An open invitation to join the Pediatric Proton/Photon Consortium Registry to standardize data collection in pediatric radiation oncology.

OBJECTIVE: The Pediatric Proton/Photon Consortium Registry (PPCR) is a comprehensive data registry composed of pediatric patients treated with radiation. It was established to expedite outcomes-based research. The attributes which allow the PPCR to be a successful collaboration are reviewed. METHODS AND MATERIALS: Current eligibility criteria are radiotherapy patients < 22 years treated at one of the 15 US participating institutions. Detailed health and treatment data are collected about the disease presentation and treatment exposures, and annually thereafter, in REDCap (Research Electronic Data Capture). DICOM (Digital Imaging and Communications in Medicine) imaging and radiation plans are collected through MIM/MIMcloud. An optional patient-reported quality-of-life (PedsQL) study is administered at 10 sites. RESULTS: Accrual started October 2012 with 2,775 participants enrolled as of 25 July 2019. Most patients, 62.0%, were treated for central nervous system (CNS) tumors, the most common of which are medulloblastoma (n = 349), ependymoma (n = 309), and glial/astrocytoma tumors (n = 279). The most common non-CNS diagnoses are rhabdomyosarcoma (n = 284), Ewing's sarcoma (n = 153), and neuroblastoma (n = 130). While the majority of participants are US residents, 18.7% come from 36 other countries. Over 685 patients participate in the PedsQL study. CONCLUSIONS: The PPCR is a valuable research platform capable of answering countless research questions that will ultimately improve patient care. Centers outside of the USA are invited to participate directly or may engage with the PPCR to align data collection strategies to facilitate large-scale international research. ADVANCES IN KNOWLEDGE: For investigators looking to carry out research in a large pediatric oncology cohort or interested in registry work, this paper provides an updated overview of the PPCR.

Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol.

INTRODUCTION: A broad range of stakeholders have called for randomised evidence on the potential clinical benefits and harms of proton therapy, a type of radiation therapy, for patients with breast cancer. Radiation therapy is an important component of curative treatment, reducing cancer recurrence and extending survival. Compared with photon therapy, the international treatment standard, proton therapy reduces incidental radiation to the heart. Our overall objective is to evaluate whether the differences between proton and photon therapy cardiac radiation dose distributions lead to meaningful reductions in cardiac morbidity and mortality after treatment for breast cancer. METHODS: We are conducting a large scale, multicentre pragmatic randomised clinical trial for patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes. A total of 1278 patients with non-metastatic breast cancer will be randomly allocated to receive either photon or proton therapy. The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease. Secondary endpoints are urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease. The Radiotherapy Comparative Effectiveness (RadComp) Clinical Events Centre will conduct centralised, blinded adjudication of primary outcome events. ETHICS AND DISSEMINATION: The RadComp trial has been approved by the institutional review boards of all participating sites. Recruitment began in February 2016. Current version of the protocol is A3, dated 08 November 2018. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets. TRIAL REGISTRATION NUMBER: NCT02603341.

Minimal toxicity after proton beam therapy for prostate and pelvic nodal irradiation: results from the proton collaborative group REG001-09 trial.

BACKGROUND: Proton beam therapy (PBT) reduces normal organ dose compared to intensity modulated radiation therapy (IMXT) for prostate cancer patients who receive pelvic radiation therapy. It is not known whether this dosimetric advantage results in less gastrointestinal (GI) and genitourinary (GU) toxicity than would be expected from IMXT. MATERIAL AND METHODS: We evaluated treatment parameters and toxicity outcomes for non-metastatic prostate cancer patients who received pelvic radiation therapy and enrolled on the PCG REG001-09 trial. Patients who received X-ray therapy and/or brachytherapy were excluded. Of 3210 total enrolled prostate cancer patients, 85 received prostate and pelvic radiation therapy exclusively with PBT. Most had clinically and radiographically negative lymph nodes although 6 had pelvic nodal disease and one also had para-aortic involvement. Pelvic radiation therapy was delivered using either 2 fields (opposed laterals) or 3 fields (opposed laterals and a posterior beam). Median pelvic dose was 46.9 GyE (range 39.7-56) in 25 fractions (range 24-30). Median boost dose to the prostate +/- seminal vesicles was 30 GyE (range 20-41.4) in 16 fractions (range 10-24). RESULTS: Median follow-up was 14.5 months (range 2.8-49.2). Acute grade 1, 2, and 3 GI toxicity rates were 16.4, 2.4, 0%, respectively. Acute grade 1, 2, and 3 GU toxicity rates were 60, 34.1, 0%, respectively. CONCLUSIONS: Prostate cancer patients who receive pelvic radiation therapy using PBT experience significantly less acute GI toxicity than is expected using IMXT. Further investigation is warranted to confirm whether this favorable acute GI toxicity profile is related to small bowel sparing from PBT.

Seven-Year Outcomes Following Accelerated Partial Breast Irradiation Stratified by ASTRO Consensus Groupings.

OBJECTIVES: Limited long-term data exist regarding outcomes for patients treated with accelerated partial breast irradiation (APBI), particularly, when stratified by American Society for Radiation Oncology (ASTRO) Consensus Statement (CS) risk groups. The purpose of this analysis is to present 5- and 7-year outcomes following APBI based on CS groupings. MATERIALS AND METHODS: A total of 690 patients with early-stage breast cancer underwent APBI from 1993 to 2012, receiving interstitial brachytherapy (n=195), balloon-based brachytherapy (n=290), or 3-dimensional conformal radiotherapy (n=205) at a single institution. Patients were stratified into suitable, cautionary, and unsuitable groups with 5-year outcomes analyzed. Seven-year outcomes were analyzed for a subset with follow-up of ≥2 years (n=625). RESULTS: Median follow-up was 6.7 years (range, 0.1 to 20.1 y). Patients assigned to cautionary and unsuitable categories were more likely to have high-grade tumors (21% to 25% vs. 9%, P=0.001), receive chemotherapy (15% to 38% vs. 6%, P<0.001), and have close/positive margins (9% to 11% vs. 0%, P<0.001). There was no difference in ipsilateral breast tumor recurrence at 5 or 7 years: 2.2%, 1.2%, 2.8% at 5 years (P=0.57), and 2.2%, 1.9%, 4.6% at 7 years (P=0.58) in the suitable, cautionary, and unsuitable groups, respectively. As compared with the suitable group, increased rates of distant metastases were noted for the unsuitable and cautionary groups at 5 years (P=0.04). CONCLUSIONS: No differences in rates of ipsilateral breast tumor recurrence were seen at 5 or 7 years when stratified by ASTRO CS groupings. Modest increases in distant recurrence were noted in the cautionary and unsuitable groups. These findings suggest that the ASTRO CS groupings stratify more for systemic recurrence and may not appropriately select patients for whole versus partial breast irradiation.

Outcomes According to Breast Cancer Subtype in Patients Treated With Accelerated Partial Breast Irradiation.

BACKGROUND: The purpose of the study was to determine outcomes for patients treated with accelerated partial breast irradiation (APBI) on the basis of breast cancer subtype (BCST). PATIENTS AND METHODS: Our single-institution, institutional review board-approved APBI database was queried for patients who had complete testing results for the estrogen (ER), progesterone (PR), and HER2/neu receptors to determine outcomes for each BCST. Women were assigned as luminal A (LA), luminal B (LB), HER2, and basal BCST using their ER, PR, and HER2/neu receptor status. Degree of ER expression supplemented the receptor-based luminal BCST assignment. Two hundred seventy-eight patients had results for all 3 receptors (LA = 164 [59%], LB = 81 [29%], HER2 = 5 [2%], basal = 28 [10%]), which were submitted for analysis (ipsilateral breast tumor recurrence [IBTR], regional nodal failure, distant metastasis [DM], disease-free survival [DFS], cause-specific survival [CSS], and overall survival [OS]). RESULTS: Median follow-up was 5.4 years (range, 0.1-12.4 years). Basal and HER2 subtype patients had higher histologic grades (Grade 3 = 75% vs. 10% LA/LB; P < .001), larger tumors (13.0 mm basal vs. 10.7 mm LA/LB; P = .059), and were more likely to receive chemotherapy (68% vs. 15% LA/LB; P < .001). Margin and nodal status were similar among BCSTs. At 5 years, IBTR rates were similar (1.8%, 2.9%, 0%, and 4.8%) for LA, LB, HER2, and basal subtypes, respectively (P = .62). DM was only seen in LA (2.9%) and LB (1.3%) (P = .83). DFS (95%-100%), CSS (97%-100%), and OS (80%-100%) were not statistically different (P = .97, .87, .46, respectively). CONCLUSION: Five-year local control rates after breast-conserving surgery, APBI, and appropriate systemic therapy are excellent for luminal, HER2, and basal phenotypes of early-stage breast cancer; however, further study of receptor subtype effect on risk stratification in early-stage breast cancer is needed.

Management of solitary and multiple brain metastases from breast cancer.

As local and systemic control of breast cancer improves, metastasis to the brain remains a common event requiring a specialized management approach. Women diagnosed with breast cancer who develop brain metastases have superior overall survival compared to patients with other forms of metastatic carcinoma. This article summarizes some of the unique aspects of care for patients with breast cancer metastases to the brain.

Dosimetric evaluation of target coverage as a predictor of local failure following stereotactic body radiation therapy for spinal tumors.

PURPOSE: To perform a dosimetric analysis of target coverage and determine parameters predictive for local failure (LF) in patients undergoing spinal stereotactic body radiation therapy (sSBRT).Materials and Methods: Sixty-seven spinal tumors in 59 patients were treated with image-guided linac-based sSBRT from 2008-2012. Median prescription dose was 18Gy (8-35) delivered in 1-5 fractions (87% single-fraction). Prescription dose was targeted to cover ≥ 80% of PTV within spinal cord (SC) dose constraints (9/11Gy to 0.1cc SC/SC+2mm). Twelve tumors had local failure (LF, median time-to-failure 3.7 months) and were compared to 14 tumors with >1-year follow-up and local control (LC). Univariate and multivariate analyses were performed to determine parameters predictive of LF. RESULTS: Median follow-up was 7.4 months and 24.7 months for LF and LC, respectively. Post-SBRT, 42% of LF patients had neurological symptoms due to tumor progression. No patients developed post-SBRT myelopathy. Pre-treatment PTV volumes were not statistically different (median/mean/range 61.8/74.5/19.9-206.4cc for LF vs 39.4/47.1/10.3-119.7cc for LC; p=0.13). LF tumors had larger volumes receiving <80% of prescription dose (5.2cc vs 1.9cc, p=0.02) and larger overlap volume between GTV/SC within 2 and 3mm (p=0.01/p=0.007). LF tumors had lower GTV minimum dose (5.6 vs 8.5Gy, p=0.001) and smaller GTV to SC distance (0.06 vs 0.19mm, p=0.049). Maximum SC doses were not statistically different (6.4Gy LC vs 9.2Gy LF, p=0.33). GTV minimum dose was predictive of LF, with a trend for overlapping GTV/SC volume within 2mm. CONCLUSIONS: Minimum GTV dose, PTV volume receiving <80% prescription dose, smaller GTV-SC distance, and large overlapping volume of PTV/SC are predictive of LF after SBRT. Given the absence of SC toxicity but neurological progression upon LF, less conservative SC constraints should be considered.

Impact of the number of cautionary and/or unsuitable risk factors on outcomes after accelerated partial breast irradiation.

PURPOSE: To examine clinical outcomes of accelerated partial-breast irradiation (APBI) stratified by the number of American Society for Radiation Oncology consensus statement cautionary/unsuitable risk factors (RFs) present. METHODS AND MATERIALS: A total of 692 patients were treated with APBI at a single institution between April 1993 and January 2012 using interstitial (n=195), balloon (n=292), and 3-dimensional conformal radiation therapy (n=205) techniques. Clinical outcomes were evaluated by risk group and number of RFs. RESULTS: Median follow-up was 5.2 years (range, 0-18.3 years). Most patients were classified as suitable (n=240, 34%) or cautionary (n=343, 50%) risk, whereas 16% (n=109) were unsuitable. In patients with increasing total RFs (1 RF, 2 RF, 3+ RF), higher rates of grade 3 histology (10% vs 18% vs 32%, P<.001), estrogen receptor negativity (0 vs 12% vs 29%, P<.001), close/positive margins (0 vs 6% vs 17%, P<.001), and use of adjuvant chemotherapy (3% vs 12% vs 33%, P<.001) were noted. When pooling cautionary and unsuitable patients, increased ipsilateral breast tumor recurrence/regional recurrence was most notable for patients with 3 or more combined RFs versus 2 or fewer combined RFs (P<.001). CONCLUSIONS: Patients with 3 or more cautionary or unsuitable RFs may be at risk for higher local, regional, and distant recurrence after breast-conserving therapy using APBI. Patients with 2 or fewer total RFs have 98% locoregional control at 5 years. Inclusion of total number of RFs in future risk stratification schemes for APBI may be warranted.

Brachytherapy-based partial breast irradiation is associated with low rates of complications and excellent cosmesis.

BACKGROUND: Recent retrospective, claims-based analyses have suggested a potential increased rate of toxicities associated with brachytherapy-based accelerated partial breast irradiation (APBI). The purpose of this analysis was to examine cosmesis and toxicity data from the prospective American Society of Breast Surgeons (ASBS) breast brachytherapy registry trial to compare to the findings from the claims analyses. METHODS: The ASBS breast brachytherapy registry is a prospective nonblinded multi-institutional registry trial. Patients with Stage 0-II breast cancer undergoing breast conserving therapy were eligible. A total of 1665 patients were enrolled and 1449 treated between 2002 and 2004 with a median followup of 63 months. All patients were treated with the MammoSite (Hologic, Inc.) single-lumen device to deliver adjuvant APBI (34Gy in 3.4Gy fractions). RESULTS: The rate of excellent/good cosmesis was 90.6% at 84 months. The rate of a complication (symptomatic seroma, infection, fat necrosis, telangiectasias) at 1 year/any time point was 24.2%/38.5%, whereas the rate of noninfectious complications at 1 year/any time point was 14.8%/28.9%. The rate of symptomatic seroma, fat necrosis, infection, and telangiectasia at any time was 13.4%, 2.5%, 9.6%, and 13.0%, respectively. CONCLUSIONS: The final toxicity analysis from ASBS breast brachytherapy registry trial confirms the previously noted excellent cosmesis and toxicity profiles and fails to confirm retrospective claims analyses that have suggested higher rates of toxicity for brachytherapy-based APBI.

Cost-efficacy of acceleration partial-breast irradiation compared with whole-breast irradiation.

The purpose of this study was to analyze the cost-efficacy of multiple accelerated partial-breast irradiation (APBI) techniques compared with whole breast irradiation (WBI) delivered utilizing 3-dimensional conformal radiotherapy (3D-CRT) and intensity-modulated radiation therapy (IMRT). A previously reported matched-pair analysis consisting of 199 patients receiving WBI and 199 patients receiving interstitial APBI formed the basis of this analysis. Cost analyses included a cost minimization analysis, incremental cost- effectiveness ratio (ICER) analysis, and cost per quality adjusted life year (QALY) analysis. Per 1,000 patients treated, the cost savings with the utilization of APBI compared to WBI IMRT is $14.9 million, $10.9 million, $8.8 million, $5.0 million, and $9.7 million for APBI 3D-CRT, APBI IMRT, APBI single-lumen (SL), APBI multi-lumen (ML), and APBI interstitial, respectively. Per 1,000 patients treated, the cost savings with the utilization of APBI compared to WBI 3D-CRT is $6.0 million, $2.0 million, and $0.7 million for APBI 3D-CRT, APBI IMRT, and APBI interstitial, respectively. The cost per QALY for APBI SL, APBI ML, and APBI interstitial compared with APBI 3D-CRT are $12,273, $66,032, and $546, respectively. When incorporating non-medical costs and cost of recurrences the cost per QALY was $54,698 and $49,009 for APBI ML compared with APBI 3D-CRT. When compared to WBI IMRT, all APBI techniques are cost-effective based on cost minimization, ICER, and QALY analyses. When compared to WBI 3D-CRT, external beam APBI techniques represent a more cost-effective approach based on cost minimization with brachytherapy representing a cost-effective approach based on cost per QALY.

Impact of margin status on outcomes following accelerated partial breast irradiation using single-lumen balloon-based brachytherapy.

PURPOSE: To examine the impact of margin status on clinical outcomes for patients enrolled in the American Society of Breast Surgeons (ASBrS) MammoSite(®) Registry Trial. METHODS AND MATERIALS: One thousand four hundred forty-nine cases of early-stage breast cancer underwent breast-conserving therapy with a single-lumen balloon-based applicator used to deliver adjuvant accelerated partial breast irradiation (34Gy in 10, bid fractions). One thousand two hundred fifty-five cases (87%) had invasive breast cancer (median size=10mm) and 194 cases (13%) had ductal carcinoma in situ (DCIS; median size=8mm). RESULTS: Patients were stratified by margin status into negative (n=1326), close (<2mm; n=110), and positive (n=13) margins. One hundred twenty-three cases (8.5%) had close or positive margins. Overall, no statistical difference in the 6-year rate of ipsilateral breast tumor recurrence (IBTR) was noted for close margins compared with that of margin-negative patients (8.7% vs. 4.1%, p=0.10) or for positive margins compared with that of margin-negative patients (14.3% vs. 4.1%, p=0.41). In patients with DCIS, there was a statistically significant increase in IBTR with close margins (17.6% vs. 4.2%, p=0.004) and when close and positive margins were pooled (15.7% vs. 4.2%, p=0.01 with a nonsignificant reduction in disease-free survival for DCIS patients with close margins (82.4% vs. 90.8%, p=0.12). The increase in IBTR for close and close/positive patients was secondary to statistically significant increases in elsewhere failures rather than true recurrences/marginal misses. CONCLUSION: Nonsignificant increases in the rates of IBTR were noted with close and positive margins for invasive cancer with further data required to validate these findings.

Five-year outcomes and toxicities using 3-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation.

BACKGROUND: Limited 5-year data exist on clinical outcomes and toxicities for patients undergoing 3-dimensional conformal radiation therapy (3D-CRT) APBI. PATIENTS AND METHODS: Two hundred five patients were treated with 3D-CRT APBI between August, 2000 and December, 2011. Cases with > 1 year of follow-up were analyzed for cosmesis, chronic toxicities, and clinical outcomes. Outcome by American Society for Radiation Oncology (ASTRO) Consensus Panel (CP) group were also compared. Rates of excellent and good cosmesis for 3D-CRT were evaluated over time for stability. RESULTS: One hundred ninety-two patients were evaluated; median follow-up was 4.8 years (range, 1.0-11.2 years). Seventy-two patients (37.5%) were categorized as ASTRO CP subgroup 'suitable,' 89 (46.4%) 'cautionary,' and 31 (16.1%) 'unsuitable.' At 5 years, the rate of IBTR, regional recurrence, distant metastases, cause-specific survival, and overall survival were 0%, 0%, 2%, 99%, and 92%, respectively. Thirty-seven percent of patients had excellent cosmesis, 44% good cosmesis, 15% fair cosmesis, and 4% poor cosmesis. No statistically significant differences in excellent (37% vs. 37%; P = .99) or good (49% vs. 37%; P = .28) cosmesis were noted between patients with < 5 years follow-up and those with ≥ 5 years follow-up. The rates of grade III fibrosis and telangiectasia were 7.5% and 7.6%, respectively. CONCLUSION: In the largest group of patients published to date using 3D-CRT to deliver APBI, no local recurrences were noted at 5 years. More than 80% of patients had excellent or good cosmesis.

Evaluation of current consensus statement recommendations for accelerated partial breast irradiation: a pooled analysis of William Beaumont Hospital and American Society of Breast Surgeon MammoSite Registry Trial Data.

PURPOSE: To determine whether the American Society for Radiation Oncology (ASTRO) Consensus Statement (CS) recommendations for accelerated partial breast irradiation (APBI) are associated with significantly different outcomes in a pooled analysis from William Beaumont Hospital (WBH) and the American Society of Breast Surgeons (ASBrS) MammoSite® Registry Trial. METHODS AND MATERIALS: APBI was used to treat 2127 cases of early-stage breast cancer (WBH, n=678; ASBrS, n=1449). Three forms of APBI were used at WBH (interstitial, n=221; balloon-based, n=255; or 3-dimensional conformal radiation therapy, n=206), whereas all Registry Trial patients received balloon-based brachytherapy. Patients were divided according to the ASTRO CS into suitable (n=661, 36.5%), cautionary (n=850, 46.9%), and unsuitable (n=302, 16.7%) categories. Tumor characteristics and clinical outcomes were analyzed according to CS group. RESULTS: The median age was 65 years (range, 32-94 years), and the median tumor size was 10.0 mm (range, 0-45 mm). The median follow-up time was 60.6 months. The WBH cohort had more node-positive disease (6.9% vs 2.6%, P<.01) and cautionary patients (49.5% vs 41.8%, P=.06). The 5-year actuarial ipsilateral breast tumor recurrence (IBTR), regional nodal failure (RNF), and distant metastasis (DM) for the whole cohort were 2.8%, 0.6%, 1.6%. The rate of IBTR was not statistically higher between suitable (2.5%), cautionary (3.3%), or unsuitable (4.6%) patients (P=.20). The nonsignificant increase in IBTR for the cautionary and unsuitable categories was due to increased elsewhere failures and new primaries (P=.04), not tumor bed recurrence (P=.93). CONCLUSIONS: Excellent outcomes after breast-conserving surgery and APBI were seen in our pooled analysis. The current ASTRO CS guidelines did not adequately differentiate patients at an increased risk of IBTR or tumor bed failure in this large patient cohort.

Outcome after ipsilateral breast tumor recurrence in patients with early-stage breast cancer treated with accelerated partial breast irradiation.

PURPOSE: Limited outcomes exist in patients who develop an ipsilateral breast tumor recurrence (IBTR) after accelerated partial breast irradiation (APBI). The purpose of this study was to evaluate these outcomes and patterns of failure in our cohort of patients undergoing APBI. METHODS AND MATERIALS: A total of 534 patients with early-stage breast cancer were treated with APBI between 1993 and 2010. Clinical, pathologic, and treatment-related variables were analyzed. Clinical outcomes, including further IBTR, regional recurrence, disease-free survival, cause-specific survival, and overall survival were analyzed. RESULTS: Eighteen (3.3%) patients developed an IBTR, for a 5-year actuarial rate of 2.0%; 14 (77.8%) of the recurrences were thought to represent new primary cancers. After IBTR, 13 (72.2%) patients were managed with salvage mastectomy and 4 (22.2%) patients with a second attempt at breast-conserving therapy. Five-year rates of disease-free survival, cause-specific survival, and overall survival after salvage mastectomy for IBTR were 81%, 100%, and 100%, respectively. In the 4 patients treated with a second attempt at breast-conserving therapy, no IBTR, axillary failure, regional recurrence, or distant metastases were noted at 5 years. CONCLUSIONS: IBTRs that developed after APBI resulted in excellent clinical outcomes comparable with those observed after whole-breast irradiation.

Failure rate and cosmesis of immediate tissue expander/implant breast reconstruction after postmastectomy irradiation.

BACKGROUND: This study reports the rate of breast reconstruction failure and cosmetic outcomes after postmastectomy radiation therapy (PMRT) with temporary tissue expanders (TEs) or implants in place. PATIENTS AND METHODS: Ninety-four patients underwent mastectomy (93 unilateral, 1 bilateral; 95 cases total) and immediate TE reconstruction followed by PMRT. Ninety TEs and 5 permanent implants were irradiated. All patients received a dose of 5400 cGy given in 180-cGy fractions to the reconstructed breast. Twenty-one patients (22%) received tangents alone and 74 patients (78%) were treated with tangents and a supraclavicular field using a monoisocentric technique. Bolus was used in 91 patients (96%). Eighty-eight patients (93%) received chemotherapy and 78 patients (82%) received endocrine therapy. RESULTS: With a median follow-up of 24.1 months, 19 patients (20%) experienced failure of reconstruction. The 1-, 2-, and 3-year actuarial rate of reconstruction failure was 9.7%, 19.3%, and 25.5%, respectively. Infection was the most common cause of failure. Of the 19 failures, 8 patients underwent salvage procedures with flap reconstruction. Univariate analysis was performed examining age, chemotherapy use, hormone therapy use, use of a supraclavicular field, smoking status, diabetes, hypertension, and menopausal status. No risk factors were found to be associated with reconstruction failure. In patients who did not experience reconstruction failure, good/excellent cosmesis was observed in 75% of patients. CONCLUSION: In the current series of women with a high risk of locoregional recurrence, PMRT with a TE/implant in place provides good cosmesis in the majority of women, with an acceptable risk of expander or implant loss.

Tumor bed control with balloon-based accelerated partial breast irradiation: incidence of true recurrences versus elsewhere failures in the American Society of Breast Surgery MammoSite(®) Registry Trial.

BACKGROUND: Randomized trials demonstrate that lumpectomy plus whole-breast irradiation (WBI) yields survival equivalent to mastectomy. Studies that use WBI, however, typically report higher tumor bed recurrence rates than elsewhere failures (EF) (historically considered new primary lesions). The rate of true recurrence (TR) versus EF was queried for a large patient cohort treated with accelerated partial breast irradiation (APBI). METHODS: A total of 1,449 cases of early-stage breast cancer were treated on the American Society of Breast Surgeons MammoSite(®) Registry Trial with lumpectomy plus balloon-based APBI (34 Gy, 10 BID fractions). A total of 1,255 cases (87 %) had invasive breast cancer, and 194 patients (13 %) had ductal carcinoma in situ. Rates of TR versus EF were calculated and compared to historical WBI controls. RESULTS: Median follow-up was 60 (range 0-109) months. Fifty patients (3.5 %) developed an ipsilateral breast tumor recurrence (IBTR). The 5-year actuarial rate of IBTR was 3.6 % (invasive breast cancer 3.6 %, ductal carcinoma in situ 3.4 %). Fourteen IBTR (1.1 %) were TR, while 36 (2.6 %) were EF. Estrogen receptor-negative status was associated with IBTR for invasive malignancies as well as for EF only (p < 0.001). Trends for increased rates of EF were noted for increased tumor size (p = 0.067) and extensive intraductal component (p = 0.087). No pathologic factors were explicitly associated with TR. CONCLUSIONS: IBTR after balloon-based APBI is low and similar to rates reported for WBI. In this data set, APBI had fewer tumor bed recurrences (presumably initial cancer recurrences) than EF (presumably new primary lesions). This suggests that balloon-based APBI has a tumor bed control rate that is at least equal to (and potentially higher than) WBI.

Clinical outcomes using accelerated partial breast irradiation in patients with ductal carcinoma in situ.

BACKGROUND: Limited data exist on the use of accelerated partial breast irradiation (APBI) in patients with ductal carcinoma in situ (DCIS). The purpose of this analysis was to evaluate clinical outcomes after APBI in patients with DCIS. PATIENTS AND METHODS: Between December 2002 and December 2010, 99 patients with DCIS underwent APBI as part of their breast-conserving therapy (BCT). Partial breast irradiation techniques included interstitial brachytherapy, balloon-based brachytherapy, and 3-dimensional conformal radiotherapy (3D-CRT). Clinical outcomes including local recurrence, regional recurrence, disease-free survival (DFS), cause-specific survival, and overall survival (OS) were analyzed. RESULTS: Mean follow up was 3.0 years, with a mean patient age of 61.8 years. At 5 years, the rates of local recurrence and regional recurrence were 1.4% and 0%, respectively. Overall survival was 94%, whereas cause-specific survival was 100%. No difference was noted in local control for each treatment technique. When comparing rates using the Eastern Cooperative Oncology Group (ECOG) E-5194 trial groupings, the rate of local recurrence in our cohort was 2.0% for patients with grade I/II disease < 2.5 cm and 0% for grade III < 1.0 cm, representing a 50% and 100% decrease, respectively, in local recurrence compared with excision alone. CONCLUSIONS: Patients with DCIS treated with APBI had excellent clinical outcomes regardless of the APBI technique used. Until the publication of prospective phase III trials, these data confirm previous reports highlighting the efficacy of APBI in the treatment of noninvasive carcinoma of the breast.

Twenty-year outcomes after breast-conserving surgery and definitive radiotherapy for mammographically detected ductal carcinoma in situ.

BACKGROUND: Management of mammographically detected ductal carcinoma in situ (DCIS) at a single institution was reviewed to determine long-term clinical outcomes after treatment with breast-conserving therapy (BCT). METHODS: Data from all patient-cases with DCIS who received BCT between 1980 and 1993 were reviewed. Patient demographics and pathologic factors were analyzed for their effect on outcomes, including ipsilateral breast tumor recurrence (IBTR) and survival. BCT included breast-conserving surgery followed by external-beam radiotherapy to the whole breast, with 86 % of patients receiving a lumpectomy cavity boost. The median dose to the whole breast was 50 Gy and 60.4 Gy to the lumpectomy cavity. RESULTS: A total of 129 cases were evaluated; the median follow-up was 19.3 years. Twenty-one patients developed an ipsilateral breast tumor recurrence (IBTR), 76.2 % of which were invasive (n = 16). Fourteen recurrences (66 %) were within the same breast quadrant (true recurrence), while an additional 7 cases developed an IBTR elsewhere in the breast. True recurrences were more prevalent in women <45 years of age (20 %/24 % vs. 5.1 %/8 %) at 10 and 20 years (p = 0.02). The 5-, 10-, 15-, and 20-year actuarial rates of IBTR for this cohort were 8.7, 10.4, 12.1, and 16.3 % (IBTR), while overall survival at 5, 10, and 20 years was 97.6, 96.8, and 96.8 %, respectively. CONCLUSIONS: Mammographically detected DCIS remains a clinically distinct subset of noninvasive breast cancer. With 20 year follow-up, local control and overall survival are excellent after BCT.