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Purpose/Objectives To assess whether an association exists between surgical localization technique and size of lumpectomy cavity on radiation (RT) planning CT scan. Adjuvant RT with boost to lumpectomy cavity has been shown to improve local control compared to adjuvant whole breast radiation alone, but larger cavity sizes can lead to worse cosmetic outcomes following boost administration, which could lead providers to omit boost. Therefore, decreasing cavity size could increase guideline-concordant boost administration and minimize adverse cosmetic outcomes. Materials/Methods A retrospective review was conducted of all patients undergoing breast conserving surgery with either wire- or magnetic seed -guided lumpectomy followed by adjuvant RT at a single institution from 2018 to 2021. Data were collected from pre-surgical work-up, surgical pathology, and radiation planning. Women undergoing bracketed wire localization and patients treated by a surgeon who only performed wire localized procedures were excluded. The primary outcome was lumpectomy cavity size as measured on planning CT. We first conducted an overlapping weights propensity score analysis to account for imbalance between groups in age, BMI, breast size as measured on planning CT scan, pre-operative imaging tumor volume, neoadjuvant therapies, lumpectomy histology (DCIS alone vs DCIS + invasive vs invasive alone vs invasive with lobular features vs no residual), and multifocality. Multivariable analysis (MVA) of CT cavity volume included the above weighted variables as well as surgeon and radiation oncologist. Secondary analyses included MVA of total pathologic volume, bivariable analysis of boost delivery, bivariable analysis of electron vs photon boost, stratification by surgeon, and fixed effect model for year of surgery. Results Of 617 women who received lumpectomy during the study period, 387 were included in final analysis. Patients who underwent seed localization were less likely to have multifocal disease, less likely to have calcifications on mammogram, more likely to have ultrasound measurements for pre-op imaging, and had smaller tumor size on pre-op imaging. Four surgeons performed all cases, with rates of seed use per surgeon ranging from 27.7% to 70.7% but generally increasing throughout the study period. There was no difference between wire and seed localization in the need for additional margins based on intra-operative margin analysis (58.4 vs 62.7%, p = 0.5). There was no difference in positive margins (6.4 vs 5.4%, p = 0.81) or second surgeries (9.4 vs 8.1%, p = 0.79). Rates of close margins were the same for DCIS (23.4 vs 17.3%, p = 0.35) and invasive carcinoma (7.6 vs 6.8%, p = 0.97) between techniques. Initial uncorrected bivariable analysis shows wire localization has a non-significant trend toward increased CT cavity volume (4.56cc, p = 0.15) and a significant association with total pathology volume (21.7cc, p = 0.004). For the primary outcome, breast size, time from surgery to simulation, and surgeon were all significantly associated with CT cavity volume but there was no significant difference by localization technique (p=0.38). For pathology volume, there was a non-significant trend toward increased specimen volume with wire localization (p = 0.07), and significant associations with BMI, histology, and pre-op imaging volume. When stratified by surgeon, there was no surgeon for whom one localization technique led to significantly different CT or pathology volume over the other. There were no significant changes of the treatment effect over time (p = 0.79). There was no significant difference between wire and seed localization in indicated boost delivery (85% vs 79%, p = 0.14) or electron boost (42% vs 56%, p = 0.13). Conclusion There was no significant difference in CT cavity size between wire localization and magnetic seed localization, suggesting that the choice between these surgical techniques does not impede RT boost delivery. Citation Format: Michael Dykstra, Jessica Thompson, Jessica Aldous, Shannon Jiang, Tasha Hughes, James Hayman, Aleksandar Dragovic, Jennifer Shah, Alfred Chang, Corey W. Speers, Michael Sabel, Lesly Dossett, Matthew Schipper, Reshma Jagsi. Effect of Wire vs Magnetic Seed Localization on Lumpectomy Cavity Size [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-09-05.

Until recently, most patients with sentinel lymph node-positive (SLN+) melanoma underwent a completion lymph node dissection (CLND), as mandated in published trials of adjuvant systemic therapies. Following multicenter selective lymphadenectomy trial-II, most patients with SLN+ melanoma no longer undergo a CLND prior to adjuvant systemic therapy. A retrospective analysis of clinical outcomes in SLN+ melanoma patients treated with adjuvant systemic therapy after July 2017 was performed in 21 international cancer centers. Of 462 patients who received systemic adjuvant therapy, 326 patients received adjuvant anti-PD-1 without prior immediate (IM) CLND, while 60 underwent IM CLND. With median follow-up of 21 months, 24-month relapse-free survival (RFS) was 67% (95% CI 62% to 73%) in the 326 patients. When the patient subgroups who would have been eligible for the two adjuvant anti-PD-1 clinical trials mandating IM CLND were analyzed separately, 24-month RFS rates were 64%, very similar to the RFS rates from those studies. Of these no-CLND patients, those with SLN tumor deposit >1 mm, stage IIIC/D and ulcerated primary had worse RFS. Of the patients who relapsed on adjuvant anti-PD-1, those without IM CLND had a higher rate of relapse in the regional nodal basin than those with IM CLND (46% vs 11%). Therefore, 55% of patients who relapsed without prior CLND underwent surgery including therapeutic lymph node dissection (TLND), with 30% relapsing a second time; there was no difference in subsequent relapse between patients who received observation vs secondary adjuvant therapy. Despite the increased frequency of nodal relapses, adjuvant anti-PD-1 therapy may be as effective in SLN+ pts who forego IM CLND and salvage surgery with TLND at relapse may be a viable option for these patients.

BACKGROUND Preventable medical errors represent a major public health problem. To prevent future errors, improve disclosure, and mitigate malpractice risks, organizations have adopted strategies for transparent communication and emphasized quality improvement through peer review. These principles are incorporated into the Agency for Healthcare Research and Quality (AHRQ) Communication and Optimal Resolution (CANDOR) Toolkit, which facilitates (1) transparent communication, (2) error prevention, and (3) achieving optimal resolution with patients and families; however, how medical errors should be addressed when they are discovered between systems—intersystem medical error discovery (IMED)—remains unclear. Without mechanisms for disclosure and feedback on the part of the discovering provider, uncertainty remains as to the extent to which IMED is communicated with patients or responsible providers. Furthermore, known barriers to disclosure and reporting one’s own error may not be relevant or may be replaced by other unknown barriers when considering scenarios of IMED. OBJECTIVE This study aims to develop and test implementation of a modified CANDOR process for application to IMED scenarios. METHODS We plan a series of studies following an implementation framework. First, we plan a participatory, consensus-building stakeholder panel process to develop the modified CANDOR process. We will then conduct a robust preimplementation analysis to identify determinants of implementation of the modified process. Using the Consolidated Framework for Implementation Research as a theoretical framework, we will assess organizational readiness by key informant interviews and individual-level behaviors by a survey. Findings from this analysis will inform the implementation toolkit that will be developed and pilot-tested at 2 cancer centers, sites where IMED is hypothesized to occur more frequently than other settings. We will measure 5 implementation outcomes (acceptability, appropriateness, reach, adoption, and feasibility) using a combination of key informant interviews and surveys over the pre- and postimplementation phases. RESULTS This protocol was funded in August 2018 with support from the AHRQ. The University of Michigan Medical School Institutional Review Board has reviewed and approved the scope of activities described. As of April 2019, step 1 of aim 1 is underway, and aim 1 is projected to be completed by April 2020. Data collection is projected to begin in January 2020 for aim 2 and in August 2020 for aim 3. CONCLUSIONS Providing a communication and resolution strategy applicable to IMED scenarios will help address the current blind spot in the patient safety movement. This work will provide important insights into the potential utility of an implementation toolkit to improve transparent communication and optimal resolution of IMED scenarios. The natural progression of this work will be to test the toolkit more broadly, understand the feasibility and barriers of implementation on a broader scale, and pilot the implementation in new organizations. INTERNATIONAL REGISTERED REPOR PRR1-10.2196/13396