American Society Research Articles

Hemodynamic effects of withholding vs. continuing angiotensin II receptor blockers on the day of prone positioning spinal surgery in elderly patients.

The hemodynamic effects of withholding vs. continuing angiotensin II receptor blockers (ARBs) before surgery in elderly patients undergoing spinal surgery in a prone position during anesthesia induction to skin incision are still unknown. In this prospective study, 80 patients undergoing spinal surgery in a prone position with general anesthesia, aged 60-79 years, American Society of Anesthesiologists (ASA) II or III, were enrolled. Patients who had ARBs only in their preoperative medication list were randomly divided into two groups at a 1:1 ratio: In Group A, ARBs were continued on the morning of surgery, while in Group B, they were withhold. Norepinephrine was infused to maintain the blood pressure at the baseline level of ±20% during anesthesia induction in all patients. The primary outcome was the consumption of norepinephrine in each group from anesthesia induction to skin incision. The secondary outcomes include changes in invasive arterial blood pressure and heart rate, the fluid infusion volumes, the amounts of anesthetic drugs, and the total time from induction to skin incision. There were no significant differences in the demographics, the fluid infusion volumes, the amounts of anesthetic drugs, the total time from induction to skin incision, and hemodynamics at different time points (p > 0.05), while significant differences were found in norepinephrine consumption between the two groups (p < 0.001). Compared with Group B, the consumption of norepinephrine increased significantly in Group A (93.3 ± 29.8 vs. 124.1 ± 38.7 μg, p = 0.000). In addition, the same trend was illustrated in the pumping rate of norepinephrine between Group B (0.04 ± 0.01 μg·kg-1·min-1) and Group A (0.06 ± 0.02 μg·kg-1·min-1) (p = 0.004). Our study conducted in elderly patients with hypotension undergoing prone spinal surgery demonstrated a greater pumping rate of norepinephrine during anesthesia induction in patients with ARBs continuing before surgery than those withholding, indicating that it was more difficult to maintain hemodynamic stability.Clinical Trial Registration: https://www.chictr.org.cn/showproj.html?proj=141081, ChiCTR2100053583.

Quality of Preanesthesia Teleconsultation: The TELECAM Randomized Controlled Trial.

Introduction: Preanesthesia teleconsultation helps reduce availability constraints as well as direct and indirect expenses. The TELECAM trial was performed to assess the quality of preanesthesia teleconsultation in terms of clinical parameters evaluation, feasibility, patient satisfaction and preoperative anxiety, and anesthesiologist satisfaction. Methods: TELECAM was an investigator-initiated, prospective, single-center, randomized, controlled, parallel group, evaluator-blinded, open-label study. Patients with a scheduled ambulatory surgery (orthopedic or hand surgery) were randomized into the in-person preanesthesia consultation group or the preanesthesia teleconsultation (conducted at the patient's home or workplace) group. The quality of the teleconsultation was evaluated through agreement on intubation difficulty, predictable mask ventilation difficulty, and American Society of Anesthesiologists (ASA) scores between the preanesthesia consultation and the preanesthesia in-person visit. Results: A total of 241 patients were included, and 208 were considered in the analyses. The feasibility of teleconsultation was high, with a feasibility ratio of 87.5%. The quality of the preanesthesia consultation regarding the evaluation of predictable intubation, mask ventilation difficulties, and ASA score, did not differ between the two groups (p = 0.23, 0.29, and 0.06, respectively). The preoperative satisfaction was higher for patients who had a preanesthesia teleconsultation (p = 0.04). Patients' preoperative anxiety did not differ between the two groups (p = 0.90). The median satisfaction of the anesthesiologists who performed the teleconsultation reached a maximum of 10 (IQR: 8.0; 10.0). Conclusion: This study showed positive results for the quality of preanesthesia teleconsultation on the evaluation of clinical parameters, with high feasibility and satisfaction of the patients and anesthesiologists. The trial was registered in ClinicalTrials (NCT03470896).

Renal Failure Without Hemodialysis Is a Risk Factor for Postoperative Complications in Colorectal Cancer Surgery.

Surgical outcomes of colorectal cancer (CRC) in patients with renal failure (RF) remain to be clarified. The objective of this research was to investigate how RF impacts the surgical outcomes in patients with CRC. A retrospective analysis was performed on clinical data from 633 patients who underwent colorectal resection for CRC between January 2017 and December 2021. Outcomes of the patients with and without RF were compared. RF was defined as estimated Glomerular Filtration Rate less than 30. Forty-five (7%) patients with RF were identified. RF was a significant risk factor for postoperative complications after colorectal cancer surgery (odds ratio=2.19, 95% confidence interval=1.08-4.42, p=0.0284). The patients with RF had significantly more comorbidity (p=0.016), and higher American Society of Anesthesiologists physical status (p<0.01). Hemoglobin level (p<0.01) and PNI (p<0.01) were significantly lower in those with RF. Postoperative complications were significantly higher (p=0.016), and the postoperative hospital stay was significantly longer (p<0.01) among patients with RF compared to those without RF. Patients with RF, excluding those undergoing hemodialysis, had significantly more complications compared to those without RF (p=0.004). Careful attention should be paid to perioperative management in RF colorectal cancer patients.

Abstract PO3-18-09: OPERA-01: A randomized, open-label, phase 3, study of palazestrant (OP-1250) vs standard-of-care treatment for ER+, HER2- advanced or metastatic breast cancer after endocrine and CDK4/6 inhibitor therapy

Abstract Background: In estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC), adding a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor to endocrine therapy (ET) has improved outcomes and is the current standard-of-care treatment in the first-line setting. However, resistance to first-line treatment develops in most patients (pts), which is often attributed to acquired mutations in ESR1. Limited data exist for ET-based treatment options after progression on prior ET and CDK4/6 inhibitors, and most pts will transition to chemotherapy for further treatment. Therefore, there is a significant unmet need for more effective ET in pts with ER-positive, HER2-negative MBC to improve outcomes and delay time to chemotherapy. Palazestrant (OP-1250) is a small molecule oral complete ER antagonist (CERAN) and selective ER degrader (SERD) that binds the ligand binding domain of ER and completely blocks ER-driven transcriptional activity in both wild-type (ESR1-wt) and mutant (ESR1-mut) forms of ER. In preclinical studies, palazestrant demonstrated better tumor shrinkage in ESR1-wt and ESR1-mut models when compared to fulvestrant; it also showed efficacy in brain metastasis models. In a phase 1/2 monotherapy study in pts with heavily pretreated ER-positive, HER2-negative advanced breast cancer (BC) or MBC (NCT04505826), palazestrant showed a tolerable safety profile, promising antitumor efficacy, and favorable pharmacokinetics (PK) supporting once a day (qd) dosing. The recommended Phase 2 dose of palazestrant is 120 mg qd. Methods: The OPERA-01 trial is an international, multicenter, randomized, open-label, phase 3 clinical trial comparing the efficacy and safety of palazestrant as a single agent to standard-of-care ET (fulvestrant, anastrozole, letrozole, or exemestane) in pts with ER-positive, HER2-negative advanced BC or MBC that has relapsed or progressed on 1 or 2 prior lines of ET for MBC, which includes a CDK4/6 inhibitor. Eligible pts are women (pre- or post-menopausal) or men who have a confirmed diagnosis of ER-positive, HER2-negative locally advanced evaluable BC or MBC not amenable to curative therapy. ER and HER2 status are determined according to the American Society of Clinical Oncology/College of American Pathologists guidelines. Patients must have Eastern Cooperative Oncology Group performance status 0 or 1. Prior treatments must include 1 or 2 prior lines of ET as monotherapy or in combination with a CDK4/6 inhibitor for MBC; must have received CDK4/6 inhibitor in combination with ET and have disease progression during or within 28 days of completion of each line of prior treatment for MBC; most recent ET given for ≥6 months. Prior chemotherapy in the metastatic setting is not permitted. Patients (N∼500) are randomized to palazestrant or standard-of-care ET monotherapy, and are stratified by ESR1 mutation status, prior lines of ET for advanced disease (1 vs 2 lines), and presence or absence of visceral disease. The primary endpoint of progression-free survival will be assessed by blinded independent central review in pts with and without ESR1 mutations in the intent-to-treat population. Secondary endpoints include overall survival, antitumor activity (objective response rate, clinical benefit rate, and duration of response), safety, patient-reported outcomes, and PK in pts with and without ESR1 mutations. The study is planned to be conducted globally. Citation Format: Arlene Chan, Jane Meisel, Komal Jhaveri, Joo Hyuk Sohn, Meritxell Bellet- Ezquerra, Jason Schroeder, Mark Shilkrut, Barbara Pistilli. OPERA-01: A randomized, open-label, phase 3, study of palazestrant (OP-1250) vs standard-of-care treatment for ER+, HER2- advanced or metastatic breast cancer after endocrine and CDK4/6 inhibitor therapy [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 PO3-18-09.

Testing Theories of States' Adoption of the Direct Primary

Understanding the origins of primary elections has important implications for evaluating their role in American elections. While there is little argument about the importance of primaries to the American electoral system, there is less agreement about why states adopted the direct primary and what they were intended to accomplish. Previous scholarship has laid out three theories: the strength of the progressive movement, parties' efforts to maintain one-party rule, and the urbanization of American society. Using comprehensive state-level data from 1892 to 1930, we test these theories of states' adoption of direct primaries. We find a strong influence of the strength of the progressive movement and the rate of urbanization on the adoption of the direct primary, but we do not, however, find any influence of state partisan competition. Our findings reinforce original arguments about the importance of the progressive movement and urbanization in the adoption of the direct primary.

Surgical Management of Thoracolumbar Adjacent Segment Disease: Techniques and Outcomes in 107 Patients Undergoing Surgical Intervention.

Adjacent segment disease (ASD) is a known sequela of thoracolumbar instrumented fusions. Various surgical options are available to address ASD in patients with intractable symptoms who have failed conservative measures. However, the optimal treatment strategy for symptomatic ASD has not been established. We examined several clinical outcomes utilizing different surgical interventions for symptomatic ASD. A retrospective review was performed for a consecutive series of patients undergoing revision surgery for thoracolumbar ASD between October 2011 and February 2022. Patients were treated with endoscopic decompression (N = 17), microdiscectomy (N = 9), lateral lumbar interbody fusion (LLIF; N = 26), or open laminectomy and fusion (LF; N = 55). The primary outcomes compared between groups were re-operation rates and numeric pain scores for leg and back at 2 weeks, 10 weeks, 6 months, and 12 months postoperation. Secondary outcomes included time to re-operation, estimated blood loss, and length of stay. Of the 257 patients who underwent revision surgery for symptomatic ASD, 107 patients met inclusion criteria with a minimum of 1-year follow-up. The mean age of all patients was 67.90 ± 10.51 years. There was no statistically significant difference between groups in age, gender, preoperative American Society of Anesthesiologists scoring, number of previously fused levels, or preoperative numeric leg and back pain scores. The re-operation rates were significantly lower in LF (12.7%) and LLIF cohorts (19.2%) compared with microdiscectomy (33%) and endoscopic decompression (52.9%; P = 0.005). Only LF and LLIF cohorts experienced significantly decreased pain scores at all 4 follow-up visits (2 weeks, 10 weeks, 6 months, and 12 months; P < 0.001 and P < 0.05, respectively) relative to preoperative scores. Symptomatic ASD often requires treatment with revision surgery. Fusion surgeries (either stand-alone lateral interbody or posterolateral with instrumentation) were most effective and durable with respect to alleviating pain and avoiding additional revisions within the first 12 months following revision surgery. This study emphasizes the importance of risk-stratifying patients to identify the least invasive approach that treats their symptoms and reduces the risk of future surgeries.

Abstract PO1-11-10: Use of a standardized tool for the evaluation and treatment of cancer related cognitive impairment (chemo-brain) among breast cancer patients

Abstract There is a steep linear increase in patients surviving a cancer diagnosis. Clinical solutions that address the high prevalence of cancer-related treatment effects (CRTE) are urgently needed. A stark example of this need is the dearth of screening and treatment programs for cancer related cognitive impairment (CRCI) (colloquially called “chemo-brain”). Up to 75% of cancer patients report neurocognitive changes that leave patients unable to cope with the expectations of employers, colleagues, families, and friends. The prevalence of neurological disorders is 275% higher among adult cancer patients, when compared to an adult cancer-free population. For many adolescent and young adult cancer patients, the onset of CRCI occurs during "cognitive prime time"; a time when individuals are pursuing education, careers, and raising families. To address a gap in CRTE we have implemented a virtual multi-disciplinary intervention to measure and treat CRCI. Our CRCI intervention follows National Comprehensive Cancer Network and American Society of Clinical Oncology (ASCO) guidelines for CRCI. These guidelines indicate a multi-disciplinary approach with emphasis on increasing physical activity levels, cognitive-behavioral therapy, memory adaptive training, mood management, and sleep optimization. Our approach also follows recent ASCO guidelines for nutrition counseling. Our CRCI program utilizes medical oncologists, physician assistants, mental health therapists, registered dietitians, and occupational therapists. A nationally validated patient reported outcome (PRO) measurement, analysis, and reporting platform informs clinical treatment pathways, monitors patient progress, guides clinical decision making, and improves patient/provider communication. Using health status measures for CRCI, and following American Cancer Society and ASCO guidelines, patients are risk-stratified into three personalized cancer survivor care pathways: 1) low-complexity patients; 2) medium-complexity patients; and 3) high-complexity patients. Low-complexity patients baseline PROs score in the normal range, medium-complexity patients are those who score below the norm (moderate to large effect size difference from normal), and high-complexity patients are those who score well below the norm (greater than larger effect size difference from normal). Low-complexity patients are enrolled into a self-management and continuation of care program. Medium-complexity patients are enrolled into a shared care program. High-complexity patients are enrolled into an acute care program. All three clinical pathways include continued risk-factor vital-sign surveillance. Nearly 100% (99%) of patients who enroll in our primary cancer survivor care program complete our PRO baseline (N=80). From a convenient sample of breast cancer patients (N=42), provisional results of patient-specific segmentation analyses reveal a nearly perfect bell-shaped curve, with 51% of the population classified within the definition of medium-complexity and even split of outliers (high-complexity 24% and low-complexity 24%). Additionally, of all patients in our primary cancer survivor care program who completed at least three measurement time points for health status measures of cognitive impartment (N=38), 92% had a positive experience, 71% had a clinically significant improvement in cognitive health, 21% had a no change in cognitive status, and only 8% had a decline in cognitive health. If these data, and PRO implementation approach hold true, this program could be scaled to national and international cancer survivor population suffering from CRCI. Citation Format: John Librett, Mark Kosinski, Gregory Litton. Use of a standardized tool for the evaluation and treatment of cancer related cognitive impairment (chemo-brain) among breast cancer patients [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 PO1-11-10.

Meeting Abstracts from the 2024 Annual Scientific Meeting of the American Society of Colon and Rectal Surgeons.

Meeting Abstracts from the 2024 Annual Scientific Meeting of the American Society of Colon and Rectal Surgeons.

Abstract PO1-10-07: A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients with Metastatic Breast Cancer: Primary Results of a Prospective Intervention Trial

Abstract Background: Tumor genomic testing (TGT) has become standard-of-care for all patients with metastatic breast cancer (MBC). American Society of Clinical Oncology (ASCO) and American College of Medical Genetics (ACMG) guidelines for patient education prior to TGT are not widely followed. We have previously demonstrated disparities in general genomic knowledge across race and income. The purpose of this study was to develop a concise (3-4 minute) video for patient education prior to TGT and evaluate the video’s impact in a prospective interventional trial. We report the results of the primary endpoint of the MBC cohort (ClinicalTrials.gov NCT05215769). Methods: We previously published our internal quality improvement cycle involving provider surveys, patient focus groups, and adult learning theory-based content development for TGT educational videos. An animated video incorporating culturally diverse images available in English and Spanish was created to be applicable to any cancer type, with MBC-specific content included for patients with breast cancer. A total of 150 participants were enrolled at a single tertiary academic institution, of whom 53 were diagnosed with MBC. Participants completed validated survey instruments immediately prior to video viewing (T1), immediately post-viewing (T2) and 60-90 days later, after TGT results were documented (T3). Instruments included: 1) 10-question objective genomic knowledge/understanding (GKU); 2) 10-question video message-specific knowledge/recall (VMSK); 3) 11-question Trust in Physician/Provider (TIPP); 4) attitudes regarding TGT. The primary objective was to assess change in VMSK between T1 and T2 and a cohort of 50 participants provided 90% power to detect an effect size of 0.47 from pre- to post-video using two-sided Wilcoxon signed-rank test with alpha of 0.05. Associations of VMSK, GKU, and TIPP with categorical demographic variables were explored with Kruskal-Wallis test. Results: From April 2022 to May2023, a total of 150 participants were enrolled (MBC n=53, lung cancer n=38, metastatic cancer of any type n=59). The MBC cohort analysis is presented. The MBC cohort had a median age of 59; all were female; majority Caucasian (48/53, 91%); most were married/in domestic partnership (35/53, 66%). For the primary endpoint, there was a significant increase in video message-specific knowledge (Wilcoxon signed rank p&amp;lt; 0.0001) but there was no significant change in general genomic knowledge (p=0.89) or trust in provider (p=0.59). Improvement of video message-specific knowledge was consistent across demographic groups, including age, income, and education. Of the 10-questions in the VMSK survey, results for four questions significantly improved after viewing the video, including questions informing the likelihood of TGT impact on treatment decision, incidental germline findings, and cost of testing (Table 1). Baseline genomic knowledge was significantly associated with income (nominal p=0.028), with higher income associated with higher baseline knowledge. Conclusions: A concise, 3-4 minute, broadly applicable video incorporating culturally diverse images administered prior to TGT significantly improved video message-specific knowledge across all demographic groups. Ongoing work includes analysis of additional cohorts (lung, any type) and evaluation in community oncology setting with a goal to provide a paradigm to efficiently educate and empower patients while addressing ASCO/ACMG guidelines within the flow of clinical practice. Table 1. Response to video message-specific questions before versus after tumor genomic testing educational video intervention Citation Format: Daniel Stover, Deloris Veney, Lai Wei, Amanda Toland, Carolyn Presley, Tasleem Padamsee, Clara Lee, Heather Hampel, William Irvin, Jawad Francis, Michael Bishop, Shelly Hovick, Leigha Senter. A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients with Metastatic Breast Cancer: Primary Results of a Prospective Intervention Trial [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 PO1-10-07.

Abstract PO5-16-06: Prophylactic Neurokinin-1 Receptor Antagonist Use Pre- and Post- Choosing Wisely Initiative among Women with Breast Cancer

Abstract Objective: In April 2012, the American Society of Clinical Oncology (ASCO) issued recommendations as a part of the Choosing Wisely (CW) campaign with the aim to identify the areas of low-value utilization. One of the CW recommendations is not to use expensive antiemetics, specifically Neurokinin-1 Receptor Antagonist (NK1-RA) for patients initiating low or moderate emetic risk chemotherapy. The purpose of this study was to determine the impact of CW on prophylactic NK1-RA use among women with breast cancer. Methods: Using Optum’s de-identified Clinformatics® Data Mart Database for 2010 to 2018, a retrospective cohort study was conducted for women aged ≥18 years with breast cancer with at least one newly initiated claim for low/minimal/moderate emetic risk chemotherapy (n = 25,549). All approved antiemetics - aprepitant, fosaprepitant, rolapitant, and netupitant/palonosetron) were included. An interrupted time series using a segmented regression model was used to assess the effect of CW on the prophylactic NK1-RA use. Results: The prophylactic use of NK1-RAs among patients with breast cancer receiving low/minimal/moderate emetic risk chemotherapy decreased from 11.1% pre-CW to 7.7% post-CW. Segmented regression analysis showed that there was a significant increase of 0.11 per 100 patients per quarter in the use of prophylactic NK1-RAs prior to CW recommendation. However, immediately after the CW (occurred in Q42013), there was a significant decline in prophylactic NK1-RA use by 1.03 per 100 patients in Q22014. For the time after intervention, there was a significant decline in NK1-RA use by 0.37 per 100 patients per quarter in the post-CW period compared to the pre-CW period (p&amp;lt; 0.05). Conclusion: This study highlights a significant but modest decline in the inappropriate use of prophylactic NK1-RAs after the implementation of CW antiemetic recommendation. Continued statewide or local educational efforts for dissemination of CW recommendations are needed to facilitate appropriate prophylactic use of NK1-RAs. Table. Adjusted* Interrupted Time Series Segmented Regression Analysis of Prophylactic NK1-RA use among women with breast cancer before and after the Choosing Wisely initiative *Adjusted for insurance, health plan type, age, comorbidity, and emetic risk Citation Format: Shweta Kamat, Britny Brown, Steven Cohen, Ami Vyas. Prophylactic Neurokinin-1 Receptor Antagonist Use Pre- and Post- Choosing Wisely Initiative among Women with Breast Cancer [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 PO5-16-06.

Abstract PO1-08-04: Universal Germline Genetic Testing for Breast Cancer: Implementation in a Rural Practice and Impact on Shared Decision Making

Abstract Background: Prior work from our group has shown a high rate of familial breast cancer (BC) among rural BC patients (pts), with 33% reporting &amp;gt; 1 first-degree family members with BC and 55% meeting NCCN germline genetic testing (GGT) criteria (Shelton CH et al. NC Med. J; 2022). In 2018, we increased GGT to include all BC pts and observed: 1) many pts were out-of-criteria per NCCN guidelines but had actionable pathogenic germline variants (PGVs) and 2) knowledge of GGT factored significantly into shared decision making by providers and patients, including for positive and negative results. Beginning in 2019, concurrent with the recommendation from the American Society of Breast Surgeons, we expanded this model of universal GGT to an IRB-approved study to measure the impact of prospective testing on shared decision-making. Herein we report the real-world implementation of universal GGT for patients with BC and genetics-informed treatment decision-making in a rural community practice. Methods: From 2019-2022 all BC pts at a small, rural community hospital were offered GGT. Demographics, clinical features, and GGT results were collected along with clinician-reported clinical recommendations for treatment based on GGT results. Descriptive statistics and two-tailed Fisher’s exact test were employed and significance was set at p&amp;lt; 0.05. Results: 210 BC pts were offered GGT and 192 (91%) underwent testing [97% female, 95% non-Hispanic White, mean age at diagnosis of 62, 75% Stage I], with all but 7 pts completing GGT before primary treatment decisions. 104 (54%) of patients were in-criteria (IC) and 88 (46%) out-of-criteria (OOC) with NCCN GGT guidelines. PGVs were identified in 25 pts (13%) and 15 genes, most commonly BRCA1/2 (5 pts), PALB2 (3), monoallelic MUTYH (3) and ATM, BARD1, CHEK2 (2 pts each). PGV frequencies were 15% in IC and 11% in OOC patients (p=0.495). 46 (24%) pts had only a variant of uncertain significance (VUS) results. 70% of patients had &amp;gt; 1 clinical management change based on their GGT results. Changes in breast surgery, uptake of risk-reducing bilateral salpingo-oophorectomy, surveillance and clinical follow-up were significantly higher in patients with PGV compared to those with VUS/negative results (p &amp;lt; 0.0001). Compared to those with negative results, patients with PGVs in BRCA1 and BRCA2 were significantly more likely to undergo bilateral mastectomy (BLM) while those with PGVs in other genes or with VUS were not significantly more likely to elect for BLM than those with negative results. Clinicians reported that return of GGT reinforced their recommendation for 73/138 (53%) of patients who underwent breast-conserving therapy. GGT results aided in radiation therapy strategy for 54% of pts, most often resulting in dose de-escalation (accelerated fractionation) for negative/VUS pts (Table). Conclusions: Universal GGT for patients with BC was successfully implemented in a rural community practice with &amp;gt;90% uptake. Treatment was enhanced in those with clinically actionable PGVs and de-escalated in those without PGVs. Universal GGT for patients with BC is feasible to implement as the standard of practice within rural populations, enabling optimization of clinical care to patients’ genetic profile and may reduce unnecessary healthcare resource utilization. Universal Germline Genetic Testing for Breast Cancer: Implementation in a Rural Practice and Impact on Shared Decision Making Changes in Radiation Therapy Strategy based on GGT Citation Format: Charles Shelton, Sarah Nielsen, Antonio Ruiz, Lauren Shelton, Karen Freas, Sarah Poll, Brandie Heald, Daniel Pineda-Alvarez, Edward Esplin, Rachel Ellsworth, Hannah Montgomery. Universal Germline Genetic Testing for Breast Cancer: Implementation in a Rural Practice and Impact on Shared Decision Making [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 PO1-08-04.

Abstract PO1-27-11: Survival Benefit of Adjuvant Endocrine Therapy in Patients with Estrogen Receptor Low-Positive Breast Cancer

Abstract Background: Estrogen receptor (ER) low-positive (1–10%) breast cancer is a very rare subtype that accounts for only 2–5% of all breast cancer cases and was introduced as a new category in the 2020 American Society of Clinical Oncology/College of American Pathologist Guidelines. There are limited data on the overall benefit of endocrine therapy for patients with ER low-positive cancers. The objective of this study was to analyze the clinicopathological characteristics and treatment patterns in patients with ER low-positive breast cancer and to compare disease-free survival (DFS) between patients who received and did not receive endocrine therapy. Methods: A retrospective search of the prospectively maintained database of our institution identified consecutive women with ER low-positive (1–10%) primary invasive breast cancer who underwent curative surgery at Seoul National University Hospital (Seoul, Korea) between January 2010 and April 2021. Standard immunohistochemical staining techniques were used to assess the level of ER, progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) expression, and semiquantitative scores (0–100%) were reported for ER and PR. DFS was defined as the time from surgery to the development of any recurrence and was compared between women who received and did not receive adjuvant endocrine therapy using univariable and multivariable Cox proportional hazards regression. Results: A total of 721 women (median age, 51 years; range, 24–83 years) with ER low-positive cancer were included in the analysis. Overall, 28% (203/721) had AJCC stage I, 42% (304/721) had stage II, and 30% (214/721) had stage III. PR expression was negative (&amp;lt; 1%) in 79% (571/721), low-positive (1–10%) in 12% (90/721), and high-positive ( &amp;gt;10%) in 8% (60/721). HER2 expression was negative in 54% (390/721) and positive in 46% (331/721). Most women (88% [634/721]) received adjuvant endocrine therapy, including all women with PR expression &amp;gt;10%. Of the 661 women with PR expression ≤10%, 87 (13%) did not receive adjuvant endocrine therapy. HER2-targeted therapy was performed in 81% (268/331) of women with HER2-positive cancer. During a median follow-up of 5.7 years, 98 (14%) had recurrence (25 locoregional/contralateral and 73 distant metastases). AJCC stage III (HR, 3.6; 95% CI: 2.4, 5.4; P &amp;lt; .001) and receiving total mastectomy (HR, 1.8; 95% CI: 1.2, 2.8; P = .004) were associated with worse DFS. Receiving adjuvant endocrine therapy was independently associated with better DFS in the entire cohort (HR, 0.46; 95% CI: 0.28, 0.76; P = .002) and in the HER2-negative subgroup (HR, 0.40; 95% CI: 0.22, 0.75; P = .004). In the HER2-positive subgroup, receiving adjuvant endocrine therapy was not significantly associated with better DFS (HR, 0.55; 95% CI: 0.23, 1.32; P = .18). Conclusion: In this large cohort of women with ER low-positive breast cancers, adjuvant endocrine therapy was administered in the majority of cases, including those with PR &amp;gt;10% expression. Receiving adjuvant endocrine therapy was associated with better DFS, especially when HER2 expression was negative. Citation Format: Su Hyun Lee, Han Suk Ryu, Myoung-jin Jang, Kyung-Hun Lee, Han-Byoel Lee. Survival Benefit of Adjuvant Endocrine Therapy in Patients with Estrogen Receptor Low-Positive Breast Cancer [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 PO1-27-11.

Abstract PO5-22-10: Are contralateral prophylactic mastectomy rates impacted by ASBrS guidelines to offer germline genetic testing to all patients with breast cancer? Results from a large, prospective, single-institution cohort

Abstract Background: It is unclear whether the release of the American Society of Breast Surgeons’ (ASBrS) guideline to offer germline genetic testing to all patients with breast cancer impacted contralateral prophylactic mastectomy (CPM) rates. The objective of this study was to describe trends of germline testing and CPM rates, and to determine predictors of CPM uptake. Methods: This is a retrospective review of two prospectively maintained single institutional databases: Dana-Farber/Brigham Cancer Center’s surgical database, merged with Dana-Farber Cancer Institute’s Genetics and Prevention database. Trends in germline testing and CPM rates were described, in relation to the February 2019 ASBrS guideline release, and a multivariable logistic regression model was used to determine factors associated with CPM utilization. Patients with unilateral stage 0-III breast cancer who underwent surgery between January 2016 and July 2020 were included. Patients were considered “tested” if they underwent germline genetic testing and results were disclosed before their index operation. CPM was defined as contralateral mastectomy performed at index operation or anytime thereafter, excluding mastectomy for a new contralateral breast cancer event. Results: Among 6,064 women in the cohort, 2,455 (40.5%) had germline genetic testing before their index surgery. Rates of testing significantly increased over the study period from 33.7% in 2016 to 64.9% in 2020 (p&amp;lt; 0.001). A total of 783/6,064 (12.9%) patients underwent CPM which was 40.7% (783/1,926) of the patients who underwent mastectomy. The CPM rate was 13.3% before the guideline release (2016 – January 2019) and 12.5% after (February 2019 – 2020). There was no significant change in CPM rate over time (p=0.527), including before (p=0.380) and after (p=0.220) the 2019 guideline release. The following factors were associated with increased CPM rates on multivariable logistic regression: identification of a pathogenic/likely pathogenic variant in a breast cancer predisposition gene (Adjusted Odds Ratio [Adj. OR] 24.43), genetic testing with a negative test result (Adj. OR 1.52), number of relatives with breast/ovarian cancer (Adj. OR 1.18 and 1.39, respectively for each additional relative), younger age (Adj. OR 0.97 if pre-menopausal, 0.91 if post-menopausal, for each year decrement), and cT2-3 tumors (Adj. OR 1.53 and 1.94, respectively as compared to other cT stages); all p&amp;lt; 0.05. Conclusions: Despite increasing germline genetic testing rates, CPM rates were stable over time, indicating that offering genetic testing to more patients does not increase CPM rates in our experience. Selection bias is most certainly contributing to the apparent association between CPM and genetic testing, even if there is a negative test result, as the classic indications for genetic testing are similar to those for CPM. Citation Format: Anna Weiss, Stephen Knapp, Danielle Braun, Brenna Barton, Monica McGrath, Samantha Stokes, Alison Laws, Laura Warren, Stefania Morganti, Filipa Lynce, Brittany Bychkovsky, Huma Rana, Dillon Davis, Jill Stopfer, Judy Garber, Tari King. Are contralateral prophylactic mastectomy rates impacted by ASBrS guidelines to offer germline genetic testing to all patients with breast cancer? Results from a large, prospective, single-institution cohort [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 PO5-22-10.

Plastic Surgeons' Perspective on the FDA Breast Implant Regulatory Mandates.

In 2021, the US Food and Drug Administration (FDA) issued a new checklist, labeling and rupture screening recommendations for breast implants to improve the decision-making process. This study aims to understand the plastic surgeon's perspective on these changes and their perceived impact on clinical practice. In September 2023, a 27 multiple-choice cross-sectional survey was distributed to 4,352 active members of the American Society of Plastic Surgeons to evaluate attitudes on the FDA's black box warning, informed decision checklist, and updated rupture screening recommendations. A total of 591 responses were collected (13.6%). The majority of respondents were between the ages of 45 to 64 (58%) and had been in practice for more than 20 years (52%). Surgeons felt like some additions were appropriate, however the majority (57%) stated that the informed decision checklist did not have a positive impact on workflow; 66% were also neutral or disagreed with the reported incidence rates related to complications and cancer. Nearly half of respondents (47%) did not feel the black box warning improved their patients' understanding of the risks and benefits. Additionally, 47% of respondents also believed these requirements, in combination, did not improve the overall patient experience with implants. Respondents had an overall positive response towards the addition of risk information provided by the FDA issued guidance and updates to rupture screening recommendations. However, they remain divided as to whether the black box warning and patient decision checklist had an overall positive impact on clinical practice patterns.

DOES AN INTRAOPERATIVE FEMORAL FRACTURE IMPACT ONE-YEAR PATIENT-REPORTED OUTCOME MEASURES WHEN USING A CEMENTLESS CORAIL STEM?

The significance of periprosthetic fractures about a total hip arthroplasty (THA) is becoming increasingly important. Recent studies have demonstrated post-operative periprosthetic fracture rates are higher amongst cemented polished taper slip (PTS) stem designs compared to collared cementless (CC) designs.However, in the National Joint Registry, the rate of intra-operative periprosthetic femoral fractures (IOPFF) with cementless implant systems remains higher (0.87% vs 0.42%. p &lt;0.001) potentially leading to more post-operative complications.This study identifies the incidence of IOPFF, the fracture subtype and compares functional outcomes and revision rates of CC femoral implants with an IOPFF to CC stems and PTS stems without a fracture.5376 consecutive CC stem THA, carried out through a posterior approach were reviewed for IOPFF. Each fracture was subdivided into calcar fracture, greater trochanter (GT) fracture or shaft fracture.1:1:1 matched analysis was carried out to compare Oxford scores at one year. Matching criteria included; sex (exact), age (± 1 year), American Society of Anaesthesiologists (ASA) grade (exact), and date of surgery (± 6 months).Electronic records were used to review revision rates.Following review of the CC stems, 44 (0.8%) were identified as having an IOPFF. Of these 30 (0.6%) were calcar fractures, 11 (0.2%) GT fractures and 3 (0.06%) were shaft fractures. There were no shaft penetrations.Overall, no significant difference in Oxford scores at one year were observed when comparing the CC IOPFF, CC non-IOPFF and PTS groups.There were no CC stems revised for any reason with either a calcar fracture or trochanteric fracture within the period of 8 years follow-up.IOPFF do occur more frequently in cementless systems than cemented. The majority are calcar and GT fractures. These fractures, when identified and managed intra-operatively, do not have worse functional outcomes or revision rates compared to matched non-IOPFF cases.

Goal-Directed Fluid Therapy Using Normal Saline versus Ringer's Lactate in Pediatric Neurosurgical Patients: A Randomized Controlled Trial

Abstract Background Ringer's lactate (RL) and 0.9% sodium chloride (NS) are used intraoperatively in pediatric surgical patients. The fluid of choice in pediatric neurosurgical patients is still under research. Hence, we compared NS and RL intraoperatively with a primary objective of measuring the absolute difference in serum chloride concentrations (ΔCl-) after surgery from baseline. Secondary objectives included changes in other electrolytes, osmolarity, pH, creatinine, brain relaxation score (BRS), and neurological outcome at discharge using a modified Rankin scale (mRS). Methods This prospective randomized trial was conducted in American Society of Anesthesiologists status I to II children, aged 6 months to 14 years, after Institutional Ethical Committee approval and written informed consent. Forty patients were randomized in group-S (received 0.9% Saline) and group-R (received RL). The fluid administration was guided by Pleth Variability Index (target &lt;13%). Arterial blood samples were taken at the start of surgery, during tumor resection, and at the end of surgery. Results Twenty-one patients in NS and 19 patients in RL were enrolled. ΔCl- was 12 (9–16) mmol/L in NS group and 4 (2–15) mmol/L in RL group, p = 0.03. NS group developed more metabolic acidosis (6 [28.6%] vs. 0 [0.0%], p = 0.021). There was no difference in the other electrolytes, serum osmolarity, BRS, perioperative creatinine, and mRS between groups, p = 0.36, p = 0.096, p = 0.658, and p = 0.168, respectively. Conclusion Intraoperative use of NS causes derangement in chloride balance, leading to metabolic acidosis compared to RL in children undergoing neurosurgical procedures. However, there was no difference in the other parameters, including serum osmolarity, BRS, and mRS.

Patterns of anatomical injury and anaesthesia procedures in wounded Ukrainian soldiers from Anti-Terrorist Operation/Operation Joint Forces: 2014–2021

IntroductionThe study aims to analyse the causes and anatomical patterns of explosive and gunshot wounds in Ukrainian soldiers acquired during the Anti-Terrorist Operation/Operation Joint Forces. We also investigated how general...

Abstract PO5-02-11: Is There A Survival Benefit With Adjuvant Chemotherapy Use In Elderly Breast Cancer Patients? A Retrospective Study Using The National Cancer Database

Abstract Background Geriatric patients (Age &amp;gt;=65 years) with Breast Cancer (BC) face a unique challenge due to the relatively lower functional status, as well as co-existing comorbidities. Studies like the recently published meta-analysis by the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) group provide irrefutable evidence for the recurrence free survival benefit of anthracycline and taxane based adjuvant chemotherapy (ACT) regimes in early-stage BC patients. However, the age range of the trials analyzed ranged between 46-55 years, with underrepresentation of the geriatric group. The question on whether ACT results in an overall survival (OS) benefit for the elderly remains at large, which we hope to answer through our study. Methods The 2019 National Cancer Database (NCDB) was used to extract patients aged &amp;gt;= 65 years with breast cancer. We included stage 1-3 patients and stratified them into those who received ACT (ACT+) and those who did not (ACT-). Patients who received ACT were identified from the columns that specified the times of events from diagnosis or from the column for systemic therapy-surgery sequence. Patients should have had definitive surgery for their BC management to be included. Odds Ratio (OR) from logistic regression was used to analyze the utility of ACT based on various factors. Kaplan Meier (KM) survival curves and Hazard Ratio (HR) estimates from multivariate cox model was used to compare OS outcomes. Results Our cohort had 866,071 (ACT+: 642721, ACT-:223350) patients. The age distribution showed that ACT+ had 86.45% in the 65-80 years group and 13.55% in the &amp;gt;80 years group. ACT- had 68.32% aged 65-80 and 31.68% &amp;gt;80 years. The distribution of various demographic, pathologic and clinical factors by ACT use are shown in Table 1. Factors associated with ACT use based on OR estimates are shown in Table 2. ACT use is more likely in younger age group (65-80), lower comorbidity score, poorly differentiated and undifferentiated tumors, ER/PR negativity, T2 and lymph node positivity, those who underwent partial mastectomy and regional lymph node surgery, and HER2 positivity. Both 5-year (86.3 vs 74.2%) and 10-year (66 vs 50.8) OS were better with ACT+ (Table 2). The HR using propensity score (PS) weighted cox model revealed a higher hazard rate on omitting ACT [1.436, 95% Confidence Interval (CI) 1.417,1.456, p&amp;lt; .0001] (Table 2). HR estimates between ACT- vs ACT+, stratified by subgroups [Age (65-80, &amp;gt;80), T stage, grade (G), HER2] favored ACT use in all groups except G1 tumors (Table 3). Discussion Our study using a large national database, supports the use of ACT in the geriatric BC population by showing a clear OS advantage of 15.2% at 10 years. This benefit was observed even in BC patients aged more than 80 years with a HR of 1.683 when compared to ACT-, as represented in Table 3. While the existing literature provides robust evidence for ACT use in situations such as a high oncotype recurrence score, our study provides real-world evidence from a population-based dataset to supports its use in the elderly, including those above 80 years. The geriatric assessment recommended by the American Society of Clinical Oncology guideline for geriatric oncology should be followed in this setting. Utilization of geriatric assessment tools among oncologists has been poor with a survey revealing that 60% of providers did not utilize these tools in making treatment decisions. Limitations of our study include the potential for missing confounding factors and the retrospective nature of the study using a large database. Table 1 Demographic, pathological, and clinical characteristics of the study population and their distribution based on ACT use. Table 2 Odds Ratio for ACT use, KM survival curves and HR estimates of ACT use Table 3 HR estimates of mortality for ACT- vs ACT+ stratified by various subgroups Citation Format: Prashanth Ashok Kumar, Metlapalli Venkata Sravanthi, Dongliang Wang, Danning Huang, Abirami Sivapiragasam. Is There A Survival Benefit With Adjuvant Chemotherapy Use In Elderly Breast Cancer Patients? A Retrospective Study Using The National Cancer Database [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 PO5-02-11.

Abstract PO1-20-08: Primary breast implant-associated squamous cell carcinoma with subsequent TEMPUS testing and failure of immunotherapy

Abstract Primary squamous cell carcinoma of the breast is a rare entity, and there are a limited number of cases in the literature describing squamous cell carcinoma arising from breast implants. It has been hypothesized that these implant-associated cancers may arise from epithelialization of the implant capsule followed by chronic inflammation. None of the cases in the literature were treated with immunotherapy. We present a case of an aggressive, primary sarcomatoid squamous cell carcinoma of the breast arising from a breast implant that was treated unsuccessfully with simultaneous chemotherapy and immunotherapy following TEMPUS testing. Introduction: Breast augmentation is the most common plastic surgery procedure performed worldwide, with more than 300,000 done in the United States every year. While breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is extensively discussed in recent literature, other breast implant-associated cancers are rarer and less studied. Breast implant-associated squamous cell carcinoma (BIA-SCC) specifically is an extremely rare complication of breast augmentation and no guidelines for treatment exist. The American Society of Plastic Surgeons (ASPS) released a statement on BIA-SCC on 9/2022 following a safety communication from the FDA, and it is recommended health care providers submit case reports of BIA-SCC to a patient registry. Case study: We present the case of a female patient who underwent bilateral breast augmentation in 2006 with Mcghan textured, pre-pectoral, areolar saline implants. In 2022, she presented with swelling and a lump in her breast and underwent bilateral breast implant removal with capsulectomy. Pathology showed triple negative sarcomatoid squamous cell carcinoma of the right breast capsule. TEMPUS testing on the breast biopsy revealed a PIK3CA mutation and PD-L1 negative status. Her case was discussed with a multi-disciplinary team including plastic surgery, multiple oncologists, and radiation oncology and her clinical picture was determined to be most consistent with BIA-SCC. Based on the KEYNOTE-522 study, she was determined to be a candidate for neoadjuvant therapy with pembrolizumab and chemotherapy as she was newly diagnosed, previously untreated, nonmetastatic, and had a triple negative tumor. She received two cycles of carboplatin, paclitaxel, and pembrolizumab but unfortunately rapidly progressed with chest wall extension, multiple new pulmonary nodules, worsening lymphadenopathy, right ventricular tumor thrombus, and new malignant pleural effusion and was transitioned to hospice. Discussion: Seven cases of BIA-SCC, one case of squamous cell carcinoma (SCC) after liquid silicone injection augmentation, one case of squamous metaplasia on the breast implant capsule, and one case of epithelization of the breast implant capsule have been previously described in the literature (Table 1). None of the available cases of BIA-SCC report TEMPUS testing, and none of the patients were treated with immunotherapy. The origin of BIA-SCC is unclear, but several theories have been described including chronic inflammation leading to conversion of epithelial tissue on the capsule to SCC. It is unknown how the breast implant capsule might become epithelialized to begin with – introduction of epithelium intraoperatively during augmentation, rupture of epidermal cysts, existence of epithelium in the area from a childhood injury or from birth, or epithelization from chronic shear forces from the augmentation or leakage of the implant are all possibilities. With the ongoing data gathering through the FDA patient registry, we will continue to learn more about these rare cancers and potentially get further insight into their origins. Table 1 An overview of cases of BIA-SCC in the literature Citation Format: Emily Podany, Katherine Clifton. Primary breast implant-associated squamous cell carcinoma with subsequent TEMPUS testing and failure of immunotherapy [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 PO1-20-08.

Abstract PO4-01-14: Effects of neoadjuvant endocrine therapy on early-stage breast cancer: a retrospective cohort study of patients during the COVID19 pandemic

Abstract Background: At the height of the COVID19 pandemic, many surgical procedures across the country including at Dartmouth-Hitchcock Medical Center (DHMC) were postponed to redirect resources. The American Society of Breast Surgeons shared guidelines to manage patients experiencing surgical delays. For estrogen receptor positive (ER+), HER2- early-stage tumors, recommendations were to use neoadjuvant endocrine therapy (NET). NET is usually under-utilized for locally advanced hormone receptor-positive breast cancer (BC) despite literature concluding that chemotherapy and NET have comparable clinical response rates but with lower toxicity for the latter. The COVID19 pandemic thus presented a unique occasion to extend the use of NET for localized BC. Herein, we examined the rate of adoption of NET and associated patient/tumor characteristics at DHMC during the lockdown. Methods: A retrospective analysis of patients diagnosed with early-stage ER+, HER2- BC between December 2019 and June 2020. Data extracted from chart review included age, menopausal status, tumor stage/grade, body mass index (BMI), and adherence to adjuvant endocrine therapy (ET). A “delay in surgery” was defined as days between surgical consult and surgery over 14 days. Descriptive statistics were applied to data collected on patient/tumor characteristics, and the number of patients accepting or declining NET. Results: 109 cases were identified within the study period, with 42 found with surgical delay. The median age of the delayed group was 62 and the majority of patients were post-menopausal. 36 patients received NET with most started on an aromatase inhibitor. Median BMI was 28.5. Median duration of treatment was 39.5 days. Three cases were noted to have some decrease in cellularity for pathologic partial response and four had no definite response. The majority of patients on NET had no change in pathological grade. Out of the 36 patients who had NET, 30 (83.3%) remain on adjuvant ET. In contrast, only 59% (43 out of 73 patients) of those who did not receive NET were on adjuvant ET at the median follow up time of 2.75 years post-therapy initiation. Of note, 16 (out of 73) patients who were not on NET were either lost to follow up, had their care transferred to another health network or were not offered ET. Results are reported in Tables 1 and 2. Conclusions: Delays in surgery during the COVID19 crisis resulted in increased use of NET in early-stage BC. Impact of NET use includes possible increase in long-term adherence to adjuvant ET with a trend towards statistical significance (odds ratio of 3.25, p=0.08). A larger sample size is needed to evaluate this finding and a prospective trial is in progress (NCT04568616). NET is a viable treatment option during surgical delays and may help increase long-term adherence to adjuvant ET. Table. Patient and tumor characteristics Table. Number of patients on adjuvant ET Citation Format: Mary Chamberlin, Todd Miller, Marie Anne Christine Buteau, Steven Tau. Effects of neoadjuvant endocrine therapy on early-stage breast cancer: a retrospective cohort study of patients during the COVID19 pandemic [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 PO4-01-14.