Management of Mastitis, Abscess, and Fistula.

Peripheral nonlactational abscesses behave like other soft tissue abscesses and resolve with drainage and antibiotics. Subareolar abscesses tend to recur or develop fistulae between obstructed ducts and the border of the areola and are usually seen in women in their thirties who have a history of smoking or a congenitally cleft nipple. The underlying cause of subareolar abscesses and fistulae is the obstruction of terminal ducts due to keratin plugging caused by squamous metaplasia of the ducts. Successful resolution of the problem requires excision of the terminal ducts in and just below the nipple along with the correction of nipple deformity, if present.

American Society of Breast Surgeons presidential address: could quality measures impede quality care?

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.

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.

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.

The surgeon's role in breast brachytherapy.

Although two-thirds of invasive breast cancers and half of non-invasive breast cancers are amenable to lumpectomy, only about 70% of such patients choose breast conservation. Of that group, up to one-third do not follow-up with radiation therapy despite it being clinically indicated. The reasons include the patient's and surgeon's attitude toward breast conservation as well as the inconvenience and distance of a suitable radiation facility. The advent of shorter courses of radiation therapy may encourage more patients to seek adjuvant therapy. An increasingly popular and more convenient alternative to traditional whole-breast radiation therapy in patients with early-stage breast cancer is accelerated partial breast irradiation (APBI), for which the American Society of Breast Surgeons and the American Brachytherapy Society have promulgated guidelines for candidate selection. Although several methods are emerging, the most widely used brachytherapy technique utilizes the MammoSite single-catheter balloon brachytherapy device. In a best practices symposium convened in 2006, breast surgeons from academic and community practices with extensive experience in balloon brachytherapy developed general guidelines for integrating APBI into a breast surgical practice. Important considerations include patient age, histology, tumor location and size, and breast size. Thoughtful lumpectomy planning is essential to optimize balloon placement. Real-time sonographic guidance is essential as the surgeon should attend closely to volume excised and cavity shape. A cavity evaluation device can act as a place holder while patient suitability for APBI is considered. Many breast surgeons expert in this procedure insert the balloon catheter in the office either through a de novo skin entrance site removed from the lumpectomy incision or through the original incision. Optimally, insertion occurs within 2-3 weeks after lumpectomy. Close and continual communication with the radiation oncologist is essential to assure optimal outcomes. In this review, several key aspects of a successful APBI program from a surgeon's perspective as well as a consensus panel from a best practices symposium on the topic herein are highlighted.

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 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; p = 0.01). Radiation recall in those receiving CTX 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.

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).

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.

Prospective randomized study comparing cryo-assisted and needle-wire localization of ultrasound-visible breast tumors.

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.

Initial outcomes for patients treated on the American Society of Breast Surgeons MammoSite clinical trial for ductal carcinoma-in-situ of the breast.

BACKGROUND: 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). METHODS: 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. RESULTS: Skin spacing for the MammoSite applicator was as follows: < 5 mm, 3 patients (1.78%); 5 to 7 mm, 18 patients (10.65%); and > or = 7 mm, 148 patients (87.57%). Patients with a device-to-skin distance of > or = 7 mm had the best cosmetic result. Patients with a device-to-skin distance of > or = 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. CONCLUSIONS: 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.

Axillary ultrasonography to detect recurrence after sentinel node biopsy in breast cancer.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Descriptions and outcomes of insertion techniques of a breast brachytherapy balloon catheter in 1403 patients enrolled in the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial.

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.

First analysis of patient demographics, technical reproducibility, cosmesis, and early toxicity: results of the American Society of Breast Surgeons MammoSite breast brachytherapy trial.

BACKGROUND: Eighty-seven institutions participated in a Registry Trial that was designed to collect data on the clinical use of the MammoSite breast brachytherapy catheter for delivering breast irradiation. Patient demographics, technical reproducibility, cosmesis, and early toxicity were evaluated. METHODS: From May 4, 2002 through July 30, 2004, 1419 patients with Stage 0, I, or II breast carcinoma who were undergoing breast-conserving therapy were enrolled on the trial. The device was placed in 1403 of these patients. The 1237 patients (87% of enrolled patients) who received accelerated partial breast irradiation (APBI) (34 grays prescribed to 1.0 cm in 10 fractions; 95% of patients who received APBI) constituted the study population; 86% of those patients (1068) had Stages I-II breast carcinoma (median tumor size, 10 mm), and 14% of those patients (169) had Stage 0 breast carcinoma. Ninety-one percent of the patients with invasive carcinoma (977 of 1068 patients) had negative lymph node status, and 99% of all patients had negative margins. The median patient age was 65 years. Systemic chemotherapy alone was administered to 79 patients with invasive carcinoma (7%), hormone therapy was administered to 501 patients (45%), and both were administered to 39 patients (4%). The median follow-up was 5 months. RESULTS: Five hundred fifty-four catheters (45%) were placed with an open cavity at the time of lumpectomy, and 683 catheters (55%) were placed with a closed cavity after lumpectomy. Skin spacing ranged from 2 mm to 75 mm (median, 10 mm). In 89% of patients, there was a minimum balloon-to-skin distance of 7 mm (2% of patients had distances < 5 mm). In terms of cosmetic assessment, 95% of patients (1030 of 1084 patients) who had a cosmetic assessment had a good/excellent result (last follow-up visit). Cosmetic results at 12 months were good/excellent in 92% of 248 evaluable patients. The median skin spacing (> or = 7 mm vs. < 7 mm) was associated significantly with a good/excellent cosmetic result (96.1% vs. 86.8%; P = 0.0001) overall and at 6 months (P = 0.006). Increasing skin spacing was associated with a good/excellent cosmetic result as a continuous variable (P < 0.0001). In total, 92 of 1140 evaluable patients (8.1%) developed an infection in the breast, which was device-related in 5.3% of patients (60 of 1140 patients). Good/excellent cosmetic results were noted in 86% of these patients (last follow-up visit). Fifteen of 442 evaluable patients (3.4%) developed a radiation recall reaction. Good/excellent cosmetic results were noted in 93% of these patients at their last follow-up visit. One local recurrence (0.1%) was reported (new primary carcinoma). CONCLUSIONS: Clinical evaluation of the ability of the MammoSite breast brachytherapy catheter to deliver APBI demonstrated acceptable technical reproducibility between multiple institutions and use in appropriate groups of patients. Cosmetic results at 12 months (92% good/excellent) were comparable to those reported with whole-breast RT. Early toxicity rates (infections, radiation recall) appeared to be acceptable.

Early experience with balloon brachytherapy for breast cancer.

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.