United States

Since the beginning of the COVID-19 pandemic, there have been over 775 million reported cases worldwide. A significant proportion of these patients suffer from long-COVID, experiencing symptoms such as severe fatigue, myalgias, and gastrointestinal (GI) dysfunction. Both chronic post-infectious disorders and GI conditions are linked to persistent sympathetic nervous system activation (PSA), however the specific interactions between long-COVID and GI disorders requires additional investigation. We hypothesized that individuals with pre-existing GI disorders would have higher rates of long-COVID. We also postulated that long-COVID increases the risk for GI disorder diagnosis.

We utilized de-identified electronic health record data from TriNetX, a global health research network with over 124 million patients. We constructed queries to identify subjects with upper functional (UF), lower functional (LF), upper structural (US), or lower structural (LS) GI disorder diagnoses. Afterwards, we analyzed the prevalence of long-COVID (defined as new malaise and fatigue symptoms lasting ≥1 month post-infection and not present in the previous 4 years) in patients with and without GI conditions. Additionally, we compared the rates of GI symptom development in patients with and without long-COVID diagnosis. Changes in GI disorder incidence in the 4 years before and after the pandemic onset (January 1, 2020) were also examined. Data were evaluated with chi-squared analysis.

Subjects with long-COVID had higher pre-COVID GI disorder prevalence compared to subjects without long-COVID [UF (1.12%), LF (2.33%), US (13.13%), and LS (0.80%)] (p&lt;0.001). There was also a 0.65%, 0.83%, 4.93% increase in UF, LF, and LS post-COVID diagnoses prevalence, respectively, and a 5.77% decrease in US diagnoses (p&lt;0.001) between patients with long-COVID and without long-COVID. In the general population, post-pandemic, the prevalence of LF and US diagnoses increased by 0.14% and 0.38% (p&lt;0.001), while UF and LS diagnoses decreased by 0.015% and 0.17% (p&lt;0.001). 

These results suggest that GI disorders, especially upper structural and functional GI disorders, pose a higher risk for long-COVID symptoms. However, the nuanced prevalences of GI conditions following long-COVID reflect a need for further research on the long-term impacts and mechanisms of PSA-mediated GI tract dysfunction following SARS-CoV-2 infection.

AMA Research Challenge 2024 

The Impact of Gastrointestinal Conditions on Long-COVID: Insights from a Global Health Network

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Since the beginning of the COVID-19 pandemic, there have been over 775 million reported cases worldwide. A significant proportion of these patients suffer from long-COVID, experiencing symptoms such as severe fatigue, myalgias, and gastrointestinal (GI) dysfunction. Both chronic post-infectious disorders and GI conditions are linked to persistent sympathetic nervous system activation (PSA), however the specific interactions between long-COVID and GI disorders requires additional investigation. We hypothesized that individuals with pre-existing GI disorders would have higher rates of long-COVID. We also postulated that long-COVID increases the risk for GI disorder diagnosis.

We utilized de-identified electronic health record data from TriNetX, a global health research network with over 124 million patients. We constructed queries to identify subjects with upper functional (UF), lower functional (LF), upper structural (US), or lower structural (LS) GI disorder diagnoses. Afterwards, we analyzed the prevalence of long-COVID (defined as new malaise and fatigue symptoms lasting ≥1 month post-infection and not present in the previous 4 years) in patients with and without GI conditions. Additionally, we compared the rates of GI symptom development in patients with and without long-COVID diagnosis. Changes in GI disorder incidence in the 4 years before and after the pandemic onset (January 1, 2020) were also examined. Data were evaluated with chi-squared analysis.

Subjects with long-COVID had higher pre-COVID GI disorder prevalence compared to subjects without long-COVID [UF (1.12%), LF (2.33%), US (13.13%), and LS (0.80%)] (p<0.001). There was also a 0.65%, 0.83%, 4.93% increase in UF, LF, and LS post-COVID diagnoses prevalence, respectively, and a 5.77% decrease in US diagnoses (p<0.001) between patients with long-COVID and without long-COVID. In the general population, post-pandemic, the prevalence of LF and US diagnoses increased by 0.14% and 0.38% (p<0.001), while UF and LS diagnoses decreased by 0.015% and 0.17% (p<0.001). 

These results suggest that GI disorders, especially upper structural and functional GI disorders, pose a higher risk for long-COVID symptoms. However, the nuanced prevalences of GI conditions following long-COVID reflect a need for further research on the long-term impacts and mechanisms of PSA-mediated GI tract dysfunction following SARS-CoV-2 infection.

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Background: Colorectal Cancer (CRC) is the third most common and deadly cancer in the United States (U.S.). Widespread adoption and utilization of screening programs and patient education have likely contributed to the decline in CRC incidence, but morbidity and mortality still remain high. Racial disparities at every step in the cancer care continuum have been well-reported among large U.S. cohort studies, with Black patients experiencing worse outcomes. Care access, screening enrollment, and timely receipt of cancer treatment are known contributing factors. Our project’s aim was to investigate if racial disparities in CRC care exist in the more-equal access health care system of the national Veterans Affairs (VA) system.

Methods: In this retrospective cohort study, patient data was collected from the VA Central Cancer Registry. All veterans with incidental or first-time diagnosis of CRC from January 2017 to December 2021 were included and categorized as Non-Hispanic White (White) or Non-Hispanic Black (Black) race. Patients of other races were excluded given limited sample size.

Variables of interest included: sociodemographic factors (age, sex, VA priority group, rural vs. urban); BMI; tobacco and alcohol use; diabetes mellitus; and Deyo-Charlson comorbidity score. Study outcomes included stage at diagnosis (American Joint Committee on Cancer staging system), receipt of cancer treatment, and survival. Treatment included surgical resection, chemotherapy, or radiation therapy in any or no combination.

Results: A total of 8,021 patients with CRC (76.3% White, 23.7% Black) were identified, with a median age of 71 (IQR 66-76). Black patients were more likely to be younger at time of cancer diagnosis (median 68 years) compared to White patients (median 71 years; p-value<0.05). On multivariable analysis, after adjusting for the above listed variables of interest, there were no statistically significant differences in the following outcomes by race: stage at diagnosis (odds ratio (OR) 0.98; 95% confidence interval (CI) 0.87-1.11); receipt of any cancer treatment (additionally adjusted for stage: OR 0.86; 95% CI 0.74-1.00); or overall survival (additionally adjusted for stage and treatment: OR 0.97; 95% CI 0.87-1.08).

Conclusion: The well-described racial disparities in timing of cancer diagnosis, receipt of care, and survival seen in patients with CRC throughout the U.S. are not observed in the more equitable VA health care system. These findings highlight that equal access to care, including screening and surveillance programs, largely eliminates racial disparities in CRC outcomes. Adoption of similar systematic efforts in health care systems outside of the VA could lead to reduction in cancer care disparities.

The Impact of Race on Colorectal Cancer Outcomes in the Nationwide Veterans Affairs Health Care System


Background: The COVID-19 pandemic led to a decrease in colorectal cancer (CRC) screening. Preceding the pandemic, CRC screening rates had shown an increase across all racial groups. However, post- pandemic, there has been a decline in screening rates among AA, which will exacerbate existing disparities. 

Objective: This study aims to analyze CRC screening data collected before and after the COVID-19 pandemic to understand the distribution of pandemic- associated screening decreases on CRC disparities in the AA population. 

Methods: A systematic literature search through PubMed, Embase, and Google Scholar was done using keywords “Colorectal cancer screening”, “Covid 19”, “Colorectal Cancer”, “Colonoscopy”, and “African Americans”. The initial search resulted in 367 articles, of which nine studies in the USA (Ohio, Missouri, NYC, California) met the inclusion criteria (adults, 18+, English). We assessed patient colonoscopy records and reviewed the literature to correlate the influence of factors such as reallocation of health resources, financial burdens, decreased advocacy, and psychosocial factors on CRC screening. 

Results: African Americans had a 47% decrease (from 50,129 to 26,713) in CRC screening colonoscopy from 2019 to 2020, whereas Whites had a 39% decrease (from 403,596 to 244,414). Spanish patients had a 31% decrease (from 19,842 to 13,615). Quartile 1 HHI had a 36% decrease (from 455 to 290). Quartile 4 HHI had a 33% decrease (from 166 to 111). Quartile 1 education had a 18% decrease (from 1,905 to 1,557). Quartile 4 education had a 14% decrease (from 2,237 to 1,935). Patients from low SVI had a 20% decrease (from 23,136 to 18,402). High SVI patients had a 22% decrease (from 25,859 to 20,064). 

Conclusion: The pandemic led to an overall decrease in colonoscopies that was significantly more pronounced among AA, especially those from low socioeconomic backgrounds. To address this, enhanced screening programs are essential to mitigate the impact of pandemic-related delays or cancellations on screenings. These efforts are crucial to counteracting the exacerbation of existing disparities tied to socioeconomic status and healthcare access. 


Understanding and Addressing Pre- and Post- COVID-19 Disparities in CRC Screening and Outcomes among African Americans

Background
Protocolizing pain management perioperatively can reduce opioid exposure in children. Our group designed a multi-modal, opioid free pain management protocol with intent to decrease opioids in children undergoing hernia repair. The purpose of this study is to evaluate protocol usage and outcomes after implementation.
Methods
The protocol utilizes non-opioid analgesics, nerve blocks, and child life perioperatively. Patient characteristics, pre plus intra-operative (PIO) and post-operative (PO) opioid use, and protocol adherence were compared pre- and post-implementation. Adherence was stratified by level of opioid use - high (no PIO or PO use), medium (no PIO but + PO use), and low (+PIO, +PO use).
Results
After seven months, 175 cases were analyzed with 103 pre- and 72 post-implementation. There were no significant differences in demographics or hernia type. The median age and weight were 4.00 years (IQR 1.60, 6.00) and 17.60 kg (IQR 11.97, 24.90). Post-implementation, there was a significant increase in nerve blocks (37 (51.4%) vs. 6 (5.8%), p<.0001) and PIO non-opioid analgesics (64 (88.9%) vs. 24 (23.3%), p<.0001). We also saw a significant decrease in PIO opioids (8 (11.1%) vs. 89 (86.4%), p<.0001). Additionally, we noted a significant increase in PO non-opioid pain medications (38 (52.8%) vs. 34 (33%), p=.012). And again, there was a significant decrease in PO opioid usage in the post-implementation group (22 (30.6%) vs. 77 (74.8%), p <.0001). Pain scores where not significantly affected. No significant differences were found in PO complications, including nausea, vomiting or respiratory events. 89% of cases had either high or medium protocol adherence.
Conclusion
Our protocol decreased the use of opioids in pediatric patients undergoing hernia repair. Adherence to the protocol was good and resulted in increased use of non-opioid analgesics for pain.

Implementation of an Opioid Free Pediatric Hernia Repair Protocol​

Background. Unintentional injuries are a major cause of death in the US, with unintentional falls being the most significant cause of hospitalization for injury in adults. A known contributor to fall risk is frailty, an age-related state of physiological decline and vulnerability to life stressors. Frailty itself is a significant predictor of fall risk and poor outcomes among both midlife (50 to 64 years old) and older adults (65 years old and greater), yet CDC fall screening guidelines are restricted to older adults. Moreover, the incidence and impact of frailty on outcomes in midlife trauma patients remains understudied. Herein, we assessed the incidence of frailty among midlife trauma patients from 2012 to 2021 and evaluated the impact of frailty on patients’ outcomes.

Methods. The American College of Surgeons Trauma Quality Improvement Program (TQIP) database was used. Trauma patients aged 50 to 64 were included to assess the incidence of frailty over a 10-year period (2012-2021) and the impact of frailty on outcomes in midlife adults. Demographics, injury and hospital information, comorbidities, complications, mortality, and discharge disposition were extracted. Frailty was scored using the modified frailty index-5 (mFI-5). Descriptive statistics were obtained. Frailty incidence was assessed using Poisson regression analysis, and multivariate analyses were performed on 2021 data to assess the impact of frailty on patients’ outcomes. Our primary endpoints were hospital length of stay (LOS) and discharge disposition; secondary endpoints included ICU LOS, days on a ventilator, complications, and mortality. P < 0.001 was considered significant.

Results. The frailty rate of midlife trauma patients more than doubled over the 10-year period, rising from 2.40% in 2012 to 5.09% in 2021. Upon adjustment for demographics, the incidence of frailty in this population increased by 8% per year (incidence rate ratio (IRR)=1.08 [95% CI 1.08, 1.09]). On multivariate analysis adjusting for demographics, insurance status, injury severity score, vitals on arrival, and mode of transportation, frailty was associated with increased risk of death (OR=2.272 [2.006-2.574]), longer hospital and ICU stay (MR=1.458 [1.427-1.489] and MR=1.297[1.242-1.355]), and discharge requiring higher level of care (OR=2.270 [2.163-2.383]).

Conclusion. Frailty has increased in midlife adult trauma patients over the 10-year period studied. Moreover, frailty is associated with several negative health outcomes for midlife adults. These results underscore the need for fall screening in midlife adult patients and further exploration into methods to delay the onset of frailty.

Incidence and impact of frailty in midlife trauma patients

Background
Compared to standard breast conserving surgery (BCS), oncoplastic breast conserving surgery (OBCS) has improved tumor exposure, resection of wider diameters and higher volumes, low rates of recurrence and re-resection, superior cosmetic outcomes, improved patient satisfaction, and decreased postoperative breast volume requiring lower doses of postoperative radiotherapy. OBCS has no difference in postoperative complications or overall survival compared to BCS. Racial disparities exist in both rates of reconstruction after mastectomy as well as complication rate after breast reconstruction, and though the use of OBCS has increased, there is little research investigating how race affects outcomes in OBCS. Our study compares outcomes between Hispanic and Non-Hispanic patients undergoing OBCS at a large community hospital.

Methods
A retrospective review was performed on patients who underwent oncoplastic surgery for breast cancer. Subjects were divided into Hispanic vs non-Hispanic groups. Primary outcomes included need for re-excision, hematoma formation, wound infection, areolar loss, skin necrosis, and delayed wound healing. 

Results
There were 30 patients (73%) in the Hispanic group and 11 patients (27%) in the non-Hispanic group. There was no significant difference in smoking status, hypertension, and diabetes mellitus (p=0.361, p=0.126, p=0.909) between the two groups. The average age in the Hispanic group was 55.8 +/- 9.1 whereas in the non-Hispanic group it was 58.4 +/-8.6 (p=0.416). The average BMI in the Hispanic group was 29.86 +/- 5.3 compared to 30.98 +/- 4.91 (p=0.549) in the non-Hispanic group. The average tumor size in the Hispanic group was 19.6mm +/- 11.1mm compared to 28.8mm +/- 26.4mm (p=0.148) in the non-Hispanic group. 

There were no significant differences in the need for margin re-excision (p=0.969) or post operative hematoma formation (p=0.478). There was no documented post operative wound infection, areolar loss, or skin necrosis in either group. The Hispanic group had significantly lower rates of delayed wound healing (3% in the Hispanic group vs 27% the non-Hispanic group, p=0.022). 

Conclusion
Oncoplastic breast conserving surgery is a valuable option when considering reconstruction for lumpectomy in the Hispanic population. There were no significant differences in demographics or outcomes amongst our two populations, except the Hispanic group had a lower rate of delayed wound healing. This study is limited by its small sample size and a future study with large samples is needed to corroborate these findings. Nonetheless, the benefits of oncoplastic breast conserving surgery cannot be understated and should always be considered for all patients who are appropriate candidates.


Oncoplastic Breast Conservation Surgery Outcomes are Similar Amongst Hispanic and Non-Hispanic Populations at a Large Community Hospital

Objectives: 
Vascular Ehlers-Danlos Syndrome (VEDS) is a rare connective tissue disorder impacting type III collagen production. We aim to delineate the impact of sex on variation in aortopathy, arteriopathy, and mortality among patients with VEDS. 
Methods: 
A cross-sectional analysis of 557 patients with VEDS and COL3A1 pathogenic variants was performed. Primary outcomes were distribution of aortopathy and arteriopathy, and all-cause mortality. Statistical analysis was performed utilizing Student’s t-tests (continuous data) and Pearson’s c2 tests (categorical data). 
Results:  
In the cohort, males were younger (35.8±16.6 vs. 39.2±16.0 years, P=0.017) and had more diagnoses of hypertension (16.1% vs. 8.1%, P=0.003), inguinal hernias (10.9% vs. 0.6%, P<0.001), and spontaneous pneumothoraces (10.5% vs 5.8%, P=0.043) compared to females. There was no difference in age of VEDS diagnosis, family history, or genotype frequency between males and females. Additionally, there were no statistical differences in stroke, myocardial infarction, intestinal perforation, musculoskeletal conditions. Aortopathy and arteriopathy differed between sexes. Aortopathy and arteriopathy was more common in males (74.2% vs. 57.9%, P<0.001), with more involvement of the visceral arteries (29% vs 18.4%, P=0.003), iliac arteries (23.8% vs 14.9%, P=0.008), and aorta (35.5% vs. 18.8%, P<0.001). Females had more frequent carotid cavernous fistulae (CCF, 6.2% vs 0.8%, P<0.001), carotid and great vessel involvement (23.6% vs. 15.7%, P = 0.21), and spontaneous coronary arterial dissection (SCAD, 3.2% vs 0.8%, P=0.05). Males had higher all-cause mortality (32.3% vs 20.4%, P=.001). 
Conclusions:  
Males with VEDS had more visceral artery, iliac artery, and aortic involvement, and females had greater frequency of SCAD, CCF, and carotid and great vessel involvement. These findings are similar to aortic and arterial disease in the general population. Unlike the general population, the age of onset appears to be similar between males and females with VEDS. These findings demonstrate sex-based differences in VEDS manifestation and highlight potential gaps in our understanding of patient risk factors.

Sex Differences in Vascular Ehlers-Danlos Syndrome

Background
Despite advances in revascularization strategies, lower extremity amputations remain a mainstay of treatment for chronic limb threatening ischemia (CLTI). Peripheral arterial occlusive disease results in approximately 185,000 major amputations in the United States per year. The Society for Vascular Surgery guidelines on the management of CLTI emphasize the importance of engaging patients in physical rehabilitation and obtaining prosthetics to optimize functional status after major amputation. Amputees who ambulate with a prosthetic are more well equipped to perform activities of daily living and have a survival advantage versus non-ambulatory amputees. We hypothesize that sociodemographic variables, particularly disadvantaged financial environments, have the potential to impact both rate of prosthetic utilization and the achievement of ambulation post major amputation. 

Methods
All cases in the Vascular Quality Initiative amputation module were queried. Inclusion was limited to below-, through-, and above-knee amputations. Two outcomes were investigated: Non-ambulatory status after amputation (min 120 days F/U) and not having obtained a prosthetic (min 90 days F/U). The ambulation status and prosthetic status analyses had 6984 and 6793 patients meet inclusion. Multivariable binary logistic regression was performed for the outcomes using significant (P<0.05) factors on univariable analysis.

Results
Factors with significant multivariable association for the outcome of no prosthetic utilization in follow up included: advancing age (aOR 1.011/year (1.006-1.016), P<.001); female sex (aOR 1.43 (1.28-1.61), P<.001); top 20% area of deprivation index representing most deprived areas (aOR 1.24 (1.09-1.41) P=.001); race (P=.002) with incidence of no prosthetic use at 61% for Native American, 46% for Asians; 52% for Black, 62% for Hawaiian/Pacific Islanders, 43% for White, 53% for multiracial, and 50% for unidentified race; Insurance status (P=.028) with protective status for commercial insurance (39% rate of no prosthetic) and non US insurance (33%) versus Medicare (51%), Medicaid (48%), VA insurance (49%), Self Pay (42%) and Medicare Advantage (51%). 

Conclusions
Living within the most financially disadvantaged areas and race both have a significant independent association with lack of prosthetic use following major amputation. Black, Native American and Pacific Islander demographic patients experience lack of prosthetic use at a higher rate than White and Asian patients independent of co-morbidities and socioeconomic co-variables. Female patients utilize a prosthetic and ambulate less frequently than males after major amputation, largely due to a higher rate of above knee amputation. Co-morbidities, and not socioeconomic variables are the leading drivers of non-ambulation.

The Impact of Sociodemographic Variables on Functional Recovery Following Lower Extremity Amputation

Introduction
In preparation for bariatric surgery, patients undergo nutritional counseling and are recommended to follow strict dietary instructions for weight loss. Significant weight loss reduces liver volume, reduces perioperative complications, and sets the foundation for long-term surgical success. Research suggests that educating patients about various food choices and integrating exercise routines into their daily lives can further enhance surgical outcomes and promote healthier long-term decision making. 

Traditionally, nutritional counseling for bariatric surgery patients was given through one-on-one in-person sessions. However, during the COVID-19 pandemic, most of these sessions were conducted virtually. Despite the growing prevalence of virtual sessions, there has been limited research on their effectiveness in comparison to in-person sessions. This study analyzes the efficacy of preoperative nutritional counseling by comparing in-person sessions to virtual sessions. 

Methods
A retrospective chart review of 365 patients who underwent bariatric weight loss surgery at Carle Foundation Hospital from 2018-2023 was conducted. Based on the method of pre-operative diet counseling, two groups were identified: patients who received virtual counseling and those who received in-person counseling. Data was collected on weight and BMI changes between the initial nutrition consultation date and the surgery date. Significance was calculated using the independent t-test and Spearman's correlation coefficient.

Results
Of the cohort of 365 patients, 80.8% (295) of patients received in-person counseling while 19.2% (70) of patients received virtual counseling. 81.4% (297) of patients were female. The in-person group demonstrated greater average weight losses compared to the virtual group (7.46 kg vs. 0.51 kg, p = 0.011). Similarly, the in-person group had a greater mean BMI change (-2.60 kg/m² vs. -0.39 kg/m², p = 0.019). The average minutes spent in the first nutrition consultation for the in-person and virtual groups was 48.0 minutes and 41.1 minutes respectively. While there was no correlation between time spent during consultation and weight loss for the in-person group (r = 0.064, p > 0.05), there is a positive correlation for the virtual group (r = 0.415, p < 0.001). 

Conclusion
Our results suggest that in-person education is more effective for weight loss and BMI reduction. There is a positive correlation between time spent in the first pre-operative nutrition consult and weight loss for virtual patients.

The Impact of Virtual Nutrition Counseling on Preoperative Weight Loss Prior to Bariatric Surgery

Background: 
Patients with peripheral artery disease (PAD) are at high risk of thrombosis leading to critical limb ischemia, amputation, and death. Many PAD patients also develop anemia, which affects the composition of blood, but its effect on the coagulation profile is not fully understood. We used thromboelastography with platelet mapping (TEG-PM) to measure viscoelastic properties of blood clotting in addition to the traditional clotting labs to examine the effect of anemia on coagulation parameters in PAD patients. 


Methods: 
PAD patients were prospectively evaluated from 2021 to 2024 at a large single center. TEG-PM was performed on whole blood samples that were collected prior to the patient’s revascularization. Past medical history, medication regimen, coagulation and complete blood count labs were taken from the patient’s medical record. Patients were stratified as anemic or non-anemic per WHO hemoglobin guidelines, and non-parametric T-tests were used to compare numerical variables, while Fisher’s exact test was used for categorical variables.  

Results: 
Of 397 patients, data from 211 anemic and 124 non-anemic patients were analyzed. Anemic patients displayed significantly higher values for clot strength (MA) in CK (65.5(±6.7) vs 61.3(±6.3), p<0.0001), CFF (29.1(±10.7) vs 21.4(±7.7), p<0.0001), Actf (16.1(±7.5) vs 10.3(±5.4), p<0.0001), ADP (52.8(±15.0) vs 44.6(±15.4), p<0.0001), and AA (41.4(±19.7) vs 35.3(±17.0), p=0.0072). This shows that anemic patients had greater fibrin activation (MA-ActF), fibrin contribution to clot strength (MA-CFF), and greater activation from platelets (MA-AA and MA-ADP). Anemics had significantly lower TEG-PM values of CKk (1.32(±0.70) vs 1.61(±0.63), p<0.0001), CKa (71.0(±10.5) vs 68.6(±8.9), p<0.0001), and CFFflev (515(±201) vs 400 (±145), p<0.0001), indicating faster clot propagation. In traditional coagulation labs, anemic patients had significantly longer times for INR (1.28(±0.42) vs 1.19(±0.49), p<0.0001), PT (16.0(±7.7) vs 15.3(±5.7), p=0.0023), and APTT (49.5(±26.6) vs 35.4(±14.1), p<0.0001), showing longer clotting times.  

Conclusion: 
PAD patients with anemia showed hypercoagulability through TEG-PM parameters of clot strength and fibrin activation, and hypocoagulability through traditional clotting labs. These results underscore the complexity of the effect of anemia along the coagulation cascade. Understanding this interaction can inform therapies to optimally prevent thrombosis in the anemic PAD patient population.

Effect of Anemia on Coagulation Parameters in Patients with Peripheral Arterial Disease 

Background: CDK4/6 inhibitors (CDKi) + endocrine therapy (ET) comprise the standard 1st line treatment for ER+ HER2- metastatic breast cancer (MBC). However, there is a gap in understanding how timing of MBC recurrence affects clinical outcomes on CDKi. We conducted a study to compare clinical outcomes of MBC patients on CDKi based on timing of MBC recurrence.
Methods: This retrospective study enrolled ER+ HER2- MBC patients diagnosed from Jan 2015 to Jan 2023, who received CDKi + ET as 1st line treatment for MBC. Patients were categorized as de novo MBC (dMBC), if they had 1. Stage 4 disease at initial diagnosis or 2. MBC diagnosed < 6 months of the primary breast cancer (PBC) diagnosis and before starting any systemic treatment for PBC. Patients with distant recurrence occurring < 5 years, 5-10 years, and >10 years from PBC were categorized as early, intermediate, and late MBCs (eMBC, iMBC, laMBC). Endpoints were Progression-Free Survival (PFS) and Overall Survival (OS) from MBC diagnosis. Baseline variables were compared using t-tests (continuous) and Chi-square tests (categorical). Endpoint analyses were conducted using Kaplan-Meier method and compared using Log rank test. Multivariate analyses were performed using Cox models.
Results: Out of 280 patients enrolled, 67 were dMBC, 75 eMBC, 56 iMBC, and 82 laMBC. The laMBC group had a higher mean age (years) compared to other groups (71 vs. 62 in dMBC+ eMBC + iMBC, p<0.001). 64.5% of laMBC had visceral disease compared to 50.5% of dMBC + eMBC + iMBC (p=0.031). 65.7% of dMBC patients were treated with palbociclib compared to 80.8% of eMBC + iMBC + laMBC (p=0.010). Higher % of eMBC were PR- vs other cohorts (41.3 vs 23.9 dMBC + iMBC + laMBC, p<0.001). Among the 3 non dMBC groups, prior ET sensitivity (no recurrence for 2 years on adjuvant ET) was lower in eMBC (45.3%) compared to iMBC + laMBC (81.9%, p<0.001). 61.3% of eMBC patients were on adjuvant ET at recurrence compared to 17.4% of iMBC + laMBC (p<0.001). Other variables were similar. Table shows unadjusted endpoint analyses. In multivariate analyses, the risk of PFS events were not significantly different among cohorts (age<=65, ECOG performance status (PS) >=2 and PR- were independently associated with shorter PFS); risk of death was higher in eMBC vs laMBC (HR 1.73, p=0.047).
Conclusions: In this retrospective study of ER+ HER2- MBC patients treated with 1st line CDKi + ET, timing of MBC recurrence was not associated with PFS differences after adjusting for other variables. However, patients with MBC recurring < 5 years of PBC had the higher likelihood of death compared to those recurring >10 years of PBC.

Cohort PFS events Median PFS, years [95% Confidence Interval (CI)] p value
dMBC 35/66 2.7 [1.8-Not Evaluable (NE)] 0.024
eMBC 57/74 1.6 (1.3-1.9) 
iMBC 35/56 2.1 (1.4-5.0) 
laMBC 44/82 3.2 (2.2-5.2) 

OS events Median OS, years (95% CI) p value
23/67 4.1 (3.9-8.1) 0.179
40/75 3.8 (2.6-4.9) 
22/56 4.6 (2.8-7.7) 
28/82 5.2 (4.1-NE)

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