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Background Recent studies have suggested that more frequent postoperative surveillance imaging via computed tomography following lung cancer resection may not improve outcomes. We sought to validate these findings using a uniquely compiled dataset from the Veterans Health Administration, the largest integrated health-care system in the United States. Methods We performed a retrospective cohort study of veterans with pathologic stage I non-small cell lung cancer receiving surgery (2006-2016). We assessed the relationship between surveillance frequency (chest computed tomography scans within 2 years after surgery) and recurrence-free survival and overall survival. Results Among 6171 patients, 3047 (49.4%) and 3124 (50.6%) underwent low-frequency ( Conclusions We found that high-frequency surveillance does not improve outcomes in surgically treated stage I non-small cell lung cancer. Future lung cancer treatment guidelines should consider less frequent surveillance imaging in patients with stage I disease.

Equitable access to care is a critical component of comprehensive surgical lung cancer management. Despite this, quality measures (QMs) assessing preoperative access to care are lacking. This study determined several preoperative QMs on the basis of contemporary treatment guidelines and hypothesized that poor access to care was associated with worse outcomes.This retrospective cohort study used a specially compiled Veterans Health Administration data set of patients with clinical stage I non-small cell lung cancer (NSCLC) who underwent surgical treatment (2006-2016). The study defined 4 QMs that patients with clinical stage I NSCLC should routinely meet in the preoperative period: timely surgery, positron emission tomography imaging, appropriate smoking management, and pulmonary function testing. The relationship between meeting these QMs and various short- and long-term outcomes was assessed.Among 9749 veterans undergoing surgery for clinical stage I NSCLC, 3371 (34.6%) met all QMs. Factors associated with lower likelihood of meeting all QMs included Black race (adjusted odds ratio [aOR], 0.744; 95% CI, 0.652-0.848), higher area deprivation index score (eg, quartile 5 vs 1; aOR, 0.747; 95% CI, 0.647-0.863), and increased distance to hospital (eg, quartile 5 vs 1; aOR, 0.700; 95% CI, 0.605-0.811). Adherence to all QMs was associated with significantly lower likelihood of postoperative mortality (aOR, 0.623; 95% CI, 0.433-0.896) and improved overall survival (adjusted HR, 0.897; 95% CI, 0.844-0.954).Inadequate access to preoperative care is associated with worse short- and long-term outcomes in clinical stage I NSCLC. Future Veterans Health Administration policy measures should focus on providing more equitable guideline-concordant care to veterans.

Domino liver transplantation (DLT) utilizes a phenotypically normal explant from select recipients as a donor graft in another patient. The procedure is not widely employed and remains restricted to a small number of centers. The purpose of this study was to assess the national profile of DLT in the United States (US) and evaluate current survival outcomes.The United Network for Organ Sharing (UNOS) database was queried for all liver transplants (LT) between 1996 and 2020. Outcomes of interest were long-term graft and patient survival.Of 181,976 LTs performed nationally during the study period, 185 (0.1%) were DLTs. Amyloidosis and maple syrup urine disease (MSUD) accounted for 83% of dominoed allografts. Out of 210 explants with amyloidosis, 103 (49%) were dominoed into secondary recipients. Only 50 (22%) of all MSUD explants (n = 227) were dominoed. Graft survival was 79%, 73% and 53% at 3-, 5- and 10-years, respectively, for DLT recipients. Overall patient survival was 83%, 76% and 57% at 3-, 5- and 10-years.Despite excellent long-term survival outcomes, DLT allografts comprise a very small percentage of the liver donor pool. A large proportion of potential DLTs may be unconscionably excluded despite shortages in deceased donor organs.

Background The development of cytomegalovirus (CMV) infection after kidney transplant remains a significant cause of posttransplant morbidity, graft loss, and mortality. Despite appropriate antiviral therapy, recipients without previous CMV exposure can currently be allocated a kidney from a donor with previous CMV infection (D+R-) which carries the greatest risk of posttransplant CMV infection and associated complications. Preferential placement of CMV D- organs in negative recipients (R-) has been shown to reduce the risk of viral infection and associated complications. Methods To assess the long-term survival and economic benefits of allocation policy reforms, a decision analytic model was constructed to compare receipt of CMV D- with CMV D+ organ in CMV R- recipients using data from transplant registry, Medicare claims, and pharmaceutical costs. Results For CMV R- patients, receipt of a CMV D- organ was associated with greater average survival (14.3 vs 12.6 years), superior quality-adjusted life years (12.6 vs 9.8), and lower costs ($529 512 vs $542 963). One-way sensitivity analysis demonstrated a survival advantage for patients waiting as long as 30 months for a CMV D- kidney. Conclusions Altering national allocation policy to preferentially offer CMV D- organs to CMV R- recipients could improve survival and lower costs after transplant if appropriately implemented.

With improved survivorship in liver transplantation (LT), there is an emerging focus on functional recovery and health-related quality of life (HRQoL) after surgery. The present study aimed to assess HRQoL after LT using the Patient-Reported Outcomes Measurement Information System (PROMIS).This was a prospective analysis of LT recipients between 2020 and 2021. A total of 238 patients were contacted by phone at 3, 6, and 12 months postoperatively using the PROMIS 29-Profile. Scores were recorded and computed using the HealthMeasures Scoring Service.PROMIS was available for 174 patients at 3 (n = 58), 6 (n = 57), and 12 months (n = 59). Overall, mean PROMIS scores were 47.6 ± 3, 47.6 ± 3, and 47.6 ± 3 at 3, 6, and 12 months, respectively. Most domains improved postoperatively by 12 months except for anxiety and sleep disturbance measures. The lowest domain in the immediate postoperative period was physical functioning, but this had the closest return to normative population values. Pain interference was above the population reference during the initial postoperative period, improving by 12 months where they were below mean population values. Depression and fatigue scores improved by 6 months and appeared to stabilize by 12 months post-LT. Patients demonstrated increased social participation, and scores were remarkably higher than general population means at each timepoint.LT can impact physical, mental, and social health which, in this setting, remains largely unexplored using PROMIS instruments. We report that although overall patient well being can improve, some mental health domains require further consideration during the postoperative period.

In the US, obesity continues to be a severe health issue now affecting adolescents. Bariatric surgery remains the most effective treatment for obesity, but use among adolescents remains low. The objective of this study was to identify current national trends in bariatric surgery among adolescents.Using the Nationwide Inpatient Sample database, adolescents aged 9 to 19 with a diagnosis of morbid obesity who underwent a laparoscopic gastric bypass (Roux-en-Y gastric bypass) or laparoscopic sleeve gastrectomy (SG) between 2015 and 2018 were identified. Demographics, comorbidities, and in-hospital complications were collected. National estimates were calculated. The trend of annual number of operations was determined by Kruskal-Wallis rank test.Between 2015 and 2018, 1,203 adolescents were identified, resulting in a nationwide estimate of 4,807 bariatric cases. The number of bariatric operations increased annually from 1,360 in 2015 to 1,740 operations in 2018 (p = 0.0771). The majority of patients were female (76%), 17 to 19 years old (84.1%), and White (47.9%). Most patients underwent SG (82.0%). Black and Hispanic patients comprised 40.2% of the cohort. Significant comorbidities included diabetes, dyslipidemia, nonalcoholic fatty liver disease, hypertension, and sleep apnea. The average length of stay decreased from 2.12 days to 1.64 days. There were no in-hospital mortalities, and complications were less than 1%.With the increasing prevalence of obesity among adolescents in the US, bariatric surgery increased over time but was performed less in patients younger than 16 years of age and racial minorities. Bariatric surgery among adolescents remains safe, with extremely low complication rates and zero in-hospital mortality.

Background Outcomes after lung retransplantation (LRT) remain inferior compared with primary lung transplantation (PLT). This study examined the impact of center volume on 1-year survival after LRT. Methods Using the United Network for Organ Sharing database, the study abstracted patients undergoing PLT and LRT between January 2006 and December 2017, excluding combined heart-lung transplants and multiple retransplants. One-year survival rates after PLT and LRT were compared using propensity score matching. In the LRT cohort, multivariable Cox models with and without time-dependent coefficients were fitted to examine association between transplant center volume and 1-year survival. Center volume was categorized on the basis of inspection of restricted cubic splines. Results A total of 20,675 recipients (PLT 19,853 [96.0%] vs LRT 822 [4.0%]) were included. One-year survival was lower for LRT recipients in the matched cohort (PLT 84.8% vs LRT 76.7%). There was steady improvement in 1-year survival after LRT (2006 to 2009 72.1% vs 2010 to 2013 76.6% vs 2014 to 2017 80.1%). Higher center volume was associated with better 1-year survival after LRT. This survival difference was noted in the initial 30 days after transplantation (intermediate vs low volume hazard ratio, 0.282 [95% confidence interval, 0.151 to 0.526]; high vs low volume hazard ratio, 0.406 [95% confidence interval, 0.224 to 0.737]), but it became insignificant after 30 days. Conclusions Superior 1-year survival after LRT at higher-volume centers is predominantly the result of better 30-day outcomes. This finding suggests that LRT candidates may be referred to higher-volume centers for surgery.

Background Traditionally, curative resection was considered the cornerstone of treatment for perihilar cholangiocarcinoma. More recently, liver transplantation (LT) offered an alternative for patients with unresectable disease. The purpose of this study was to assess our experience with perihilar cholangiocarcinoma and LT. Methods A perihilar cholangiocarcinoma protocol was commenced in 2006 whereby diagnosed patients were enrolled onto an institutional registry for LT consideration. Data on patient progression and oncologic outcomes were assessed. Results Fifty-eight patients were initially enrolled onto the protocol and 38 proceeded to LT following neoadjuvant chemoradiation (mean age 55.6 ± 11.4 years). Mean time to LT was 3.7 ± 2 months and, among those transplanted, 14 (37%) had underlying primary sclerosing cholangitis (PSC). Thirteen (34%) patients developed malignant recurrence and there were no differences in disease recurrence between PSC (n = 3) and non-PSC (n = 10) patients (p = 0.32). Overall patient survival was 91%, 58% and 52% at 1-, 3- and 5-years corresponding with 81%, 52% and 46% graft survival, respectively. Conclusion Rigorous patient selection and chemoradiation treatment algorithms can be highly effective in treating perihilar cholangiocarcinoma. For appropriately selected candidates, LT can provide a 52% 5-year survival for patients who would otherwise have no surgical treatment option.

Objective To define the relationship between the duration of smoking cessation and post-operative complications for patients with lung cancer undergoing surgical treatment. Background Smoking increases the risk of post-operative morbidity and mortality in patients with lung cancer undergoing surgical treatment. While smoking cessation before surgery can mitigate these risks, the ideal duration of pre-operative smoking cessation remains unclear. Methods Using a uniquely compiled Veterans Health Administration (VHA) dataset, we performed a retrospective cohort study of patients with clinical stage I non-small cell lung cancer (NSCLC) undergoing surgical treatment between 2006 and 2016. We characterized the relationship between duration of pre-operative smoking cessation and risk of post-operative complications or mortality within 30-days using multivariable restricted cubic spline functions. Results The study included a total of 9509 patients, of whom 6168 (64.9%) were smoking at the time of lung cancer diagnosis. Among them, only 662 (10.7%) patients stopped smoking prior to surgery. Longer duration between smoking cessation and surgery was associated with lower odds of major complication or mortality (aOR for every additional week, 0.919; 95% CI, 0.850-0.993; P = 0.03). Compared to non-smokers, patients who quit at least 3 weeks before surgery had similar odds of major complication (aOR, 1.005; 95% CI, 0.702-1.437; P = 0.98) whereas those who quit within 3 weeks of surgery had significantly higher odds of major complication (aOR, 1.698; 95% CI, 1.203-2.396; P = 0.003). Conclusion Smoking cessation at least 3 weeks prior to the surgical treatment of lung cancer is associated with reduced morbidity and mortality. Providers should aggressively encourage smoking cessation in the pre-operative period, since it can disproportionately impact outcomes in early-stage lung cancer.

To develop and validate the Veterans Administration (VA) Lung Cancer Mortality (VALCAN-M) score, a risk prediction model for 90-day mortality following surgical treatment of clinical stage I non-small cell lung cancer (NSCLC).While surgery remains the preferred treatment for functionally fit patients with early-stage NSCLC, less invasive, non-surgical treatments have emerged for high-risk patients. Accurate risk prediction models for post-operative mortality may aid surgeons and other providers in optimizing patient-centered treatment plans.We performed a retrospective cohort study using a uniquely compiled VA dataset including all Veterans with clinical stage I NSCLC undergoing surgical treatment between 2006 and 2016. Patients were randomly split into derivation and validation cohorts. We derived the VALCAN-M score based on multivariable logistic regression modeling of patient-and treatment-variables and 90-day mortality.A total of 9749 patients were included (derivation cohort: n=6825, 70.0%; validation cohort: n=2924, 30.0%). The 90-day mortality rate was 4.0% (n=390). The final multivariable model included 11 factors that were associated with 90-day mortality: age, body mass index, history of heart failure, forced expiratory volume (FEV1, % predicted), history of peripheral vascular disease, functional status, delayed surgery, American Society of Anesthesiology performance status, tumor histology, extent of resection (lobectomy, wedge, segmentectomy, or pneumonectomy), and surgical approach (minimally invasive or open). The c-statistic was 0.739 (95% CI=0.708-0.771) in the derivation cohort.The VALCAN-M score uses readily available treatment-related variables to reliably predict 90-day operative mortality. This score can aid surgeons and other providers in objectively discussing operative risk among high-risk patients with clinical stage I NSCLC considering surgery versus other definitive therapies.

Simultaneous pancreas-kidney transplantation (SPK) carries about a 7%–22% risk of technical failure, but the impact of early pancreas allograft loss on subsequent kidney graft and patient survival is not well-defined. We examined national transplant registry data for type 1 diabetic patients who received SPK between 2000 and 2021. Associations of transplant type (i.e., SPK, deceased‐donor kidney transplant [DDKA], living‐donor kidney transplant [LDKA]) with kidney graft failure and patient survival were estimated by multivariable inverse probability of treatment-weighted accelerated failure-time models. Compared to SPK recipients with a functioning pancreas graft 3 months posttransplant (SPK,P+), LDKA had 18% (Time Ratio [TR] 0.82, 95%CI: 0.70–0.95) less graft survival time and 18% (TR 0.82, 95%CI: 0.68–0.97) less patient survival time, DDKA had 23% (TR 0.77, 95%CI: 0.68–0.87) less graft survival time and 29% (TR 0.71, 95%CI: 0.62–0.81) less patient survival time, and SPK with early pancreas graft loss had 34% (TR 0.66, 95%CI: 0.56–0.78) less graft survival time and 34% (TR 0.66, 95%CI: 0.55–0.79) less patient survival time. In conclusion, SPK,P+ recipients have better kidney allograft and patient survival compared with LDKA and DDKA. Early pancreas graft failure results in inferior kidney and patient survival time compared to kidney transplant alone.

INTRODUCTION: Among individuals with low income, medication cost is a well-established barrier to medication adherence. Spending less on basic needs to pay for medication is a particularly concerning cost-coping strategy and may be associated with worse health outcomes. The aims of this study were (1) to describe the demographic and health status characteristics of those who report spending less on basic needs to pay for medication, and (2) to understand the associated psychosocial and financial challenges of individuals who make these choices. METHODS: We administered a survey to primarily low-income adults (n=270) in St. Louis, Missouri as part of a larger study from 2016–2018. Logistic regression was used to model the odds of reporting spending less on basic needs in order to pay for medication. RESULTS: Spending less on basic needs to pay for medication was significantly more likely in individuals with fair or poor health status (OR = 2.00; 95% CI, 1.03 to 3.93), greater number of chronic conditions (OR = 1.21 per additional 1 condition, 95% CI, 1.06 to 1.40), greater medication expenditure (OR = 1.41 per additional $100; 95% CI, 1.11 to 1.89), and difficulty paying bills (OR = 1.43; 95% CI, 1.11 to 1.85). Individuals who spent less on basic needs were less likely to be fully adherent to their medication regimen (OR = 0.38; 95% CI, 0.18 to 0.77). CONCLUSIONS: Screening for unmet basic needs and offering referrals to social safety net programs in the primary care setting may help patients achieve sustainable medication adherence.

The role of robotic surgery in bariatrics remains controversial. Patient selection for robotic surgery is not well-studied. The objective of this study was to identify factors associated with robotic surgery and its temporal trends. The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database from 2015 to 2018 was used. Adult patients undergoing primary sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) using the laparoscopic or robotic approach were identified. Revisional, hybrid, or those with concomitant procedures were excluded. Logistic regression was conducted to identify factors associated with undergoing robotic-assisted surgery. Among 211,568 patients who underwent SG, 9.1% underwent a robotic SG; among 76,805 patients who underwent RYGB, 7.9% of patients underwent a robotic RYGB. During 2015-2018, robotics increased from 7.1 to 11.3% for SG and 7.4 to 8.6% for RYGB. After controlling for patient characteristics, there was still an increasing trend in the use of robotic surgery: SG (multivariable-adjusted odds ratio, aOR, 1.18; 95% confidence interval, CI, 1.17–1.20) and RYGB (aOR, 1.05; 95% CI, 1.03–1.08). For both robotic SG and RYGB, functional status and African American race were associated with undergoing robotic surgery, while races other than White or African American and Hispanic ethnicity were not. Pre-operative IVC filter was associated with robotic SG, while the presence of GERD, diabetes, and COPD were associated with robotic RYGB. Robotic bariatric surgery has increased over time. Our findings identified factors associated with the receipt of robotic surgery. Reasons for these factors require further investigation to better delineate indications for this technology.

PURPOSE. To evaluate the cost-effectiveness of axillary observation versus sentinel lymph node biopsy (SLNB) after negative axillary ultrasound (AUS). In patients with clinical T1-T2 N0 breast cancer and negative AUS, SLNB is the current standard of care for axillary staging. However, SLNB is costly, invasive, decreasing in importance for medical decision-making, and is not considered therapeutic. Observation alone is currently being evaluated in randomized clinical trials, and is thought to be noninferior to SLNB. METHODS. We performed cost-effectiveness analyses of observation versus SLNB after negative AUS in post-menopausal women with clinical T1-T2 N0, HR(+)/HER2(−) breast cancer. Costs at the 2016 price level were evaluated from a third-party commercial payer perspective using the MarketScan® Database. We compared cost, quality-adjusted life years (QALYs), and net monetary benefit (NMB). Multiple sensitivity analyses varying baseline probabilities, costs, utilities, and willingness-to-pay thresholds were performed. RESULTS. Observation was superior to SLNB for patients with N0 and N1 disease, and for the entire patient population (NMB in US$: $655,659 for observation versus $641,778 for SLNB for the entire patient population). In the N0 and N1 groups, observation incurred lower cost and was associated with greater QALYs. SLNB was superior for patients with >3 positive lymph nodes, representing approximately 5% of the population. Sensitivity analyses consistently demonstrated that observation is the optimal strategy for AUS-negative patients. CONCLUSION. Considering both cost and effectiveness, observation is superior to SLNB in post-menopausal women with cT1-T2 N0, HR(+)/HER2− breast cancer and negative AUS.

BACKGROUND: Obesity is a substantial public health concern; however, gold-standard behavioral treatments for obesity are costly and burdensome. Existing adaptations to the efficacious Diabetes Prevention Program (DPP) demonstrate mixed results. Our prior research applying the Multiphase Optimization Strategy (MOST) to DPP identifies a more parsimonious, less costly intervention (EVO) resulting in significant weight loss. OBJECTIVE: The aim of the remotely conducted EVO trial is to test the non-inferiority of EVO against DPP. We will conduct economic evaluations alongside the trial to estimate delivery and patient costs, cost-effectiveness, and lifetime healthcare costs of EVO as compared to DPP. Exploratory analyses will examine maintenance, moderators, and mediators of the treatment effect. STUDY DESIGN: The EVO trial will recruit nationally to randomize 524 participants with obesity. Participants will receive either EVO or DPP over a 6 month period. EVO participants will be provided online lessons, a smartphone application to self-monitor diet, physical activity, and weight, and attend 12 brief calls with a Health Promotionist. DPP participants will receive the first 6 months of the Center for Disease Control’s T2D materials and attend 16 one-hour video call sessions with staff certified in DPP delivery. Weight will be measured at baseline, 3-, 6-, and 12-months. Itemized delivery cost will be collected. Staff and participants will also provide information to estimate costs for intervention-related activities. SIGNIFICANCE: The EVO trial could establish evidence supporting dissemination of a scalable, cost-effective behavioral treatment with potential to shift clinical practice guidelines, inform policy, and reduce the prevalence of obesity.

The American College of Surgeons Commission on Cancer recently updated its sampling recommendations for early stage NSCLC from at least 10 lymph nodes to at least one N1 (hilar) and three N2 (mediastinal) lymph node stations. Nevertheless, intraoperative lymph node sampling minimums remain subject to debate. We sought to evaluate these guidelines in patients with early stage NSCLC.We performed a cohort study using a uniquely compiled data set from the Veterans Health Administration. We manually abstracted data from operative notes and pathology reports of patients with clinical stage I NSCLC receiving surgery (2006-2016). Adequacy of lymph node sampling was defined using count-based (≥10 lymph nodes) and station-based (≥three N2 and one N1 nodal stations) minimums. Our primary outcome was recurrence-free survival. Secondary outcomes were overall survival and pathologic upstaging.The study included 9749 patients. Count-based and station-based sampling guidelines were achieved in 3302 (33.9%) and 2559 patients (26.3%), respectively, with adherence to either sampling guideline increasing over time from 35.6% (2006) to 49.1% (2016). Adherence to station-based sampling was associated with improved recurrence-free survival (multivariable-adjusted hazard ratio = 0.815, 95% confidence interval: 0.667-0.994, p = 0.04), whereas adherence to count-based sampling was not (adjusted hazard ratio = 0.904, 95% confidence interval: 0.757-1.078, p = 0.26). Adherence to either station-based or count-based guidelines was associated with improved overall survival and higher likelihood of pathologic upstaging.Our study supports station-based sampling minimums (≥three N2 and one N1 nodal stations) for early stage NSCLC; however, the marginal benefit compared with count-based guidelines is minimal. Further efforts to promote widespread adherence to intraoperative lymph node sampling minimums are critical for improving patient outcomes after curative-intent lung cancer resection.

This cross-sectional study examines the rate of HPV vaccination and the number eligible for this vaccination among younger veterans and civilians.

Objective: Current guidelines recommend adjuvant therapy for patients with completely resected non-small cell lung cancer (NSCLC) with high-risk clinical or pathologic features. Despite this, the relationship between these features and cancer recurrence is poorly elucidated. Methods: We conducted a retrospective cohort study using a uniquely compiled dataset from the US Veterans Health Administration (VHA) including all Veterans with pathologic early-stage (≤5cm, N0) NSCLC receiving definitive surgical treatment (2010-2016). Based on National Comprehensive Cancer Network guidelines, we evaluated 6 high-risk features: tumor size, tumor grade, visceral-pleural invasion, lymphovascular invasion, non-anatomic wedge resection, and adequacy of nodal sampling. We developed a score reflecting the relationship between these high-risk features and recurrence, using a multivariable competing risk model (death as competing event). The score performance was then tested in an external cohort from the National Cancer Database (NCDB). Results: The study included 3,799 Veterans. The median follow-up was 7.1 years. Recurrence was detected in 800 (21.1%) patients. The association between high-risk features and cancer recurrence were as follows: tumor size (e.g., 31-40mm vs. 0-10mm, multivariable-adjusted hazard ratio, aHR 1.676, 95% CI 1.229-2.285, p=0.001), tumor grade (e.g., III vs. I, aHR 1.884, 95% CI 1.448-2.449, p Conclusions: High-risk clinicopathologic features are associated with dramatically higher risk of recurrence and worse overall survival. Multivariable assessment of these features using a comprehensive yet pragmatic score may help to standardize adjuvant treatment eligibility following curative intent resection. Citation Format: Brendan T. Heiden, Daniel B. Eaton, Su-Hsin Chang, Yan Yan, Martin W. Schoen, Bindiya G. Patel, Theodore S. Thomas, Bryan F. Meyers, Benjamin D. Kozower, Varun Puri. Comprehensive validation of high-risk clinicopathologic features in early-stage, node-negative non-small cell lung cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 734.

Background: Glucagon-like peptide 1 (GLP-1) agonists are increasingly used in diabetics due to their cardiac and renal benefits along with their actions as antihyperglycemics. They also showed inhibitory effects in ovarian, breast, prostate, and pancreatic cancers in preclinical studies. However, to our knowledge, no studies have examined whether GLP-1 agonists have a similar effect in multiple myeloma. Using a population-based study design, we aimed to assess the association of GLP-1 agonist use in the progression of MGUS to MM in patients with diabetes mellitus (DM). Methods: Patients diagnosed with MGUS from 1999-2021 in the Veterans Health Administration were identified via ICD codes and further confirmed by a natural language processing (NLP)-based algorithm. Progression to smoldering MM (sMM) or MM was also confirmed by another NLP-based algorithm. Only patients with DM, IgG, IgA, or light chain MGUS, and black and white patients were included. We excluded patients who experienced progression within 1 year of MGUS diagnosis or within 2 years of DM diagnosis, and patients diagnosed with MGUS before DM diagnosis. We performed 1:2 matching for patients with and without GLP-1 agonist exposure based on their follow-up time. Gray’s test was performed to detect the difference between the two cumulative incidence functions (CIF) for progression stratified by GLP-1 agonist use status. The association between GLP-1 agonist use and progression was estimated by multivariable-adjusted hazard ratio (aHR) using Fine-Gray distribution hazard model with death as a competing event and time-varying GLP-1 agonist use. The covariates included age, BMI, monoclonal protein (M-spike) level (≥1.5g/dL), creatinine (>1.5 mg/dL), glycated hemoglobin (HbA1c; < 7%, 7% - 9%, and > 9%) at MGUS diagnosis, metformin and sodium-glucose co-transporter 2 inhibitor (SLGT2i) use, as well as sex, race, MGUS heavy chain subtype, light-chain MGUS, Charlson Comorbidity Index, and months from diagnoses of DM to MGUS. Results: Our NLP algorithm confirmed 19,551 patients with DM and MGUS. After applying our inclusion and exclusion criteria, we had 14,832 patients, of which 1,303 had GLP-1 agonist use. After matching, our analytic cohort included 1,303 patients with exposure, and 2,606 patients without. There is no evidence to show that CIFs were different between the exposed and unexposed groups. However, the multivariable analysis showed that GLP-1 agonist use was associated with decreased progression to MM: aHR 0.35, 95% confidence interval 0.14-0.90, p = 0.03. Conclusions: For DM patients with MGUS, GLP-1 agonist use is associated with a 65% reduction in risk of progression from MGUS to sMM/MM. Prospective studies examining whether GLP-1 agonists can be used as possible chemoprevention in MGUS patients with DM should be explored. Citation Format: Nikhil Grandhi, Lawrence Liu, Mei Wang, Theodore Thomas, Akhil Kumar, Kristin Vargo, Kristen Sanfilippo, Grahm Colditz, Su-Hsin Chang. Glucagon-like peptide 1 agonist use and the progression of monoclonal gammopathy of undetermined significance to multiple myeloma in US veterans with diabetes mellitus. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4358.

Background: Metformin is an oral antihyperglycemic with possible antineoplastic properties based on preclinical and retrospective studies. A retrospective study of Veterans demonstrated a reduction in monoclonal gammopathy of undetermined significance (MGUS) to multiple myeloma (MM) progression in patients with diabetes mellitus (DM) treated with metformin for ≥4 years. However, it is unclear whether there are racial differences to this effect of metformin. Methods: Patients diagnosed with MGUS from 1999-2021 in the Veterans Health Administration were identified. We used a natural language processing-based algorithm to confirm MGUS diagnosis and progression, including smoldering MM and MM. Only patients with DM, IgG, IgA, or light chain MGUS, and black and white patients were included in the analyses. We excluded patients who experienced progression within 6 months of MGUS diagnosis, patients who were diagnosed with MGUS before DM diagnosis, and patients who died, progressed to MM, or were lost to follow up within four years of MGUS diagnosis. We defined metformin users as those who had metformin use for ≥4 years after DM diagnosis and before MM development. Cumulative incidence functions (CIF) were stratified by metformin use status. Gray’s test was performed to detect the difference between the two functions. The association between metformin use and progression was estimated by multivariable-adjusted hazard ratio (aHR) using Fine-Gray distribution hazard model with death as a competing event. The covariates included age, BMI, monoclonal protein (M-spike) level (≥1.5g/dL), creatinine, and glycated hemoglobin (HbA1c) at MGUS diagnosis, as well as sex, race, MGUS heavy chain subtype, light-chain MGUS, and Charlson Comorbidity Index. Results: Our NLP algorithm confirmed 19,551 patients with DM and MGUS. After applying our inclusion and exclusion criteria, we had 13,068 (35% black and 65% white) patients of which, 4,268 (26.2% black and 36.2% white) were metformin users. Cumulative incidence function was stratified by metformin use status were statistically significant different (p=0.04) with a lower progression rate for metformin users (see Fig). The multivariable analysis demonstrated a statistically significant reduction in progression with metformin use in the overall cohort (aHR 0.79; 95% CI 0.67-0.95). Further multivariable analyses showed that metformin use was associated with a significant reduction in progression rate in white patients (aHR 0.73; 95% CI 0.58-0.91) but not in black patients (aHR 0.90; 95% CI 0.69-1.17). Conclusions: For patients with DM and MGUS, ≥4 years of metformin use was associated with a reduced risk of progression of MGUS to MM in white patients but not in black patients. Citation Format: Lawrence W. Liu, Nikhil Grandhi, Mei Wang, Theodore Thomas, Akhil Kumar, Kristin Vargo, Kristen M. Sanfilippo, Graham Colditz, Su-Hsin Chang. Racial differences in the association of metformin use with progression of monoclonal gammopathy of undetermined significance to multiple myeloma in US veterans with diabetes mellitus [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1960.

Background: Assessment of comorbid diseases is essential to clinical research and may risk-stratify patients for adverse events and death. Total number of prescription medications and drug classes could be an easy-to-use tool for estimating patient risk independent of established methods such as the Charlson Comorbidity Index (CCI) that is created from administrative data. Additionally, clinicians have access to prescription medication lists, facilitating assessment of comorbidities in clinical settings. Methods: Retrospective observational study of US Veterans treated for metastatic castrate resistant prostate cancer in the Veterans Health Administration who received treatment with abiraterone or enzalutamide between May 2011-June 2, 2017. We determined number of unique drugs and anatomic therapeutic chemical (ATC) drug classes prescribed in the year prior up to 14 days before initiation of treatment. Multivariable logistic regression and Cox proportional hazard modeling was used to assess the association between number of drugs with all-cause 90-day mortality and overall survival (OS) while accounting for important covariates including age, CCI, body-mass index, prostate specific antigen, race, prior docetaxel, hemoglobin, albumin, bilirubin, and creatinine. Results: Among 11,021 Veterans, a median (IQR) of 11 (6,18) unique medications and 10 (5,15) unique ATC medication classes were filled in the year prior to treatment. The median age was 75 years with median CCI of 3 and 2,550 were black (23.1%). Increasing age was associated with increased CCI across age strata with mean CCI of 3.7 in age Conclusion: The number of prescription medications and drug classes are independently associated with short- and long-term outcomes in patients undergoing treatment for metastatic castrate resistant prostate cancer, even after accounting for important covariates including age and CCI. Assessment of patient medications may provide a simple, yet reliable tool to assess comorbidities, risk of adverse events, and death. Citation Format: Martin W. Schoen, Carley Pickett, Daniel B. Eaton, Brendan T. Heiden, Su-Hsin Chang, Yan Yan, Melanie P. Subramanian, Varun Puri. Number of prescription drugs and overall survival in metastatic castrate resistant prostate cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 6741.

ImportanceSurgical resection remains the preferred treatment for functionally fit patients diagnosed with early-stage non–small cell lung cancer (NSCLC). Process-based intraoperative quality metrics (QMs) are important for optimizing long-term outcomes following curative-intent resection.ObjectiveTo develop a practical surgical quality score for patients diagnosed with clinical stage I NSCLC who received definitive surgical treatment.Design, Setting, and ParticipantsThis retrospective cohort study used a uniquely compiled data set of US veterans diagnosed with clinical stage I NSCLC who received definitive surgical treatment from October 2006 through September 2016. The data were analyzed from April 1 to September 1, 2022. Based on contemporary treatment guidelines, 5 surgical QMs were defined: timely surgery, minimally invasive approach, anatomic resection, adequate lymph node sampling, and negative surgical margin. The study developed a surgical quality score reflecting the association between these QMs and overall survival (OS), which was further validated in a cohort of patients using data from the National Cancer Database (NCDB). The study also examined the association between the surgical quality score and recurrence-free survival (RFS).ExposuresSurgical treatment of early-stage NSCLC.Main Outcomes and MeasuresOverall survival and RFS.ResultsThe study included 9628 veterans who underwent surgical treatment between 2006 and 2016. The cohort consisted of 1446 patients who had a mean (SD) age of 67.6 (7.9) years and included 9278 males (96.4%) and 350 females (3.6%). Among the cohort, 5627 individuals (58.4%) identified as being smokers at the time of surgical treatment. The QMs were met as follows: timely surgery (6633 [68.9%]), minimally invasive approach (3986 [41.4%]), lobectomy (6843 [71.1%]) or segmentectomy (532 [5.5%]), adequate lymph node sampling (3278 [34.0%]), and negative surgical margin (9312 [96.7%]). The median (IQR) follow-up time was 6.2 (2.5-11.4) years. An integer-based score (termed the Veterans Affairs Lung Cancer Operative quality [VALCAN-O] score) from 0 (no QMs met) to 13 (all QMs met) was constructed, with higher scores reflecting progressively better risk-adjusted OS. The median (IQR) OS differed substantially between the score categories (score of 0-5 points, 2.6 [1.0-5.7] years of OS; 6-8 points, 4.3 [1.7-8.6] years; 9-11 points, 6.3 [2.6-11.4] years; and 12-13 points, 7.0 [3.0-12.5] years; P P P Conclusions and RelevanceThe findings of this study suggest that adherence to intraoperative QMs may be associated with improved OS and RFS. Efforts to improve adherence to surgical QMs may improve patient outcomes following curative-intent resection of early-stage lung cancer.