potential areas for individual or institutional improvement and demonstrates the commitment of breast surgeons to quality improvement. This commitment may gain even greater importance if trends continue toward performance-based physician payment, patient steerage, licensure, and board certification.