Saint Francis Medical Center

Abstract Background: The benefit of adjuvant regional nodal irradiation including the chest wall after mastectomy (CWI+RNI) and with whole breast irradiation (WBI+RNI) after breast conserving surgery (BCS) is well established in pts with pathologically positive axillary nodes (pN+). Pts who present with axillary node involvement (cN+), receive neoadjuvant chemotherapy (NC), and are found to be pathologically node-negative at surgery (ypN0), have lower loco-regional recurrence (LRR) rates compared to those who remain pathologically node-positive (ypN+). This phase III, randomized trial aimed to evaluate whether CWI+RNI after mastectomy or addition of RNI to WBI after BCS significantly improves invasive breast cancer recurrence-free interval (IBC-RFI) in cN+ pts found to be ypN0 after NC. Methods: Eligible pts had clinical cT1-3, N1, M0 invasive breast cancer (biopsy-proven N+ by FNA/core needle bx), completed ≥8 wks of NC (and anti-HER2 therapy if HER2+), and were ypN0 after mastectomy or BCS and sentinel node biopsy (SLNB, ≥2 nodes), axillary lymph node dissection (ALND), or both. Pts were randomized to “No RNI” (i.e., observation after mastectomy or WBI after BCS) vs. “RNI” (i.e., CWI+RNI after mastectomy or WBI+RNI after BCS). Primary endpoint was IBC-RFI. Secondary endpoints reported here: LRR-free interval (LRRFI), distant recurrence-free interval (DRFI), disease-free survival (DFS), and overall survival (OS). Study was designed to have 80% power to detect 35% reduction in annual rate of IBC-RFI for an absolute risk reduction of 4.6% (5-yr cumulative rate). Per protocol, final analysis was to occur after 172 events or 10 yrs after study initiation.Here we report the time-driven analysis prespecified in the protocol. Results: From 9/13-12/20, 1,641 pts were enrolled; 1,556 pts were available for primary event analysis; median f/u time 59.5 mos (IQR 40.7-74.1). Pt/tumor characteristics were well balanced between groups. Median age 52 yrs (range 21-84); 31% non-white; 21% cT1, 60% cT2, 19% cT3; 23% triple-negative, 21% HR+/HER2-, 56% HER2+; 58% BCS; 55% SLNB, 45% ALND+/-SLNB; and 78% had breast pathologic complete response. At the time of the analysis, 109 IBC-RFI events (63% of the planned 172) were confirmed (“No RNI”: 59, “RNI”: 50). There was no statistically significant difference between groups for IBC-RFI (HR=0.88, 95%CI 0.60-1.29; p=0.51), 5-yr point estimates: 91.8% for “No RNI” and 92.7% for “RNI.” There were no statistically significant differences between the treatment groups for secondary endpoints. There were no study-related deaths and no unexpected toxicities.Grade 4 toxicity was rare (0.1% with “No RNI”, 0.5% with “RNI”); 6.5% of pts developed grade 3 toxicity in “No RNI” and 10% in “RNI” group. Most common grade 3 toxicity was radiation dermatitis (3.3% in “No RNI,” 5.7% in “RNI”). Conclusion: In pts who present with biopsy-proven axillary node involvement and convert their axillary nodes to ypN0 after NC, CWI+RNI after mastectomy, or WBI+RNI after BCS, did not significantly improve IBC-RFI, LRRFI, DRFI, DFS, or OS. These findings suggest that downstaging involved axillary nodes with NC can result in optimization of adjuvant radiotherapy without adversely affecting oncologic outcomes. Follow-up of pts for long-term outcomes continues. NCT01872975 *EPM and JW are co-first authors. Table 1 Citation Format: Eleftherios Mamounas, Hanna Bandos, Julia White, Thomas Julian, Atif Khan, Simona Shaitelman, Mylin Torres, Frank Vicini, Patricia Ganz, Susan McCloskey, Nilendu Gupta, X. Allen Li, Peter Lucas, Nadeem Abu-Rustum, Saumil Gandhi, Rahul Tendulkar, Robert Coleman, Keiichi Fujiwara, Samantha Seaward, William Irvin, Kristin Higgins, Robert Mutter, Jean-Francois Boileau, Andrew Muskovitz, Reshma Jagsi, Anna Weiss, Curran Walter Jr., Norman Wolmark. Loco-Regional Irradiation in Patients with Biopsy-proven Axillary Node Involvement at Presentation Who Become Pathologically Node-negative After Neoadjuvant Chemotherapy: Primary Outcomes of NRG Oncology/NSABP B-51/RTOG 1304 [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 GS02-07.

Traumatic diaphragmatic hernia is a sign of severe thoracoabdominal trauma that is often difficult to detect because of nonspecific presenting symptoms, delayed presentation, and distracting injuries. Diagnosis depends on imaging and a high degree of suspicion in patients who present with respiratory or gastrointestinal symptoms after trauma, and prompt surgical repair is required. This case reviews a patient who presented to the emergency department with burning epigastric pain radiating to the left chest and hematemesis ~1month after sustaining a blunt abdominal injury. Imaging studies revealed a substantial portion of the gastric body in the left hemithorax. Robot-assisted reduction of the stomach was performed followed by repair with tension-free primary closure without mesh reinforcement and gastropexy. The patient was monitored for return of bowel function and discharged upon recovery. This case report highlights the diagnostic challenges of traumatic diaphragmatic hernia and the benefit of robot-assisted repair.

Patients with human immunodeficiency virus (HIV) infection have a higher prevalence of colonic neoplasms than the general population. In these patients, tumors develop at an earlier age, are diagnosed at more advanced stages, and have a dismal prognosis. Current guidelines recommend initiating colon cancer screening in HIV patients at the age of 45 which is consistent with screening age in the general population. We present a rare case of colon cancer diagnosed in an HIV-infected patient at a young age of only 34 years. Therefore, we recommend early screening for colon cancer in HIV patients than the general population.

Schizoaffective disorder, bipolar type is a chronic mental health disorder that may manifest as mania. Clozapine is effective in treating acute mania and in achieving mood stabilization. However, on rare occasions, the use of clozapine has been associated with cardiotoxicity. Here, we present a case of a 31-year-old man who at baseline is known to have schizoaffective disorder, bipolar type, and cannabis dependence and was admitted to our hospital with a psychotic relapse. He was treated with clozapine, uptitrated to a maximum daily dose of 200mg twice daily by day 10. Thereafter he became febrile and experienced malaise, myalgias, and chest pain. He was noted on electrocardiogram to have sinus tachycardia without ischemic changes. In this context, he had a troponin leak, increased white blood cell count, serologies and cultures were negative and chest x-ray revealed no acute disease of the chest. Due to the suspicion of clozapine-induced cardiotoxicity, a transthoracic echocardiogram was done, which revealed mildly depressed left ventricular (LV) systolic function without pericardial effusion. Thereafter, clozapine was withdrawn and switched to lithium. Additionally, the cardioselective, metoprolol tartrate was initiated. Within 36-48 hours, he had resolution of symptoms and remained cardiovascularly stable. Clozapine uncommonly causes cardiotoxicity and early features may be non-specific. Awareness of this and recognizing early features aids in reducing the associated cardiovascular morbidity and mortality.

Laboratory testing is a helpful tool for clinicians, but can be costly and harmful to patients. A quality improvement project was initiated to reduce laboratory testing for patients receiving extracorporeal membrane oxygenation (ECMO) in a pediatric intensive care unit (PICU) at a tertiary care center. Preliminary data was gathered to demonstrate preimplementation practice, cost, and patient need for packed red blood cell (pRBC) transfusions. A new protocol was created by an interprofessional team based on best practice and benchmarking with high-performing organizations. The project was evaluated using two comparison groups, pre- and postimplementation for anyone receiving ECMO therapy in the PICU. The average laboratory tests per ECMO day decreased by 52% (128.4 vs. 61.1), cost per case decreased by 14.7%, pRBC transfusions decreased from 100% to 85%, length of stay (LOS) decreased by 8 days, and mortality rates decreased by 9.5%. The revised pediatric ECMO laboratory testing guidelines were successfully implemented and reduced laboratory cost without adverse effects on mortality rates or LOS.

Laboratory testing is a helpful tool for clinicians, but can be costly and harmful to patients. A quality improvement project was initiated to reduce laboratory testing for patients receiving extracorporeal membrane oxygenation (ECMO) in a pediatric intensive care unit (PICU) at a tertiary care center. Preliminary data was gathered to demonstrate preimplementation practice, cost, and patient need for packed red blood cell (pRBC) transfusions. A new protocol was created by an interprofessional team based on best practice and benchmarking with high-performing organizations. The project was evaluated using two comparison groups, pre- and postimplementation for anyone receiving ECMO therapy in the PICU. The average laboratory tests per ECMO day decreased by 52% (128.4 vs. 61.1), cost per case decreased by 14.7%, pRBC transfusions decreased from 100% to 85%, length of stay (LOS) decreased by 8 days, and mortality rates decreased by 9.5%. The revised pediatric ECMO laboratory testing guidelines were successfully implemented and reduced laboratory cost without adverse effects on mortality rates or LOS.