Troy Scroggins

Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for Tis,1,2 breast cancer

BACKGROUND We hypothesized that wide-field brachytherapy (BRT) after margin negative excision would result in complication rates, local recurrence rates, and cosmesis scores equivalent to external beam radiotherapy (ERT). METHODS Patients with T(is,1,2) tumors less than or equal to 4 cm, 0 to 3 positive axillary nodes, and negative inked surgical margins were entered prospectively into BRT phase I/II trial. Patients who met the eligibility criteria for BRT but were treated with ERT during the same time period were retrospectively identified as controls. A blinded panel of healthcare professionals graded cosmetic outcome. RESULTS Fifty patients with 51 breast cancers received BRT from January 1992 to October 1993. We identified 94 patients eligible for BRT but concurrently treated with ERT. At a median follow-up of 75 months, the two groups were similar for grade III treatment toxicities, local/regional recurrence rates, and cosmesis scores. CONCLUSIONS For selected breast cancer patients undergoing breast-conserving therapy, BRT is an attractive alternative to ERT.

Initial clinical experience with the MammoSite breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy.

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.

RTOG 95-17, a Phase II trial to evaluate brachytherapy as the sole method of radiation therapy for Stage I and II breast carcinoma—year-5 toxicity and cosmesis

PURPOSE Radiation Therapy Oncology Group (RTOG) 95-17, a Phase II trial to evaluate multicatheter brachytherapy (mCathBrachy) as the sole method of radiation therapy for Stage I-II breast cancer (BrCa), was the first cooperative group trial in North America to evaluate accelerated partial breast irradiation (APBI) and include patient-reported outcomes (PROs). This report presents the year-5 toxicity and cosmesis data. METHODS AND MATERIALS After lumpectomy and axillary dissection for invasive BrCa (tumor size <3cm with zero to three positive lymph nodes), 100 patients (pts), 98 evaluable, were treated (txed) with mCathBrachy from 1997 to 2000 with 34Gy administered twice daily in 10 high-dose-rate fractions or 45Gy in 3.5-6 days as a low-dose-rate implant to 1-2cm beyond the lumpectomy bed. The PROs and physician-reported outcomes of toxicity, cosmesis, and tx satisfaction at year-5 are reported here, defined as data submitted 54-78 months after tx. RESULTS Grade (G) 1-2 skin toxicity developed in 78% of the pts and G3 in 13% (no G4). The tx effects included skin dimpling/indentation (37%), fibrosis (45%), telangiectasias (45%), skin catheter marks (54%), and symptomatic fat necrosis (15%). Breast asymmetry was reported in 73%. Rates of excellent-to-good cosmesis were similar between PROs (66%) and radiation oncologists (68%). The PROs of tx satisfaction at year-5 was 75%. CONCLUSIONS RTOG 95-17 documents the year-5 skin toxicity and tx effects of mCathBrachy APBI, which are associated with PROs of good-to-excellent cosmesis and high tx satisfaction. This emphasizes the importance of PROs when assessing BrCa tx. National Surgical Adjuvant Breast and Bowel Project B39/RTOG 0413 will allow for definitive comparisons between APBI and whole breast radiation therapy.

Postlumpectomy Insertion of the MammoSite Brachytherapy Device Using the Scar Entry Technique: Initial Experience and Technical Considerations

Abstract:  For women undergoing breast‐conserving surgery, recent reports suggest that in selected cases accelerated partial breast irradiation may yield results equal to that of whole breast irradiation. Over 31 months, 19 patients underwent accelerated partial breast irradiation using the MammoSite as the sole radiation treatment following breast‐conserving surgery. Seventeen patients had the MammoSite inserted postoperatively using the scar entry technique (SET). Treatments were delivered using high dose rate iridium 192 given twice a day for 5 days. Three complications (two minor, one major) occurred. Late radiation morbidity and overall cosmetic results were evaluated. Eighty percent of patients had either no change from baseline or slight change in skin pigment. More than 90% had good or excellent overall cosmetic outcomes. Patients undergoing accelerated partial breast irradiation with the MammoSite inserted using SET had excellent overall cosmetic results. Advantages of the SET over intraoperative placement are presented.

Long-term outcome from RTOG 9517: A phase I/II study of accelerated partial breast irradiation (APBI) with mulitcatheter brachytherapy (MCT) following lumpectomy for early-stage breast cancer.

147 Background: Comparison of APBI to whole breast irradiation post lumpectomy for breast conservation is ongoing in phase III trials. However, APBI has gained acceptance in clinical practice despite relatively limited long-term data. RTOG 9517 studied MCT, one of the earliest methods of APBI, and can uniquely provide long-term cancer outcomes. METHODS Eligibility was stage I/II unifocal breast cancer <3cm, invasive non-lobular histology without EIC, negative surgical margins, and 0-3 positive axillary nodes; no extracapsular extension. The target volume was the lumpectomy cavity plus a 2 cm radial and 1 cm ant/post margin. Low Dose Rate (LDR), 45 Gy in 3.5-5 day, or High Dose Rate (HDR) 34 Gy in 10 BID fractions over 5 days was delivered. A rapid dosimetry review was done to assure dose delivery per protocol. Systemic therapy was per physicians discretion. The primary endpoint was HDR and LDR MCT reproducibility. This analysis focuses on ipsilateral breast failure (IBF), contralateral breast cancer events (CBE), regional (RF) and distant failure (DF) (cumulative incidence) disease-free (DFS), relapse-free (RFS), and overall survival (OS), (Kaplan-Meier). RESULTS The median follow up is 12.1 years (yr). 100 patients were accrued from 1997-2000; 98 were evaluable; 65 HDR and 33 LDR MCT. Median age was 62; 88% had T1 tumors; 12% T2; 81% p N0, 19% pN1; 77% ER and/or PR +; 19% ER - and PR -; 33 % received adjuvant chemotherapy and 64% antiendocrine therapy. There have been 6 IBF for a 10 yr rate of 6.2%; 2 IBF were outside the APBI field. There were 5 total RF for a 10 yr rate of 5.2%, respectively. There have been 5 CBE for a 10 yr rate of 4.2%. Failure patterns were: 4 isolated IBF, 1 isolated RF, 8 DF only, 1 IBF+RF, 1 IBF+RF+DF, 1 RF+CBE, 1 RF+DF, 3 CBE, and 1 CBE+DF (21 total failures). Eleven patients have developed DF; 8 have died of breast cancer, 22 have died from other causes. The 10 yr DFS, RFS and OS are 69.8%, 71.9%, and 78.0%, respectively. CONCLUSIONS This multi-institutional phase II trial studying MCT-APBI continues to report durable local regional cancer control rates with long term follow-up. Supported by NCI U10 grants CA21661 and CA37422.