MammoSite Balloon Brachytherapy Research Articles

Extended (5-year) Outcomes of Accelerated Partial Breast Irradiation Using MammoSite Balloon Brachytherapy: Patterns of Failure, Patient Selection, and Dosimetric Correlates for Late Toxicity

Accelerated partial breast irradiation (APBI) with balloon and catheter-based brachytherapy has gained increasing popularity in recent years and is the subject of ongoing phase III trials. Initial data suggest promising local control and cosmetic results in appropriately selected patients. Long-term data continue to evolve but are limited outside of the context of the American Society of Breast Surgeons Registry Trial. A retrospective review of 157 patients completing APBI after breast-conserving surgery and axillary staging via high-dose-rate (192)Ir brachytherapy from June 2002 to December 2007 was made. APBI was delivered with a single-lumen MammoSite balloon-based applicator to a median dose of 34 Gy in 10 fractions over a 5-day period. Tumor coverage and critical organ dosimetry were retrospectively collected on the basis of computed tomography completed for conformance and symmetry. At a median follow-up time of 5.5 years (range, 0-10.0 years), the 5-year and 7-year actuarial incidences of ipsilateral breast control were 98%/98%, of nodal control 99%/98%, and of distant control 99%/99%, respectively. The crude rate of ipsilateral breast recurrence was 2.5% (n=4); of nodal failure, 1.9% (n=3); and of distant failure, 0.6% (n=1). The 5-year and 7-year actuarial overall survival rates were 89%/86%, with breast cancer-specific survival of 100%/99%, respectively. Good to excellent cosmetic outcomes were achieved in93.4% of patients. Telangiectasia developed in 27% of patients, with 1-year, 3-year, and 5-year actuarial incidence of 7%/24%/33%; skin dose >100% significantly predicted for the development of telangiectasia (50% vs 14%, P<.0001). Long-term single-institution outcomes suggest excellent tumor control, breast cosmesis, and minimal late toxicity. Skin toxicity is a function of skin dose, which may be ameliorated with dosimetric optimization afforded by newer multicatheter brachytherapy applicators and a more rigorous skin dose constraint of ≤100%.

Use of MammoSite balloon brachytherapy for early-stage breast cancer

Use of MammoSite balloon brachytherapy for early-stage breast cancer

Initial Clinical Experience With the Strut-Adjusted Volume Implant (SAVI) Breast Brachytherapy Device for Accelerated Partial-Breast Irradiation (APBI): First 100 Patients With More Than 1 Year of Follow-Up

The Strut-Adjusted Volume Implant (SAVI; Cianna Medical, Aliso Viejo, CA) is a multichannel single-entry brachytherapy device designed to allow dose modulation to minimize normal tissue dose while simultaneously maximizing target coverage. This is the first report on the initial 102 patients with nearly 2 years of median follow-up. One hundred two patients were treated at two institutions. Data were collected on eligibility and dosimetry and followed for toxicity and recurrence. The median follow-up is 21 months. Overall dosimetry is outstanding (median percent of target volume receiving 90% of the prescription dose was 95.9%, volume of target receiving 150% of the prescription dose was 27.8 mL, and volume of target receiving 200% of the prescription dose was 14.0 cm(3)). No devices were pulled prior to treatment completion. For patients with a skin bridge of less than 7 mm, the maximum median skin dose was 280 cGy (median percent of target volume receiving 90% of the prescription dose was 95.2%, volume of target receiving 150% of the prescription dose was 25.8 cm(3) and volume of target receiving 200% of the prescription dose was 12.7 mL). For patients with both chest wall and skin of less than 7 mm, the maximum median lung dose was 205 cGy with simultaneous skin dose of 272 cGy. The rate of telangiectasia was 1.9%. Grade 1 hyperpigmentation developed in 10 patients (9.8%) and Grade 2 fibrosis in 2 patients (1.9%). There were 2 symptomatic seromas and 2 cases of asymptomatic fat necrosis (1.9%). Of the patients, 27% were not eligible for MammoSite balloon brachytherapy (Hologic, Inc., Marlborough, MA) and 5% were not eligible for any balloon brachytherapy. The recurrence rate was 1%. The SAVI appears to safely allow an increase in eligibility for APBI over balloon brachytherapy or three-dimensional conformal radiation, highlighting the outstanding device flexibility to maximize the target dose and minimize the normal tissue dose. The device was well tolerated by patients.

Angiosarcoma following MammoSite® partial breast irradiation

Angiosarcoma is a rare tumor of endothelial origin which commonly arises in small blood or lymphatic vessels. Its development in the treated breast following adjuvant external beam radiation is also rare. To our knowledge, there are no reported cases in the literature or MammoSite registry which describe the occurrence of angiosarcoma in the treated breast following MammoSite brachytherapy. This is a case report of a 74 year old female who developed angiosarcoma 4 years after receiving MammoSite balloon brachytherapy following surgical resection of a T1mic N0 M0 infiltrating ductal carcinoma.

Mammographic Appearance Following Accelerated Partial Breast Irradiation by Using MammoSite Brachytherapy

To describe a single institution's experience with mammographic appearance in low-risk patients with early stage breast cancer who have received accelerated partial breast irradiation (APBI) by using MammoSite balloon brachytherapy. This study was approved by an institutional review board and was conducted under strict adherence to the Privacy Rule of HIPAA. This was a retrospective review of patients who underwent MammoSite brachytherapy from October 2003 to March 2007. Informed consent for participation in the research project was waived by the institutional review board. Posttherapy mammograms were categorized as showing mild, moderate, or severe distortion and were correlated with patient complaints and complications. Twenty-two women were included in the study, and 93 mammograms were obtained during a median follow-up period of 46 months (range, 22-58 months). Median age was 61 years (range, 47-81 years). One patient developed severe distortion after APBI, while two patients developed only mild distortion throughout follow-up. Eleven (79%) of 14 patients developed moderate distortion, with a median peak in distortion occurring at 21 months. Four (18%) patients developed fat necrosis, two (9%) developed seromas, and two (9%) developed both fat necrosis and seromas. None of the patients required biopsy, and none had an ipsilateral breast recurrence. One patient died of metastatic disease with no evidence of local recurrence. Patients treated with MammoSite APBI developed peak distortion 21 months following therapy, which may be sooner than distortion following conventional whole breast radiation.

Six-year experience: long-term disease control outcomes for partial breast irradiation using MammoSite balloon brachytherapy

Background This report describes estimated 4-year tumor bed and ipsilateral breast recurrence-free intervals, event-free survival, disease-specific survival, and overall survival in a cohort of MammoSite brachytherapy (MBT) patients with mature follow-up treated at a single institution over a 6-year period. Methods and Materials An analysis of MBT cases was performed by using a prospectively collected quality-assurance database, departmental chart review, and electronic medical records. Patient-, tumor-, treatment-, and outcome-specific data were extracted and recorded into a research database. Patients were eligible for inclusion in this analysis if they were at least 6 months post-MBT. Results From May 2002 through March 2008, 111 MBT patients have been treated and were eligible for the present analysis. With a median follow-up of 46 months, the estimated 4-year outcomes for the entire cohort were tumor bed control 99%, ipsilateral breast control 95%, event-free survival 88%, disease-specific survival 97%, and overall survival 92%. Conclusions The present study shows low rates of local and ipsilateral breast disease failure in a well-defined cohort of MBT patients with mature follow-up.

Five-year results: the initial clinical trial of Mammosite balloon brachytherapy for partial breast irradiation in early-stage breast cancer

Five-year results: the initial clinical trial of Mammosite balloon brachytherapy for partial breast irradiation in early-stage breast cancer

Accelerated partial breast irradiation: Preliminary experience with the IntraBeam System

11581 Local failure after breast conserving surgery (BCS) and breast radiation usually occurs at the tumor site. This has increased interest in accelerated partial breast irradiation (APBI), because better local control should be achieved if radiation is delivered directly to the tumor bed. The interstitial catheter and Mammosite balloon brachytherapy procedures require multiple visits to the radiation center and another procedure to remove the devices. Veronesi’s intraoperative radiotherapy technique (IORT) and the Mobetron require a special operating room (OR), expensive equipment, and are not very mobile. The IntraBeam IORT system is ideal for APBI. It is inexpensive, safe, easy to use, mobile and can be used in any standard OR. The system also can be used at multiple sites. The photon radiation unit, control console, and applicators all fit easily in cases, requiring only a stand at another site. This makes the system versatile and cost effective. It is convenient for the patient because it requires no further surgery or visits to the radiation center. The procedure is very practical for the community setting. We have performed the procedure to compliment BCS in 54 patients, 49 as part of the original surgery, while 5 had re-exploration of the previous segmental mastectomy site. Because of the final pathology, 3 patients had total mastectomies and 8 went on to have total breast irradiation. When total breast radiation is required, the IntraBeam IORT serves as the radiation boost. There have been no serious surgical or radiation complications, however, most patients developed seromas, managed by aspiration. There were no wound infections. One patient had re-excision of the segmental mastectomy site after 22 months because of severe induration. The pathology report was only radiation fibrosis and fat necrosis. Patient satisfaction has been great and there have been no local recurrences. However, our follow-up is not long enough to determine the true efficacy of preventing local recurrence. No significant financial relationships to disclose.

MammoSite Balloon Brachytherapy: Errors, Pitfalls, and Technical Issues for a Practicing Surgeon

MammoSite Balloon Brachytherapy: Errors, Pitfalls, and Technical Issues for a Practicing Surgeon

Preliminary results and evaluation of MammoSite balloon brachytherapy for partial breast irradiation for pure ductal carcinoma in situ: a phase II clinical study

Preliminary results and evaluation of MammoSite balloon brachytherapy for partial breast irradiation for pure ductal carcinoma in situ: a phase II clinical study

Five-year results: the initial clinical trial of Mammosite balloon brachytherapy for partial breast irradiation in early-stage breast cancer

Objective Patients with early-stage invasive ductal breast cancer were prospectively evaluated using MammoSite RTS balloon brachytherapy (RTS Cytyc Corp, Marlborough, MA) as the sole modality for delivering accelerated partial breast irradiation to the lumpectomy bed with breast-conserving surgery. This report presents the 5-year results of the treated patients. Methods From May 2000 to October 2001, 70 patients were enrolled in this prospective study. Forty-three patients completed accelerated partial breast irradiation with MammoSite brachytherapy following lumpectomy and axillary staging. Thirty-six patients have been followed for a median of 5.5 years (mean 65.2 months). Criteria for entry into the study were unifocal invasive ductal carcinoma, tumor size ≤2 cm, age ≥45 years, absence of extensive intraductal component, cavity size ≥3 cm in 1 dimension, node-negative, and final margins negative per National Surgical Adjuvant Breast and Bowel Project definition. A minimum balloon-to-skin surface distance of 5 mm was required. A dose of 34 Gy was delivered in 10 fractions over 5 days prescribed to 1 cm from the applicator surface using iridium-192 high-dose-rate brachytherapy. Data on infection, seromas, cosmetic outcome, and toxicities were collected at 3 and 6 months and at yearly intervals. Local recurrences, both true recurrences in the lumpectomy bed and failures outside the initially treated target volume (elsewhere failures), were recorded. Contralateral breast failure rates were noted. Results The catheter was not implanted in 16 of the 70 enrolled patients due to cavity size not amenable to balloon placement (n = 10), ineligible by criteria (n = 4), and skin spacing (n = 2). Fifty-four patients were implanted and 43 were successfully treated with MammoSite balloon brachytherapy. Reasons for catheter explantation in 11 patients were poor cavity conformance in 7, inadequate skin spacing in 2, positive node in 1 and age less than 45 years in 1. Of the 43 patients who completed treatment, the infection rate was 9.3%. Seroma formation occurred in 32.6% of patients, of which 12% were symptomatic requiring aspiration. Asymptomatic fat necrosis was identified in 4 of the 43 patients, noted from time of catheter removal at 11, 14, 42, and 63 months. Good–excellent cosmetic outcomes were achieved in 83.3% of the 36 patients with more than 5 years of follow-up. Cosmetic outcomes were improved, with increased skin spacing having statistical significance at skin spacing ≥7 mm. The only serious adverse events were 2 infections: mastitis and abscess. Seven of the 43 treated patients have been discontinued from follow-up. None had a local recurrence recorded at last visit. Reasons for exit from the study were death from metastatic disease (n = 3), lost to follow-up (n = 2), and placed in hospice for other medical conditions (n = 2). No local recurrences (either at the tumor bed or elsewhere in the breast) or regional recurrences have occurred in the 36 patients who have been followed for a median of 5.5 years. No contralateral cancers have developed. Conclusions MammoSite balloon brachytherapy as a sole modality for delivering radiation to the tumor bed has been successful in achieving excellent local control in this initial clinical study of patients with early-stage invasive ductal breast cancer. This has been achieved with minimal toxicities and good–excellent cosmetic outcomes in 83.3%. Accelerated partial breast irradiation using the MammoSite balloon in a carefully selected group of patients has demonstrated 5-year local recurrence results comparable to those achieved with conventional whole breast radiation therapy and interstitial catheter brachytherapy as reported at 5-year data points in studies of these treatment modalities. Poor cavity conformance and inadequate skin distance were the main factors limiting use of the MammoSite device. Extended follow-up will be required to determine the long-term efficacy of this treatment modality.

Clinical and dosimetric experience with MammoSite-based brachytherapy under the RTOG 0413 protocol.

MammoSite balloon brachytherapy is a relatively new technique for partial breast irradiation. The present paper focuses on the treatment planning, dosimetry, and quality assurance aspects of that treatment, based on the Radiation Therapy Oncology Group 0413 randomized prospective trial (RTOG 0413) protocol. We investigate the usefulness of evaluating implants for treatment appropriateness according to the full set of RTOG criteria as compared with the manufacturer's guidelines. We describe our methods to improve MammoSite balloon implants that would otherwise not comply with the protocol. The initially acquired computed tomography (CT) images are evaluated for tissue conformance, balloon surface–to–skin distance, and balloon symmetry. If the implant fails to meet the foregoing criteria, corrective action such as delay in the CT scan, balloon manipulation, or fluid volume adjustment is taken, and the patient is re‐scanned. If the corrective action appears to be successful, three dimensional treatment planning and dose–volume histogram analysis is performed to evaluate the geometric and dosimetric parameters with regard to the RTOG 0413 protocol. The evaluated parameters include• volume ratio of the lumpectomy cavity to the ipsilateral breast,• target volume coverage,• tissue–balloon conformance,• balloon symmetry,• minimal balloon surface–to–skin distance,• maximum skin dose, and• normal breast tissue dose–volume parameters V150 and V200.Among our implants, 21.7% did not initially meet the RTOG 0413 acceptance criteria. Asymmetry and poor conformance values reduce the target volume coverage, and so an implant with moderate conformance and asymmetry can be within the manufacturer's guidelines, but still not meet the RTOG criteria. Our intervention corrected all but one of the implants that failed to meet the criteria. Manipulating the cavity and adjusting the balloon volume may salvage an implant and meet the strict geometric and dosimetric criteria imposed by the RTOG 0413 protocol.PACS number: 7.53.Jw

A dosimetric comparison of MammoSite high-dose-rate brachytherapy and Xoft Axxent electronic brachytherapy

Purpose Over 20,000 patients have been treated with partial breast irradiation (PBI) using the MammoSite balloon brachytherapy applicator (IBB). Recently, a new form of balloon-based PBI, Xoft Axxent electronic brachytherapy (KVB), which uses a 50-kV x-ray source, has been introduced. This analysis was undertaken to dosimetrically compare the results of treatment using these two methods of PBI. Methods and Materials The study population consisted of 15 patients previously treated with IBB. The planning CT scans from these 15 patients were used to construct hypothetical treatment plans using the source characteristics of the KVB device. The plans were then compared using the dosimetric parameters discussed below. Results The mean % V 90 was 99.6% vs. 99.0% ( p = nonsignificant [ns]), the mean % V 100 was 96.5% vs. 96.5%, the mean % V 150 was 41.8% vs. 59.4% ( p < 0.05), the mean % V 200 was 11.3% vs. 32.0% ( p < 0.05), and the mean % V 300 was 0.4% vs. 6.7% ( p < 0.05) for the IBB and KVB methods, respectively. The mean ipsilateral breast % V 50 was 19.8% vs. 13.0% ( p < 0.05), the mean ipsilateral lung % V 30 was 3.7% vs. 1.1% ( p < 0.05), and the mean heart % V 5 was 59.2% vs. 9.4% ( p < 0.05) for the IBB and KVB methods, respectively. Conclusions The IBB and KVB methods of PBI offer comparable target volume coverage; however, the KVB method is associated with an increased volume of breast tissue in the high-dose regions and a decreased dose to the adjacent normal tissues.

Preliminary results and evaluation of MammoSite balloon brachytherapy for partial breast irradiation for pure ductal carcinoma in situ: a phase II clinical study

Background This report presents the preliminary results and evaluation of the MammoSite balloon catheter (MammoSite Radiation Therapy System; Cytyc Corporation, Marlboro, MA) as the sole method of delivering partial breast irradiation to the lumpectomy bed with breast-conserving surgery in patients with pure ductal carcinoma in situ (DCIS). Methods Twelve institutions are participating in this phase II clinical study. A total of 133 patients have been enrolled and 100 patients have successfully completed the prescribed radiation therapy. A dose of 34 Gy was delivered in 10 fractions over 5 days prescribed to 1 cm from the applicator surface using iridium-192 high-dose rate brachytherapy. Patients who met the following criteria were selected for enrollment into the study: age 45 years or older, unicentric pure DCIS, mammographic lesion of 3 cm or less, negative margins as defined by 1 mm or more, postoperative final gross pathologic size of tumor of 5 cm or less, clinically node negative, and a postlumpectomy mammogram showing the absence of any residual suspicious microcalcifications. The placement of the MammoSite catheter was performed either at the time of the lumpectomy or postlumpectomy. The minimum distance from the balloon surface to the surface of the skin is greater than 5 mm. Data collection points are at time of enrollment, time of implant, 3 months, 6 months, and then yearly at 1- to 5-year follow-up visits. Data collected are local control rates, cosmetic outcome using the Harvard Scale, toxicities, serious adverse events, disease-free survival, cause-specific survival, and contralateral breast failure. The Van Nuys Prognostic Index scores were calculated for each patient. Local recurrence is defined as either invasive or noninvasive recurrence within the target volume. Ipsilateral elsewhere recurrence is defined as either an invasive or noninvasive recurrence occurring outside of the target volume in the previously treated breast. This recurrence is classified as a new primary tumor. Results The mean follow-up period was 9.5 months (range, 1–24 mo). The MammoSite catheter was explanted for the following reasons: inadequate skin distance (5.1%; 6 of 117), poor cavity conformance (5.1%; 6 of 117), positive margins (2.6%; 3 of 117), final histology (.85%; 1 of 117), and physician decision (.85%; 1 of 117). Of the patients in whom the MammoSite was explanted because of skin spacing or cavity conformance, 50% were at sites of new users (institutions that have placed fewer than 10 Mammosite catheters). Cosmetic results were rated as excellent in 63%, good in 35%, and fair in 2% in the 86 patients with a follow-up visit. Two patients were diagnosed with an ipsilateral local recurrence, 1 outside of the target volume and 1 true recurrence/marginal miss. One patient was diagnosed at 8 months and the other was diagnosed at 11 months. Both of these ipsilateral failures were DCIS. The Van Nuys Prognostic Index of these 2 patients was 9 and 8, respectively. Data collected showed the mean age at placement was 60.8 y, mean tumor size was 10.6 mm, mean actual closest surgical margin was 6.8 mm (range, .1–40 mm), a re-excision rate of 35%, postlumpectomy placement was 71%, and the mean skin-to-balloon surface distance was 13 mm with 89% ≥7 mm. No serious adverse events were reported. The infection rate was 4.0%. Conclusions Accelerated partial breast irradiation delivered with the MammoSite balloon was clinically successful in patients entered into a phase II clinical study with pure DCIS, with results comparable with other studies reported in the literature that have evaluated use of the MammoSite balloon brachytherapy for delivery of radiation therapy in early breast cancers. Inadequate skin distance and poor cavity conformance were the main factors limiting the use of the MammoSite device. Cosmetic results were good to excellent in 98%. There have been 2 ipsilateral breast recurrences.

MammoSite Balloon Brachytherapy: Errors, Pitfalls, and Technical Issues for a Practicing Surgeon

This article describes the technical aspects of insertion of the MammoSite radiation therapy system for patients with T1-2 disease. Practicing breast surgeons should be aware of the errors and pitfalls, the importance of cosmetic issues, and patient selection procedures.

Equivalent Biological Effective Dose (BEDeq) Modeling of Tumor Control Probability in Partial Breast Irradiation

Purpose/Objective: A variety of Partial Breast Irradiation (PBI) Protocols have been developed to treat the original tumor bed with a margin, including brachytherapy and external beam 3D-CRT. In our study we performed biologically effective dose (BEDeq) analysis of interstitial, Mammosite Balloon brachytherapy, and external beam techniques utilized at William Beaumont and New York University comparing the integral dose of both the planning target volume (PTV) and normal breast.

The MammoSite balloon brachytherapy catheter for accelerated partial breast irradiation

Whole-breast irradiation after lumpectomy for early-stage breast cancer appears to prevent relapse only at the site of initial involvement, and therefore it is likely that radiation can safely be limited to tissues immediately surrounding the excision cavity. Accelerated partial-breast irradiation (APBI) with the MammoSite catheter (Proxima Therapeutics, Alpharetta, GA) has been proposed as a means through which APBI can be offered to a wide range of patients. Although sufficient follow-up is not yet available regarding local control, survival, late toxicity, and long-term cosmetic results, early results are promising. This article reviews the current literature reflecting treatment, dose optimization, outcomes, and toxicity of APBI with the MammoSite brachytherapy catheter.

Accelerated treatment of breast cancer: dosimetric comparisons between interstitial HDR brachytherapy, mammosite balloon brachytherapy, and external beam quadrant radiation

Accelerated treatment of breast cancer: dosimetric comparisons between interstitial HDR brachytherapy, mammosite balloon brachytherapy, and external beam quadrant radiation