Sheldon Feldman

Limitation in gamma probe localization of the sentinel node in breast cancer patients with large excisional biopsy.

BACKGROUND Radiolocalization and selective biopsy of the sentinel node to correctly predict the status of remaining lymph nodes may provide an alternative to axillary dissection in selected breast cancer patients with clinically negative lymph nodes. STUDY DESIGN In a nonrandomized, multicenter clinical trial, gamma probe localization for lymphatic mapping and sentinel node biopsy along with axillary dissection was performed on 75 patients with invasive breast cancer and clinically negative lymph nodes. The accuracy of the sentinel node biopsy to correctly predict the status of the remaining axillary lymph nodes was established through standard pathologic investigation. RESULTS A sentinel node was identified in 70 of 75 patients with a technical success rate of 93%. Of these 70 patients, 21 (30%) had axillary nodal metastases identified pathologically. Four of these 21 (19%) had sentinel nodes negative for metastases. All 4 false-negative patients had prior excisional biopsies. The false-negative group had a larger mean maximal biopsy dimension than the true-positive group. Eleven of the 21 patients with axillary metastases had a diagnosis made by core needle biopsy with no false negatives. CONCLUSIONS The accuracy of the sentinel node biopsy in correctly predicting the status of remaining axillary lymph nodes may be limited in patients with large excision before radiolocalization of the sentinel node. Our findings suggest that excisional biopsy should be avoided prior to lymphatic mapping for sentinel node biopsy.

Conducting Molecular Epidemiological Research in the Age of HIPAA: A Multi-Institutional Case-Control Study of Breast Cancer in African-American and European-American Women

Breast cancer in African-American (AA) women occurs at an earlier age than in European-American (EA) women and is more likely to have aggressive features associated with poorer prognosis, such as high-grade and negative estrogen receptor (ER) status. The mechanisms underlying these differences are unknown. To address this, we conducted a case-control study to evaluate risk factors for high-grade ER- disease in both AA and EA women. With the onset of the Health Insurance Portability and Accountability Act of 1996, creative measures were needed to adapt case ascertainment and contact procedures to this new environment of patient privacy. In this paper, we report on our approach to establishing a multicenter study of breast cancer in New York and New Jersey, provide preliminary distributions of demographic and pathologic characteristics among case and control participants by race, and contrast participation rates by approaches to case ascertainment, with discussion of strengths and weaknesses.

A Novel Automated Assay for the Rapid Identification of Metastatic Breast Carcinoma in Sentinel Lymph Nodes

The authors prospectively evaluated the performance of a proprietary molecular testing platform using one‐step nucleic acid amplification (OSNA) for the detection of metastatic carcinoma in sentinel lymph nodes (SLNs) in a large multicenter trial and compared the OSNA results with the results from a detailed postoperative histopathologic evaluation (reference pathology) and from intraoperative imprint cytology (IC).

Do additional shaved margins at the time of lumpectomy eliminate the need for re-excision?

BACKGROUND Most women diagnosed with breast cancer undergo breast-conservation surgery. Re-excision rates for positive margins have been reported to be greater than 50%. The purpose of our study was to determine if removing additional shaved margins from the lumpectomy cavity at the time of lumpectomy reduces re-excisions. METHODS A retrospective study was performed on 125 women who had undergone lumpectomy with additional shaved margins taken from the lumpectomy cavity. Pathology reports were reviewed for tumor size and histology, lumpectomy and additional margin status, and specimen and margin volume. RESULTS If additional margins were not taken, 66% would have required re-excision. Because of taking additional shaved margins, re-excision was eliminated in 48%. CONCLUSION Excising additional shaved margins at the original surgery reduced reoperations by 48%. There is a balance between removing additional margins and desirable cosmesis after breast-conservation surgery. The decision to take extra margins should be based on the surgeons judgment.

The feasibility of a second lumpectomy and breast brachytherapy for localized cancer in a breast previously treated with lumpectomy and radiation therapy for breast cancer

PURPOSE With accumulating evidence supporting partial-breast irradiation, we conducted a Phase I/II study to evaluate the role of a second conservative surgery and brachytherapy for patients presenting with a local recurrence/new primary in a breast who has previously undergone a lumpectomy and external radiation therapy for breast cancer. METHODS AND MATERIALS Fifteen patients with a localized lesion in the breast have undergone a second lumpectomy and received low-dose-rate brachytherapy on protocol. The first 6 patients received a dose of 30Gy. With no unacceptable acute toxicity observed, the brachytherapy dose was increased to 45Gy. Three patients received adjuvant chemotherapy and 8 patients are on antiestrogen therapy. RESULTS The median time interval between the primary breast cancer diagnosis and the second cancer event in the ipsilateral breast is 94 months (range, 28-211). With a median followup of 36 months after brachytherapy, the 3-year Kaplan-Meier overall survival, local disease-free survival and mastectomy-free survival are 100% and 89%, respectively. There was no Grade 3/4 fibrosis or necrosis observed. All patients had baseline asymmetry due to the breast volume deficit from the second lumpectomy. With breast asymmetry as a given, the cosmetic result observed in all patients has been good to excellent. CONCLUSIONS Early results suggest low-complication rates, high rate of local control and freedom from mastectomy. Additional studies are needed to establish whether a second lumpectomy and breast brachytherapy are an acceptable alternative to mastectomy for patients presenting with a localized cancer in a previously irradiated breast.

Intra-operative Touch Preparation Cytology; Does It Have a Role in Re-excision Lumpectomy?

ObjectiveBreast carcinoma is the most frequently diagnosed malignancy in women of North America. The combination of breast conservation surgery and radiotherapy has become a standard of treatment for the majority of breast cancers. It is critical to obtain clear margins to minimize local recurrence. However, avoiding multiple re-excisions for margin clearance helps optimize cosmetic results in patients undergoing breast conservation surgery. Intra-operative touch preparation cytology (IOTPC) may decrease the need for multiple re-excisions and thereby improve cosmesis. The literature suggests that IOTPC can be useful in evaluation of margins. Klimberg et al. evaluated the touch preparation technique prospectively in 428 patients undergoing breast biopsy for undiagnosed breast masses. Margin evaluation was correct in 100% of the lesions and was used to re-excise the margins when touch prep results were positive. They reported a diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of 100% for the touch prep technique.To the best of our knowledge, there has been no published data on the role of IOTPC for evaluation of margins in re-excision cases. This report describes our experience with IOTPC for margin assessment for re-excision partial mastectomy at Beth Israel Medical Center (BIMC). The purpose of this study is to determine whether IOTPC is reliable for evaluating margins in patients undergoing re-excision for involved or close margins.MethodsA prospective study of 30 patients, who have undergone re-excision partial mastectomy for involved or close margins after breast conservation surgery with the use of IOTPC for margin assessment at BIMC was performed. The re-excision lumpectomy specimens were oriented by the surgeon intra-operatively and were submitted fresh to pathology for cytologic assessment. The touch prep method consisted of touching the corresponding margin onto the glass slide. The principle of this technique is that if cancer cells are present they will stick to the slide, while fat cells will not. A slide was prepared for each re-excision specimen. Air-dried samples were stained immediately using the Diff-Quik method and examined under the microscope by a cytopathologist.ResultsThirty patients underwent re-excision lumpectomy for involved or close margins with touch preparation cytology for assessment of 68 margins. Twenty-six patients had invasive ductal carcinoma and/or ductal carcinoma in situ, three patients had invasive lobular carcinoma and the remaining one patient had a combination of invasive lobular and ductal carcinoma. There was a correlation between touch prep cytology and final pathology in 56/68 margins, which accounts for 82.4% of the cases.ConclusionIntra-operative touch preparation cytology for assessment of margins in patients undergoing re-excision lumpectomy for involved or close margins has a sensitivity of 75%, specificity of 82.8%, positive predictive value of 21.4%, and negative predictive value of 98.2%. This high negative predictive value and a single false negative margin are quite significant. Therefore, based on our experience, IOTPC can be a useful tool for intra-operative assessment of margins for patients undergoing re-excision partial mastectomy.

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.

Quality Assurance Initiative at One Institution for Minimally Invasive Breast Biopsy as the Initial Diagnostic Technique

BACKGROUND In 2005, the American College of Surgeons Consensus Conference issued a statement about the diagnostic workup of image-detected breast abnormalities. Guidelines include use of image-guided percutaneous needle biopsy as the gold standard for diagnosing image-detected breast abnormalities. In this study, we evaluate a method to audit use of excisional biopsy among different breast surgeons at our institution. STUDY DESIGN From March to September 2007, 465 patients undergoing breast operation for benign or malignant lesions at our institution were interviewed by a surgical resident or physicians assistant. If an excisional biopsy was scheduled for initial diagnosis, the patient and surgeon were asked whose preference it was to perform the operation. Three attending groups were designated: academic breast surgeons, private practice breast surgeons on clinical faculty, and general surgeons who perform breast operations in addition to other procedures. Use of excisional biopsy was compared between these groups. RESULTS Compliance for preoperative interview completion was 79%, differing substantially between surgeon groups with rates of 91%, 74%, and 58% for the academic breast, private practice, and general surgeons, respectively. Excisional biopsy for diagnosis made up 10%, 35%, and 37% of the case load for academic breast, private practice, and general surgeons, respectively. Patient and surgeon agreed 85% of the time for preference of performing diagnostic excisional biopsies. CONCLUSIONS Excisional biopsies continue to be performed as the initial diagnostic procedure for 40% of patients. Tracking biopsy practices by surgeon can improve adherence with current recommendations.

Presurgical Trial of Metformin in Overweight and Obese Patients with Newly Diagnosed Breast Cancer

Introduction: We conducted a presurgical trial to assess the tissue-related effects of metformin in overweight/obese breast cancer (BC) patients. Methods: Metformin 1,500 mg daily was administered to 35 nondiabetics with stage 0–III BC, body mass index (BMI) ≥ 25 kg/m2. The primary endpoint was tumor proliferation change (i.e., ki-67). Tumor proliferation change was compared to untreated historical controls, matched by age, BMI, and stage. Results: There was no reduction in ln(ki-67) after metformin (p = .98) or compared to controls (p = .47). There was a significant reduction in BMI, cholesterol, and leptin. Conclusion: Despite no proliferation changes, we observed reductions in other relevant biomarkers.

Early-Stage Breast Cancer Treated With 3-Week Accelerated Whole-Breast Radiation Therapy and Concomitant Boost

PURPOSE To report early outcomes of accelerated whole-breast radiation therapy with concomitant boost. METHODS AND MATERIALS This is a prospective, institutional review board-approved study. Eligibility included stage TisN0, T1N0, and T2N0 breast cancer. Patients receiving adjuvant chemotherapy were ineligible. The whole breast received 40.5 Gy in 2.7-Gy fractions with a concomitant lumpectomy boost of 4.5 Gy in 0.3-Gy fractions. Total dose to the lumpectomy site was 45 Gy in 15 fractions over 19 days. RESULTS Between October 2004 and December 2010, 160 patients were treated; stage distribution was as follows: TisN0, n = 63; T1N0, n = 88; and T2N0, n = 9. With a median follow-up of 3.5 years (range, 1.5-7.8 years) the 5-year overall survival and disease-free survival rates were 90% (95% confidence interval [CI] 0.84-0.94) and 97% (95% CI 0.93-0.99), respectively. Five-year local relapse-free survival was 99% (95% CI 0.96-0.99). Acute National Cancer Institute/Common Toxicity Criteria grade 1 and 2 skin toxicity was observed in 70% and 5%, respectively. Among the patients with ≥ 2-year follow-up no toxicity higher than grade 2 on the Late Effects in Normal Tissues-Subjective, Objective, Management, and Analytic scale was observed. Review of the radiation therapy dose-volume histogram noted that ≥ 95% of the prescribed dose encompassed the lumpectomy target volume in >95% of plans. The median dose received by the heart D05 was 215 cGy, and median lung V20 was 7.6%. CONCLUSIONS The prescribed accelerated schedule of whole-breast radiation therapy with concomitant boost can be administered, achieving acceptable dose distribution. With follow-up to date, the results are encouraging and suggest minimal side effects and excellent local control.