Operative trends for pancreatic and hepatic malignancies during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic disrupted routine health care, including many elective and non-cancer operations in the United States. Most hepato-pancreato-biliary malignancy patients require outpatient imaging, tissue sampling, and staging, and many undergo neoadjuvant therapy before operative intervention. The aims of this study were to evaluate the effect of the COVID-19 pandemic on hepato-pancreato-biliary oncologic operations and to determine whether trends in neoadjuvant therapy were altered by the pandemic. METHODS: Adult patients in the United States undergoing oncologic operations for pancreatic, primary and secondary hepatic malignancies, with or without neoadjuvant therapy, were extracted from the Vizient Clinical Data Base. Control chart analysis was used to plot trends over time and to determine whether changes were statistically significant. Wilcoxon rank-sum tests also compared monthly operative volume from pre-pandemic (12 month) and pandemic (28 months) periods. RESULTS: A total of 36,553 patients were identified over 40 months. Mean monthly pancreatic oncologic operations were unaffected by the pandemic (P = .257). Operations for pancreatic oncologic operations with prior neoadjuvant therapy increased throughout the pandemic (P = .002). Oncologic operations for primary and secondary hepatic malignancies were significantly reduced for 4 and 2 months, respectively, at the beginning of the pandemic but returned to their pre-pandemic baseline within 4 months (P = .169 and P = .598). CONCLUSION: Pancreatic operation volumes for cancer did not change, but pancreatic operations after neoadjuvant therapy continued to increase during the pandemic. Operations for hepatic malignancy were transiently disrupted but quickly normalized. These observations suggest that surgery for hepato-pancreato-biliary malignancies was prioritized during the pandemic.

Extent of Resection and Long-Term Outcomes for Appendiceal Adenocarcinoma: a SEER Database Analysis of Mucinous and non-Mucinous Histologies.

BACKGROUND: Mucinous appendiceal adenocarcinomas (MAA) and non-mucinous appendiceal adenocarcinomas (NMAA) demonstrate differences in rates and patterns of recurrence, which may inform the appropriate extent of surgical resection (i.e., appendectomy versus colectomy). The impact of extent of resection on disease-specific survival (DSS) for each histologic subtype was assessed. PATIENTS AND METHODS: Patients with resected, non-metastatic MAA and NMAA were identified in the Surveillance, Epidemiology, and End Results database (2000-2020). Multivariable models were created to examine predictors of colectomy for each histologic subtype. DSS was calculated using Kaplan-Meier estimates and examined using Cox proportional hazards modeling. RESULTS: Among 4674 patients (MAA: n = 1990, 42.6%; NMAA: n = 2684, 57.4%), the majority (67.8%) underwent colectomy. Among colectomy patients, the rate of nodal positivity increased with higher T-stage (MAA: T1: 4.6%, T2: 4.0%, T3: 17.1%, T4: 21.6%, p < 0.001; NMAA: T1: 6.8%, T2: 11.4%, T3: 25.6%, T4: 43.8%, p < 0.001) and higher tumor grade (MAA: well differentiated: 7.7%, moderately differentiated: 19.2%, and poorly differentiated: 31.3%; NMAA: well differentiated: 9.0%, moderately differentiated: 20.5%, and 44.4%; p < 0.001). Nodal positivity was more frequently observed in NMAA (27.6% versus 16.4%, p < 0.001). Utilization of colectomy was associated with improved DSS for NMAA patients with T2 (log rank p = 0.095) and T3 (log rank p = 0.018) tumors as well as moderately differentiated histology (log rank p = 0.006). Utilization of colectomy was not associated with improved DSS for MAA patients, which was confirmed in a multivariable model for T-stage, grade, and use of adjuvant chemotherapy [hazard ratio (HR) 1.00, 95% confidence interval (CI) 0.81-1.22]. CONCLUSIONS: Colectomy was associated with improved DSS for patients with NMAA but not MAA. Colectomy for MAA may not be required.

Racial disparities in rates of invasiveness of resected intraductal papillary mucinous neoplasms in the United States.

BACKGROUND: Racial and ethnic disparities have been observed in the multidisciplinary management of pancreatic ductal adenocarcinoma. Intraductal papillary mucinous neoplasm is the most common identifiable precursor to pancreatic ductal adenocarcinoma, where early surgical intervention before the development of an invasive intraductal papillary mucinous neoplasm improves survival. The association of race/ethnicity with the risk of identifying invasive intraductal papillary mucinous neoplasms during resection has not been previously defined. METHODS: The American College of Surgeons National Quality Improvement Program targeted pancreatectomy database (2014-2021) was queried for patients with race/ethnicity data who underwent resection of an intraductal papillary mucinous neoplasm. Backward Wald logistic regression modeling (P ≤ 0.05 for entry; P > .10 for removal) was used to identify independent predictors of invasion. RESULTS: A total of 4,505 cases of resected intraductal papillary mucinous neoplasms were identified, with 923 (20.5%) demonstrating invasive intraductal papillary mucinous neoplasms. The cohort of individuals other than non-Hispanic Whites were significantly more likely to have invasive intraductal papillary mucinous neoplasms (White, 19.9%; Black, 24.2%; Asian, 23.7%; Hispanic, 22.6%; P = .026). Such disparity could not be explained by greater comorbidity, as non-White patients were significantly younger (age <65 years: 41.7% vs 33.2%, P < .001) and had better physical status (American Society of Anesthesiologists score ≤2: 28.8% vs 25.2%, P = .053). After controlling for clinicodemographic variables, being an individual of race/ethnicity other than White was independently associated with higher odds of invasive intraductal papillary mucinous neoplasms (odds ratio, 1.280; 95% confidence interval, 1.046-1.566; P = .017). No differences in postoperative morbidity were observed. CONCLUSION: In a national cohort of patients with resected intraductal papillary mucinous neoplasms, individuals who identified as being of race/ethnicity other than White were significantly more likely to have invasive intraductal papillary mucinous neoplasms during surgical resection.

Recurrence-free survival dynamics following adjuvant chemotherapy for resected colorectal cancer: A systematic review of randomized controlled trials.

BACKGROUND: Several cytotoxic chemotherapies have demonstrated efficacy in improving recurrence-free survival (RFS) following resection of Stage II-IV colorectal cancer (CRC). However, the temporal dynamics of response to such adjuvant therapy have not been systematically quantified. METHODS: The Cochrane Central Register of Trials, Medline (PubMed) and Web of Science were queried from database inception to February 23, 2023 for Phase III randomized controlled trials (RCTs) where there was a significant difference in RFS between adjuvant chemotherapy and surgery only arms. Summary data were extracted from published Kaplan-Meier curves using DigitizeIT. Absolute differences in RFS event rates were compared at matched intervals using multiple paired t-tests. RESULTS: The initial search yielded 1469 manuscripts. After screening, 18 RCTs were eligible (14 Stage II/III; 4 Stage IV), inclusive of 16,682 patients. In the absence of adjuvant chemotherapy, the greatest rate of recurrence was observed in the first year (mean RFS event rate; 0-0.5 years: 0.22 ± 0.21; 0.5-1 years: 0.20 ± 0.09). Adjuvant chemotherapy was associated with significant decreases in the RFS event rates for the intervals 0-0.5 years (0.09 ± 0.09 vs. 0.22 ± 0.21, p < 0.001) and 0.5-1 years (0.14 ± 0.11 vs. 0.20 ± 0.09, p = 0.001) after randomization, but not at later intervals (1-5 years). In Stage IV trials, RFS event rates significantly differed for the interval 0-0.5 years (p = 0.012), corresponding with adjuvant treatment durations of 6 months. In Stage II/III trials, which included therapies of 6-24 months duration, there were marked differences in the RFS event rates between surgery and chemotherapy arms for the intervals 0-0.5 years (p < 0.001) and 0.5-1 years (p < 0.001) with smaller differences in the RFS event rates for the intervals 1-2 years (p = 0.012) and 2-3 years (p = 0.010). CONCLUSIONS: In a systematic review of positive RCTs comparing adjuvant chemotherapy to surgery alone for Stage II-IV CRC, observed RFS improvements were driven by early divergences that occurred primarily during active cytotoxic chemotherapy. Late recurrence dynamics were not influenced by adjuvant therapy use. Such observations may have implications for the use of chemotherapy for micrometastatic clones detectable by cell-free DNA-based methodologies.

Association between SMAD4 Mutations and GATA6 Expression in Paired Pancreatic Ductal Adenocarcinoma Tumor Specimens: Data from Two Independent Molecularly-Characterized Cohorts.

Several molecular biomarkers have been identified to guide induction treatment selection for localized pancreatic ductal adenocarcinoma (PDAC). SMAD4 alterations and low GATA6 expression/modified "Moffitt" basal-like phenotype have each been associated with inferior survival uniquely for patients receiving 5-FU-based therapies. SMAD4 may directly regulate the expression of GATA6 in PDAC, pointing to a common predictive biomarker. To evaluate the relationship between SMAD4 mutations and GATA6 expression in human PDAC tumors, patients with paired SMAD4 mutation and GATA6 mRNA expression data in the TCGA and CPTAC were identified. In 321 patients (TCGA: n = 180; CPTAC: n = 141), the rate of SMAD4 alterations was 26.8%. The rate of SMAD4 alteration did not vary per tertile of normalized GATA6 expression (TCGA: p = 0.928; CPTAC: p = 0.828). In the TCGA, SMAD4 alterations and the basal-like phenotype were each associated with worse survival (log rank p = 0.077 and p = 0.080, respectively), but their combined presence did not identify a subset with uniquely inferior survival (p = 0.943). In the CPTAC, the basal-like phenotype was associated with significantly worse survival (p < 0.001), but the prognostic value was not influenced by the combined presence of SMAD4 alterations (p = 0.960). SMAD4 alterations were not associated with poor clinico-pathological features such as poor tumor grade, advanced tumor stage, positive lymphovascular invasion (LVI), or positive perineural invasion (PNI), compared with SMAD4-wildtype. Given that SMAD4 mutations were not associated with GATA6 expression or Moffitt subtype in two independent molecularly characterized PDAC cohorts, distinct biomarker-defined clinical trials are necessary.

COVID-19 Effect on Surgery for Gastrointestinal Malignancies: Have Operative Volumes Recovered?

BACKGROUND: COVID-19 disrupted elective operations, cancer screening, and routine medical care while simultaneously overwhelming hospital staff and supplies. Operations for gastrointestinal (GI) malignancies rely on endoscopic screening, staging, and neoadjuvant therapy (NAT), each of which was disrupted by the pandemic. The aim was to evaluate the effect of the COVID-19 pandemic on the US national rates of gastrointestinal oncologic operations. METHODS: The Vizient Clinical Data Base® was queried for oncologic operations for esophageal, gastric, and colorectal malignancies with and without NAT from March 2019 to March 2022. Control chart analysis examined operative volume over time while Wilcoxon rank sum tests were used to compare mean monthly volume before and during the pandemic. RESULTS: A total of 95,912 patients were identified over 36 months; 5.8% esophageal, 6.3% gastric, 77.5% colonic, and 10.4% rectal operations. Esophageal operative volume decreased for 9 months during the pandemic and was significantly lower during than before the pandemic (p=0.002). Gastric operations decreased for 10 months early in the pandemic, but rebounded so that after 2 years volumes were unchanged (p=0.49). Colonic operations experienced a sharp decrease for 4 months at the beginning of the pandemic, but volumes quickly increased and overall were unchanged (p=0.29). Rectal operations decreased for 13 months and were significantly lower during than before the pandemic (p=0.018). Oncologic operations for patients receiving NAT varied. CONCLUSION: COVID-19 significantly disrupted the volume of gastrointestinal oncologic operations in the USA. Esophageal and rectal oncologic operations experienced prolonged and significant reductions while gastric and colonic oncologic operations transiently decreased but rebounded during the pandemic.

Combination of Immunotherapy and Radiation Therapy in Gastrointestinal Cancers: An Appraisal of the Current Literature and Ongoing Research.

Oncological outcomes are improving in gastrointestinal cancer with advancements in systemic therapies, and there is notable potential in combining immunotherapy and radiation therapy (RT) to allow for further improvements. Various preclinical and early phase II studies have shown promising synergy with immunotherapy and RT in gastrointestinal cancer. A few recent phase III studies have shown improved survival with the addition of immunotherapy to standard treatment for gastrointestinal cancer. The timing, duration, sequencing, and integration with other anti-cancer treatments are still areas of ongoing research. We have reviewed the published and ongoing studies of the combinations of immunotherapy and RT in gastrointestinal cancers.

Surgery Refusal Among Black and Hispanic Women with Non-Metastatic Breast Cancer.

BACKGROUND: Studies have shown a lower receipt of treatment among minority women with non-metastatic breast cancer. Those who refuse surgery have increased disease-specific mortality, contributing to disproportionately higher breast cancer mortality in non-Hispanic black (NHB) and Hispanic women. This study aimed to assess surgery refusal in these groups, identify factors associated with surgery refusal, and characterize the association between surgery refusal and survival. METHODS: Surveillance, Epidemiology, and End Results (SEER) Program data from 2005 to 2015 for NHB and Hispanic women with a diagnosis of non-metastatic breast cancer (n = 113,987) was divided into data of those who underwent surgery and data of those who refused surgery. Sociodemographic and tumor clinical/pathologic differences were analyzed by multivariate logistic regression of predictors of surgery refusal and Cox-proportional hazard model of disease-specific mortality. RESULTS: Of 799 patients who refused surgery, 562 were NHB and 237 were Hispanic. The percentage of patients refusing surgery increased from 0.6% in 2005 to 0.9% in 2015. The women who refused surgery were more likely to be older than 81 years, less likely to be married, and more likely to be uninsured or have Medicaid. The refusers presented with more advanced disease and more frequent estrogen receptor-positivity (ER+) and progesterone receptor-positivity (PR+) subtype on histology. Breast cancer-specific mortality increased significantly with surgery omission. Surgery refusal was independently associated with NHB race. CONCLUSION: Surgery refusal among NHB and Hispanic women with potentially curable non-metastatic breast cancer is rising, especially among NHB women, women older than 60 years, single women, and women with a later stage of disease at diagnosis. Additional studies are needed to analyze qualitative data in these populations and their underlying health beliefs, communication needs, and possible use of alternative medicine.

In search of lost time: Delays in adjuvant therapy for pancreatic adenocarcinoma among under-resourced patient populations.

BACKGROUND: The initiation of adjuvant chemotherapy for pancreatic adenocarcinoma within 12 weeks after surgery is recommended by the National Comprehensive Cancer Network. This study seeks to identify factors associated with delayed adjuvant chemotherapy and whether delays impact survival in under-resourced populations. METHODS: Patients with nonmetastatic pancreatic adenocarcinoma who received a definitive resection followed by adjuvant chemotherapy between 2006 and 2017 were queried from the National Cancer Database. Multivariate logistic regression models were constructed to determine the relationship between socioeconomic/clinical variables and delayed adjuvant chemotherapy. Kaplan Meier curves compared survival between under-resourced patients receiving delayed versus timely adjuvant chemotherapy. RESULTS: Among 25,008 patients, timely adjuvant chemotherapy varied by stage (stage 1: 67.9% vs stage 2: 75.8% vs stage 3: 89.2%; P < .001). Older age (odds ratio 1.02, 95% confidence interval 1.02-1.03; P < .001), Non-Hispanic Black race (odds ratio 1.25, 95% confidence interval 1.11-1.41; P < .001), increasing comorbidity score (odds ratio 1.18, 95% confidence interval 1.12-1.23; P < .001), 30-day readmission (odds ratio 1.45, 95% confidence interval 1.28-1.63; P < .001), and undergoing a Whipple (odds ratio 1.30, 95% confidence interval 1.16-1.44; P < .001) were associated with delayed adjuvant chemotherapy. Conversely, the highest neighborhood median income quartile (odds ratio 0.84, 95% confidence interval 0.73-0.97; P = .021), private insurance (odds ratio 0.59, 95% confidence interval 0.46-0.76; P < .001), Medicare (odds ratio 0.68, 95% confidence interval 0.52-0.88; P = .003), and receipt of neoadjuvant therapy (odds ratio 0.05, 95% confidence interval 0.04-0.06; P < .001) were associated with timely adjuvant chemotherapy. Non-Hispanic Black patients and patients with the lowest neighborhood education had worse overall survival when receiving delayed versus timely adjuvant chemotherapy. CONCLUSION: Timely adjuvant chemotherapy for pancreatic adenocarcinoma was only achieved in 73.3% of patients. Age, race, comorbidities, median income, and insurance were identified as barriers. Delayed adjuvant chemotherapy was associated with worse survival among under-resourced populations.

Liver-Directed Treatment Options Following Liver Tumor Recurrence: A Review of the Literature.

Recurrence following curative-intent hepatectomy for colorectal cancer liver metastasis, hepatocellular carcinoma, or cholangiocarcinoma is unfortunately common with a reported incidence as high as 75%. Various treatment modalities can improve survival following disease recurrence. A review of the literature was performed using PubMed. In addition to systemic therapy, liver-directed treatment options for recurrent liver disease include repeat hepatectomy, salvage liver transplantation, radiofrequency or microwave ablation, intra-arterial therapy, and stereotactic body radiation therapy. Repeat resection can be consider for patients with limited recurrent disease that meets resection criteria, as this therapeutic approach can provide a survival benefit and is potentially curative in a subset of patients. Salvage liver transplantation for recurrent hepatocellular carcinoma is another option, which has been associated with a 5-year survival of 50%. Salvage transplantation may be an option in particular for patients who are not candidates for resection due to underlying liver dysfunction but meet criteria for transplantation. Ablation is another modality to treat patients who recur with smaller tumors and are not surgical candidates due to comorbidity, liver dysfunction, or tumor location. For patients with inoperable disease, transarterial chemoembolization, or radioembolization with Yttrium-90 are liver-directed intra-arterial therapy modalities with relatively low risks that can be utilized. Stereotactic body radiation therapy is another palliative treatment option that can provide a response and local tumor control for smaller tumors.

A Scoping Review of the Classification, Diagnosis, and Management of Hepatic Adenomas.

BACKGROUND: Hepatic adenomas (HA), or hepatocellular adenomas, are benign, solid liver lesions that develop in otherwise normal livers, often in the setting of increased estrogen levels. While considered a benign tumor, there is a risk for substantial complications such as hemorrhage and malignant transformation. We review the diagnosis, classification, and potential therapeutic management options for patients with HA. METHODS: A scoping narrative review was conducted based on recent literature regarding classification, diagnosis, and management of HA. RESULTS: While HAs are typically considered benign, complications such as hemorrhage and malignant transformation may occur in approximately 25% and 5% of patients, respectively. Recent advances in imaging and molecular profiling have allowed for the classification of HAs into subtypes allowing for patient risk stratification that helps guide management. Surgical resection should be considered in asymptomatic patients who are male, have an adenoma ≥5 cm in diameter, or have the ß-catenin-activated subtype due to an increased risk of hemorrhage and/or malignant transformation. CONCLUSION: Molecular profiling has aided in the stratification of patients relative to the risk of complications to predict better the potential behavior of HAs.

Inflammatory breast cancer, trimodal treatment, and mortality: Does where you live matter?

BACKGROUND: The objective of this study is to examine the associations among neighborhood socioeconomic status, trimodal treatment, and disease-specific mortality among inflammatory breast cancer patients using data from the Surveillance, Epidemiology, and End Results program. METHODS: Patients diagnosed with inflammatory breast cancer (T4d) from 2010 to 2016 were identified in the Surveillance, Epidemiology, and End Results program. The cohort was stratified into neighborhood socioeconomic status groups (low, middle, high) based on National Cancer Institute census tract-level index. Trimodal treatment was defined as receipt of modified radical mastectomy, chemotherapy, and radiation therapy. Bivariable analysis, log-rank test, and a Cox proportional hazards model (hazard ratio, 95% confidence interval) were conducted to evaluate the relationship between neighborhood socioeconomic status, trimodal treatment, and disease-specific mortality. RESULTS: In total, 4,374 patients met study criteria. There was no difference between the neighborhood socioeconomic status groups in receipt of trimodal treatment (P = .19). On multivariable analysis, there was no association between low neighborhood socioeconomic status (hazard ratio 1.13, 0.98-1.30; ref high neighborhood socioeconomic status) or middle neighborhood socioeconomic status (hazard ratio 1.01, 0.88-1.64; ref high neighborhood socioeconomic status) and disease-specific mortality. Notably, triple negative subtype (hazard ratio 2.66, 2.21-3.20; ref luminal A) and Black race (hazard ratio 1.41, 1.16-1.72; ref White) were associated with a higher disease-specific mortality. CONCLUSION: For inflammatory breast cancer patients in the Surveillance, Epidemiology, and End Results program, disease-specific mortality appears to be driven by tumor biology and patient characteristics instead of treatment disparities or neighborhood socioeconomic status.

From street address to survival: Neighborhood socioeconomic status and pancreatic cancer outcomes.

BACKGROUND: Neighborhood factors may influence cancer care through physical, economic, and social means. This study assesses the impact of neighborhood socioeconomic status on diagnosis, treatment, and survival in pancreatic cancer. METHODS: Patients with pancreatic adenocarcinoma were identified in the 2010-2016 Surveillance Epidemiology and End Results database. Neighborhood socioeconomic status (divided into tertiles) was based on an National Cancer Institute census tract-level composite score, including income, education, housing, and employment. Multivariate models predicted metastasis at time of diagnosis and receipt of surgery for early-stage disease. Overall survival compared via Kaplan-Meier and Cox proportional hazards. RESULTS: Fifteen thousand four hundred and thirty-six patients (29.7%) lived in low neighborhood socioeconomic status, 17,509 (33.7%) in middle neighborhood socioeconomic status, and 19,010 (36.6%) in high neighborhood socioeconomic status areas. On multivariate analysis, neighborhood socioeconomic status was not associated with metastatic disease at diagnosis (low neighborhood socioeconomic status odds ratio 1.02, 95% confidence interval 0.97-1.07; ref: high neighborhood socioeconomic status). However, low neighborhood socioeconomic status was associated with decreased likelihood of surgery for localized/regional disease (odds ratio 0.60, 95% confidence interval 0.54-0.68; ref: high neighborhood socioeconomic status) and worse overall survival (low neighborhood socioeconomic status hazard ratio 1.18, 95% confidence interval 1.15-1.21; ref: high neighborhood socioeconomic status). CONCLUSION: Patients from resource-poor neighborhoods are less likely to receive stage-appropriate therapy for pancreatic cancer and have an 18% higher risk of death.

Hispanic Ethnicity and Breast Cancer: Disaggregating Surgical Management and Mortality by Race.

OBJECTIVE: Breast cancer is the leading cause of cancer death among Hispanic women. Unfortunately, few studies disaggregate Hispanic patients by race to understand its implications on treatment and clinical outcomes such as mortality. The aim of this study is to examine surgical management and overall mortality among different subgroups of women who self-identify as Hispanic. METHODS: Hispanic female patients, ages 18-90, stages I-III, diagnosed with breast cancer between 2010 and 2015 from the National Cancer Data Base were identified. The study cohort was divided into three ethnoracial categories: (1) Hispanic White (HW), 2) Hispanic Black (HB), and 3) Hispanic Other (HO). Descriptive statistics and multivariate models were constructed to determine the relationship between sociodemographic factors, clinical variables, surgical management, and mortality when disaggregated by race. RESULTS: There were 56,675 Hispanic women who met the study criteria. Most where HW (n=50,599, 89.3%) and the rest were HB (n=1,334, 2.4%) and HO (n=4,742, 8.3%). There was no difference between the three groups on receipt of breast conservation therapy (P=0.12). HB (48.5%) and HO (46.6%) women were more likely to undergo reconstruction than those who identified as HW (38.7%) (P<0.001). Additionally, HB (38.3%) women were more likely to undergo tissue-based reconstruction than HW (29.0%) and HO women (30%) (P=0.0008). There was no difference between the groups in the utilization of contralateral prophylactic mastectomy (CPM) (P=0.078). On multivariable analysis, there was no difference in mortality between HB and HW patients (HR 1.18, 95%CI 0.92-1.51; Ref HW). However, HO women had a 24% relative risk reduction in mortality (HR 0.76, 95% CI 0.63-0.92; HW ref). CONCLUSION: Findings from this study suggest there are ethnoracial disparities in reconstruction utilization and mortality among Hispanic women. Future studies should examine how culture, language, healthcare access, and patient preferences contribute to these disparities.

Access Denied: Inequities in Clinical Trial Enrollment for Pancreatic Cancer.

BACKGROUND: The influence of social determinants of health (SDH) on participation in clinical trials for pancreatic cancer is not well understood. In this study, we describe trends and identify disparities in pancreatic cancer clinical trial enrollment. PATIENTS AND METHODS: This is a retrospective study of stage I-IV pancreatic cancer patients in the 2004-2016 National Cancer Database. Cohort was stratified into those enrolled in clinical trials during first course of treatment versus not enrolled. Bivariate analysis and logistic regression were used to understand the relationship between SDH and clinical trial participation. RESULTS: A total of 1127 patients (0.4%) enrolled in clinical trials versus 301,340 (99.6%) did not enroll. Enrollment increased over the study period (p < 0.001), but not for Black patients or patients on Medicaid. The majority enrolled had metastatic disease (65.8%). On multivariate analysis, in addition to year of diagnosis (p < 0.001), stage (p < 0.001), and Charlson score (p < 0.001), increasing age [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.96-0.97], non-white race (OR 0.54, CI 0.44-0.66), living in the South (OR 0.42, CI 0.35-0.51), and Medicaid, lack of insurance, or unknown insurance (0.41, CI 0.31-0.53) were predictors of lack of participation. Conversely, treatment at an academic center (OR 6.36, CI 5.4-7.4) and higher neighborhood education predicted enrollment (OR 2.0, CI 1.55-2.67 for < 7% with no high school degree versus > 21%). DISCUSSION: Age, race, insurance, and geography are barriers to clinical trial enrollment for pancreatic cancer patients. While overall enrollment increased, Black patients and patients on Medicaid remain underrepresented. After adjusting for cancer-specific factors, SDH are still associated with clinical trial enrollment, suggesting need for targeted interventions.

Hormone receptor-positive breast cancer and black race: does sex matter?

PURPOSE: Black breast cancer patients have worse clinical outcomes than their White counterparts. There are few studies comparing clinical outcomes between Black male breast cancer (MBC) and female breast cancer (FBC) patients. The objective of this study is to examine differences in presentation, treatment, and mortality between Black MBC and FBC. METHODS: The National Cancer Database was queried for all Black MBC and FBC patients, ages 18-90, with hormone receptor-positive breast cancer diagnosed between 2010 and 2016. Hormone receptor positivity was defined as estrogen receptor-positive, progesterone-positive and HER 2-negative cancer. Sociodemographic and clinical variables were compared between MBC and FBC patients on bivariable analysis. After propensity score matching, overall survival was evaluated using the log-rank test and Cox proportional hazards. RESULTS: Compared to FBC patients, MBC patients had higher rates of metastatic disease (stage 4, MBC 4.4% vs. FBC 2.6%, p < 0.001), larger tumors (tumor size < 2 cm, MBC 32.1 vs. FBC 49.1%, p < 0.001) and a higher percentage of poorly differentiated tumors (grade 3, MBC 28.5% vs. FBC 21.4%, p < 0.001). MBC patients had lower rates of hormone therapy (MBC 66.4% vs. FBC 80.7%, p < 0.001) and neoadjuvant chemotherapy (MBC 5.8% vs. FBC 7.5%, p = 0.05) than FBC. On propensity score matched analysis, Black MBC patients had a higher overall mortality (p25 of 60 months vs. 74 months) compared to FBC patients (p = 0.0260). CONCLUSION: Among hormone receptor-positive Black MBC and FBC patients, there are sex-based disparities in stage, hormone therapy use and overall survival.

Low neighborhood socioeconomic status is associated with higher mortality and increased surgery utilization among metastatic breast cancer patients.

PURPOSE: Low socioeconomic status (SES) is associated with advanced stage, lower-quality care, and higher mortality among breast cancer patients. The purpose of this study is to examine the association between neighborhood SES (nSES), surgical management, and disease-specific mortality in de novo metastatic breast cancer (MBC) patients in the Surveillance, Epidemiology, and End Results (SEER) Program. METHODS: MBC patients ages 18 to 85+ years diagnosed from 2010 through 2016 were identified in SEER. The cohort was divided into low, middle, and high nSES based on the NCI census tract-level index. Univariable and multivariable analyses were used to examine the relationship between nSES, surgery, and disease specific mortality in MBC patients. RESULTS: There were 24,532 de novo MBC patients who met study criteria, with 28.7 % undergoing surgery. Over the study period, surgery utilization decreased across all nSES groups. However, lower nSES was associated with a higher odds of undergoing surgery (low OR 1.25 [1.15-1.36] p < 0.001; middle OR 1.09 [1.01-1.18] p = 0.022; ref high). Living in an area with lower SES was associated with a worse disease specific mortality (low HR 1.24 [1.25, 1.44; ], middle 1.20 [1.1-1.29]: ref high). Specifically, there was a 9.26 month mean survival differences between the lowest (41.02 ± 0.47 months) and highest (50.28 ± 0.47 months) nSES groups. CONCLUSION: These results suggest area of residence may contribute to differences in surgical management and clinical outcomes among de novo MBC patients. Future studies should examine the contributions of patient characteristics and preferences within the context of surgeon recommendations.