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HSR24-160: Immune Checkpoint Inhibitor-Induced Type 1 Diabetes Mellitus: Patient Characteristics, Clinical Outcomes, and Survival Implications of Autoantibodies

John Sharp, Cassandra Pasadyn, Songzhu Zhao, Lai Wei, Carolyn Presley, Dwight Owen, Kathleen Wyne, and Alexa Meara

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Neoadjuvant Therapy for Rectal Cancer Affects Lymph Node Yield and Status Without Clear Implications on Outcome: The Case for Eliminating a Metric and Using Preoperative Staging to Guide Therapy

Sherif R. Z. Abdel-Misih, Lai Wei, Al B. Benson III, Steven Cohen, Lily Lai, John Skibber, Neal Wilkinson, Martin Weiser, Deborah Schrag, and Tanios Bekaii-Saab

Background: Nodal status has long been considered pivotal to oncologic care, staging, and management. This has resulted in the establishment of rudimentary metrics regarding adequate lymph node yield in colon and rectal cancers for accurate cancer staging. In the era of neoadjuvant treatment, the implications of lymph node yield and status on patient outcomes remains unclear. Patient and Methods: This study included 1,680 patients with locally advanced rectal cancer from the NCCN prospective oncology database stratified into 3 groups based on preoperative therapy received: no neoadjuvant therapy, neoadjuvant chemoradiation, and neoadjuvant chemotherapy. Clinicopathologic characteristics and survival were compared between the groups, with univariate and multivariate analyses undertaken. Results: The clinicopathologic characteristics demonstrated statistically significant differences and heterogeneity among the 3 groups. The neoadjuvant chemoradiation group demonstrated the statistically lowest median lymph node yield (n=15) compared with 17 and 18 for no-neoadjuvant and neoadjuvant chemotherapy, respectively (P<.0001). Neoadjuvant treatment did impact survival, with chemoradiation demonstrating increased median overall survival of 42.7 compared with 37.3 and 26.6 months for neoadjuvant chemotherapy and no-neoadjuvant therapy, respectively (P<.0001). Patients with a yield of fewer than 12 lymph nodes had improved median overall survival of 43.3 months compared with 36.6 months in patients with 12 or more lymph nodes (P=.009). Multivariate analysis demonstrated that neither node yield nor status were predictors for overall survival. Discussion: This analysis reiterates that nodal yield in rectal cancer is multifactorial, with neoadjuvant therapy being a significant factor. Node yield and status were not significant predictors of overall survival. A nodal metric may not be clinically relevant in the era of neoadjuvant therapy, and guidelines for perioperative therapy may need reconsideration.

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CLO20-054: A Phase 2 Trial of Nivolumab and Temozolomide in Advanced Neuroendocrine Tumors (NETs): Interim Efficacy Analysis

Dwight H. Owen, Lai Wei, Ashima Goyal, Ye Zhou, Sheryl-Ann Suffren, Rajani Jacob, Carly Pilcher, Gregory A. Otterson, Claire F. Verschraegen, Manisha H. Shah, and Bhavana Konda

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HSR22-165: Pulmonary Function Tests (PFTs) and Immune Checkpoint Inhibitor Pneumonitis

Maria Kathleen Riley, Alex Wong, Songzhu Zhao, Jing Wang, Vince Esguerra, Mingjia Li, Kari Kendra, Gabrielle Lopez, Carolyn Presley, Lai Wei, Dwight Owen, and Kevin Ho

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CLO24-061: Overall Survival (OS) Impact for NSCLC Patients With irAE and Non-irAE Hospital Admissions During First-Line Pembrolizumab Treatment

Adam Khorasanchi, Songzhu Zhao, Lai Wei, Mingjia Li, Kevin Ho, Hamzah Abu-Sbeih, Evelyn Goodyear, Austin Secor, Peter Shields, Kai He, Jacob Kaufman, Regan Memmott, Asrar Alahmadi, David Carbone, Gregory Otterson, Alexa Meara, Carolyn Presley, and Dwight Owen

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CGE23-070: Baseline Neutrophil to Lymphocyte Ratio and Its Change Over Time Predict Overall Survival in Metastatic Non–Small Cell Lung Cancer Patients Who Received First Line Pembrolizumab Therapy

Kenneth Chian, Mingjia Li, Songzhu Zhao, Saira Farid, Timothy Gauntner, Daniel Spakowicz, Lai Wei, Austin Secor, Evelyn Goodyear, Parthib Das, Kai He, Asrar Alahmadi, Regan Memmott, Jacob Kaufman, Carolyn Presley, Peter Shields, David Carbone, Greg Otterson, and Dwight Owen

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Bone Metastases, Skeletal-Related Events, and Survival in Patients With Metastatic Non–Small Cell Lung Cancer Treated With Immune Checkpoint Inhibitors

Angel Qin, Songzhu Zhao, Abdul Miah, Lai Wei, Sandipkumar Patel, Andrew Johns, Madison Grogan, Erin M. Bertino, Kai He, Peter G. Shields, Gregory P. Kalemkerian, Shirish M. Gadgeel, Nithya Ramnath, Bryan J. Schneider, Khaled A. Hassan, Nicholas Szerlip, Zoey Chopra, Sara Journey, Jessica Waninger, Daniel Spakowicz, David P. Carbone, Carolyn J. Presley, Gregory A. Otterson, Michael D. Green, and Dwight H. Owen

Background: Bone metastases and skeletal-related events (SREs) are a frequent cause of morbidity in patients with metastatic non–small cell lung cancer (mNSCLC). Data are limited on bone metastases and SREs in patients with mNSCLC treated using immune checkpoint inhibitors (ICIs), and on the efficacy of bone-modifying agents (BMAs) in this setting. Here we report the incidence, impact on survival, risk factors for bone metastases and SREs, and impact of BMAs in patients with mNSCLC treated with ICIs in a multi-institutional cohort. Patients and Methods: We conducted a retrospective study of patients with mNSCLC treated with ICIs at 2 tertiary care centers from 2014 through 2017. Overall survival (OS) was compared between patients with and without baseline bone metastases using a log-rank test. A Cox regression model was used to evaluate the association between OS and the presence of bone metastases at ICI initiation, controlling for other confounding factors. Results: We identified a cohort of 330 patients who had received ICIs for metastatic disease. Median patient age was 63 years, most patients were treated in the second line or beyond (n=259; 78%), and nivolumab was the most common ICI (n=211; 64%). Median OS was 10 months (95% CI, 8.4–12.0). In our cohort, 124 patients (38%) had baseline bone metastases, and 43 (13%) developed SREs during or after ICI treatment. Patients with bone metastases had a higher hazard of death after controlling for performance status, histology, line of therapy, and disease burden (hazard ratio, 1.57; 95% CI, 1.19–2.08; P=.001). Use of BMAs was not associated with OS or a decreased risk of SREs. Conclusions: Presence of bone metastases at baseline was associated with a worse prognosis for patients with mNSCLC treated with ICI after controlling for multiple clinical characteristics. Use of BMAs was not associated with reduced SREs or a difference in survival.

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Association Between Pretreatment Chest Imaging and Immune Checkpoint Inhibitor Pneumonitis Among Patients With Lung Cancer

Alexander Wong, Maria Riley, Songzhu Zhao, Jessica Zimmer, Matthew Viveiros, Jing Gennie Wang, Vincent Esguerra, Mingjia Li, Gabrielle Lopez, Kari Kendra, David P. Carbone, Kai He, Asrar Alahmadi, Jacob Kaufman, Regan M. Memmott, Peter G. Shields, Jeremy Brownstein, Karl Haglund, Meng Welliver, Gregory A. Otterson, Carolyn J. Presley, Lai Wei, Dwight H. Owen, and Kevin Ho

Background: Immune checkpoint inhibitors (ICIs) are a first-line and perioperative treatment for lung cancer. Pneumonitis is a potentially life-threatening complication of ICI treatment in 2% to 5% of patients; however, risk factors for developing ICI pneumonitis (ICI-p) remain undefined. Methods: We conducted a retrospective cohort study of consecutive patients with lung cancer who received at least one dose of ICI from 2015 through 2020 at The Ohio State University. Pneumonitis cases were documented by the treating oncologist and retrospectively evaluated for agreement between an oncologist and a pulmonologist. Patient demographic and clinical characteristics were recorded and summarized between those with and without pneumonitis for the overall cohort. Univariate and multivariable survival analyses using the Fine-Gray competing risk model were used to examine the associations. Results: A total of 471 patients with lung cancer were included, of which 402 had non–small cell lung cancer and 69 had small cell lung cancer; 39 (8%) patients in the overall cohort developed ICI-p. Preexisting interstitial abnormalities and prior chest radiation were both significantly associated with ICI-p on univariate analysis (hazard ratio [HR], 8.91; 95% CI, 4.69–16.92; P<.001; and HR, 2.81; 95% CI, 1.50–5.28; P=.001). On multivariable analyses, interstitial abnormalities remained a strong independent risk factor for ICI-p when controlling for chest radiation and type of immunotherapy (HR, 9.77; 95% CI, 5.17–18.46; P<.001). Among patients with ICI-p (n=39), those with severe (grade 3–5) pneumonitis had worse overall survival compared with those with mild (grade 1 or 2) pneumonitis (P=.001). Abnormal pulmonary function test results at both 12 and 18 months prior to ICI initiation were not significantly associated with ICI-p. Conclusions: Preexisting interstitial abnormalities on chest CT and prior chest radiation are independent risk factors that are strongly associated with ICI-p in patients with lung cancer. These findings highlight a potential need for closer observation for ICI-p among patients with these risk factors.