Contralateral Breast Failure Research Articles

Comparative Outcome Analysis of Two Dose Schedules for Post-Mastectomy Radiation Therapy

Prior to 2015, patients at our institution who received radiation therapy following mastectomy with reconstruction were treated to 54Gy to the chest wall without boost (PMRT-noB) or 50-50.4Gy to the chest wall followed by a 10Gy scar boost (PMRT-B) at the discretion of the treating physician. The purpose of this study was to investigate clinical outcomes using these two treatment regimens. We performed a matched-pair analysis to compare patients s/p mastectomy with reconstruction treated with PMRT-noB or PMRT-B at a single institution from 1996-2015. 116 patients (58 pairs) were matched by age (+/- 3y), T-stage, N-stage, chemotherapy (y/n), and ER status. Clinical outcomes were analyzed using t-tests for continuous variables, χ2 for categorical variables, and Kaplan-Meier estimates. P-values <0.05 were significant. Median follow-up for all patients was 6.1y (1.6-14.3y); 7.6y and 4.8y for PMRT-noB and PMRT-B, respectively (p=0.16). Median age at diagnosis was 47y (28-68y). 64% of patients underwent modified radical mastectomy, 34% simple mastectomy, and 2% total mastectomy. 89% of patients had immediate tissue expander reconstruction in a 2-stage process; others were immediate permanent implant, TRAM flap, or latissimus dorsi flap. Median tumor size was 3.2cm (0-18.5cm); 2cm v 2.5cm for PMRT-noB v PMRT-B (p=0.98). There were no statistical differences in menopausal status, histology, margin status, or tumor grade. 41% had neoadjuvant chemo, 57% had adjuvant chemo, and 85% received anti-hormone therapy. More patients in the PMRT-noB group received Herceptin, 29% v 14% (p=0.04). Clinical outcomes were excellent at 5 years and seen in Table 1. There were no differences in LC, LRC, CLBF, DM, DFS, or OS between the groups. Implant loss was 14% in both the PMRT-noB and PMRT-B groups (p=1). Tissue expander loss was higher in the PMRT-B group, 20% v 8%, trending to significance (p=0.07). Infection rates were similar, 14% v 17% in the PMRT-noB v PMRT-B groups (p=0.09). 16% of patients receiving PMRT-noB required surgery due to post-RT toxicity v 12% PMRT-B (p=0.56). No differences were seen in clinical outcomes comparing 54Gy to chest wall v 50-50.4Gy followed by a 10Gy scar boost. Rates of implant/expander loss and infection were similar. Additional analysis of acute and chronic post-RT skin and chest wall toxicities is underway. These data support the use of a lower chest wall dose, which is expected to decrease integral dose to the chest wall, heart, and lungs, while achieving the same clinical outcomes.Abstract TU_12_3433; Table 1Clinical Outcomes at 5 yearsOutcomeAll patients (n=116)PMRT-noB (n=58)PMRT-B (n=58)p-valueLocal Control (LC)98%100%96.5%0.135Locoregional Control (LRC)98%100%96.5%0.152Contralateral Breast Failure (CLBF)0%0%0%0.527Distant Metastasis (DM)12%9%14%0.325Disease Free Survival (DFS)87%91%86%0.428Overall Survival (OS)99%100%98%0.632 Open table in a new tab

Accelerated partial-breast irradiation (APBI) versus whole-breast irradiation (WBI) in treatment of the biological subtypes of breast cancer: An analysis of comparative effectiveness.

45 Background: To assess if partial vs whole breast irradiation (RT) in treatment of the various biological (bio-) subtypes of breast cancer would lead to differing clinical results, a match pair analysis of APBI vs WBI was undertaken. Methods: Between 3/1993 and 9/2013 all breast CA patients (pts) treated at one institute with either APBI or WBI were matched 1:1 by follow-up (FU) +/- 15 yrs, stage and bio-subtype. This yielded 772 pts of whom 640 were luminal A, 42 luminal B, 58 triple neg (TNBC), 6 HER2+, and 26 triple +. Outcomes were analyzed across the various bio-subtypes for all the pts (APBI + WBI), APBI alone and WBI alone. The endpoints assessed were local recurrence (LR), true recurrence/marginal miss (TR/MM), elsewhere failure (EF), regional recurrence (RR), distant metastasis (DM), disease-free survival (DFS), and contralateral breast failure (CLBF). Results: Mean age was 66 (32-94) with a mean FU of 5.2 years (0.1-18.3). Regarding systemic therapy, 75% received endocrine Rx, while chemotherapy was documented in 21%. For all pts (APBI+WBI) there was no significant difference across the various bio-subtypes with respect to 5, 10 and 15 yr actuarial LR, TR/MM, EF, RR, DM, DFS and CLBF. Likewise, for the 386 APBI-alone treated pts, no significant difference was found between the various bio-subtypes for all the same endpoints reported. However, for the 386 WBI pts, a significant difference was seen in the 15-year actuarial LR between luminal A and TNBC (1.5% vs 7.4%, p = 0.007). Significance was also found in the 15-year actuarial DFS between luminal A/B and TNBC (98.0%, 95.2%; 86.0%, respectively, p = 0.009). Conclusions: In comparing partial to whole breast RT across the various biological subtypes of breast CA, APBI is at least as effective as WBI. However, the retrospective nature of this study along with the limited numbers of pts in the HER2+ and triple + subsets are weaknesses which are acknowledged to exist in this dataset. The addition of further pts in all the biological subtypes, particularly the HER2+ and triple + subsets, along with results from randomized trials incorporating biomarker data will be needed to substantiate these findings.

Outcomes after local recurrence following breast-conserving therapy for early-stage breast cancer.

66 Background: Limited data exist for patients who develop local recurrence (LR) following breast conserving therapy (BCT) for early stage breast cancer (ESBC). This study is to evaluate outcomes and predictors of failure following LR in patients treated with BCT. Methods: 1,654 women with ESBC underwent BCT from 1980 – 2013 at a single institution. All patients had breast-conserving surgery followed by whole breast irradiation (WBI) or accelerated partial breast irradiation (APBI). Subset analysis was performed for patients who developed LR as a first event. Clinical outcomes analyzed include contralateral breast failure (CLBF), regional recurrence (RR), distant metastases (DM), cause-specific survival (CSS), and overall survival (OS). Continuous variables were analyzed with an independent samples t-test and categorical variables with χ2. Univariate analysis was performed to determine factors predictive for events after LR. Results: 112 (7%) patients developed LR (87 WBI; 25 APBI), with median time to LR of 6.6 yrs (0.1-28). Median follow-up for the LR group was 14 yrs (0.7-31) overall; 10 (0.7-19) and 16 yrs (1.4-31) for APBI and WBI, respectively (p=0.01). A change from initial to LR pathology was seen for: ER status 21%, PR status 25%, HER2 status 13%, grade 38%, histology 40%, and LVSI 38%. Salvage treatment following LR was mastectomy ± chemotherapy (CHT) in 75%, wide local excision ± RT in 19%, CHT in 2%, and other in 4%. Outcomes following salvage treatment for LR are shown in the table. No differences were seen in outcomes between patients treated with APBI v WBI. Univariate analysis failed to demonstrate any factors predictive for events following LR. Conclusions: Patients who developed LR following BCT for ESBC had excellent clinical outcomes at 5 and 10 yrs, demonstrating effective salvage treatment in this cohort of patients. No differences were noted between patients undergoing APBI v WBI. Further identification of histopathologic patterns between first cancer and LR is currently underway. [Table: see text]

Outcomes of African American Women Undergoing APBI for Early-Stage Breast Cancer: A Matched Pair Analysis

There are little data evaluating outcomes with the use of APBI for breast conservation therapy in African American women. This matched pair analysis compares the long-term outcomes of African American versus white women who underwent APBI at our institution. One hundred fifty-six patients with DCIS (33%) or stage I/II invasive breast cancer (77%) who underwent APBI at our institution between 1993 and 2013 were included in this matched pair analysis. 39 African American and 117 white patients underwent a 1:3 match according to age (+/- 5 years), T-stage (Tis vs T1 vs T2), and estrogen receptor (ER) status (+/-). Clinical outcomes were compared using the Kaplan-Meier method. The median follow-up was 76 months. All patients received 34 Gy (brachytherapy) or 38.5 Gy (3D-CRT) in 10 B.I.D fractions. No significant differences were seen in tumor size, age at diagnosis, T-stage, N-stage, grade, margin status, ER/PR/HER 2 status, treatment type (interstitial, balloon-based, or 3D-CRT), adjuvant chemotherapy, or use of adjuvant hormone therapy by race (all P > 0.05). Local recurrence was higher for African American compared to white, with 5-year rate of 7.9% vs 1.1% (p = 0.03). Regional recurrence was also higher in African American, with 5-year rate of 5.8% vs 0% (p = 0.02). The 5-year contralateral breast failure and distant metastasis rates were 0% vs 0% (p = 0.6) and 2.7% vs 2.0% (p = 0.99), respectively. At 5 years, there were no statistically significant differences in OS (93% vs 88%, p = 0.27), CSS (96% vs 99%, p = 0.20), or DFS (92% vs 97%, p = 0.16) between the African American and white patients, respectively. On univariate analysis, age (p = 0.034) and tumor size (p = 0.025) were predictive for IBTR while nodal status (p = 0.049) and grade (p = 0.027) were predictive for regional recurrence in African American patients. No factors were predictive for white patients. On multivariate analysis, tumor size (p = 0.045) and age (p = 0.024) remained independent predictors of IBTR for African American patients. Our results show similar overall, cause-specific, and disease-free survival for African American patients undergoing APBI for breast conservation compared to matched White counterparts. In this small matched cohort, there was increased risk of locoregional recurrence in the African American patients and further study is needed to explore the biological, molecular, socioeconomic, and treatment related factors accounting for this difference.

Ten-year outcomes of accelerated partial breast irradiation compared with whole breast irradiation: A matched-pair analysis.

55 Background: Breast conserving therapy (BCT) represents a standard of care in the management of early stage breast cancer; while adjuvant radiation therapy was traditionally delivered using whole breast irradiation (WBI), accelerated partial breast irradiation (APBI) offers an alternative to WBI that shortens the duration of treatment and may improve toxicity profiles and quality of life. The purpose of this analysis is to compare clinical outcomes of patients treated with WBI versus APBI. Methods: A total of 3,009 patients were treated with BCT at single institution between 1980 and 2012 with 2,528 patients receiving WBI and 481 patients receiving APBI (interstitial or balloon-based). A matched-pair analysis was performed with patients matched according to age (+/- 3 years), T stage (Tis vs T1 vs T2), and estrogen receptor (ER) status (+/-). All patients had a minimum of 12 months of follow up. A total of 247 matches were made with clinical outcomes compared using the Kaplan-Meier method. Results: Mean follow-up was 8.1 years for WBI vs. 7.8 years for APBI (p&lt;0.001), a difference of less than 4 months. There were no differences with respect to age (p=0.88), tumor stage (p=1.0), or ER status (p=1.0). Long-term cosmesis was good to excellent in 94% vs. 95% of patients (p=0.78). WBI patients demonstrated a trend for slightly larger tumors (13.0 vs. 11.4 mm, p=0.06). At 10 years, no difference in ipsilateral breast tumor recurrence (4% vs. 4%, p=0.11), regional recurrence (1% vs. 1%, p=0.20), distant metastases (3% vs. 6%, p=0.47), disease free survival (93% vs. 91%, p=0.10), or contralateral breast failure (9% v. 3%, p=0.06) was noted when comparing WBI and APBI. In addition, 10 year cause-specific survival (94% v. 93%, p=0.72) and overall survival (83% vs. 75%, p=0.34) were similar. Conclusions: At 10 years, no differences in locoregional recurrence, distant metastasis or survival were found between patients undergoing whole breast irradiation or accelerated partial breast irradiation using interstitial catheter or balloon-based brachytherapy. These data represent one of the only APBI series with prolonged follow-up and show similar outcomes in a matched group of patients undergoing WBI or APBI.

Four-year clinical update from a prospective trial of accelerated partial breast intensity-modulated radiotherapy (APBIMRT)

This prospective Phase II single-arm study gathered data on the use of intensity-modulated radiotherapy (IMRT) to deliver accelerated partial breast irradiation (APBI). Four-year efficacy, cosmesis, and toxicity results are presented. Between February 2004 and September 2007, 136 consecutive patients with Stage 0/I breast cancer and negative margins ≥0.2 cm were treated on protocol. Patients received 38.5 Gy in 10 equal fractions delivered twice daily. Breast pain and cosmesis were rated by patient, and cosmesis was additionally evaluated by physician per Radiation Therapy Oncology Group (RTOG) criteria. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) was used to grade toxicities. 136 patients (140 breasts) with median follow-up of 53.1 months (range, 8.9–83.2) were evaluated. Population characteristics included median age of 61.9 years and Tis (13.6 %), T1a (18.6 %), T1b (36.4 %), and T1c (31.4 %). Kaplan–Meier estimates at 4 years: ipsilateral breast tumor recurrence 0.7 %; contralateral breast failure 0 %; distant failure 0.9 %; overall survival 96.8 %; and cancer-specific survival 100 %. At last follow-up, patients and physicians rated cosmesis as excellent/good in 88.2 and 90.5 %, respectively; patients rated breast pain as none/mild in 97.0 %. Other observations included edema (1.4 %), telangiectasia (3.6 %), five cases of grade 1 radiation recall (3.6 %), and two cases of rib fractures (1.4 %). This analysis represents the largest cohort and longest follow-up of APBI utilizing IMRT reported to date. Four-year results continue to demonstrate excellent local control, survival, cosmetic results, and toxicity profile.

Prone Accelerated Partial Breast Irradiation After Breast-Conserving Surgery: Five-year Results of 100 Patients

To report the 5-year results of a prospective trial of three-dimensional conformal external beam radiotherapy (3D-CRT) to deliver accelerated partial breast irradiation in the prone position. Postmenopausal patients with Stage I breast cancer with nonpalpable tumors <2 cm, negative margins and negative nodes, positive hormone receptors, and no extensive intraductal component were eligible. The trial was offered only after eligible patients had refused to undergo standard whole-breast radiotherapy. Patients were simulated and treated on a dedicated table for prone setup. 3D-CRT was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days with port film verification at each treatment. Rates of ipsilateral breast failure, ipsilateral nodal failure, contralateral breast failure, and distant failure were estimated using the cumulative incidence method. Rates of disease-free, overall, and cancer-specific survival were recorded. One hundred patients were enrolled in this institutional review board-approved prospective trial, one with bilateral breast cancer. One patient withdrew consent after simulation, and another patient elected to interrupt radiotherapy after receiving two treatments. Ninety-eight patients were evaluable for toxicity, and, in 1 case, both breasts were treated with partial breast irradiation. Median patient age was 68 years (range, 53-88 years); in 55% of patients the tumor size was <1 cm. All patients had hormone receptor-positive cancers: 87% of patients underwent adjuvant antihormone therapy. At a median follow-up of 64 months (range, 2-125 months), there was one local recurrence (1% ipsilateral breast failure) and one contralateral breast cancer (1% contralateral breast failure). There were no deaths due to breast cancer by 5 years. Grade 3 late toxicities occurred in 2 patients (one breast edema, one transient breast pain). Cosmesis was rated good/excellent in 89% of patients with at least 36 months follow-up. Five-year efficacy and toxicity of 3D-CRT delivered in prone partial breast irradiation are comparable to other experiences with similar follow-up.

3-Year Follow-Up of the Partial Breast Irradiation Trial for DCIS Using the MammoSite® Brachytherapy Balloon Catheter.

Abstract Purpose: To report the 3-year median follow-up of a prospective Phase II partial breast irradiation (PBI) trial utilizing the MammoSite® interstitial balloon as the sole radiation therapy treatment after lumpectomy for ductal carcinoma in situ (DCIS).Materials and Methods: One hundred and thirty-three patients were enrolled from May 2003 through January 2006 to reach the 100-patient partial breast irradiation (PBI) target goal of 34 Gy in 10 fractions, 1 cm peripheral to the MammoSite® balloon surface, b.i.d. with Iridium192 HDR brachytherapy. The eligibility criteria were age 45, unicentric pure DCIS, mammographic size ≤3cm, negative margin of ≥1 mm, gross pathology size ≤5 cm, clinically node negative, post-lumpectomy mammogram absent of residual microcalcificaion. A USC/VNPI score was then calculated based on age, tumor size, margin width, and nuclear grade [ref: Silverstein MJ, Am J Surg 2003;186(4):337-343]. Placement of the balloon was performed at the time of lumpectomy or post-lumpectomy with a required minimum distance of the balloon surface to skin (skin bridge) of 5 mm. Data was collected at enrollment, at implant, 3 and 6-months, then yearly for local control, cosmesis (Harvard Scale), toxicity, adverse events, disease-free survival, cause-specific survival, and contralateral breast failure. Local recurrence is defined as either invasive or non-invasive within the target volume. Ipsilateral elsewhere recurrence (IER) is defined as invasive or non-invasive outside of the target volume.Results: Of the 133 patients enrolled, thirty-three were not treated for the following reasons: less than 5 mm skin bridge (n=13), poor cavity conformance (n=10), positive margin (n=3), microinvasion (n=3), MD decision (n=2), patient request (1), and other (1). The nuclear grade distribution of the tumors were: NG1(17%), NG2(44%), and NG3(39%). The mean age was 60.8 years. The mean tumor size was 10.6 mm; mean closest surgical margin was 6.8 mm (R=0.1-40mm); post-lumpectomy placement in 72%; mean skin bridge distance was 13 mm with 89% ≥7mm. No patients have been lost to follow-up, and at a median 3-year follow-up, the cosmetic results have been rated as excellent/good in 94 and fair in 6 patients. There have been only four recurrences, all non-invasive with the following histological patterns listed in the table below. One was an IER.Recurrence DetailsCase No.Months Since PlacementInvasiveUSC/VNPI ScoreOriginal Tumor GradeComedo Necrosis18No93Yes211No83No317No62Yes432No52Yes No serious adverse events were reported with an infection rate of 9% (7 breast infections; 2 cellulitis).Conclusion: This is the longest reported prospective Phase II study using a PBI technique for pure DCIS patients, and continues to demonstrate the efficacy of the MammoSite® balloon for treating pure DCIS breast tumors, with no new recurrences since our last report at SABCS 2007. All the recurrences were noninvasive, and had at least one or more risk factors of a high USC/VNPI score, high nuclear tumor grade, or had a comedo necrosis pattern. There have been no recurrences in nuclear grade 1 or 2 patients in the absence of a comedo necrosis pattern. The cosmesis also continues to be excellent or good long-term in 96% patients. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 952.

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.

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.

Changes in temporal patterns of local failure after breast-conserving therapy and their prognostic implications

Purpose The purpose of this analysis was to evaluate patterns and rates of ipsilateral breast tumor recurrence (IBTR) over time based on the type of failure (true recurrence/marginal miss [TR/MM] vs. elsewhere [E]) and to compare these to rates of contralateral failure in women with Stages I/II breast cancer treated with conservative surgery (CS) and radiation therapy (RT). Methods and materials Between 1980 and 1997, 1448 patients with Stages I/II invasive breast carcinoma were treated with CS and RT to a median total dose of >60 Gy. IBTRs were analyzed in terms of their location as follows: TR/MM, referring to those occurring in the same quadrant, and E, referring to the development of a malignancy remote from the index lesion. Outcomes were characterized in terms of their temporal recurrence patterns and correlated with rates of contralateral breast failure (CL). The median follow-up was 8.5 years. Results A total of 79 ipsilateral and 98 contralateral failures were observed during the follow-up period corresponding to 5-, 10-, and 15-year actuarial rates of 2%, 7%, and 10% and 4%, 9%, and 12% respectively. Fifty-nine ipsilateral failures (74.7%) were designated as TR/MM and 20 (25.3%) as E. The corresponding 5-, 10-, and 15-year actuarial rates of TR/MM and E failures were 2%, 5%, and 8% and 0.1%, 2%, and 3%, respectively. The median times to total ipsilateral, TR/MM, E, and contralateral failure were 6.5, 5.7, 7.4, and 5.2 years, respectively. Between 0 and 5 years of follow-up, E failures represented 7% of the total ipsilateral failures observed. From 5–10 and 10–15 years, E failures represented 39% and 27% of the total, respectively ( p = 0.01). Contralateral failure was significantly more likely to occur in the first 5 years of follow-up than IBTR, accounting for 50 (63.3%) of the 79 failures in that interval ( p = 0.02). No significant differences in survival rates were detected between any of the various failure types. On multivariate analysis, only reduced time to tumor recurrence was found to be adversely associated with overall survival. Conclusions The rates and patterns of IBTR vary with time and, after 5 years, approach the rates of development of a contralateral breast cancer. E failures are, overall, less frequent than TR/MM but contribute increasingly to the IBTR rate after 5 years. Time to tumor recurrence is the most reliable predictor of prognosis after IBTR.