Lumpectomy For Breast Cancer Research Articles

Real world clinical outcomes from targeted intraoperative radiotherapy (TARGIT-IORT) during lumpectomy for breast cancer: data from a large cohort at a national cancer institute.

Randomised evidence supports the use of partial breast irradiation (PBI) with targeted intraoperative radiotherapy (TARGIT-IORT) for early stage breast cancer, but prospective data from real-world adoption of this technique is also important. The aim of this study was to determine if the outcome reported in TARGIT-A trial could be replicated in large cohort of early stage breast cancer treated with TARGIT-IORT. This prospective observational study analysed all patients treated with TARGIT-IORT between 2004 and 2021 in a single national cancer institute. TARGIT-IORT during lumpectomy was performed according to the risk-adapted TARGIT-A protocol using the Intrabeam® device. We analysed the completeness of follow up, 5-year in-breast-tumour-recurrence (IBTR), long term local recurrence free survival, distant disease-free survival, overall survival and breast-cancer-related survival, using the Kaplan-Meier method. A covariate analysis was performed to investigate risk factors for IBTR. We also analysed high grade toxicity events. The study included 814 patients and the a median follow up was 72 months. The majority of patients (60.3%) received TARGIT-IORT as PBI modality ("exclusive IORT" group); 39.7% received additional EBRT. There was no significant difference between the 5 years IBTR for the whole study population and the "exclusive IORT" cohort (1.6% (95%CI=1.1-2.1%) and 2.5% (95%CI=1.7%-3.3%) respectively). 5 years overall survival and tumour related survival were >95%. In 21% of patients with recurrence, breast was preserved. Radiotherapy toxicity (CTCAE Grade>2) was very rare (0.9%). This large single institute study found that breast cancer control and survival outcomes with TARGIT-IORT were consistent with TARGIT-A trial results. This "real world" experience confirmed that the randomised evidence showing the value of TARGIT-IORT as partial breast irradiation modality that can be replicated in routine clinical practice.

Wirelessly Powered Visible Light-Emitting Implant for Surgical Guidance during Lumpectomy.

Achieving negative surgical margins, defined as no tumor found on the edges of the resected tissue, during lumpectomy for breast cancer is critical for mitigating the risk of local recurrence. To identify nonpalpable tumors that cannot be felt, pre-operative placements of wire and wire-free localization devices are typically employed. Wire-free localization approaches have significant practical advantages over wired techniques. In this study, we introduce an innovative localization system comprising a light-emitting diode (LED)-based implantable device and handheld system. The device, which is needle injectable and wire free, utilizes multiple wirelessly powered LEDs to provide direct visual guidance for lumpectomy. Two distinct colors, red and blue, provide a clear indication of tissue depth: blue light is absorbed strongly in tissue, visible within a close range of <1 cm, while red light remains visible through several centimeters of tissue. The LEDs, integrated with an impedance-matching circuit and receiver coil, are encapsulated in biocompatible epoxy for injection with a 12 G needle. Our findings demonstrate that the implant exhibits clearly perceivable depth-dependent color changes and remains visible through >2 cm of ex vivo chicken breast and bovine muscle tissue using less than 4 W of transmitted power from a handheld antenna. These miniaturized needle-injectable localization devices show promise for improving surgical guidance of nonpalpable breast tumors.

Abstract PO4-11-12: Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS)

Abstract Background: In pegulicianine fluorescence guided surgery (pFGS), a standard of care lumpectomy procedure is performed, and additional tissue is taken from cavity walls at sites of high pFGS signal. This approach been shown to reduce 2nd surgeries and remove additional tumor left by standard surgery, but may remove more tissue, potentially worsening cosmetic outcomes. Patient breast satisfaction surveys were used to assess cosmesis after pFGS. Methods: A prospective Pivotal trial of pFGS in women undergoing lumpectomy surgery for stage 0-III breast cancer was conducted at 14 US sites (NCT03686215). We assessed the safety and efficacy of the Lumicell DVS in identifying and removing residual cancer from the lumpectomy cavity in real time. Patient Reported Outcome Measures (PROM) data was collected as an exploratory endpoint. The BREAST-Q, a validated tool that measures patient perspectives after different breast procedures, was used to collect PROM data. An 11-question BREAST-Q survey was used to measure patients’ breast satisfaction at baseline (pre-surgery) and at multiple timepoints through 6-months post lumpectomy. Descriptive statistics of participating patients’ responses were collected and analyzed. Survey results were analyzed by the distribution of patient ratings for each question and the change in the distribution of ratings over time, with comparison of baseline to post-lumpectomy. Comparison of patient satisfaction with or without additional pFGS-directed tissue removal was performed with Item Response Theory assuming all items equally discriminative of responding patients. For each timeframe, responses to BREAST-Q items were used to create a response score for each patient. Scaled factor scores (0-100) were compared between groups with and without additional tissue removed during pFGS. Results: Of the 357 patients evaluated for efficacy in the primary Pivotal study analysis, 255 patients agreed to participate in the PROM surveys (71%). Approximately 60% of the participating respondents completed a pre- and initial post-lumpectomy survey while only 34% of the participating patients completed a pre- and 6-month post-lumpectomy survey. Most patients responded either “Very Satisfied” or “Somewhat Satisfied” across all surveyed timeframes. No significant difference in patient breast satisfaction was found at any time point between the groups with and without additional pFGS-guided shaves removed (p &amp;gt;0.05). There were 4 patients with scores of 3 or higher pre-surgery but 2 or lower post-surgery. Among these, 1 had no pFGS-guided shaves taken. The remaining 3 had had pFGS-guided shaves taken, but 2 required a second lumpectomy surgery and 1 underwent mastectomy, these additional surgeries likely accounting for decreased cosmetic outcomes. Discussion: Patient perspective of breast satisfaction was not decreased by the amount of extra tissue removed by pFGS. These data suggest that pFGS using the Lumicell DVS does not significantly decrease breast cosmesis. Three of 4 patients with decreased satisfaction had 2nd surgeries, confirming the importance of finding approaches to decrease 2nd surgeries. This data was collected during the COVID-19 pandemic, which may have adversely impacted the compliance rate of survey completion. Studies in larger cohorts with longer follow up are required to better assess the relative impact of 2nd surgeries, radiation, and systemic therapy on breast satisfaction PROM scores after lumpectomy. Citation Format: Kelly Hunt, Irene Wapnir, E Shelley Hwang, David Carr, Peter Blumencranz, Kate Smith, Manna Chang, Jorge Ferrer, Barbara Smith. Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-11-12.

Comparison of long-term oncologic outcomes of central lumpectomy and conventional breast-conserving surgery for invasive breast cancer: propensity score matching analysis.

Central lumpectomy (CL) is a breast-conserving surgical (BCS) technique that involves excision of the nipple-areolar complex with breast tumor in centrally located breast cancers. We aimed to investigate the long-term clinical outcomes of CL in comparison with conventional BCS (cBCS). Patient records who underwent BCS with clear resection margins for invasive breast cancer between 2004 and 2018 were retrospectively reviewed. Of the total 6,533 patients, 106 (1.6%) underwent CL. Median follow-up duration was 73.4months. 1:3 propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were used to minimize selection bias. The CL group showed a significantly higher ipsilateral breast tumor recurrence (IBTR) rate than the cBCS group (10-year IBTR rate: 5.8% vs. 3.1%, p = 0.004), even after adjusting for other variables (hazard ratio (HR), 2.65; 95% confidence interval (CI), 1.07-6.60, p = 0.048). However, there were no significant differences observed inregional recurrence, distant metastasis, oroverall survival rates between the two groups. Both PSM and IPTW analyses showed significantly higher IBTR in the CL group (PSM HR, 3.27; 95% CI, 0.94-11.36; p = 0.048 and IPTW HR, 4.66; 95%CI, 1.85-11.77; p < 0.001). Lastly, when analyzing 2,213 patients whose tumors were located within 3cm of the nipple, the CL group showed a significantly higher IBTR than the cBCS group before and after PSM. CL was associated with a higher rate ofIBTR compared to cBCS, while other survival outcomes were comparable. For centrally located tumors, CL may be considered for patients preferring breast preservation. However, higher risk for IBTR should be informed and careful surveillance may be necessary during the early post-operative follow-up periods.

Steroid-induced mania in a patient with previously well-controlled organic bipolar 1-like affective disorder secondary to acquired brain injury: case report and literature review

Steroid-induced neuropsychiatric sequelae are common, and pose significant risks to people usually receiving glucocorticoids in the context of physical illness. Steroid-induced mania and hypomania are the most common of the acute complications, yet despite great progress in understandings in neurophysiology there are no recent studies which review the factors which might predict who will experience this severe complication, nor are there consensus guidelines on management. We report the unusual case of a woman in her 50s admitted to a psychiatric unit with steroid-induced mania despite compliance with two mood stabilisers, several days after the administration of a Dexamethasone and Docetaxel chemotherapy regime adjunctive to lumpectomy for breast cancer. She had previously been diagnosed with an organic affective disorder (with classical bipolar 1 pattern) following severe ventriculitis related to ventricular drain insertion for obstructive hydrocephalus secondary to a colloid cyst. She had no psychiatric illness before this brain injury, but has a maternal history of idiopathic bipolar 1 affective disorder. Her episode of steroid-induced mania resolved following use of sedative medications, continuation of her existing mood stabilisers, and reductions of the steroid dosing in collaboration with her oncology team, which also protected her from further manic relapses during continued chemotherapy. Established mental illness, a family history, and acquired brain injury may reflect risk factors for steroid-induced mania through currently unclear pathways. Future epidemiological studies could better confirm these observations, and basic neuroscience may look to further explore the role of extrinsic glucocorticoids in the pathophysiology of affective disorders.

Out-of-Pocket Cost Modeling of Adjuvant Antiestrogen and Radiation Therapy After Lumpectomy for Early-Stage Breast Cancer Across Medicaid and Medicare Plans

The optimal adjuvant therapy (antiestrogen therapy [ET] + radiation therapy or ET alone, or in some reports radiation therapy alone) in older women with early-stage breast cancer has been highly debated. However, granular details on the role of insurance in the out-of-pocket cost for patients receiving ET with or without radiation therapy are lacking. This project disaggregates out-of-pocket costs by insurance plans to increase treatment cost transparency. Several radiation therapy schedules are accepted standards as per the National Comprehensive Cancer Network guidelines. For our financial estimate model, we used the 5-fraction and 15-fraction radiation therapy and ET prescribed over a 5-year duration. The total aggregate out-of-pocket costs were determined from the sum of treatment costs, deductibles, and copays/coinsurance based on Medicaid, Original Medicare, Medigap Plan G, and Medicare Part D Rx plans. The model assumes a Medicare- and/or Medicaid-eligible patient ≥70 years of age with node-negative, early-stage estrogen-receptor-positive breast cancer. Patient out-of-pocket costs were estimated from publicly available insurance data from plan-specific benefit coverage materials using a 5-year time horizon. Original Medicare beneficiaries face a total out-of-pocket treatment charge of $2738.52 for ET alone, $2221.26 for 5-fraction radiation therapy alone, $2573.92 for 15-fraction radiation therapy alone, $3361.26 for combined ET+ 5-fraction radiation therapy, and $3713.92 for combined ET + 15-fraction radiation therapy. Medigap Plan G beneficiaries have an out-of-pocket charge of $1130.00 with radiation therapy alone and face an out-of-pocket of $2270.00 for ET alone and combined ET+ radiation therapy. For Medicaid beneficiaries, all treatments approved by Medicaid are covered without limit, resulting in no out-of-pocket expense for either adjuvant treatment option. This model (based on actual cost estimates per insurance plan rather than claims data), by estimating expenses within Medicare and Medicaid plans, provides a level of transparency to patient cost. With knowledge of the costs borne by patients themselves, treatment decisions informed by patients' individual priorities and preferences may be further enhanced.

EE67 Insurer and Patient Costs for Repeat Breast Surgery After Initial Lumpectomy for Breast Cancer

EE67 Insurer and Patient Costs for Repeat Breast Surgery After Initial Lumpectomy for Breast Cancer

Cannabis Use Patterns among Patients with Early-Stage Breast Cancer in a Large Multicenter Cohort from a State with Legalized Adult Non-Medical Cannabis

Cannabis use among patients with cancer is an area of great interest given its widespread acceptance despite the lack of supporting clinical data. The absence of data limits the understanding of potential clinical benefits of cannabis and the ability of providers to deliver evidence-based recommendations for patient care. We explored cannabis use patterns in patients with early-stage breast cancer in a large multicenter cohort in a state with legalized adult non-medical cannabis. Initial questions about cannabis use history and frequency were introduced in Michigan Radiation Oncology Quality Consortium (MROQC) breast cancer patient surveys on 2/1/2020 for female patients receiving radiation after lumpectomy for non-metastatic breast cancer. Expanded questions were introduced on 6/28/2022 to assess mode of administration, active ingredient, and reason for use. Summary statistics were generated. A multivariable model using logistic regression identified patient characteristics associated with cannabis use. Among 3948 eligible patients, 2738 (69.35%) completed survey questions, and 2462/2738 (89.9%) completed the initial question on cannabis use. Among those, 364/2462 (14.8%) noted cannabis use in the last 30 days, 588 (23.9%) noted remote use (>30 days ago), 1462 (59.4%) reported never having used cannabis, 44 (1.8%) preferred not to answer cannabis use questions, and 4 (0.4%) did not provide use history. Younger age [age <50 vs 60-70, OR 2.5 (95% CI 1.65, 3.79) p<0.001)], Hispanic ethnicity [OR 2.20 (95% CI 1.06, 4.56) p = 0.03], history of smoking [OR 2.56 (95% CI 1.88, 3.48) p<0.001], current smoking [OR 4.70 (95% CI 3.22, 6.86) p<0.001)], and prior chemotherapy [OR 1.40 (95% CI 1.00, 1.96) p = 0.05] predicted recent cannabis use in a multivariable model. Of the 364 patients endorsing cannabis use in the last 30 days, 89 (24.5%), 72 (19.8%), 29 (8.0%), 66 (18.1%), 30 (8.2%), and 78 (21.4%) reported using cannabis 1-2 days, 3-5 days, 6-9 days, 10-19 days, 20-29 days, and all 30 days, respectively. The most common modes of administration among 76 individuals who responded to the expanded questionnaire to date were oral (39.4%), smoking (30.3%), and topical (10.5%). The products used contained tetrahydrocannabinol (THC; 26.3%), cannabidiol (CBD; 19.7%), balanced levels of THC and CBD (19.7%), or active ingredients that were unknown to the patient (34.2%). Patients frequently endorsed cannabis use for insomnia, anxiety, and pain. Many patients with early-stage breast cancer are using cannabis. Younger age, Hispanic ethnicity, smoking, and chemotherapy history are predictors of cannabis use. Patients are often unaware of the active ingredients in the products that they use, suggesting an important role for patient education and a need to equip providers to advise patients in their care.

Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery

BackgroundAlthough lumpectomy and mastectomy provide equivalent survival for patients with breast cancer, local recurrence after lumpectomy increases breast cancer mortality. Positive lumpectomy margins, which imply incomplete tumor removal, are the strongest predictor of local recurrence and are identified days after surgery, necessitating a second surgery.MethodsIn this prospective trial, we assessed margin status with or without pegulicianine fluorescence-guided surgery (pFGS) for stages 0 to 3 breast cancers. To prevent surgeons from performing smaller than standard lumpectomies in anticipation of pFGS assistance, patients were randomly assigned 10:1 to pFGS or control groups, thus randomization was not designed to provide a control group for evaluating device performance. In patients undergoing pFGS, additional pFGS-guided cavity margins were excised at sites of pegulicianine signal. We evaluated three coprimary end points: the percentage of patients for whom pFGS-guided margins contained cancer, sensitivity, and specificity.ResultsOverall, 406 patients received 1.0 mg/kg intravenous pegulicianine followed by lumpectomy. Among 392 patients randomly assigned, 316 had invasive cancers, and 76 had in situ cancers. In 27 of 357 patients undergoing pFGS, pFGS-guided margins removed tumor left behind after standard lumpectomy, 22 from cavity orientations deemed negative on standard margin evaluation. Second surgeries were avoided by pFGS in 9 of 62 patients with positive margins. On per-margin analysis, pFGS specificity was 85.2%, and sensitivity was 49.3%. Pegulicianine administration was stopped for adverse events in six patients. Two patients had grade 3 serious adverse events related to pegulicianine.ConclusionsThe use of pFGS in breast cancer surgery met prespecified thresholds for removal of residual tumor and specificity but did not meet the prespecified threshold for sensitivity. (Funded by Lumicell, Inc. and the National Institutes of Health; Clinicaltrials.gov number, NCT03686215.)

Microwave ablation without subsequent lumpectomy versus breast-conserving surgery for early breast cancer: a propensity score matching study

Purpose To compare the efficacy of ultrasound-guided percutaneous microwave ablation (MWA) without subsequent lumpectomy and breast-conserving surgery (BCS) in patients with early breast cancer (BC). Materials and methods This retrospective cohort study enrolled 106 patients with early BC (T0/1/2 N0/1 M0) treated by MWA (n = 21) or BCS (n = 85) from October 2014 to December 2020. Propensity score matching (PSM) was performed to balance the baseline characteristics between MWA and BCS groups. The tumor progression, overall survival (OS), disease-specific survival (DSS), complications, and cosmetic results were compared. Results After PSM, there were 21 patients with balanced baseline characteristics in each group. After a median follow-up of 43 months (range, 15–89 months), there was no significant difference in tumor progression (10% vs 2%, p = 0.18), OS (96% vs 99%, p = 0.36), DSS (100% vs 99%, p > 0.99), and complications (0% vs 19%, p = 0.58). The operation time of MWA was shorter (60 min vs 101 min, p < 0.001) than that of BCS. For the management of metastatic lymph nodes, five (5/21, 24%) patients with six metastatic nodes underwent ablation in the MWA group and three patients (3/21, 14%) with six metastatic nodes underwent axillary lymph node dissection in the BCS group. All the patients in the MWA group reported excellent cosmetic results, but 29% of BCS patients expressed dissatisfaction with breast asymmetry (10%) and scar formation (19%) (p < 0.001). Conclusion This pilot study indicated that in selected early BC patients, microwave ablation without subsequent lumpectomy had comparable tumor control effect with breast-conserving surgery and better cosmetic results at an intermediate follow-up. Highlights MWA without subsequent lumpectomy has a comparable interim survival effect and better cosmetic results as BCS in the treatment of selected early breast cancer. MWA has the potential to be a viable and promising therapeutic option for breast cancer patients reluctant or intolerant to surgery with the advantage of minimal invasion.

Aging a Decade in a Day: Age Cutoff Bias in Adjuvant Therapy Allocation for Early-Stage Breast Cancer

Physicians may expedite interpretation of data presented as a continuous variable by binning the data into "high" and "low" subgroups (cutoff heuristic). Use of this cognitive shortcut with age may lead to fewer nuanced or inappropriate decisions. We hypothesized an age cutoff heuristic may lead to non-evidence-based adjuvant treatment allocation among patients with early-stage breast cancer. Two cohorts with strong indications for adjuvant treatment regardless of age that underwent lumpectomy for early-stage breast cancer between 2004 and 2017 were identified in the National Cancer Database. Cohort 1 had higher-risk features (estrogen receptor negative, endocrine therapy not planned, final margins positive, or size >3 cm; n=160,990) and was appropriate for radiation. Cohort 2 had hormone receptor positivity with tumors >5 mm (n=394,946) and was appropriate for endocrine therapy. Multivariable logistic regressions with odds ratios (ORs) and 99.8% confidence intervals (CIs) were performed to determine whether any single year-over-year age difference was independently associated with a difference in likelihood of adjuvant therapy recommendation. In cohort 1, radiation recommendation decreased sharply at age 70, ranging from 90% to 92% between the ages of 50 and 69 years to 81% for those aged 70 years. Multivariable logistic regressions showed year-over-year age difference was an independent predictor for adjuvant radiation recommendation at only age 70 versus 69 (OR, 0.47; CI, 0.39-0.57; P < .001). For cohort 2, endocrine therapy recommendation showed a small decline at age 70, and year-over-year age difference was a predictor of endocrine therapy recommendation at only age 70 versus 69 (OR, 0.86; CI, 0.74-0.99; P=.001). We observed a unique decline in appropriate adjuvant therapy recommendation between ages 69 and 70. This suggests use of an age cutoff heuristic to process patient age in this population as a categorical, binary variable. This is a previously undescribed phenomenon in early-stage breast cancer.

Dosimetric benefits of 3D-printed modulated electron bolus following lumpectomy and whole-breast radiotherapy for left breast cancer.

Radiotherapy with electrons is commonly applied to the tumor bed after whole-breast radiotherapy following breast conservation surgery for breast cancer patients. However, the radiation dose to adjacent organs-at-risk (OARs) and conformity of planning target volume (PTV) cannot be optimized. In this study, we examine the feasibility of using modulated electron bolus (MEB) to improve PTV conformity and reduce the dose to these OARs. Twenty-seven patients with left breast cancer were retrospectively selected in this study. For each patient, a tangential photon plan in RayStation treatment planning system with prescription of 26 Gy in 5 fractions was created as base plan. Two electron plans, one without bolus and one with MEB using Adaptiiv software based on the PTV were created. Various dosimetric parameters of OARs including left lung, heart, left anterior descending artery (LAD) and ribs and the conformity indices of PTV of these 2 electron plans together with the base plans were compared. Statistically significant decreases in the dosimetric parameters (V5Gy, V10Gy, V20Gy, and mean dose) of the ipsilateral left lung and the heart were observed with MEB. The median maximum dose to the LAD and the ribs decreased by 6.2% and 4.5% respectively. The median conformity index was improved by 14.3% with median increases of monitor units by 1.7%. Our results show that MEB is feasible resulting in reduction of doses to the predefined OARs and an improved conformity of PTV. By using 3D printing, MEB might be considered as an alternative to conventional electron boost.

NRG RTOG 1005: A Phase III Trial of Hypo Fractionated Whole Breast Irradiation with Concurrent Boost vs. Conventional Whole Breast Irradiation Plus Sequential Boost Following Lumpectomy for High Risk Early-Stage Breast Cancer

<h3>Purpose/Objective(s)</h3> Randomized trials support a supplemental radiation dose (Boost) to the lumpectomy (L) cavity region after whole breast irradiation (WBI), providing a 20-30% relative reduction of in-breast recurrence (IBR); with the disadvantage that it extends treatment duration ⁓ 1 week. Hypofractionated WBI (H-WBI) in ≤ 3 weeks is used after L to deliver adjuvant WBI with acceptable toxicity and comparable IBR as conventional WBI (C-WBI) 50 Gy in 2 Gy fractions (F). NRG RTOG 1005 sought to determine whether a boost delivered concomitantly with H-WBI over 15 F is non-inferior for IBR compared to boost delivered sequentially after C-WBI in patients (pts) considered at High Risk of IBR. <h3>Materials/Methods</h3> Protocol-specified High Risk pts post L with stages 0, I & II breast cancer were randomized to C-WBI 50 Gy in 25 F or 42.7 Gy in 16 F plus sequential boost of 12 Gy in 6 F or 14 Gy in 7 F (Arm I) or H-WBI 40 Gy in 15 F plus concomitant boost of 8 Gy in 15 F of 0.53 Gy per day (Arm II). Radiation was target based 3-dimensional conformal radiation therapy (3DCRT) or intensity modulated radiation therapy (IMRT) and quality review (QA) was required. Stratification was by age (<50 vs ≥ 50), adjuvant chemotherapy (Y vs N), ER status (+ vs -) and histologic grade (1, 2 v 3). The primary endpoint is IBR. Assuming Arm I 5‐year IBR of 1.59%, 90% CI upper bound hazard ratio (HR) of 2.12 and 1‐sided significance level = 0.05, 2150 pts with at least 46 IBR events provide >80% power to conclude non‐inferiority. IBR was analyzed comparing the cause-specific hazards. Adverse Events (AE) were graded with NCI CTCAE v4. Physician-reported NRG-RTOG Global Cosmetic Score (GCS) was grouped as excellent/good vs fair/poor, and arms compared with chi-square. <h3>Results</h3> 2262 of 2354 randomized pts were eligible (Arm I n=1124; Arm II n=1138). Median age 55 years, 34% Stage II, 52% grade 3, 30% ER-, 17% close/+ margins consistent with a "High Risk" population. Radiation was 3DCRT 81%, IMRT 19%, and the QA was per protocol 81% and 88% on Arm I vs II, respectively. With a median follow-up of 7.3 years and 56 IBR events, the 5 and 7-year IBR were 2.0% and 2.2% on Arm I and 1.9% and 2.6% on Arm II. The non-inferiority comparison (Arm I reference level) resulted in a HR (90% CI): 1.32 (0.84, 2.05) and p = 0.039, thus meeting non-inferiority. No differences in AEs noted between arms, with low rates of ≥ grade 3 treatment-related AEs, 3.3% vs 3.5% for Arm I vs II, respectively (p=0.79). No difference in 3-year excellent/good cosmesis by arm: 86% for Arm I vs 84% Arm II (p=0.61). <h3>Conclusion</h3> Concomitant boost with H-WBI results in non-inferior IBR compared to sequential boost after C-WBI in high-risk cases and reduces overall treatment time. Using target based 3DCRT or IMRT, there are no differences in toxicity or cosmetic outcome for concomitant v sequential boost or the WBI fractionation regimen.

Shaves off the Cavity or Specimen in Lumpectomy for Breast Cancer.

Re-excision for positive margins (margins where tumor is positive) after breast conserving surgery (BCS) is common and burdensome for breast cancer patients. Routine shave margins can reduce positive margins and re-excision rates. Cavity shaving margin (CSM) removes margins from the lumpectomy cavity edges, whereas specimen shave margin (SSM) requires exvivo removal of margins from the resected specimen. We assessed breast cancer patients undergoing BCS who received CSM or SSM procedures from 2017 to 2019. CSM and SSM techniques were compared by analyzing positive rates of primary and final shaved margins, re-excision rates, and tissue volumes removed. Of 116 patients included in this study, 57 underwent CSM and 59 underwent SSM. Primary margins were positive or close in 19 CSM patients and 21 SSM patients (33% versus 36%; P=0.798). Seventeen CSM patients had a tumor in shaved margin specimens, compared to four patients for SSM (30% versus 7%; P<0.001); however, final shave margins were similar (5% versus 5%; P=0.983). Volumes of shave specimens were higher with SSM (40.7 versus 13.4cm3; P<0.001), but there was no significant difference in the total volume removed (146.8 versus 134.4cm3; P=0.540). For tumors 2cm or larger, the total volume removed (140 versus 206cm3; P=0.432) and rates of final margin positivity (7.5% versus 0%; P=0.684) were similar for both techniques. CSM and SSM are effective techniques for achieving low re-excision rates. Our findings suggest that surgeons performing either CSM or SSM may maintain operative preferences and achieve similar results.

Global adoption of single-shot targeted intraoperative radiotherapy (TARGIT-IORT) for breast cancer-better for patients, better for healthcare systems.

Micro abstractTargeted intraoperative radiotherapy (TARGIT-IORT) is delivered immediately after lumpectomy for breast cancer. We estimated its impact. At least 44,752 patients with breast cancer were treated with TARGIT-IORT in 260 centres in 35 countries, saving >20 million miles of travel and preventing ~2,000 non–breast cancer deaths. The TARGIT-IORT website (https://targit.org.uk/travel) provides maps and tools to find the nearest centre offering TARGIT-IORT and travel savings.BackgroundTargeted intraoperative radiotherapy (TARGIT-IORT) delivers radiotherapy targeted to the fresh tumour bed exposed immediately after lumpectomy for breast cancer. TARGIT-A trial found TARGIT-IORT to be as effective as whole-breast radiotherapy, with significantly fewer deaths from non–breast cancer causes. This paper documents its worldwide impact and provides interactive tools for clinicians and patients.MethodCentres using TARGIT-IORT provided the date of the first case and the total number of patients. We plotted these data on a customised Google Map. An interactive web-based tool provided directions to the closest centre. Using the data from the TARGIT-A trial, we estimated the total savings in travel miles, carbon footprint, and the number of non–breast cancer deaths that might be prevented.ResultsData from 242 (93%) of the 260 centres treating patients from 35 countries were available. From the first patient treated in 1998 to early 2020, at least 44,752 women with breast cancer have been treated with TARGIT-IORT. The TARGIT-IORT website (https://targit.org.uk/travel) displays the Google Map of centres with number of cases and an interactive tool for patients to find the nearest centre offering TARGIT-IORT and their travel savings. Scaling up to the already treated patients, >20 million miles of travel would have been saved and about 2,000 deaths prevented.ConclusionOne can ascertain the number of patients treated with a novel treatment. These data show how widely TARGIT-IORT has now been adopted and gives an indication of its beneficial worldwide impact on a large number of women with breast cancer.

Regional Disparities in the Use and Delivery of Adjuvant Radiation Therapy after Lumpectomy for Breast Cancer in the Medicare Population

PurposeWe examined radiation therapy (RT) use among patients with early-stage breast cancer and analyzed the contribution of patient, cancer, and regional factors to the likelihood of RT receipt across Health Service Areas. Methods and MaterialsWe identified 13,176 patients aged 66 to 79 years in the Surveillance, Epidemiology, and End Results (SEER) Program–Medicare database who were diagnosed with lymph node–negative breast cancer in 2007 to 2011 and were treated with breast-conserving surgery. Patients were stratified as being at high risk or low risk for recurrence based on National Comprehensive Cancer Network Guidelines. Receipt of RT was studied with 5 modeling approaches to determine whether RT use and regional variation in its use changed based on the risk level of the cohort. Multivariable mixed-effects logistic regression was performed for each outcome. Choropleth maps were used to describe patterns of RT use. ResultsAmong high-risk patients, 70.1% received RT, compared with 72.6% of low-risk patients (P = .002). Among patients receiving RT, 60.9% were classified as high-risk, compared with 63.0% of patients who did not receive RT (P = .002). In multivariable analyses, patients in all rural areas had lower odds of receiving RT compared with the entire cohort (odds ratio [OR], 0.73; P < .001) and had lower odds of being high-risk and receiving RT (OR, 0.69; P < .001). Black patients (OR, 0.73; P = .001) and Asian patients (OR, 0.74; P = .004) had decreased likelihood of receiving RT compared with the entire cohort. The regional interclass correlation coefficient (ICC) for the model predicting receipt of RT among all patients was 0.05 and among low-risk patients was 0.06. The regional ICC dropped to 0.02 for the model predicting being both high-risk and receiving RT among all patients. ConclusionsWe observed regional and racial and ethnic disparities in RT receipt among our cohort. Reassuringly, less regional variability was observed for RT receipt among those at high risk for recurrence. Future work is needed to understand the causes of these regional disparities to better serve patients who may benefit from treatment.

HSD3 Choosing Wisely? Use of Intensity Modulated Radiation Therapy Following Lumpectomy in Early-Stage Breast Cancer: A Seer-Medicare Analysis

The American Society for Radiation Oncology’s (ASTRO) Choosing Wisely (CW) initiative recommends against the routine use of intensity-modulated radiotherapy (IMRT) for whole breast radiotherapy in patients with breast cancer (BC). The impact of CW on use of IMRT in older patients with BC following breast-conserving surgery was evaluated. Also, factors that may predict IMRT use were assessed.

Use of breast MRI to distinguish treatment failure versus new primary tumor following single fraction breast intraoperative radiotherapy for breast cancer (SF-IORT).

e12534 Background: Single-fraction, intraoperative radiation therapy (SF-IORT) can replace whole breast radiotherapy (WBT) in select patients after lumpectomy for breast cancer. By combining histology review with co-registration of breast MRI at diagnosis and following an in-breast tumor recurrence, we sought to characterize IBTR as: missed on initial MRI, treatment failure, or new primary tumor. This has important implications for both breast MRI and understanding the effectiveness of SF-IORT. Methods: We reviewed our IORT database for patients with IBTR. Three radiologists recorded findings on DCE-MRI, mammograms and ultrasound, pathology at initial diagnosis and IBTR, and time to IBTR. Results: 90 women received SF-IORT between 12/6/2002 - 4/10/2019. There were 6 IBTRs (average age at recurrence 63, range 49-71 years). For these 6 patients, initial diagnostic mammograms showed fatty (1), scattered (4) or extremely dense (1) breasts with suspicious masses (4), calcifications (1), or asymmetry (1), average size 1.4 cm: range 0.3 - 2.0 cm. On MRI, background parenchymal enhancement was minimal (2), mild (2), moderate (1), or marked (1), showing a mass (4), mass/distortion (1), or post-biopsy marker/no abnormal enhancement (1). Initial pathology showed 2 IDC, 3 IDC/DCIS, and 1 DCIS, (average size 1.7 cm, range 1.1 - 2.4 cm) with 6/6 ER +, 5/6 PR + and 6 HER2 negative. IDC Ki-67 ranged from 5-25%. 5/6 patients had sentinel lymph node biopsy (SLNB) with 1/5 having a positive SLN. 4/6 received endocrine therapy. One patient declined follow-up mammography. After IORT, IBTR (average size 1.4 cm, range 0.7 - 3.6 cm) was diagnosed by mammography (3), palpable breast lump (2), or palpable axillary lymph node (LN) (1) shown as mass (4), mass/calcifications (1), or abnormal LN (1). IBTR occurred post-SF-IORT an average of 141.7 months, range 88.3 to 195.8 months. 2/6 IBTR occurred near the biopsy cavity. Subsequent surgery included mastectomy (3), re-excision lumpectomy/RT (2), or axillary LN dissection/RT (1) showing 4 IDC, 1 IDC/DCIS, and 1 IDC /ILC (6/6 ER +; 3/6 PR positive; 2 PR weakly positive; and 5 HER2 negative, 1 HER2 equivocal). Ki-67 ranged from 1-70%. Conclusions: 6/90 (6.6%) patients had an IBTR an average of 141.7 months post SF-IORT with 2/6 near the biopsy cavity. Breast MRI reliably screens patients for SF-IORT. Co-registration of imaging can help distinguish true recurrences from new primary tumors.

Self-Rehabilitation Through Dance: An Ethnographic Study on Candy Girls Breast Cancer Survivor Group in Kuala Lumpur, Malaysia

This study intends to examine a breast cancer survivor group called the Candy Girls. Candy Girls comprises 26 to 30 women (aged between 40 and 73 years), who are breast cancer survivors in the post-clinical phase. They all have successfully undergone various combinations of treatment such as lumpectomy, mastectomy, radiotherapy and chemotherapy for breast cancer and are on the path to recovery and post-recovery. In 2010, this group came together for a year-long research conducted by the Universiti Malaya’s Faculty of Medicine through the Department of Rehabilitation Medicine. Realising the benefits of exercise for the well-being of cancer survivors, Candy Girls decided to continue dancing on their own even after the completion of the research study. With the support of breast surgeons at the University of Malaya Medical Centre (UMMC), this group began a weekly three-hour self-administered exercise session, that is still, to this day, taking place every Saturday. Their activities focus primarily on dance. The group gradually expanded dance genres by incorporating line dance, Latin dances-based Zumba sessions, Malay folk dance forms such as joget and zapin, and Bollywood dance. While the multi-ethnic women are determined to stay healthy and happy through their weekly dance routines, they have made significant impact on women at large by performing dances at Breast Cancer Relays, Awareness Campaigns and Health Conferences. By engaging with this community of survivors, the researchers have not only been able to observe their activities but also to support them through additional yoga and dance trainings. The act of giving back to the community has further strengthened the researchers' relationship with the study subjects and has allowed deeper engagement with the community. This ethnographic research shows that dance as self-rehabilitation, not only enhances physical mobility and emotional well-being, but forges a strong group solidarity among the women as a much-needed support system for survivors.

The efficiency of MarginProbe in detecting positive resection margins in epithelial breast cancer following breast conserving surgery

IntroductionUp to 30% of patients undergoing lumpectomy for breast cancer are in need for re-excision due to either close or involved margins. We evaluated the yield of Margin Probe© (MP; Dilon Technologies, USA) in a cohort of patients undergoing lumpectomy for both palpable and non-palpable tumors. MethodsFollowing lumpectomy, margins were evaluated with MP and readings were compared to the lumpectomies’ pathological evaluation irrespective of whether additional margins were removed during surgery. Involved margins or the presence of DCIS within 1 mm of the resection margins were considered as positive margins. Results48 patients with 51 tumors underwent lumpectomy. Thirteen of the 51 lumpectomies had pathological close or involved margins. MP identified 3 out of the 13 positive margins. False-positive readings were recorded in 97 out of 287 margins. The sensitivity, specificity, positive predictive value and negative predictive value were 23.1% (95%CI 5.0% 53.8%), 66.4% (95%CI 60.7%–71.9%), 3% (95%CI 0.6%–8.5%), and 95.1% (95%CI 91.1%–97.6%) respectively. ConclusionsMP cancer detection rate is relatively low while high false-positive rate leads to unnecessary shavings in almost all patients. Evaluation of MP performance should be based on comparing MP read to pathology report.