Ductal carcinoma in situ of the breast treated with accelerated partial breast irradiation using balloon-based brachytherapy.

BACKGROUND: We reviewed our institution's experience treating patients with ductal carcinoma in situ (DCIS) of the breast with balloon-based accelerated partial breast irradiation (APBI) to determine the efficacy of this treatment approach in this group of patients. MATERIALS AND METHODS: A total of 126 cases of DCIS seen and treated with APBI using balloon-based brachytherapy constitute the study population. The median age at diagnosis was 59 years (range, 37-82) with 21% younger than age 50. Nuclear grade distribution was 52.5, 41.4, and 6.1% high, intermediate and low, respectively. Of these patients, 86% had estrogen receptor positive DCIS. The median tumor size was 6 mm (range, 1-26). Margins of excision were negative in 98.4% of patients. All patients were treated with 34 Gy in 10 fractions using either the MammoSite™ or Contura™ breast brachytherapy catheter. A total of 87 patients (73.1%) were placed on adjuvant tamoxifen or arimedex. RESULTS: With a median follow-up of 24 months (range, 0.7-73.9), three (2.4%) ipsilateral breast tumor recurrences (IBTRs) developed for a 2-year actuarial rate of 0.81%. Recurrences developed 4.8, 24.7, and 24.9 months after treatment. On univariate analysis, no variable was associated with IBTR. A subset analysis of the first 50 consecutive patients treated was also performed. With a median follow-up of 40 months (range, 15.6-73.9), one IBTR developed for a 3-year actuarial rate of 2.15%. CONCLUSIONS: Early results in patients with DCIS treated with APBI using balloon-based brachytherapy produced results similar to those with invasive cancer treated with APBI or DCIS treated with whole breast irradiation.

Initial radiation experience evaluating early tolerance and toxicities in patients undergoing accelerated partial breast irradiation using the Contura Multi-Lumen Balloon breast brachytherapy catheter.

PURPOSE: We reviewed our institution's experience treating patients with the Contura Multi-Lumen Balloon (SenoRx, Inc., Irvine, CA) breast brachytherapy catheter to deliver accelerated partial breast irradiation. METHODS AND MATERIALS: Forty-one patients treated with breast-conserving therapy received adjuvant radiation using the Contura catheter (34Gy in 3.4Gy fractions). Thirteen patients had Stage 0, 21 had Stage I, and 7 had Stage II breast cancer. Median followup was 8 months (range, 1-17). RESULTS: Median, minimum skin spacing was 10mm (range, 2-17). Median, maximum skin doses (% of prescribed dose [PD]) were 99.7 (range, 57.1-124.1). Eight patients were treated with a skin spacing

Initial surgical experience evaluating early tolerance and toxicities in patients undergoing accelerated partial breast irradiation using the Contura Multi Lumen Balloon breast brachytherapy catheter.

We reviewed our surgical experience with the Contura Multi Lumen Balloon breast brachytherapy catheter used to deliver accelerated partial breast irradiation and determined short-term treatment efficacy, cosmesis, and toxicity. Forty-six patients undergoing breast conserving therapy, including the use of Contura catheter, were analyzed. Thirty-four Gray were delivered in 10 fractions. Fourteen patients had stage 0, 24 had stage I, and 8 had stage II breast cancer. Catheters were placed with a closed cavity technique. Median minimum skin spacing was 10 mm (range, 2-18 mm). Median maximum skin doses were 99.7 per cent of the prescription dose. Nine patients were treated with a skin spacing < or = 5 mm (2 patients with 2 mm skin spacing). The percentage of patients with excellent/good cosmesis at 6 (n = 26) and 12 (n = 13) months was 100 per cent, respectively. Patient tolerance was assessed on a scale of 0-10 (0 = no pain, 10 = requiring narcotic analgesics). Pain was graded < or = 3 in 98 per cent of patients at catheter insertion and 84 per cent at catheter removal. Four breast infections (8.8%) and one symptomatic seroma developed. Adjuvant accelerated partial breast irradiation using the Contura Multi Lumen Balloon exhibited similar toxicities to standard single lumen, single dwell balloon brachytherapy with improvements in dosimetric capabilities allowing the treatment of patients with skin spacing < or = 5 mm.

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.

A prospective, randomized, multicenter clinical trial to evaluate the safety and effectiveness of a new lesion localization device.

BACKGROUND: The objective was to compare the safety and effectiveness of a new localization device to traditional flexible wires. Safety variables included blood loss, procedure time, pain and complications. Effectiveness variables included placement accuracy, lesion retrieval, histological diagnosis, procedural enhancements, and margin status. METHODS: Twelve sites enrolled 120 patients between June 2000 and June 2001, with 58 randomized to treatment and 62 to control. RESULTS: The two groups were equivalent in device placement accuracy, lesion retrieval, histological diagnosis, blood loss, pain, and complications. There was a significant difference favoring the treatment group for procedural enhancements, (ie, use as a palpable guide and retractor) and operating time. There were significantly fewer positive margins in the treatment group. CONCLUSIONS: This multicenter trial demonstrated equivalent safety and improved effectiveness for the treatment group. The new device demonstrated greater surgeon utility, reduced operative time, and fewer positive margins than the current wires.

Three-year clinical outcome using the Contura multilumen balloon breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI): improving radiation standards for the optimal application of APBI.

PURPOSE: We reviewed our institution's 3-year clinical experience in treating patients with the Contura multilumen balloon (SenoRx, Inc., Aliso Viejo, CA) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI). METHODS AND MATERIALS: Forty-six patients treated with breast-conserving therapy received adjuvant radiation using the Contura catheter (34Gy in 3.4Gy fractions). Fourteen patients had Stage 0, 24 had Stage I, and 8 had Stage II breast cancer. Median follow-up was 36 months (range, 1-44 months). RESULTS: Only one local recurrence developed (2%). The rate of persistent seroma formation at latest reported follow-up was 4.3% (2 patients) and the incidence of any clinically detectable telengiectasias was 2.2%. No major toxicities (0% Grade III) have occurred. The median skin dose (% of the prescribed dose) was 99.7. The median dose to 95% of the planning target volume for evaluation was 98.8%. The percentage of patients with excellent/good cosmetic results at 24 (n=23) and 36 (n=22) months was 100% and 97%, respectively. CONCLUSION: Adjuvant APBI using the Contura multilumen balloon catheter exhibited similar locoregional control, cosmesis, and toxicities to other forms of APBI with similar lengths of follow-up. In addition, improved radiation standards for the delivery of APBI were demonstrated.

A dosimetric comparison of the Contura multilumen balloon breast brachytherapy catheter vs. the single-lumen MammoSite balloon device in patients treated with accelerated partial breast irradiation at a single institution.

PURPOSE: A comparison of dosimetric findings in 33 patients treated with the Contura multilumen balloon (SenoRx Inc., Irvine, CA) (C-MLB) breast brachytherapy catheter vs. 33 patients treated with the MammoSite (Hologic Inc., Bedford, MA) (MS) at a single institution to deliver accelerated partial breast irradiation (APBI) was performed. METHODS AND MATERIALS: CT-based 3-dimensional planning with dose optimization was completed. APBI treatment of 34Gy in 3.4Gy fractions was delivered. Endpoints analyzed included: (1) The percentage of the prescribed dose (PD) covering the planning target volume (PTV), (2) the maximum skin dose as a percentage of the PD, (3) the maximum rib dose as a percentage of the PD, and (4) the V150 and V200. RESULTS: The C-MLB was placed more frequently in patients with closer skin spacing (<7mm) and rib spacing (<7mm) than in MS patients (45.5% vs. 12.1%, p=0.0057 and 57.6 vs. 33.3, p=0.0131, respectively). Despite closer skin spacing, the overall median skin dose was significantly lower in C-MLB patients (112% of the PD vs. 134%, p=0.0282). No statistically significant differences in the V150 or V200 were observed. In patients with very limited rib spacing (<4mm), the C-MLB delivered significantly lower rib doses than the MS (144% of the PD vs. 191%, p=0.0107). In all clinical scenarios, coverage of the PTV with the C-MLB was either equal to or significantly better than with the MS (p=0.0024). CONCLUSION: The C-MLB catheter produced clinically significant improvements in dosimetric endpoints (e.g., reduced skin and rib doses and improved PTV coverage) in most clinical scenarios.