The Clinical Utility of a 7-Gene Biosignature on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery: An Updated Analysis of the DCISionRT® PREDICT Study.

BACKGROUND: Breast-conserving surgery (BCS) followed by adjuvant radiotherapy (RT) is a standard treatment for ductal carcinoma in situ (DCIS). A low-risk patient subset that does not benefit from RT has not yet been clearly identified. The DCISionRT test provides a clinically validated decision score (DS), which is prognostic of 10-year in-breast recurrence rates (invasive and non-invasive) and is also predictive of RT benefit. This analysis presents final outcomes from the PREDICT prospective registry trial aiming to determine how often the DCISionRT test changes radiation treatment recommendations. METHODS: Overall, 2496 patients were enrolled from February 2018 to January 2022 at 63 academic and community practice sites and received DCISionRT as part of their care plan. Treating physicians reported their treatment recommendations pre- and post-test as well as the patient's preference. The primary endpoint was to identify the percentage of patients where testing led to a change in RT recommendation. The impact of the test on RT treatment recommendation was physician specialty, treatment settings, individual clinical/pathological features and RTOG 9804 like criteria. Multivariate logisitc regression analysis was used to estimate the odds ratio (ORs) for factors associated with the post-test RT recommendations. RESULTS: RT recommendation changed 38% of women, resulting in a 20% decrease in the overall recommendation of RT (p < 0.001). Of those women initially recommended no RT (n = 583), 31% were recommended RT post-test. The recommendation for RT post-test increased with increasing DS, from 29% to 66% to 91% for DS <2, DS 2-4, and DS >4, respectively. On multivariable analysis, DS had the strongest influence on final RT recommendation (odds ratio 22.2, 95% confidence interval 16.3-30.7), which was eightfold greater than clinicopathologic features. Furthermore, there was an overall change in the recommendation to receive RT in 42% of those patients meeting RTOG 9804-like low-risk criteria. CONCLUSIONS: The test results provided information that changes treatment recommendations both for and against RT use in large population of women with DCIS treated in a variety of clinical settings. Overall, clinicians changed their recommendations to include or omit RT for 38% of women based on the test results. Based on published clinical validations and the results from current study, DCISionRT may aid in preventing the over- and undertreatment of clinicopathological 'low-risk' and 'high-risk' DCIS patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03448926 ( https://clinicaltrials.gov/study/NCT03448926 ).

Psychosocial impact of proactive rapid genetic counseling following breast cancer diagnosis.

OBJECTIVE: As germline genetic referral becomes increasingly routine as part of the care of newly diagnosed breast cancer patients, it is important to understand the psychosocial impact of genetic counseling at the time of diagnosis. We examined the psychosocial and quality of life (QOL) impact of providing proactive rapid genetic counseling and testing (RGCT) in the immediate aftermath of a breast cancer diagnosis. METHODS: We randomized 330 patients in a 2:1 ratio to proactive rapid genetic counseling (RGCT; N = 222) versus usual care (UC; N = 108). Participants completed a baseline telephone survey before randomization and definitive surgery and a follow-up survey at 1-month post-randomization. We evaluated the impact of RGCT versus UC on breast cancer genetic knowledge, distress, QOL, and decisional conflict. Given that 43% of UC participants and 86% of RGCT participants completed genetic counseling prior to the 1-month assessment, we also evaluated the impact of genetic counseling participation over and above group assignment. RESULTS: The RGCT intervention led to increased breast cancer genetic knowledge relative to UC but did not differentially impact other study outcomes. Across groups patients who participated in genetic counseling had significantly increased knowledge and improved QOL compared to those who did not participate in genetic counseling. CONCLUSIONS: While prior research has documented the impact of genetic counseling and testing on surgical decisions, these results confirm that participation in genetic counseling at the time of diagnosis can yield improvements in knowledge and QOL in the short-term.

The Incidence of Adjacent Synchronous Invasive Carcinoma and/or Ductal Carcinoma In Situ in Patients with Intraductal Papilloma without Atypia on Core Biopsy: Results from a Prospective Multi-Institutional Registry (TBCRC 034).

BACKGROUND: Available retrospective data suggest the upgrade rate for intraductal papilloma (IP) without atypia on core biopsy (CB) ranges from 0 to 12%, leading to variation in recommendations. We conducted a prospective multi-institutional trial (TBCRC 034) to determine the upgrade rate to invasive cancer (IC) or ductal carcinoma in situ (DCIS) at excision for asymptomatic IP without atypia on CB. METHODS: Prospectively identified patients with a CB diagnosis of IP who had consented to excision were included. Discordant cases, including BI-RADS > 4, and those with additional lesions requiring excision were excluded. The primary endpoint was upgrade to IC or DCIS by local pathology review with a predefined rule that an upgrade rate of ≤ 3% would not warrant routine excision. Sample size and confidence intervals were based on exact binomial calculations. Secondary endpoints included diagnostic concordance for IP between local and central pathology review and upgrade rates by central pathology review. RESULTS: The trial included116 patients (median age 56 years, range 24-82) and the most common imaging abnormality was a mass (n = 91, 78%). Per local review, 2 (1.7%) cases were upgraded to DCIS. In both of these cases central pathology review did not confirm DCIS on excision. Additionally, central pathology review confirmed IP without atypia in core biopsies of 85/116 cases (73%), and both locally upgraded cases were among them. CONCLUSION: In this prospective study of 116 IPs without atypia on CB, the upgrade rate was 1.7% by local review, suggesting that routine excision is not indicated for IP without atypia on CB with concordant imaging findings.

The Clinical Utility of DCISionRT® on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery.

BACKGROUND: The role of radiation therapy (RT) following breast-conserving surgery (BCS) in ductal carcinoma in situ (DCIS) remains controversial. Trials have not identified a low-risk cohort, based on clinicopathologic features, who do not benefit from RT. A biosignature (DCISionRT®) that evaluates recurrence risk has been developed and validated. We evaluated the impact of DCISionRT on clinicians' recommendations for adjuvant RT. METHODS: The PREDICT study is a prospective, multi-institutional, observational registry in which patients underwent DCISionRT testing. The primary endpoint was to identify the percentage of patients where testing led to a change in RT recommendations. RESULTS: Overall, 539 women were included in this study. Pre DCISionRT testing, RT was recommended to 69% of patients; however, post-testing, a change in the RT recommendation was made for 42% of patients compared with the pre-testing recommendation; the percentage of women who were recommended RT decreased by 20%. For women initially recommended not to receive an RT pre-test, 35% had their recommendation changed to add RT following testing, while post-test, 46% of patients had their recommendation changed to omit RT after an initial recommendation for RT. When considered in conjunction with other clinicopathologic factors, the elevated DCISionRT score risk group (DS > 3) had the strongest association with an RT recommendation (odds ratio 43.4) compared with age, grade, size, margin status, and other factors. CONCLUSIONS: DCISionRT provided information that significantly changed the recommendations to add or omit RT. Compared with traditional clinicopathologic features used to determine recommendations for or against RT, the factor most strongly associated with RT recommendations was the DCISionRT result, with other factors of importance being patient preference, tumor size, and grade.

TARGIT-R (Retrospective): 5-Year Follow-Up Evaluation of Intraoperative Radiation Therapy (IORT) for Breast Cancer Performed in North America.

BACKGROUND: Intraoperative radiation therapy (IORT) has been investigated for patients with low-risk, early-stage breast cancer. The The North American experience was evaluated by TARGIT-R (retrospective) to provide outcomes for patients treated in "real-world" clinical practice with breast IORT. This analysis presents a 5-year follow-up assessment. METHODS: TARGIT-R is a multi-institutional retrospective registry of patients who underwent lumpectomy and IORT between the years 2007 and 2013. The primary outcome of the evaluation was ipsilateral breast tumor recurrence (IBTR). RESULTS: The evaluation included 667 patients with a median follow-up period of 5.1 years. Primary IORT (IORT at the time of lumpectomy) was performed for 72%, delayed IORT (after lumpectomy) for 3%, intended boost for 8%, and unintended boost (primary IORT followed by whole-breast radiation) for 17% of the patients. At 5 years, IBTR was 6.6% for all the patients, with 8% for the primary IORT cohort and 1.7% for the unintended-boost cohort. No recurrences were identified in the delayed IORT or intended-boost cohorts. Noncompliance with endocrine therapy (ET) was associated with higher IBTR risk (hazard ratio [HR], 3.67). Patients treated with primary IORT who were complaint with ET had a 5-year IBTR rate of 3.9%. CONCLUSION: The local recurrence rates in this series differ slightly from recent results of randomized IORT trials and are notably higher than in previous published studies using whole-breast radiotherapy for similar patients with early-stage breast cancer. Understanding differences in this retrospective series and the prospective trials will be critical to optimizing patient selection and outcomes going forward.

Delivery of nipple-sparing mastectomy within a single healthcare system: The impact of provider preferences.

Nipple-sparing mastectomy (NSM) offers superior esthetic outcomes without sacrificing oncologic safety for select patients requiring mastectomy. While disparities in oncologic care are well established, no study to date has investigated equitable delivery of the various mastectomy types. The objective of this study is to examine multilevel factors related to the distribution of NSM. Patients undergoing mastectomy between 2014 and 2018 across eight hospitals in a single healthcare system were retrospectively reviewed. Patients were categorized by mastectomy type-NSM or other mastectomy (OM). Patient information such as age, race, comorbidities, and median income by ZIP code was collected. Disease characteristics, such as mastectomy weight, breast cancer stage, and treatment history, were identified. Provider and system-level variables, such as specific provider, hospital of operation, and insurance status, were determined. Bivariate analysis was used to identify variables for inclusion in a backward multivariable model. A cohort of 1202 mastectomy patients was identified, with 388 receiving NSM. The average age was 55.8 years (NSM: 48.8, OM: 59.1, P < .001). 39.8% of white patients (n = 242) and 20.0% of African American patients (n = 88) received NSM (P < .001). Average mastectomy weight was 384.3 (SD 195.7) in the NSM group, compared to 839.4 (SD 521.1) in the OM group (P < .001). 41.4% (n = 359) of patients treated at academic centers, and 6.9% (n = 21) of patients treated at community centers received NSM (P < .001). In the multivariate model, the factor with the largest impact on NSM was specific provider. Odds of NSM decreased by 76%-88% for certain surgeons, while odds increased by 63 times for one surgeon. This study utilizes a large multi-institutional database to highlight disparities in NSM delivery. Expectedly, younger, relatively healthy patients, with smaller breast size were more likely to undergo NSM, in accordance with surgical guidelines. However, when all other factors were controlled, provider preferences played the most significant role in NSM delivery rates. These findings demonstrate the need for practice reexamination to ensure equitable access to NSM.

Predictors of contralateral prophylactic mastectomy in genetically high risk newly diagnosed breast cancer patients.

PURPOSE: Recent trends indicate increased use of contralateral prophylactic mastectomy (CPM) among newly diagnosed breast cancer patients, particularly those who test positive for a pathogenic variant in the BRCA1/2 genes. However, the rate of CPM among patients who test negative or choose not to be tested is surprisingly high. We aimed to identify patient predictors of CPM following breast cancer diagnosis among such patients. METHODS: As part of a randomized controlled trial of rapid genetic counseling and testing vs. usual care, breast cancer patients completed a baseline survey within 6 weeks of diagnosis and before definitive surgery. Analyses focused on patients who opted against testing (n = 136) or who received negative BRCA1/2 test results (n = 149). We used multivariable logistic regression to assess the associations between sociodemographic, clinical- and patient-reported factors with use of CPM. RESULTS: Among patients who were untested or who received negative test results, having discussed CPM with one's surgeon at the time of diagnosis predicted subsequent CPM. Patients who were not candidates for breast-conserving surgery and those with higher levels of cancer-specific intrusive thoughts were also more likely to obtain a CPM. CONCLUSION: The strongest predictors of CPM in this population were objective clinical factors and discussion with providers. However, baseline psychosocial factors were also independently related to the receipt of CPM. Thus, although CPM decisions are largely guided by relevant clinical factors, it is important to attend to psychosocial factors when counseling newly diagnosed breast cancer patients about treatment options.

Recommendations for prioritization, treatment, and triage of breast cancer patients during the COVID-19 pandemic. the COVID-19 pandemic breast cancer consortium.

The COVID-19 pandemic presents clinicians a unique set of challenges in managing breast cancer (BC) patients. As hospital resources and staff become more limited during the COVID-19 pandemic, it becomes critically important to define which BC patients require more urgent care and which patients can wait for treatment until the pandemic is over. In this Special Communication, we use expert opinion of representatives from multiple cancer care organizations to categorize BC patients into priority levels (A, B, C) for urgency of care across all specialties. Additionally, we provide treatment recommendations for each of these patient scenarios. Priority A patients have conditions that are immediately life threatening or symptomatic requiring urgent treatment. Priority B patients have conditions that do not require immediate treatment but should start treatment before the pandemic is over. Priority C patients have conditions that can be safely deferred until the pandemic is over. The implementation of these recommendations for patient triage, which are based on the highest level available evidence, must be adapted to current availability of hospital resources and severity of the COVID-19 pandemic in each region of the country. Additionally, the risk of disease progression and worse outcomes for patients need to be weighed against the risk of patient and staff exposure to SARS CoV-2 (virus associated with the COVID-19 pandemic). Physicians should use these recommendations to prioritize care for their BC patients and adapt treatment recommendations to the local context at their hospital.

Predictors of genetic testing uptake in newly diagnosed breast cancer patients.

BACKGROUND AND OBJECTIVES: Many newly diagnosed breast cancer patients do not receive genetic counseling and testing at the time of diagnosis. We examined predictors of genetic testing (GT) in this population. METHODS: Within a randomized controlled trial of proactive rapid genetic counseling and testing vs usual care, patients completed a baseline survey within 6 weeks of breast cancer diagnosis but before a definitive survey. We conducted a multinomial logistic regression to identify predictors of GT timing/uptake. RESULTS: Having discussed GT with a surgeon was a dominant predictor (χ2 (2, N = 320) = 70.13; P < .0001). Among those who discussed GT with a surgeon, patients who had made a final surgery decision were less likely to receive GT before surgery compared with postsurgically (OR [odds ratio] = 0.24; 95% confidence interval [CI] = 0.12-0.49) or no testing (OR = 0.28; 95% CI = 0.14-0.56). Older patients (OR = 0.95; 95% CI = 0.91-0.99) and participants enrolled in New York/New Jersey (OR = 0.22; 95% CI = 0.07-0.72) were less likely to be tested compared with receiving results before surgery. Those with higher perceived risk (OR = 1.02; 95% CI = 1.00-1.03) were more likely to receive results before surgery than to not be tested. CONCLUSIONS: This study highlights the role of patient-physician communication about GT as well as patient-level factors that predict presurgical GT.

Contralateral axillary sentinel lymph node in breast cancer recurrence.

The rare but significant reports of aberrant lymph node drainage outside of the ipsilateral axilla in patients with breast cancer necessitate a review of the staging and treatment strategies for these patients. Current staging modalities continue to describe this phenomenon as a stage IV cancer, which could have profound implications for clinical management. We report a case of a patient with recurrent right breast invasive ductal carcinoma whose preoperative lymphoscintigraphy revealed sentinel lymph node drainage to the contralateral axilla. This discovery subsequently altered surgical planning and her ultimate stage.

Factors contributing to persistent rates of contralateral prophylactic mastectomy in breast cancer patients: Examination of 1051 mastectomies across a single health system.

The American Society of Breast Surgeons (ASBrS) outlined definitive guidelines for contralateral prophylactic mastectomy (CPM) in 2016. Despite this, rates of CPM have remained steady. The objective of this study was to identify factors contributing to persistent over-delivery of CPM. Breast cancer patients across 8 hospitals in a single healthcare system from 2014 to 2018 were retrospectively reviewed. The patients were divided according to whether they received nonindicated CPMs versus other mastectomy types. Nonindicated CPM were those procedures not meeting ASBrS consensus guidelines for recommended patients. CPM rate was calculated for each year in the study period. Patient, disease, provider, and system level factors were obtained. Bivariate analysis was used to identify variables for inclusion in a backward multivariable model. A total of 1,051 patients were analyzed. Nonindicated CPM rates by year remained steady throughout the time period (P = .391). In multivariable regression, patient, disease, and provider level factors were associated with odds of undergoing CPM. Every unit increase in age was associated with a 4% reduction in odds of undergoing CPM (CI 0.941-0.986). Stage 3 breast cancer compared to stage 1 had 53% lower odds of CPM (CI 0.288-0.757). Implant-based breast reconstruction had 2.9-fold higher odds of CPM compared to no reconstruction (CI 1.476-5.551). No system level factors were statistically significant. CPM rates have not notably decreased since the ASBrS consensus statement with certain patient and provider factors impacting persistent overuse of CPM. These results inform oncologic and reconstructive providers of factors contributing to continued use of a nonindicated procedure.

Does surgeon handedness or experience predict immediate complications after mastectomy? A critical examination of outcomes in a single health system.

Surgeons often seek to perfect their technical dexterity, and hand dominance of the surgeon is an important factor given the constraints of operative field laterality. However, experience often dictates how surgeons are able to compensate. While surgeons have experienced preference for the ipsilateral breast, the impact of surgeon handedness, experience, and volume has not been directly examined in a single study. A retrospective chart review of five breast surgeons (2 LHD) at a single institution identified 365 mastectomy patients, totaling 594 breasts, between January 2015 and June 2018. The breasts were identified as ipsilateral or contralateral based on the surgeons' handedness. Surgeons were grouped based on length of surgical experience, three with ≥15 years and two with <15 years. Surgeons with greater experience were the highest volume surgeons in this series. Data included patient demographics, breast and oncologic history, surgical techniques, and surgical outcomes including complications. A total of 270 nonprophylactic and 324 prophylactic mastectomies were identified, of which 529 were performed by surgeons with greater than 15 years of experience and 65 by surgeons with less than 15 years. The overall complication rate was 33.5% (n = 199), of which 18.0% (n = 107) were on the ipsilateral breast and 15.5% (n = 92) were on the contralateral breast. 9.1% of complications required re-operation (n = 54). The odds of any complication on the ipsilateral breast were 2.9 times higher than complications on the contralateral breast when looking exclusively at surgeons with <15 years of experience (P = .0353, OR = 2.92, 1.06-8.03). Surgeons with <15 years of experience have a 2.71 (P = .05, OR 2.71, 1.361-5.373) increase in any ischemic complication and a 16 times (P < .0001, OR = 16.01, 5.038-50.933) increase in major operative ischemic complications. Our study finds that surgeons with less than 15 years of surgical experience have a 2.9 times higher rate of overall complication when operating on the ipsilateral breast. However, years of experience and surgeon volume have a much greater impact on any and ischemic complications after mastectomy.

Neoadjuvant Chemotherapy and Nipple-Sparing Mastectomy: Timing and Postoperative Complications.

BACKGROUND: As the demand for nipple-sparing mastectomy (NSM) increases and surgeons expand the eligibility criteria, a subset of patients may become candidates following neoadjuvant chemotherapy (NACT). However, the impact of NACT on postoperative complications remains unclear as the current literature is discordant. METHODS: A single-institution, retrospective chart review was performed on patients undergoing NSM from 1989 to 2017. Patient demographics, surgical intervention, systemic treatment, and complication rates were collected. Primary outcomes were 30-day postoperative complications, including nipple-areolar necrosis, skin flap necrosis, infection, wound dehiscence, hematoma, and seroma. Secondary outcomes included characterization of the timing between chemotherapy and surgical intervention, and the impact on complication rates. Each breast was considered independently for analysis, and breasts undergoing either NACT or primary surgery (PS) were compared. RESULTS: Of the 832 breasts included, 88 (10.6%) received NACT and 744 (89.4%) underwent PS. Baseline complication rates were not significantly different between the NACT group and the PS group (5.7% vs. 10.6%; p = 0.119). When controlling for age, body mass index (BMI), smoking, and prior radiation, NACT was not a predictor of complications. Time from completion of NACT to PS occurred at a median of 40.5 days (interquartile range 31.3-55.3), and decreased intervals were not associated with increased complication rates. CONCLUSIONS: Postoperative complications following NSM in patients completing NACT are comparable with those receiving PS. Patients undergoing NACT do not have a significantly increased risk of necrosis, unintended reoperations, or nipple loss. NACT should not be considered a contraindication for NSM.

Randomized trial of proactive rapid genetic counseling versus usual care for newly diagnosed breast cancer patients.

PURPOSE: Breast cancer patients who carry BRCA1/BRCA2 gene mutations may consider bilateral mastectomy. Having bilateral mastectomy at the time of diagnosis not only reduces risk of a contralateral breast cancer, but can eliminate the need for radiation therapy and yield improved reconstruction options. However, most patients do not receive genetic counseling or testing at the time of their diagnosis. In this trial, we tested proactive rapid genetic counseling and testing (RGCT) in newly diagnosed breast cancer patients in order to facilitate pre-surgical genetic counseling and testing. METHODS: We recruited newly diagnosed breast cancer patients at increased risk for carrying a BRCA1/2 mutation. Of 379 eligible patients who completed a baseline survey, 330 agreed to randomization in a 2:1 ratio to RGCT (n = 220) versus UC (n = 108). Primary outcomes were genetic counseling and testing uptake and breast cancer surgical decisions. RESULTS: RGCT led to higher overall (83.8% vs. 54.6%; p < 0.0001) and pre-surgical (57.8% vs. 38.7%; p = 0.001) genetic counseling uptake compared to UC. Despite higher rates of genetic counseling, RGCT did not differ from UC in overall (54.1% vs. 49.1%, p > 0.10) or pre-surgical (30.6% vs. 27.4%, p > 0.10) receipt of genetic test results nor did they differ in uptake of bilateral mastectomy (26.6% vs. 21.8%, p > 0.10). CONCLUSIONS: Although RGCT yielded increased genetic counseling participation, this did not result in increased rates of pre-surgical genetic testing or impact surgical decisions. These data suggest that those patients most likely to opt for genetic testing at the time of diagnosis are being effectively identified by their surgeons.

Positive Nipple Margin After Nipple-Sparing Mastectomy: An Alternative and Oncologically Safe Approach to Preserving the Nipple-Areolar Complex.

BACKGROUND: The aim of this study is to describe a less aggressive approach to management of positive nipple margin following nipple-sparing mastectomy (NSM), allowing for preservation of the nipple-areolar complex (NAC). STUDY DESIGN: A single-institution retrospective chart review was performed for patients undergoing NSM from 1989 to 2017. Positive nipple margin was defined as any residual invasive carcinoma or ductal carcinoma in situ (DCIS) within the additional nipple margin. Management included complete NAC removal, subareolar shave biopsy, or observation alone. Primary outcomes included rates of positive nipple margin and local recurrence. RESULTS: A total of 819 breasts underwent NSM, yielding a total of 32 breasts (3.9%) with positive nipple margin. Management included 11 (34.4%) subareolar shave biopsies, 15 (46.9%) complete NAC excisions, and 5 (15.6%) with observation alone, plus 1 (3.1%) lost to follow-up. Final pathology after subareolar shave biopsy did not reveal any residual disease, and no patients developed NAC necrosis or required NAC removal. Final pathology after NAC excision revealed 3 of 15 with additional disease (1 invasive ductal carcinoma, 2 DCIS). Of the five patients who had no subsequent intervention, tumor pathology was DCIS in all cases. One patient received adjuvant radiation therapy. Mean time to intervention was 3.7 ± 1.9 with mean follow-up of 2.9 years. CONCLUSIONS: Management of positive nipple margin after NSM with subareolar shave biopsy is a safe alternative to preserve the NAC.

Timing of radiation therapy in nipple-sparing mastectomy influences outcomes and patient-reported quality of life.

The aim of this study is to assess the complication profile and impact on patient-reported quality of life in those undergoing nipple-sparing mastectomy (NSM) with immediate breast reconstruction and subsequent prosthetic reconstruction in patients with prior breast radiation therapy (pRT) vs those receiving adjuvant post-mastectomy radiation therapy (PMRT). An IRB-approved, retrospective analysis was performed from 2002 to 2014 to identify NSM patients that underwent pRT or PMRT. A 22-item Likert scale questionnaire was administered by a third party to register patient-reported quality of life. Forty patients met criteria for outcomes analysis, and 30 patients answered the questionnaire. Mean age was 45.6 years old and mean follow-up was 3.8 years. Complication rates for the PMRT cohort were 61.9% vs 31.6% in the pRT cohort, P = .067, and those requiring operative intervention were PMRT 38.1% vs pRT 5.3%, P = .021. Nipple-areolar complex survival was 100% in the pRT vs 85.7% in the PMRT, P = .233. Breast-related quality of life scores were superior in the pRT group within multiple domains. Patients are more likely to develop complications requiring an operative intervention and have decreased breast-related quality of life when undergoing NSM with PMRT compared to patients undergoing NSM having received pRT.

Incidence of Adjacent Synchronous Invasive Carcinoma and/or Ductal Carcinoma In-situ in Patients with Lobular Neoplasia on Core Biopsy: Results from a Prospective Multi-Institutional Registry (TBCRC 020).

BACKGROUND: Lobular neoplasia (LN) represents a spectrum of atypical proliferative lesions, including atypical lobular hyperplasia and lobular carcinoma-in-situ. The need for excision for LN found on core biopsy (CB) is controversial. We conducted a prospective multi-institutional trial (TBCRC 20) to determine the rate of upgrade to cancer after excision for pure LN on CB. METHODS: Patients with a CB diagnosis of pure LN were prospectively identified and consented to excision. Cases with discordant imaging and those with additional lesions requiring excision were excluded. Upgrade rates to cancer were quantified on the basis of local and central pathology review. Confidence intervals and sample size were based on exact binomial calculations. RESULTS: A total of 77 of 79 registered patients underwent excision (median age 51 years, range 27-82 years). Two cases (3%; 95% confidence interval 0.3-9) were upgraded to cancer (one tubular carcinoma, one ductal carcinoma-in-situ) at excision per local pathology. Central pathology review of 76 cases confirmed pure LN in the CB in all but two cases. In one case, the tubular carcinoma identified at excision was also found in the CB specimen, and in the other, LN was not identified, yielding an upgrade rate of one case (1%; 95% CI 0.01-7) by central pathology review. CONCLUSIONS: In this prospective study of 77 patients with pure LN on CB, the upgrade rate was 3% by local pathology and 1% by central pathology review, demonstrating that routine excision is not indicated for patients with pure LN on CB and concordant imaging findings.

TARGIT-R (Retrospective): North American Experience with Intraoperative Radiation Using Low-Kilovoltage X-Rays for Breast Cancer.

BACKGROUND: Single-dose intraoperative radiotherapy (IORT) is an emerging treatment for women with early stage breast cancer. The objective of this study was to define the frequency of IORT use, patient selection, and outcomes of patients treated in North America. METHODS: A multi-institutional retrospective registry was created, and 19 institutions using low-kilovoltage IORT for the treatment of breast cancer entered data on patients treated at their institution before July 31, 2013. Patient selection, IORT treatment details, complications, and recurrences were analyzed. RESULTS: From 2007 to July 31, 2013, a total of 935 women were identified and treated with lumpectomy and IORT. A total of 822 patients had at least 6 months' follow-up documented and were included in the analysis. The number of IORT cases performed increased significantly over time (p < 0.001). The median patient age was 66.8 years. Most patients had disease that was <2 cm in size (90 %) and was estrogen positive (91 %); most patients had invasive ductal cancer (68 %). Of those who had a sentinel lymph node procedure performed, 89 % had negative sentinel lymph nodes. The types of IORT performed were primary IORT in 79 %, secondary IORT in 7 %, or planned boost in 14 %. Complications were low. At a median follow-up of 23.3 months, crude in-breast recurrence was 2.3 % for all patients treated. CONCLUSIONS: IORT use for the treatment of breast cancer is significantly increasing in North America, and physicians are selecting low-risk patients for this treatment option. Low complication and local recurrence rates support IORT as a treatment option for selected women with early stage breast cancer.