Meta-Analysis of Local Invasive Breast Cancer Recurrence After Electron Intraoperative Radiotherapy.

BACKGROUND: Electron intraoperative radiotherapy (IORT) can be used during breast conserving surgery to treat early-stage invasive breast cancer. Using data from current clinical and observational studies, this study aimed to assess the impact of single-fraction electron IORT on local recurrence rates. METHODS: Studies on single-fraction electron IORT during breast conserving surgery were identified through a search of PubMed and Google Scholar, as well as through secondary referencing. Local recurrence rate was the main outcome of interest. A meta-analysis of proportions using a binomial distribution to model the within-study variability and a random effects model was conducted to estimate a pooled local recurrence rate. To estimate a 5-year recurrence rate, a single-sample Poisson-normal model was applied to model the probability of events occurring during a fixed period (60 months). RESULTS: The study identified 13 publications. The analysis demonstrated a pooled monthly local recurrence rate of 0.02% per person-month (95% confidence interval CI 0.00-0.06%) for the studies with a follow-up period shorter than 5 years, 0.03% per person-month (95% CI 0.02-0.06%) for studies with a follow-up period of 5 years or longer, and 0.02% per person-month (95% CI 0.01-0.04%) overall. Based on this model, the predicted 5-year local recurrence rate was 2.7% (range 1.9-3.7%). CONCLUSIONS: According to the published literature, the rate of breast cancer local recurrence after electron IORT was 0.02% per person-month, with an adjusted 5-year recurrence rate of 2.7%. These findings support the recent guidelines from the American Society for Radiation Oncology (ASTRO) supporting the use of electron IORT for low-risk patients.

Secondary Mastopexy After Nipple-Sparing Mastectomy and Staged Subcutaneous Expander/Implant Reconstruction.

BACKGROUND: The acceptance of nipple-sparing mastectomy for the treatment of breast cancer in selected patients has introduced ancillary procedures to improve breast shape, correct ptosis, and enhance breast symmetry. Mastopexy before or at the time of nipple-sparing mastectomy has been performed to correct ptosis, but there have been no reports on secondary Wise pattern mastopexy after completion of staged subcutaneous expander/implant reconstruction. METHODS: Between 2005 and 2015, 155 patients (255 breasts) underwent staged subcutaneous implant/expander-based reconstruction after inframammary nipple-sparing mastectomy. Of the 155 patients, 10 (6.5%) patients required a secondary Wise pattern mastopexy (n = 14, 5.5%). The nipple was raised 2.5 to 6 cm (range, 3.8 cm), and the implant location was adjusted accordingly for optimal positioning with respect to the nipple-areola. The secondary mastopexy was performed to correct ptosis, improve breast symmetry and/or contour deformities of the breast, and relieve pain associated with large implants. RESULTS: All mastopexies healed without complications, and the goals of the revisions were achieved. There were no capsular contractures after an average of 50 months (range, 19-92 months). The patients were satisfied with the aesthetic and functional improvement. CONCLUSIONS: Secondary mastopexy after 2-stage subcutaneous expander/implant breast reconstruction is uncommon, but if needed, it may be safely performed to correct ptosis and improve breast shape, symmetry, and function.

Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

BACKGROUND: PRO-CTCAE is a library of items that measure cancer treatment-related symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN 261201000063C). The objective of this study is to examine the equivalence and acceptability of the three data collection modes (Web-enabled touchscreen tablet computer, Interactive voice response system [IVRS], and paper) available within the US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system. METHODS: Participants (n = 112; median age 56.5; 24 % high school or less) receiving treatment for cancer at seven US sites completed 28 PRO-CTCAE items (scoring range 0-4) by three modes (order randomized) at a single study visit. Subjects completed one page (approx. 15 items) of the EORTC QLQ-C30 between each mode as a distractor. Item scores by mode were compared using intraclass correlation coefficients (ICC); differences in scores within the 3-mode crossover design were evaluated with mixed-effects models. Difficulties with each mode experienced by participants were also assessed. RESULTS: 103 (92 %) completed questionnaires by all three modes. The median ICC comparing tablet vs IVRS was 0.78 (range 0.55-0.90); tablet vs paper: 0.81 (0.62-0.96); IVRS vs paper: 0.78 (0.60-0.91); 89 % of ICCs were ≥0.70. Item-level mean differences by mode were small (medians [ranges] for tablet vs. IVRS = -0.04 [-0.16-0.22]; tablet vs paper = -0.02 [-0.11-0.14]; IVRS vs paper = 0.02 [-0.07-0.19]), and 57/81 (70 %) items had bootstrapped 95 % CI around the effect sizes within +/-0.20. The median time to complete the questionnaire by tablet was 3.4 min; IVRS: 5.8; paper: 4.0. The proportion of participants by mode who reported "no problems" responding to the questionnaire was 86 % tablet, 72 % IVRS, and 98 % paper. CONCLUSIONS: Mode equivalence of items was moderate to high, and comparable to test-retest reliability (median ICC = 0.80). Each mode was acceptable to a majority of respondents. Although the study was powered to detect moderate or larger discrepancies between modes, the observed ICCs and very small mean differences between modes provide evidence to support study designs that are responsive to patient or investigator preference for mode of administration, and justify comparison of results and pooled analyses across studies that employ different PRO-CTCAE modes of administration. TRIAL REGISTRATION: NCT Clinicaltrials.gov identifier: NCT02158637.

Linguistic validation of the Spanish version of the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

PURPOSE: The U.S. NCI's PRO-CTCAE is a library of self-report items for assessing symptomatic adverse events in cancer clinical trials from the patient perspective. The aim of this study was to translate and linguistically validate a Spanish version. METHODS: PRO-CTCAE's 124 items were translated from English into Spanish using multiple forward and back translations. Native Spanish speakers undergoing cancer treatment were enrolled at six cancer treatment sites. Participants each completed approximately 50 items and were then interviewed using cognitive probes. The interviews were analyzed at the item level by linguistic themes, and responses were examined for evidence of equivalence to English. Items for which ≥20 % of participants experienced difficulties were reviewed, and phrasing was revised and then retested in subsequent interviews. Items where <20 % of respondents experienced difficulties were also reviewed and were considered for rephrasing and retesting. RESULTS: One hundred nine participants from diverse Spanish-speaking countries were enrolled (77 in Round 1 and 32 in Round 2). A majority of items were well comprehended in Round 1. Two items presented difficulties in ≥20 % of participants and were revised/retested without further difficulties. Two items presented difficulties in <20 %, and when retested exhibited no further difficulties. Two items presented difficulties in <20 %, but were not revised due to lack of alternatives. Sixteen items presented difficulties in ≤12 % and were not revised because difficulties were minor. CONCLUSIONS: The Spanish PRO-CTCAE has been developed and refined for use in Spanish-speaking populations, with high levels of comprehension and equivalence to the English PRO-CTCAE. TRIAL REGISTRATION: ClinicalTrials.gov:NCT01436240.

Primary Buttonhole Mastopexy and Nipple-Sparing Mastectomy: A Preliminary Report.

BACKGROUND: Patients undergoing nipple-sparing mastectomy and immediate-implant based reconstruction occasionally require a mastopexy based on their breast size and degree of ptosis. Previous reports have shown the feasibility of mastopexy-nipple-sparing mastectomy in selected patients to raise the nipple up to 5 cm. Major mastopexy with nipple transposition more than 6 cm in conjunction with nipple-sparing mastectomy for therapeutic indications has not been described. The authors review their experience with primary buttonhole mastopexy performed in conjunction with nipple-sparing mastectomy. METHODS: Between 2008 and 2014, 16 patients (32 breasts) underwent bilateral primary mastopexy and nipple-sparing mastectomy with immediate staged implant-based reconstruction. The Passot buttonhole technique was used for the mastopexy in all patients, raising the nipple from 7 to 12 cm. Tumor-related data, risk factors, breast size, degree of ptosis, expander size, fill volume, selection criteria, and complications are discussed. RESULTS: The average follow-up period was 33 months (range, 14 to 80 months). There were no tumor recurrences, and all patients completed their reconstruction. Two patients required removal of the expander and delayed reconstruction because of infection and implant exposure due to nipple-areola loss. The reasons for nipple-areola loss and technical modifications to enhance skin viability by retaining a thin layer of subareolar breast tissue for removal during the second-stage implant exchange are discussed. CONCLUSIONS: Primary mastopexy using the buttonhole technique performed together with nipple-sparing mastectomy is a safe procedure with predictable results in patients with very large or ptotic breasts requiring lifts greater than 6 cm. The success of the combined procedure depends on preserving a thin layer of subareolar breast tissue and removing it at the time of implant exchange.

Margins: a status report from the Annual Meeting of the American Society of Breast Surgeons.

Since the emergence of breast conserving surgery (BCS) as an alternative to mastectomy in the 1980's, there has been little consensus on what constitutes acceptable margins for cases of invasive breast cancer, how best to evaluate margins in the operating room, or an understanding of the challenging process of margin assessment by pathologists. The program committee for the 15th Annual Meeting of The American Society of Breast Surgeons organized a plenary session to discuss the latest thinking and guidelines for these important issues. The SSO/ASTRO Consensus Guideline on Margins for BCS was an important focus of discussion. The SSO/ASTRO consensus panelists concluded that "no ink on tumor" is an adequate surgical margin for BCS in patients with invasive breast cancers. Intraoperative strategies to decrease the incidence of positive margins include intraoperative localization techniques (wire-localization, ultrasound, radioactive seed) and intraoperative margin assessments with specimen radiography, imprint cytology, and frozen section. Studies also demonstrate the positive effect of shave margins with or without intraoperative margin assessment. The College of American Pathologists protocols for breast specimen margin evaluation consider multiple variables that can impact the proper assessment of margins. These variables include: tissue fixation time, specimen orientation, cold ischemia time, leaking ink, specimen pancaking and others that surgeons need to be aware of. Determining when "enough is enough" should not only be the application of guidelines and national standards, but also a multidisciplinary discussion between breast cancer specialists for what is right for the individual patient's unique circumstances.

Oncologic Safety of Staged Prepectoral Implant Reconstruction following Nipple-Sparing Mastectomy: A Mean 9-Year Follow-Up.

BACKGROUND: Prepectoral reconstruction following nipple-sparing mastectomy has recently gained popularity as an alternative to total or partial submuscular reconstruction. In the absence of long-term follow-up, concerns have been raised over the oncologic safety of using mastectomy flaps that preserve the entire thickness of the subcutaneous fat and its circulation. In this article, the authors present their average 9-year oncologic follow-up of patients who underwent nipple-sparing mastectomy and two-stage prepectoral implant reconstruction without acellular dermal matrix. METHODS: In this retrospective study, a group of previously reported (151 consecutive) breast cancer patients [246 breasts (160 therapeutic and 86 preventative)] who underwent nipple-sparing mastectomy and staged prepectoral implant reconstruction between 2005 and 2015 were followed up for an average of 109 months (range, 14 to 192 months). Tumor-related data, oncologic markers, staging, neoadjuvant/adjuvant therapy, and radiation therapy were evaluated to determine local recurrence, overall survival, and disease-free survival rates. RESULTS: The local recurrence rate in 151 patients was 2.6 percent. Eleven patients (7.3 percent) died as a result of metastatic disease and three patients died as a result of unrelated causes. The average 109-month overall survival rate was 92.9 percent, and the disease-free survival rate was 87.8 percent. Over the same period, nine patients (6 percent) were alive with distant disease. CONCLUSION: The authors' 9-year two-stage prepectoral reconstruction study of nipple-sparing mastectomy shows that the procedure is oncologically safe, having comparable recurrence, overall survival, and disease-free survival rates as total mastectomy. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Areola and nipple-areola-sparing mastectomy for breast cancer treatment and risk reduction: report of an initial experience in a community hospital setting.

BACKGROUND: The use of areola-sparing (AS) or nipple-areola-sparing (NAS) mastectomy for the treatment or risk reduction of breast cancer has been the subject of increasing dialogue in the surgical literature over the past decade. We report the initial experience of a large community hospital with AS and NAS mastectomies for both breast cancer treatment and risk reduction. METHODS: A retrospective chart review was performed of patients undergoing either AS or NAS mastectomies from November 2004 through September 2009. Data collected included patient sex, age, family history, cancer type and stage, operative surgical details, complications, adjuvant therapies, and follow-up. RESULTS: Forty-three patients underwent 60 AS and NAS mastectomies. Forty-two patients were female and one was male. The average age was 48.7 years (range, 28-76 years). Forty mastectomies were for breast cancer treatment, and 20 were prophylactic mastectomies. The types of cancers treated were as follows: invasive ductal (n = 19), invasive lobular (n = 5), ductal carcinoma-in situ (n = 15), and malignant phyllodes (n = 1). Forty-seven mastectomies (78.3%) were performed by inframammary incisions. All patients underwent immediate reconstruction with either tissue expanders or permanent implants. There was a 5.0% incidence of full-thickness skin, areola, or nipple tissue loss. The average follow-up of the series was 18.5 months (range, 6-62 months). One patient developed Paget's disease of the areola 34 months after an AS mastectomy (recurrence rate, 2.3%). There were no other instances of local recurrence. CONCLUSIONS: AS and NAS mastectomies can be safely performed in the community hospital setting with low complication rates and good short-term results.

Focused microwave thermotherapy for preoperative treatment of invasive breast cancer: a review of clinical studies.

BACKGROUND: Preoperative focused microwave thermotherapy (FMT) is a promising method for targeted treatment of breast cancer cells. Results of four multi-institutional clinical studies of preoperative FMT for treating invasive carcinomas in the intact breast are reviewed. METHODS: Externally applied wide-field adaptive phased-array FMT has been investigated both as a preoperative heat-alone ablation treatment and as a combination treatment with preoperative anthracycline-based chemotherapy for breast tumors ranging in ultrasound-measured size from 0.8 to 7.8 cm. RESULTS: In phase I, eight of ten (80%) patients receiving a single low dose of FMT prior to receiving mastectomy had a partial tumor response quantified by either ultrasound measurements of tumor volume reduction or by pathologic cell kill. In phase II, the FMT thermal dose was increased to establish a threshold dose to induce 100% pathologic tumor cell kill for invasive carcinomas prior to breast-conserving surgery (BCS). In a randomized study for patients with early-stage invasive breast cancer, of those patients receiving preoperative FMT at ablative temperatures, 0 of 34 (0%) patients had positive tumor margins, whereas positive margins occurred in 4 of 41 (9.8%) of patients receiving BCS alone (P = 0.13). In a randomized study for patients with large tumors, based on ultrasound measurements the median tumor volume reduction was 88.4% (n = 14) for patients receiving FMT and neoadjuvant chemotherapy, compared with 58.8% (n = 10) reduction in the neoadjuvant chemotherapy-alone arm (P = 0.048). CONCLUSIONS: Wide-field adaptive phased-array FMT can be safely administered in a preoperative setting, and data from randomized studies suggest both a reduction in positive tumor margins as a heat-alone treatment for early-stage breast cancer and a reduction in tumor volume when used in combination with anthracycline-based chemotherapy for patients with large breast cancer tumors. Larger randomized studies are required to verify these conclusions.

Recurrence rates for patients with early-stage breast cancer treated with IOERT at a community hospital per the ASTRO consensus statement for APBI.

PURPOSE: To report the recurrence rates after single-fraction intraoperative electron radiotherapy (IOERT) in patients with early-stage breast cancer treated on a single institution prospective Phase I/II protocol at a community hospital. Results were retrospectively analyzed according to suitability criteria from the updated American Society for Radiation Oncology (ASTRO) consensus statement for accelerated partial breast irradiation (APBI). METHODS AND MATERIALS: Patients over 40 years with early-stage invasive or in situ breast cancer (<2.5 cm and node negative) were enrolled. IOERT 2100 cGy was delivered during breast conservation surgery, and patients were followed up for a median of 3 years (0.8-6.5 years) to determine toxicity and recurrence rates. RESULTS: Single-fraction IOERT was performed in 215 cases (6 bilateral treatments, 196 patients) with 13 patients receiving whole-breast radiation (WBR) after IOERT for adverse pathologic features. Of 202 cases of IOERT without WBR, 89 patients experienced an ipsilateral breast tumor recurrence (IBTR) giving a cumulative incidence of 3.96%. When the ASTRO APBI suitability criteria were applied, the IBTR rate was significantly lower for suitable patients vs. cautionary or unsuitable patients (1.6% vs. 3.4% vs. 21.0%, p = 0.0002). 3-year progression-free survival after IOERT alone was 93.4%. For patients who received standard WBR (4500-5040 cGy) after IOERT, no Grade 3 or 4 toxicities (acute or late) occurred and all patients are disease-free. CONCLUSIONS: Single-fraction IOERT results in a low rate of IBTR when strictly adhering to ASTRO criteria for APBI suitability. Standard dose WBR for unfavorable pathologic results after 2100 cGy IOERT is well tolerated.

Staged Suprapectoral Expander/Implant Reconstruction without Acellular Dermal Matrix following Nipple-Sparing Mastectomy.

BACKGROUND: Since the introduction of nipple-sparing mastectomy as an oncologically safe procedure for the treatment of breast cancer, reconstructive efforts for immediate staged expander/implant reconstruction have focused on submuscular implantation with or without acellular dermal matrix. Suprapectoral reconstruction without acellular dermal matrix has received little attention in the reconstructive literature of nipple-sparing mastectomy. METHODS: Between 2005 and 2015, 155 patients (250 breasts) underwent nipple-sparing mastectomy with prepectoral staged expander/implant reconstruction using thick mastectomy skin flaps without acellular dermal matrix. Patients with different breast sizes, including those patients with very large breasts who required a primary mastopexy, were considered candidates for the suprapectoral reconstruction. Tumor-related data, comorbidities, and preoperative or postoperative radiation therapy were evaluated for correlation with the final outcome. RESULTS: Patients were followed up for an average of 55.5 months (range, 138.1 to 23.6 months). The tumor recurrence rate was 2.6 percent. Adverse outcomes such as capsular contracture, implant dystopia, and rippling were studied. Aesthetic outcome, based on a three-point evaluation scale, showed 53.6 percent of patients as having a very good result, 31.6 percent showing a good result, 9 percent showing a fair result, and 5.8 percent showing a poor result. CONCLUSIONS: The suprapectoral two-stage expander/implant reconstruction without acellular dermal matrix in nipple-sparing mastectomy has certain advantages with respect to breast shape, less morbidity related to expansion, ease of reconstruction, and cost effectiveness. These advantages have to be weighed against those of subpectoral reconstruction with acellular dermal matrix to determine the method of choice. CLINCAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

An evaluation of the American College of Surgeons' ultrasound education program.

BACKGROUND: Ultrasound has a wide variety of applications in surgery, but until recently few surgeons received any formal training in its use. To facilitate incorporation of ultrasound into surgical practice, the American College of Surgeons (ACoS) developed an ultrasound educational program. The purpose of this study was to evaluate the impact and effectiveness of the ACoS ultrasound education program. METHODS: A survey was mailed to all surgeons who had completed at least one of several ultrasound courses offered by the ACoS from 1998 to 2002. RESULTS: A total of 1,791 surveys were mailed out and 873 completed surveys were returned. Sixty-five percent (576) of respondents reported using ultrasound in their practices after these educational courses. Of those performing ultrasound examinations, 267 did so in one clinical area and 309 in more than one. The most common examination was breast (369 surgeons); vascular, acute/trauma, abdominal, intraoperative/laparoscopic, and head/neck were utilized fairly equally (100-200 surgeons). The number of examinations performed by surgeons before they felt competent was between 11 and 20 and did not vary by the type of ultrasound examination. Of the 267 surgeons performing ultrasound in one clinical area, 176 performed ultrasound-guided procedures. Most surgeons had access to 2 ultrasound machines, but 386 (67%) were restricted from performing ultrasound in certain locations. CONCLUSIONS: The ACoS ultrasound courses are extremely popular and have contributed to the increasing use of ultrasound in surgical practice. Surgeons successfully use ultrasound in their practices including performance of ultrasound-guided procedures but are restricted from using ultrasound in certain patient care areas. Since many surgeons received prior and/or additional training outside of the ACoS, there is a need to facilitate export of ACoS courses to other venues and to focus on incorporating ultrasound training into surgical residency programs.

Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

IMPORTANCE: To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). OBJECTIVE: To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. DESIGN, SETTING, AND PARTICIPANTS: A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit. MAIN OUTCOMES AND MEASURES: Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). RESULTS: A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P<.05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P<.05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median [range] intraclass correlation coefficient, 0.76 [0.53-.96]). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median [range] r=0.43 [0.10-.56]; all P≤.006). CONCLUSIONS AND RELEVANCE: Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.

Office-based cryoablation of breast fibroadenomas: 12-month followup.

BACKGROUND: Fibroadenomas comprise between 30% and 50% of all breast biopsies. Despite their benign nature, many women have their fibroadenomas surgically removed. We previously reported on a minimally invasive therapy using cryoablation to treat fibroadenomas. We now report on 12-month followup using this technique. STUDY DESIGN: A prospective, nonrandomized trial was initiated in June 2000 with IRB approval. The Visica Treatment System was used to cryoablate 70 biopsy-proved fibroadenomas in 57 patients using a freeze-thaw-freeze cycle lasting 6 to 30 minutes. Each patient was serially evaluated for safety, efficacy, and satisfaction. RESULTS: Fifty-seven fibroadenomas (mean 2.1 cm, range 0.8 to 4.2 cm) in 47 patients were followed for 12 months. At 1 year, with 89% median tumor volume reduction measured by ultrasonography, 75% of fibroadenomas were nonpalpable. There were no adverse events and only minor complications. Two patients (4%) had their lesions excised after 12 months; pathology revealed no viable fibroadenoma. Serial mammograms showed resorption of the fibroadenoma leaving minimal residual density without calcifications. Cosmesis was excellent with no volume deficit, as no tissue is removed. Ninety-one percent of patients were satisfied at 12 months. CONCLUSIONS: Cryoablation is safe and effective in treating breast fibroadenomas. It offers a nonsurgical, office-based treatment that is well tolerated by patients and accurately monitored with ultrasonographic guidance. At 12 months we found progressive tumor volume reduction and reduced palpability, with no volume deficit, excellent cosmesis, and satisfied patients. Ultrasonography-guided cryoablation is a preferred option for treatment of breast fibroadenomas without open surgery.

Low-risk palpable breast masses removed using a vacuum-assisted hand-held device.

BACKGROUND: This study evaluates the safety, efficacy, and patient acceptance of a vacuum-assisted, hand-held biopsy device (Mammatome) in the percutaneous removal of breast masses using ultrasound guidance. METHODS: A multicenter, nonrandomized study evaluated 216 women with low-risk palpable lesions. Lesions 1.5 to 3.0 cm in size were removed using an 8-gauge probe. Those lesions <1.5 cm were removed with the 11-gauge probe. Follow-up evaluation was performed at 10 days and 6 months after biopsy. RESULTS: A total of 127 patients had biopsies using the 8-gauge probe, and 89 patients had biopsies using the 11-gauge probe. At 6-month follow-up, 98% of the lesions remained nonpalpable, 73% with no ultrasonographically visible evidence of the original lesion. Most complications were mild and anticipated. Most patients (98%) were satisfied with incision appearance, and 92% of patients would recommend the procedure to others. CONCLUSIONS: Percutaneous removal of palpable benign breast masses using the Mammotome system is feasible and safe, and yields high patient satisfaction. The results at 6 months after biopsy demonstrated the effectiveness of benign lesion removal, with correlative clinical data demonstrating lack of palpability and no need for additional procedures. Continuing evaluation of long-term efficacy is ongoing.

Percutaneous removal of benign breast masses using a vacuum-assisted hand-held device with ultrasound guidance.

BACKGROUND: This study evaluates the safety, efficacy, and patient acceptance of a vacuum-assisted, hand-held biopsy device (Mammotome) in percutaneous removal of breast masses using ultrasound guidance. METHODS: A multicenter, nonrandomized study evaluated 124 women with low-risk palpable lesions. Lesions 1.5 cm but

Cryoablation treatment of benign breast lesions with 12-month follow-up.

OBJECTIVE: Eighty percent of all breast biopsies reveal benign findings. The most common benign tumor is a fibroadenoma. Despite their benign nature, many women eventually choose to have their bothersome lumps surgically removed. We report the use of cryoablation to treat these benign breast lesions with minimum 12-month follow-up. METHODS: After receiving Institutional Review Board approval, a prospective nonrandomized trial was initiated in June 2000. Ultrasound-guided cryoablation of core biopsy-proven benign fibroadenomas, other benign breast nodules, or nodular fibrocystic change was performed on 78 lesions in 63 patients. Eighty-five percent of lesions treated were benign fibroadenomas. The cryoablation procedure consisted of a double freeze-thaw cycle that lasted between 6 and 30 minutes and was performed most often in an office setting. Each patient was serially evaluated for treatment efficacy, complications, and patient satisfaction. RESULTS: Sixty-four of 78 lesions (mean size 2.0 cm [range 0.8 to 4.2]) were followed-up for at least 12 months after cryoablation per protocol, which included 53 fibroadenomas. At 1 year, ultrasound tumor volume resorption was 88.3% overall (87.3% for fibroadenomas), and 73% of the entire group became nonpalpable to both clinician and patient (75% for fibroadenomas). Two of the fibroadenoma patients had their palpable residual nodule excised, both revealing necrotic debris and no viable tumor in the treated volume. Serial mammograms showed resorption of the lesion leaving minimal residual density without calcifications. Cosmesis was excellent with only a small scar remaining at the probe insertion site. There was no report of visual or palpable volumetric deficit. Patient satisfaction was good to excellent in 92% of cases. CONCLUSIONS: Cryoablation was successful in treating core biopsy-proven benign breast lesions in 63 patients. At 12 months, we found gradual resorption of treated tissue with no cosmetic deficit. Ultrasound-guided cryoablation is an effective and safe treatment for benign breast lesions, as seen at 12-month follow-up, and offers an office-based, minimally invasive alternative to surgical excision.

Office-based ultrasound-guided cryoablation of breast fibroadenomas.

BACKGROUND: Fibroadenomas commonly found by palpation and routine mammography account for approximately 20% of open surgical breast biopsies. Alternatives to open surgery include tumor removal using an automated coring device and tumor ablation using heating or cooling elements. We report our initial experience with cryoablation of biopsy-proven benign fibroadenomas. METHODS: A table-top cryoablation system employing a 2.4-mm cryoprobe was used to treat biopsy-proven benign fibroadenomas up to 4 cm in maximum diameter in a prospective nonrandomized fashion. The cryoprobe was placed under ultrasound guidance. Using a treatment algorithm based on fibroadenoma size, all tumors were subjected to two freeze cycles with an interposing thaw. Skin appearance and temperature, probe temperature, iceball size, and patient comfort were closely monitored during the procedure. Follow-up examinations including ultrasonography and photographs were scheduled for up to 12 months postablation. RESULTS: Fifty patients with 57 core biopsy-proven benign fibroadenomas were treated. Seven early cases were treated in an ambulatory surgery center setting. The remaining procedures were completely office-based using only local anesthetic. Tumor diameter varied from 7 mm to 42 mm (mean 21 mm). The iceball engulfed the target lesion in each case. Transient postoperative side effects were local swelling and ecchymosis. Postoperative discomfort rarely required medication beyond acetaminophen or ibuprofen. Lesions showed progressive shrinkage and disappearance over 3 to 12 months. No skin injury was noted and appearance remained excellent. Patient satisfaction was excellent. CONCLUSIONS: With office-based use of ultrasound-guided cryoablation for fibroadenomas there was little or no pain, target lesions were reduced in size or eliminated, scarring was minimal, cosmesis outstanding, and patient satisfaction was excellent. Cryoablation offers a useful office-based alternative to surgical excision of benign fibroadenomas.