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Transparency and accountability are becoming more important, and publically reported quality measures will be used increasingly to determine how surgeons are viewed and reimbursed. That is a good thing if it is done correctly, but poorly designed quality measures might actually interfere with patient care. It will be necessary for ASBrS to remain involved in the development of relevant, true data-based measures of quality that have appropriate benchmarks and no unintended consequences. Importantly, the quality measures need to include all reasonable treatment options so that quality care is enhanced and not impeded.

The American Society of Breast Surgeons enrolled women onto a registry trial to prospectively study patients treated with the MammoSite Radiation Therapy System (RTS) breast brachytherapy device. This report examines local recurrence (LR), toxicity, and cosmesis as a function of age in women enrolled onto the trial. A total of 1449 primary early-stage breast cancers were treated in 1440 women. Of these, 130 occurred in women younger than 50 years of age. Fisher’s exact test was performed to correlate age (

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.

BACKGROUND. 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. METHODS. A total of 1440 patients (1449 cases) with early stage breast cancer who were undergoing breast-conserving therapy were treated with the MammoSite device to deliver accelerated partial breast irradiation (APBI) (34 Gy in 3.4 Gy fractions). Of these, 1255 (87%) cases had invasive breast cancer (IBC; median size = 10 mm), and 194 (13%) cases had ductal carcinoma in situ (DCIS; median size = 8 mm). Median follow-up was 30.1 months. RESULTS. Twenty-three (1.6%) cases developed an ipsilateral breast tumor recurrence (IBTR) for a 2-year actuarial rate of 1.04% (1.11% for IBC and 0.59% for DCIS). No variables were associated with IBTR. Six (0.4%) patients developed an axillary failure. The percentages of breasts with good to excellent cosmetic results at 12 (n = 980), 24 (n = 752), 36 (n = 403), and 48 months (n = 67 cases) were 95%, 94%, 93%, and 93%, respectively. Breast seromas were reported in 23.9% of cases (30% in open-cavity implants and 19% in closed-cavity implants). Symptomatic seromas occurred in 10.6% of cases, and 1.5% of cases 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 37.5 months, the 3-year actuarial rate of IBTR was 1.79%. CONCLUSIONS. Treatment efficacy, cosmesis, and toxicity 3 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. Cancer 2008. © 2008 American Cancer Society.

Background This study compared the surgical results of 2 localization methods—cryo-assisted localization (CAL) and needle-wire localization (NWL)—in patients undergoing breast lumpectomy for breast cancer. Methods A total of 310 patients were treated in an institutional review board–approved study with 18 surgeons at 17 sites. Patients were randomized 2:1 to undergo either intraoperative CAL or NWL. A cryoprobe was inserted under ultrasound guidance in the operating room and an ice ball created an 8- to 10-mm margin around the lesion. The palpable ice ball then was dissected. NWL was placed according to institutional practice and resection was performed in a standard fashion. Surgical margins, complications, re-excisions, tissue volume, procedure times, ease of localization, specimen quality, and patient satisfaction were evaluated. Positive margins were defined as any type of disease present 1 mm or less from any specimen edge. Results Positive margin status did not differ between the 2 groups (28% vs. 31%). The volume of tissue removed was significantly less in the CAL group (49 vs. 66 mL, P = .002). Re-excisions were similar in both groups. CAL was superior in ease of lumpectomy, quality of specimen, acute surgical cosmesis, short-term cosmesis, patient satisfaction, and overall procedure time for the patient. CAL had a lower invasive positive margin rate (11% vs. 20%, P = .039) but a higher observed ductal carcinoma in situ–positive margin rate (30% vs. 18%, approaching statistical significance, P = .052). Conclusions CAL is a preferred alternative to standard wire localization because it provides a palpable template, removes less tissue and improves cosmesis, decreases overall procedure time, and is more convenient for the patient and surgeon.

The 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).From 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.Skin spacing for the MammoSite applicator was as follows:5 mm, 3 patients (1.78%); 5 to 7 mm, 18 patients (10.65%); andor = 7 mm, 148 patients (87.57%). Patients with a device-to-skin distance ofor = 7 mm had the best cosmetic result. Patients with a device-to-skin distance ofor = 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.APBI 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.

Sentinel node biopsy (SNB) for breast cancer has a false-negative rate of approximately 5%. Initial reports of follow-up show lower axillary recurrence rates than expected. We performed axillary ultrasonography to determine whether occult recurrences could be detected. In a community hospital setting, 289 patients who had SNB for breast cancer in a single surgeon’s practice underwent axillary examination by the surgeon followed by axillary ultrasonography by a dedicated breast radiologist. Ultrasonography was performed one time from 4 to 79 months (median, 25 months) after surgery. Five patients with suspicious nodes had ultrasound-guided fine-needle aspiration, and one had a core biopsy. No patient had suspicious nodes on clinical examination. Only six patients had ultrasound findings that warranted intervention. Five patients had benign cytological characteristics, and one had a benign core biopsy result. No evidence of axillary recurrence was found in any patient. Axillary ultrasonography did not detect occult metastases in any patient and is not recommended for routine follow-up after SNB. The lack of ultrasound evidence of metastasis suggests that the recurrence rate is likely to remain low.

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.

BACKGROUND Thirty percent of lymph node negative patients with operable breast carcinoma experience disease recurrence within 10 years. Retrospective serial sectioning of axillary lymph nodes has revealed undetected metastases in 9–30% of these patients. These occult metastases have been shown to have an adverse effect on survival. Serial sectioning (SS) is impractical for all axillary lymph nodes harvested from Levels I and II, but it is feasible if applied only to sentinel lymph nodes. METHODS Sentinel lymph nodes from 52 patients with invasive breast carcinoma were cut at 2 mm intervals, fixed in 10% formalin, and embedded in paraffin. Sections were taken from the blocks, stained with hematoxylin and eosin (H & E), and compared with cytokeratin-stained sections taken at 0.25 mm intervals throughout the entire blocks. RESULTS Tumor metastases were found in 6 patients (12%) when the sentinel lymph nodes were sectioned at 2 mm intervals and stained with H & E, compared with 30 patients (58%) when the same lymph nodes were serially sectioned at 0.25 mm intervals and stained with cytokeratin. Of 24 patients whose metastases were detected by SS and cytokeratin staining, 12 had isolated tumor cells and 12 had colonies of several thousand malignant cells. CONCLUSIONS Routine histologic examination of axillary lymph nodes, including sentinel lymph nodes, in cases of breast carcinoma significantly underestimates lymph node metastases. This deficiency may be overcome by SS of the entire lymph nodes and staining with a specific monoclonal antibody. The percentage of patients found to have colonies of cells that were missed by routine sectioning corresponds closely to the percentage of “lymph node negative” patients who would be expected to relapse. The true clinical significance of these occult metastases will be determined by long term follow-up. [See editorial on pages 905–7, this issue.] Cancer 1999;86:990–6. © 1999 American Cancer Society.

BACKGROUND The presence or absence of regional lymph node metastases has been one of the most important determining factors in recommending adjuvant chemotherapy for patients with breast carcinoma. However, because of the 15-20% failure rate at 5 years for lymph node negative patients, other tumor-related prognostic factors have gained greater significance in this decision-making process. Many investigators have reported finding micrometastases that were not detected by routine sectioning of the lymph nodes but were identified by multiple sectioning and additional staining. This review attempts to evaluate the role of occult lymph node micrometastases and their relevance to disease recurrence. METHODS A literature search of the entire MEDLINE data base was conducted. All relevant articles were reviewed for the criteria they used to define micrometastases. The frequency of detection of micrometastases by various methodologies and the prognostic significance of such deposits were examined. RESULTS Tumor deposits involving the lymph nodes were found to be arbitrarily categorized as either micrometastases or macrometastases, with the cutoff point ranging from 0.2-2.0 mm. The detection rate of such deposits by conventional techniques was inadequate. Serial sectioning and immunohistochemistry appeared to increase the detection rate by 9-33%. A definite survival disadvantage was noted for patients with such occult metastases. CONCLUSIONS Current routine histologic examination of regional lymph nodes underestimates breast carcinoma metastases. Serial sectioning and immunohistochemistry increase the yield but are too labor-intensive and expensive for routine use. However, the introduction of the sentinel lymph node biopsy in lieu of axillary lymph node dissection in cases of breast carcinoma holds promise for making these methods practical and cost-effective. Cancer 1997; 80:1188-97. © 1997 American Cancer Society.

The metastatic status of the axillary nodes is prognostically important but its value has been questioned in the management of nonpalpable breast tumors. This study correlates the incidence of positive nodes with the size of the primary nonpalpable tumors.We retrospectively analyzed 220 invasive and 21 microinvasive breast cancers that were excised after needle localization and for which axillary dissections were subsequently performed. Of invasive cancers, 166 presented as mass lesions with or without microcalcifications and 54 as microcalcifications alone. The size of the mass lesions (n = 166) was determined mammographically and on pathologic specimens. They were subdivided into five groups according to diameter: (a)or = 5 mm, (b) 6-10 mm, (c) 11-20 mm, (d)20 mm, and (e) unrecorded size.Axillary metastases were found in 9% of patients whose cancer presented as microcalcifications alone. They were found in 0, 11, and 22% of patients in mammographic groups, a, b, and c, respectively. In the corresponding groups in which size was determined from the pathology report, metastases were found in 5, 10, and 27%.The size of nonpalpable breast cancers measured on the excised gross specimen and by mammogram accurately predicts the likelihood of axillary node metastasis.

Background The use of the MammoSite brachytherapy balloon catheter is 1 option for the delivery of accelerated partial breast irradiation during breast cancer therapy. The device can be inserted into the breast using 3 different techniques. This report describes these methods of insertion and correlates the technique with outcome data collected in a multi-institutional registry trial. Methods In the registry trial, MammoSite catheters were inserted either (1) at the time of lumpectomy into an open cavity, (2) after surgery with ultrasound guidance through a separate small lateral incision into a closed cavity, or (3) after surgery by entering directly through the lumpectomy wound (the scar entry technique). Device placement techniques in 1403 patients with early stage breast cancer treated at 87 institutions by 223 different investigators were documented in the registry. Data collected included number of cases of each technique, age of patient, tumor size, skin spacing, catheter pull rates and reasons, infection, radiation recall, cosmesis, and recurrence. Results Catheter placement at the time of lumpectomy was performed in 619 patients (44%), after surgery with ultrasound guidance in 576 patients (41%), and the scar entry technique technique in 197 patients (14%). The type of technique was not associated with age of patient, tumor size, bra size, catheter size, skin spacing, infection, radiation recall, cosmesis, or recurrence. There was a statistically significant increased incidence of premature catheter removals for pathologically related reasons with the open-cavity technique compared with the 2 postoperative methods secondary to final histology reports disqualifying the patient after MammoSite placement. Conclusions These registry data show that the MammoSite catheter can be inserted with any 1 of 3 different techniques. A postoperative placement, after the final pathology report is issued, decreases the incidence of premature removal of the catheter because of disqualifying pathology.

Hypothesis Partial-breast irradiation for carcinoma by a single source of radiation placed in the center of a balloon inserted in the lumpectomy cavity is an effective method of treating breast cancer. Previous interstitial radiation therapy using iridium seeds placed within multiple catheters has been shown to be effective but impractical and cosmetically unacceptable to women. Design Prospective registry study. Setting Three university and community hospitals. Patients Women 40 years and older with histologically diagnosed in situ and invasive T1 through T2 and N0 or N1 breast cancer treated with lumpectomy and axillary node sampling were invited to enter this institutional review board–approved study. Main Outcome Measures Evaluation of immediate and short-term complications, patients' acceptance of the treatment, and cosmesis are reported. Results Of the 129 eligible patients enrolled, 112 completed the treatment. Of these, transient skin erythema was noted in 28, localized edema in 3, and skin blisters adjacent to the balloon in 9. Infection developed in 7, necessitating drainage and antibiotic administration. In 10 patients, sonographically demonstrated seromas that developed after removal of the device were aspirated percutaneously. In 4 patients, punctured or ruptured balloons had to be replaced before the treatment could be completed. Patients quickly adjusted to the breast distension caused by the balloon, and their acceptance of the procedure was good. The cosmetic outcome was rated high. There were no recurrences during this very short follow-up. Conclusions Our early short-term experience indicates balloon brachytherapy to be an acceptable alternative to external beam radiation for selected operable breast cancers. The 1-week treatment time allows working women and those who live at a distance from radiation centers to choose breast conservation rather than mastectomy.

The use of preoperative wire localization (PWL) for excision of nonpalpable breast lesions has several disadvantages. The purpose of this study was to evaluate the use of intraoperative ultrasound localization (IUL) and to compare it with PWL.Twenty-nine patients (22 with cancer) underwent IUL in a solo surgical practice over a 21-month period. They were compared to 22 patients with cancer in the same practice who underwent PWL in a similar time period. Parameters analyzed included accuracy of lesion removal, margin involvement, extent of disease-free margin, and the amount of tissue removed.The targeted lesions were accurately removed 100% of the time, and disease-free margins were obtained at the first operation in 82% of patients in both groups. An equivalent amount of disease-free margin (IUL, 6.6 mm; PWL, 6.7 mm) was obtained with IUL while removing a smaller (IUL, 62.6 cm3; PWL, 81.1 cm3) mean volume of tissue.IUL is an accurate method of localizing most nonpalpable mass lesions identified on mammography. Equivalent margin status can be achieved while removing no more tissue than with PWL. The trauma of wire localization in an awake patient is avoided.

529 Background: This report presents 2-year data on treatment efficacy and cosmesis for patients enrolled on the ASBS sponsored MammoSite Registry trial. Methods: 1449 patients were treated with the MammoSite device to deliver APBI. 924 patients have been followed ≥ 12 months, 586 ≥ 18 months, 316 ≥ 24 months and 52 ≥ 36 months. Median follow-up for surviving patients was 14 months. Results: Eleven patients (0.8%) developed an ipsilateral breast tumor recurrence (IBTR) as some component of their initial failure (prior to distant metastases [DM]) for a 2-yr actuarial rate of 1.2%. The 2-yr actuarial rate of isolated IBTR was 0.8% (n=8). Six patients (0.4%) developed an axillary failure (AF) as some component of their initial failure (prior to DM) for a 2-yr actuarial rate of 1.0%. The 2-yr actuarial rate of isolated AF was 0.6% (n=3). The only variable associated with the development of an isolated IBTR (n=8) included an extensive intraductal component (p=0.073) (patient age, margin status, grade, histology, tumor size, nodal status, use of systemic therapy and method of device placement were not associated with IBTR). The only variable associated with the development of all IBTRs (n=11) was tumor location (inner quadrant, p=0.079). The percentage of patients with good/excellent cosmetic results at 6, 12, 18, 24 and 36 months were as follows: 95.1% (n=769 patients), 93.7% (n=621 patients), 91.3% (n=344 patients), 93.5% (n=248 patients), and 90.4% (n=52 patients) (p=NS). For the 174 patients with both a 12-month and 24 month cosmetic assessment, the rate of good/excellent cosmetic results was 94% at 12 and 24 months. At 24 months (n=248 patients), factors associated with good/excellent cosmetic results included increased skin spacing as a categorical variable (94.8% versus 86.1%, p=0.064), no infection (94.8% versus 85.7%, p=0.057), and no systemic chemotherapy treatment (95.3% versus 82.4%, p=0.012). Conclusions: Treatment efficacy and cosmesis 2 years after treatment with APBI using the MammoSite device are excellent and appear similar to those reported with standard whole breast RT. No significant financial relationships to disclose.