First analysis of patient demographics, technical reproducibility, cosmesis, and early toxicity

Abstract

BACKGROUNDEighty‐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.METHODSFrom 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.RESULTSFive 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 (≥ 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).CONCLUSIONSClinical 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. Cancer 2005. © 2005 American Cancer Society.

The feasibility of a second lumpectomy and breast brachytherapy for localized cancer in a breast previously treated with lumpectomy and radiation therapy for breast cancer

“…The patients were eligible for the study on the basis of the unicentric nature of the ipsilateral recurrence that could be removed at the time of lumpectomy achieving negative margins. The tumor size and histology characteristics of the second breast cancer events treated on our study using multicatheter interstitial PBB are very similar to the new primary breast cancers (median tumor size of 1.0 cm, and included 86% invasive cancer and 14% DCIS lesions) that were treated with Mammosite catheter brachytherapy (41).…”

Comparison of organ doses for patients undergoing balloon brachytherapy of the breast with HDR or electronic sources using Monte Carlo simulations in a heterogeneous human phantoma)

“…Preliminary results from clinical trials indicate that breast conserving surgery in conjunction with balloon brachytherapy can lead to good cosmetic outcomes, comparable to the interstitial approach. [4][5][6][7][8] At the present, balloon brachytherapy is conventionally delivered with a HDR 192 Ir source, but it can also be delivered with an electronic brachytherapy ͑eBx͒ source involving a miniaturized x-ray tube. [9][10][11][12] Ir radionuclide emits several gamma rays with energies up to 1.4 MeV that can easily penetrate through a large portion of the patient's body.…”

Full-dose intra-operative radiotherapy with electrons (ELIOT) during

“…On the contrary, Reitsamer [15], in a non-randomized study, showed that the boost given with intra-operative electron radiotherapy is superior to the external breast electron boost irradiation. Partial breast irradiation can be delivered also with interstitial brachytherapy [16][17][18], and more recently by external sources with three-dimensional radiotherapy (3D-RT) and intensity modulated radiotherapy (IMRT) [19][20].…”