Mark Gittleman

Five-year analysis of treatment efficacy and cosmesis by the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial in patients treated with accelerated partial breast irradiation.

PURPOSE To present 5-year data on treatment efficacy, cosmetic results, and toxicities for patients enrolled on the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. METHODS AND MATERIALS A total of 1440 patients (1449 cases) with early-stage breast cancer receiving breast-conserving therapy were treated with the MammoSite device to deliver accelerated partial-breast irradiation (APBI) (34 Gy in 3.4-Gy fractions). Of 1449 cases, 1255 (87%) had invasive breast cancer (IBC) (median size, 10 mm) and 194 (13%) had ductal carcinoma in situ (DCIS) (median size, 8 mm). Median follow-up was 54 months. RESULTS Thirty-seven cases (2.6%) developed an ipsilateral breast tumor recurrence (IBTR), for a 5-year actuarial rate of 3.80% (3.86% for IBC and 3.39% for DCIS). Negative estrogen receptor status (p=0.0011) was the only clinical, pathologic, or treatment-related variable associated with IBTR for patients with IBC and young age (<50 years; p=0.0096) and positive margin status (p=0.0126) in those with DCIS. The percentage of breasts with good/excellent cosmetic results at 60 months (n=371) was 90.6%. Symptomatic breast seromas were reported in 13.0% of cases, and 2.3% developed fat necrosis. A subset analysis of the first 400 consecutive cases enrolled was performed (352 with IBC, 48 DCIS). With a median follow-up of 60.5 months, the 5-year actuarial rate of IBTR was 3.04%. CONCLUSION Treatment efficacy, cosmesis, and toxicity 5 years after treatment with APBI using the MammoSite device are good and similar to those reported with other forms of APBI with similar follow-up.

Three-year analysis of treatment efficacy, cosmesis, and toxicity by the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial in patients treated with accelerated partial breast irradiation (APBI)

This report presents 3 years of data on treatment efficacy, cosmetic results, and toxicities for patients enrolled on the American Society of Breast Surgeons MammoSite (Cytyc, Bedford, Mass) Breast Brachytherapy Registry Trial.

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).

Initial outcomes for patients treated on the American Society of Breast Surgeons MammoSite Clinical Trial for ductal carcinoma-in-situ of the breast

BackgroundThe MammoSite device was designed as a breast brachytherapy applicator and is currently used to deliver accelerated partial breast irradiation (APBI). We hypothesized that APBI delivered with the MammoSite device would be well tolerated and be associated with a good cosmetic outcome in patients with ductal carcinoma-in-situ (DCIS).MethodsFrom 2002 to 2004, 191 patients with DCIS were enrolled in a registry trial to assess the MammoSite applicator. Fifteen patients were excluded from analysis because of device- or patient-related factors; 7 patients were excluded after receiving a radiotherapy boost, thus leaving 169 patients available for study. Follow-up information was available for 158 patients. The average length of follow-up was 7.35 months. Forty-three patients had at least 1 year of follow-up.ResultsSkin spacing for the MammoSite applicator was as follows: < 5 mm, 3 patients (1.78%); 5 to 7 mm, 18 patients (10.65%); and ≥7 mm, 148 patients (87.57%). Patients with a device-to-skin distance of ≥7 mm had the best cosmetic result. Patients with a device-to-skin distance of ≥7 mm also had a lower incidence of radiation dermatitis. Data on 43 patients who were followed up for at least 1 year confirmed these findings. Additional adverse events were primarily related to skin changes, with breast infections occurring in five patients (3.16%). No patient in the study has experienced a recurrence.ConclusionsAPBI delivered via MammoSite is well tolerated in patients with DCIS, and the lowest toxicity was obtained in patients with the greatest device-to-skin distance. Long-term follow-up data regarding patient satisfaction, cosmesis, and efficacy are needed and will be determined from a recently opened large randomized study.

Four-year clinical update from the American Society of Breast Surgeons MammoSite brachytherapy trial

BACKGROUND We present a 4-year update on the efficacy, cosmetic results, and complications of MammoSite breast brachytherapy in patients enrolled in the American Society of Breast Surgeons registry trial. METHODS A total of 1,449 breasts in 1,440 patients with early stage breast cancer undergoing breast-conserving therapy were treated with adjuvant, accelerated partial breast irradiation (APBI) (34 Gy in 3.4-Gy fractions) delivered with the MammoSite device. The median follow-up period for the entire group was 36.1 months. RESULTS The 3-year actuarial rate of ipsilateral breast tumor recurrence was 2.15%. The 3-year actuarial rate of axillary recurrence was .36%. Complication rates were as follows: infection, 9.5%; seroma, 26.8% (symptomatic seroma, 12.7%); and fat necrosis, 2.0%. The percentages of breasts with good or excellent cosmetic results were as follows: 12 months, 95%; 24 months, 94%; 36 months, 94%; and 48 months, 91%. CONCLUSIONS Locoregional control, complications, and cosmetic outcomes from MammoSite APBI at the 4-year update are acceptable and similar to results seen with other forms of APBI.

PET‐Guided Breast Biopsy

Abstract:  Molecular imaging, using positron emission tomography (PET), has become an integral step in the evaluation of many patients with malignancy. However, its use in patients with breast cancer has been limited by the lower levels of 18F‐fluorodeoxyglucose (FDG) uptake in some breast malignancies compared to other cancers, the small size of many breast cancers, and the need for biopsy under PET guidance. High‐resolution breast PET, or positron emission mammography (PEM), with biopsy guidance software, now addresses these issues. We report a prospective, multicenter study designed to test the efficacy and safety of PEM biopsy guidance software in women with FDG‐avid breast lesions worrisome for malignancy. The intervention chosen was vacuum‐assisted core biopsy. Nineteen subjects underwent a total of 24 PEM‐guided biopsies. All lesions were successfully targeted and sampled as determined by post‐biopsy image scan evaluation, specimen imaging, and pathologic concordance. Invasive cancer was identified in 13 of 24 lesions (54%), while four (17%) were high‐risk lesions and three of these were upgraded to malignancy at excision. No serious adverse events occurred and all patients found the procedure to cause only minimal to mild discomfort. High‐resolution PEM‐guided breast biopsy is both safe and effective for the sampling of PET‐depicted breast lesions.

Timing of Chemotherapy After MammoSite Radiation Therapy System Breast Brachytherapy: Analysis of the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial

PURPOSE To evaluate cosmetic outcome and radiation recall in the American Society of Breast Surgeons registry trial, as a function of the interval between accelerated partial breast irradiation (APBI) and initiation of chemotherapy (CTX). METHODS AND MATERIALS A total of 1440 patients at 97 institutions participated in this trial. After lumpectomy for early-stage breast cancer, patients received APBI (34 Gy in 10 fractions) with MammoSite RTS brachytherapy. A total of 148 patients received CTX within 90 days of APBI. Cosmetic outcome was evaluated at each follow-up visit and dichotomized as excellent/good or fair/poor. RESULTS Chemotherapy was initiated at a mean of 3.9 weeks after the final MammoSite procedure and was administered </=3 weeks after APBI in 54 patients (36%) and >3 weeks after APBI in 94 patients (64%). The early and delayed groups were well balanced with respect to multiple factors that may impact on cosmetic outcome. There was a superior cosmetic outcome in those receiving chemotherapy >3 weeks after APBI (excellent/good in 72.2% at </=3 weeks vs. excellent/good in 93.8% at >3 weeks; p = 0.01). Radiation recall in those receiving CTX at </=3 weeks was 9 of 50 (18%), compared with 6 of 81(7.4%) in those receiving chemotherapy at >3 weeks (p = 0.09). CONCLUSION The majority of patients receiving CTX after APBI have excellent/good cosmetic outcomes, with a low rate of radiation recall. Chemotherapy initiated >3 weeks after the final MammoSite procedure seems to be associated with a better cosmetic outcome and lower rate of radiation recall. An excellent/good cosmetic outcome in patients receiving CTX after 3 weeks was similar to the cosmetic outcome of the overall patient population who did not receive CTX.

Single-step ultrasound localization of breast lesions and lumpectomy procedure

BACKGROUND This review was made to evaluate whether the efficiencies of intraoperative ultrasound-guided localization could be extended to stereotactic biopsy cases by using a marker visible by sonography and mammography. METHODS A retrospective review identified 170 stereotactic directional vacuum-assisted biopsy (DVAB) procedures marked with an ultrasound-visible marker. Localization device, imaging method, lesion retrieval, and margin status were assessed for patients having subsequent lumpectomy or wider excision. RESULTS Nineteen of 170 patients underwent lumpectomies (12) or wider excision (7) localized by a radiofrequency device or 18G needle up to 7 weeks after stereotactic biopsy. In 15 of 19 procedures, an ultrasound-guided localization was performed intraoperatively, targeting the marker. All targeted lesions were successfully excised. In the 13 malignant lesions (of 19 surgeries), only 1 had a positive margin (8%). CONCLUSIONS Marking stereotactic biopsies with a sonographically visible marker allows ultrasound-guided intraoperative localization, improving efficiencies for the patient, surgeon, and operating room schedule.

American Society of Breast Surgeons MammoSite Radiation Therapy System Registry Trial: ductal carcinoma-in-situ subset analysis—4-year data in 194 treated lesions

BACKGROUND A subset analysis of the American Society of Breast Surgeons (ASBS) Registry Trial of patients with ductal carcinoma-in-situ (DCIS) was performed to compare results to patients receiving accelerated partial breast irradiation (APBI) for invasive tumors and to results in patients with DCIS receiving whole breast irradiation. METHODS One hundred ninety-four cases of DCIS were identified from a total of 1,449 cancers treated on the ASBS Registry Trial. Details of the trial are previously published. Analysis of the entire group of cases was performed in regards to toxicity and local control. RESULTS Median age was 62.1 years with 40.1% and 10.9% younger than 60 years and 50 years, respectively. Nuclear grade distribution was 35.6%, 31.4%, 17%, and 16% high, intermediate, low grade, and unknown, respectively. Necrosis was known to be present 42.3% of cases. Comedo/solid architecture was known to be present in 68% of cases. Median tumor size was 8.0 mm (range .1-45 mm, 15.5% unknown). Median margin was 2 mm; 2 cases had positive margins and 56 cases had less than 1-mm margins. The median follow-up time was 46.7 months. Five isolated ipsilateral breast failures occurred. The actuarial isolated ipsilateral breast failure rate was 2.45% at 4 years. The total in-breast 4-year actuarial failure rate was 3.0%. Three of the patients had a failure elsewhere (1.69% 4-year actuarial rate). Three of the failures were true recurrences (1.33% 4-year actuarial rate). Infection occurred in 16 patients for an 8.2% rate. Seroma formation was reported in 31%, with 13% and 12% symptomatic and requiring intervention, respectively. Seroma formation was statistically higher in open versus closed cases for all seromas. Cosmetic outcome was good to excellent in 90.3% of patients with evaluation at 36 months. CONCLUSIONS The ASBS Registry Trial includes the largest published collection of DCIS treated with APBI. Four-year follow-up shows result similar to those with invasive cancer treated with APBI, as well as DCIS treated with whole breast irradiation.

Local control, toxicity, and cosmesis in women >70 years enrolled in the American Society of Breast Surgeons accelerated partial breast irradiation registry trial

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. Fishers 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.