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

Vicini FA.   Cancer. 2005 Sep 15;104(6):1138-48.

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.

Clinical experience with the MammoSite((R)) radiation therapy system for brachytherapy of breast cancer: Results from an international phase II trial. Niehoff PA,  Radiother Oncol. 2006 Jun 13

BACKGROUND AND PURPOSE: In a prospective multi-center phase II trial, we investigated the MammoSite((R)) Radiation Therapy System, a new device for delivering intracavitary brachytherapy following breast conserving surgery. The MammoSite((R)) is a dual lumen, closed ended catheter with a small, spherical inflatable balloon and a port for connecting a remote afterloader to the central lumen. We analyzed the surgical procedure and placement of the MammoSite((R)), treatment planning and radiation delivery complications and cosmesis, as well the comfort for the patients. PATIENTS AND METHODS: Between 2002 and 2004 a total of 32 patients (pts) were implanted using the MammoSite((R)). The reference isodose was defined 1cm from the balloon surface. We analyzed the post-implant anatomic position of the applicator and the geometric form of the balloon via ultrasound, CT and X-ray, related side effects, cosmetic outcome and patient quality of life. RESULTS: Twenty-three out of 32 patients (72%) were eligible for MammoSite((R)) intracavitary brachytherapy. Twenty-eight percentage had to be excluded because of different reasons. Eleven patients were treated with primary brachytherapy with a total dose of 34Gy (2x3.4Gy) and 12 had a boost with a mean dose of 13.3Gy (range: 7.5-15Gy; 2x2.5Gy) combined with EBRT and doses ranged between 46 and 50Gy. In three cases a balloon rupture occurred. We observed two abscesses within 3 months of implantation and serious seroma development in 10 patients (39%). Skin related side effects were erythema in 21 patients (91%), hyperpigmentation in 13 patients (56%) and teleangiectasia in six patients (26%) after mean follow-up 20 months. CONCLUSIONS: The MammoSite((R)) Radiation Therapy System is a feasible treatment modality for intracavitary brachytherapy of breast cancer after breast conserving surgery. The advantage of the system is only one applicator is necessary for the delivery of a fractionated radiotherapy. In addition, patient tolerance of the procedure is high. Critical issues concern possible overdosages at the skin reflected by a high rate of late skin damage after only 20 months of follow-up time. The method could serve as an alternative to conventional multi-catheter brachytherapy for a selected group of patients.

Initial clinical experience with the MammoSite breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy. Keisch M;  Int J Radiat Oncol Biol Phys. 2003 Feb 1;55(2):289-93.  Department of Radiation Oncology, Mount Sinai Medical Center, Miami Beach, FL 33140, USA

PURPOSE: We present the results of the initial clinical testing of the MammoSite balloon breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy. METHODS AND MATERIALS: Seventy patients were enrolled in a multicenter prospective trial testing the applicator for safety and performance. Fifty-four patients were implanted, and 43 patients were ultimately eligible for and received brachytherapy as the sole radiation modality after lumpectomy. Patients were staged T1N0M0 with negative pathologic margins and age >45 years. A dose of 34 Gy was delivered in 10 fractions over 5 days prescribed to 1 cm from the applicator surface using 192Ir high-dose-rate brachytherapy. A minimum skin-to-balloon surface distance of 5 mm was required for treatment. Device performance, complications, and cosmesis were assessed. RESULTS: Computed tomography imaging post-balloon inflation showed 8, 14, and 21 patients with 5-6 mm, 7-9 mm, and >10 mm of skin spacing, respectively. Two patients were explanted because of inadequate skin spacing and 7 because of suboptimal conformance of the surgical cavity to the applicator balloon. One patient was explanted because of positive nodal status and another because of age. The most common side effects related to device placement included mild erythema, drainage, pain, and echymosis. No severe side effects related to implantation, brachytherapy, or explantation occurred. Side effects related to radiation therapy were generally mild with erythema, pain, and dry desquamation being the most common. At 1 month, 88% of patients were evaluated as having good-to-excellent cosmetic results. CONCLUSIONS: The MammoSite balloon breast brachytherapy applicator performed well clinically. All eligible patients completed treatment. Side effects were mild to moderate and self-limiting. Skin-balloon surface distance and balloon-cavity conformance were the main factors limiting the initial use of the device.

Acute toxicity of high-dose-rate intracavitary brachytherapy with the MammoSite applicator in patients with early-stage breast cancer. Richards GM.  Ann Surg Oncol. 2004 Aug;11(8):739-46. Epub 2004 Jul 12

Department of Radiation Oncology, St. Vincent's Comprehensive Cancer Center, 325 W. 15th Street, New York, NY 10011, USA.

BACKGROUND: Intracavitary brachytherapy with the MammoSite applicator as the sole radiation treatment in breast-conserving therapy is an option for women with early-stage breast cancer; we evaluated the acute toxicities associated with this treatment method. METHODS: Thirty-one patients with 32 stage I or II breast carcinomas underwent breast-conserving therapy, which included lumpectomy with negative margins, sentinel node biopsy, or axillary dissection, followed by brachytherapy with the MammoSite applicator. Acute radiation skin complications were graded on the day of radiotherapy completion and at weeks 2, 4, 6, and 12 after radiation treatment. Cosmesis was graded on the Harvard Scale at all follow-ups. RESULTS: The median follow-up was 11 months (range, 4-15 months). Twenty-seven of the 31 patients were treated with the device as the sole method of radiotherapy. No acute toxicities occurred during the 5 days of treatment. Nineteen patients (68%) had no to mild acute skin reactions, and 25% developed bright erythema and patchy moist desquamation. Two patients (7%) developed confluent moist desquamation within the first 4 weeks (grade 3); this healed by week 12. All skin reactions were localized to the area overlying the balloon. Sixteen percent (5 of 32) of all breasts with implants developed infection. Cosmesis was good to excellent in 86% of cases. CONCLUSIONS: Most acute skin toxicities were mild. Our infection rate was higher than in prior studies that used interstitial brachytherapy. Cosmesis was good to excellent in most patients. Breast brachytherapy with the MammoSite catheter was well tolerated; further investigations of breast brachytherapy with this system are warranted.

Acute complications of MammoSite brachytherapy: a single institution's initial clinical experience. Harper JL.   Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):169-74
Department of Radiation Oncology, Medical University of South Carolina, Charleston, SC

PURPOSE: To report the acute complications incurred by the initial 37 patients who underwent accelerated partial breast irradiation with the MammoSite balloon breast brachytherapy applicator at the Medical University of South Carolina. METHODS AND MATERIALS: Between May 2002 and March 2003, 37 patients with ductal carcinoma in situ or invasive carcinoma had MammoSite brachytherapy catheters successfully place after lumpectomy by one of four surgeons and were deemed eligible for high-dose-rate brachytherapy. An open technique was used in 32 implants and the scar entry technique was used in 5 implants. Patients had Stage pTis-pT2N1 with negative margins. A dose of 34 Gy was prescribed to 1 cm from the balloon surface using (192)Ir high-dose-rate brachytherapy and was delivered in 10 fractions twice daily. CT was used to confirm that the balloon surface was adherent to the lumpectomy cavity and to measure the balloon surface to skin surface distance. CT images and daily fluoroscopic simulations were used for treatment planning. Patients were assessed for acute toxicity on the day of therapy completion and 4 weeks after therapy by the radiation oncologist. In addition, all available data from radiation, surgical, and medical oncology were retrospectively reviewed for documentation of complications. All patients in this series had a minimal follow-up of 3 months; the mean follow-up for all patients was 7 months. RESULTS: The acute complications were categorized as operative wound complications, infections, skin toxicity, seromas, or catheter failures. Operative wound complications occurred in 3 patients (8%). Radiation Therapy Oncology Group Grade 2 and Grade 3 toxicity occurred in 2 (5.4%) and 1 (2.7%) patient, respectively. Six (16.2%) developed wound infections and 12 (32.4%) seromas. Catheter failures due to leak occurred in 2 patients (5.4%) and rupture in 3 (8%). CONCLUSION: The types of complications in this experience were similar to those in the Phase I trial of the MammoSite brachytherapy applicator. However, catheter failure due to leak occurred in our experience and was not described in the Phase I trial. The incidence of complications was greater in our series than in the Phase I trial; however, differences in toxicity scoring and the length of follow-up between the two series impeded direct comparisons. The incidences of complications over time reflect the steep learning curve for accelerated partial breast irradiation using the MammoSite brachytherapy applicator. Finally, radiation recall dermatitis developed in 1 patient treated after this review was completed.