Association between Cerebrospinal Fluid and Serum Biomarker Levels and Diagnosis, Injury Severity, and Short-Term Outcomes in Patients with Acute Traumatic Spinal Cord Injury.

Acute traumatic spinal cord injury (SCI) is recognized as a global problem that can lead to a range of acute and secondary complications impacting morbidity and mortality. There is still a lack of reliable diagnostic and prognostic biomarkers in patients with SCI that could help guide clinical care and identify novel therapeutic targets for future drug discovery. The aim of this prospective controlled study was to determine the cerebral spinal fluid (CSF) and serum profiles of 10 biomarkers as indicators of SCI diagnosis, severity, and prognosis to aid in assessing appropriate treatment modalities. CSF and serum samples of 15 SCI and ten healthy participants were included in the study. The neurological assessments were scored on admission and at discharge from the hospital using the American Spinal Injury Association Impairment Score (AIS) grades. The CSF and serum concentrations of SBDP150, S100B, GFAP, NF-L, UCHL-1, Tau, and IL-6 were significantly higher in SCI patients when compared with the control group. The CSF GBDP 38/44K, UCHL-L1, S100B, GFAP, and Tau levels were significantly higher in the AIS A patients. This study demonstrated a strong correlation between biomarker levels in the diagnosis and injury severity of SCI but no association with short-term outcomes. Future prospective controlled studies need to be done to support the results of this study.

Factors Associated with the Decision to Decline Chemotherapy in Metastatic Non-Small Cell Lung Cancer.

(1) Background: Disparities in cancer treatment and outcomes have long been well-documented in the medical literature. With the eruption of advances in new treatment modalities, the long-existing disparities are now being further uncovered and brought to the attention of the medical community. While social health determinants have previously been linked to treatment disparities in lung cancer, we analyzed data from the National Cancer Database to explore sociodemographic and geographic factors related to accepting or declining physician-recommended chemotherapy. Patients diagnosed with metastatic lung cancer between 2004 and 2016 who declined chemotherapy recommended by their physicians were included in this study. Multivariate logistic regression analysis was performed. Cox Regression and Kaplan-Meier analyses were performed to look for survival characteristics. (2) Results: 316,826 patients with Stage IV lung cancer were identified. Factors related to a higher rate of refusal by patients included older age > 70, female sex, low income, lack of insurance coverage, residency in the New England region, and higher comorbidity. Patients living in areas with lower education were less likely to decline chemotherapy. (3) Conclusion: Further understanding of the factors impacting treatment decisions would be essential to improve the efficacy of care delivery in patients with cancer and reduce reversible causes of disparity.

Social disparities in pain management provision in stage IV lung cancer: A national registry analysis.

A strong association exists between pain and lung cancer (LC). Focusing on the disparities in pain referral in LC patients, we are aiming to characterize the prevalence and patterns of referrals to pain management (PM) in Stage IV non-small-cell LC (NSLC) and small-cell LC (SCLC). We sampled the National Cancer Database for de novo stage IV LC (2004-2016). We analyzed trends of pain referral using the Cochran-Armitage test. Chi-squared statistics were used to identify the sociodemographic and clinico-pathologic determinants of referral to PM, and significant variables (P < .05) were included in one multivariable regression model predicting the likelihood of pain referral. A total N = 17,620 (3.1%) of NSLC and N = 4305 (2.9%) SCLC patients were referred to PM. A significant increase in referrals was observed between 2004 and 2016 (NSLC: 1.7%-4.1%, P < .001; SCLC: 1.6%-4.2%, P < .001). Patient and disease factors played a significant role in likelihood of referral in both groups. Demographic factors such as gender, age, and facility type played a role in the likelihood of pain referrals, highlighting the gap and need for multidisciplinary PM in patients with LC. Despite an increase in the proportion of referrals to PM issued for terminal stage LC, the overall proportion remains low. To ensure better of quality of life for patients, oncologists need to be made aware of existent disparities and implicit biases.

Impact of COVID-19 on Cancer-Related Care in the United States: An Overview.

COVID-19 impacted several health services, including cancer-related care. Its implications were significant due to the lapse in hospital resources, compounded by the delays stemming from the economic effects on patients' jobs and medical coverage. Furthermore, reports suggesting an increased risk for morbidity and mortality from COVID-19 in patients with cancer and those on active cancer treatment caused additional fear and potential delays in seeking medical services. This review provides an overview of the pandemic's impact on cancer care in the United States and suggests measures for tackling similar situations in the future.

Medullary carcinoma of the colon: A comprehensive analysis of the National Cancer Database.

PURPOSE: Medullary carcinomas (MC) of the colon are uncommon tumors. In this study, we analyzed demographic and disease characteristics as well as survival outcomes of MC versus undifferentiated (UDA) and poorly differentiated (PDA) adenocarcinomas (AC) of the colon. MATERIALS AND METHODS: The National Cancer Database (2004-2018) was utilized to identify patients with colon cancer. Patient demographics (including age, gender, race), disease characteristics (including grade, TNM stage, carcinoembryonic levels, perineural and lymphovascular invasion, lymph node status, microsatellite stability, KRAS mutation, and primary tumor site), and facility type and location were evaluated. Chi-square tests were used to compare descriptive data. Cox Regression and Kaplan Meier analyses were used to analyze survival characteristics. RESULTS: 1,041,753 patients with colon cancer were identified of whom 2709 patients had MC and 897,902 had AC (136,597 PDA and 18,042 UDA). MC was seen in older patients (mean age 74 ± 13 years) and women (72.5% vs. 27.5% males). Most MCs were poorly differentiated (63.3%), and 82.4% of patients with MC had microsatellite instability. Fewer patients with MC had perineural invasion (15.6% vs. 22.0% in PDA and 22.4% in UDA, p < 0.001) and positive lymph nodes (38.4% versus 59.9% with PDA and 59.7% with UDA, p < 0.0001). MC diagnosis increased by year (Cochran-Armitage trend test, p < 0.0001). Kaplan Meir analysis revealed a better prognosis for patients with MC when compared to PDA or UDA (p < 0.001). CONCLUSION: Given the rarity, pathologists should maintain a high suspicion for MC when encountering poorly differentiated or undifferentiated right-sided colon cancer with associated MSI-H.

Does the 21-gene recurrence score have clinical utility in HR+/HER2+ breast cancer?

The 21-gene recurrence score assay has been validated as a predictive biomarker in early-stage HR+ and HER2-breast cancer. It is not indicated for use in HER2+ disease based on national guidelines. In this study, we assessed the value of 21-gene recurrence score (RS), or OncotypeDX (ODX), testing in HR+/HER2+ breast cancer. We used the National Cancer Database to identify patients with stages I-II, HR+/HER2+ breast cancer who received multi-gene testing with ODX. We then explored the prognostic and predictive value of this biomarker through various forms of survival modeling. ODX testing was performed in n = 5,280 patients. N = 2,678 patients (50.7%) had a RS < 26, while n = 2,602 (49.3%) had a RS ≥26. In Kaplan-Meier survival modeling for patients with recurrence scores <26, there was no significant difference in overall survival (p = 0.445) between patients receiving different systemic treatment regimens. However, when recurrence scores were ≥26, there was a statistically-significant difference in overall survival between systemic treatment regimens (p < 0.001). 5-year overall survival was highest (97.4%) for patients receiving triple therapy (anti-HER2 with chemotherapy and endocrine therapy), followed by those receiving dual therapy with endocrine and anti-HER2 (96.7%), and endocrine with chemotherapy (94.9%). Patients receiving endocrine therapy alone exhibited the lowest 5-year overall survival (88.5%). RESULTS: Analysis from this large national cancer registry suggests that multigene testing may have predictive value in treatment selection for patients with early-stage, HR+/HER2+ breast cancer. Prospective trials are warranted to identify subgroups of patients with HR+/HER2+ breast cancer who can be spared anti-HER2 treatments and cytotoxic chemotherapy.

Disparities in Metabolic Conditions and Cancer Characteristics among Hispanic Women with Breast Cancer: A Multi-Institutional Study.

While the associations of common metabolic conditions with ethnicity have been previously described, disparity among Hispanic individuals based on country of origin is understudied. This multi-institutional analysis explored the prevalence of metabolic conditions and their association with cancer subtypes among Mexican and non-Mexican Hispanics. After IRB approval, we conducted a cross-sectional study at two academic medical centers with a significant Hispanic patient population (Texas Tech University Health Sciences Center, El Paso, TX (TTUHSC-EP) and Cleveland Clinic Florida in Weston, FL (CCF)). A total of n = 1020 self-identified Hispanic patients with breast cancer consecutively diagnosed between 2005 and 2014 were selected from the two institutional databases. Comparisons between Mexican and Non-Mexican Hispanics revealed variations in tumor types and metabolic conditions. Mexican Hispanics were found to have a higher prevalence of diabetes mellitus (27.8% vs. 14.2%, p < 0.001), obesity (51.0% vs. 32.5%, p < 0.001), and ductal carcinoma type (86.6 vs. 73.4%, p < 0.001). On the other hand, hormone-receptor-positive breast cancer was more common in non-Mexicans, while Mexicans had more triple-negative breast cancer, especially in premenopausal women. In addition to highlighting these variations among Hispanic patients with breast cancer, this study supports a more focused approach to addressing obesity and other metabolic conditions prevalent in the Hispanic population with breast cancer. Moreover, Hispanic individuals with breast cancer are diverse and should not be lumped under one category without reference to their country of origin regarding the impact of race and ethnicity.

Omalizumab as a treatment option for antihistamine-refractory aquagenic urticaria.

A teenage girl presented with symptoms of itching and hives on contact with water for 3 years. On specific provocative testing and ruling out underlying systemic conditions, she was diagnosed with aquagenic urticaria. Following failed attempts to control her symptoms with second-generation antihistamines, she was started on monthly subcutaneous injections of the monoclonal antibody, omalizumab. The patient demonstrated significant improvement, with symptoms being well-controlled for 2 years now. She enjoys a good quality of life and can take a shower without developing itching or hives.

Geographical Disparities and Factors Associated With the Decision to Decline Chemotherapy in Breast Cancer.

PURPOSE: Social determinants of health have been linked to treatment-related disparities in breast cancer. We analyzed data from a large national registry to explore factors related to accepting or declining recommended chemotherapy and whether patients' decisions vary geographically across the United States. METHODS: We used the National Cancer Database to study treatment decision making in patients with advanced breast cancer (American Joint Committee on Cancer clinical stage III-IV) between 2004 and 2017. We focused the analysis on patients who were recommended chemotherapy by their physicians but who declined this treatment. Multivariate logistic regression analysis was performed. RESULTS: A total of N = 215,284 patients with stage III and IV breast cancers were included. Patients in the New England region were more likely to refuse chemotherapy compared with the rest, with patients in the East South Central regions (AL, KY, MS, and TN) and West South Central (AR, LA, OK, and TX) noted to be least likely to refuse chemotherapy. Factors related to a higher rate of refusal by patients included older age > 70 years; hormone receptor-positive tumors; and having higher comorbidity. Patients identified as Hispanic, those who are privately insured, and patients at academic institutions were less likely to decline chemotherapy. CONCLUSION: This analysis identified a significant difference in rates of refusal of recommended chemotherapy by geographical location, insurance status, and treatment facility after adjusting for known social determinants of health. Further understanding of the factors affecting treatment decisions would be important to improve the efficacy of care delivery in patients with cancer and reduce reversible causes of disparity.

Management of HR+/HER2+ lobular breast cancer and trends do not mirror better outcomes.

PURPOSE: Treatment protocols for invasive lobular breast cancer (ILC) have largely followed those for invasive ductal breast cancer. This study compares treatment outcomes of endocrine therapy versus combined chemo-endocrine therapy in hormone-receptor-positive (HR+), HER2-positive (HER2+) ILC tumors in a large national registry. METHODS: We sampled the National Cancer Database (2010-2016) for female patients with stages I-III, HR+/HER2+ ILC who underwent surgery. Cochran-Armitage trend test examined trends of treatment regimen administration: Surgery only (S), chemotherapy (C), endocrine therapy (ET), and combined chemo-endocrine therapy (CET), with or without anti-HER2 therapy. Cox proportional hazard model were used to compare overall survival (OS) across ET and CET cohorts, stratifying for anti-HER2 therapy, before and after propensity score match of cohorts (2013-2016). Kaplan-Meier (KM) survival curves were also produced. RESULTS: N=11,421 were included. 58.7% of patients received Anti-Her2 therapy after 2013. CET conferred better OS over ET in the unmatched (adjusted-5-year-OS: 92.5% vs. 81.1%, p<0.001) and PS-matched (90.4% vs. 84.5%, p=0.001) samples. ET caused lower OS in patients who received Anti-Her2 therapy (HR: 2.56, 95% CI: 1.60-4.12, p<0.001) and patients who did not (HR: 1.84, 95% CI: 1.21-2.78, p=0.004), as compared to CET on multivariable analysis. KM modeling showed highest OS in the CET cohort who received Anti-Her2 (93.0%), followed by the CET cohort who did not receive Anti-Her2 (90.2%) (p=0.06). CONCLUSION: Chemotherapy followed by endocrine therapy and Anti-Her2 therapy was shown to be the most effective treatment modality in HR+/HER2+ ILC, contrasting previous data on the inconclusive benefit of chemotherapy in patients with ILC.

Factors Associated With the Decision to Decline Chemotherapy in Patients With Early-stage, ER+/HER2- Breast Cancer and High-risk Scoring on Genomic Assays.

INTRODUCTION: The rate of refusal of chemotherapy ranges from 3% to 19%, but varies widely by patient profile and treatment setting. Using a large national registry, we explore factors significantly associated with the decision to decline chemotherapy in patients with early-stage, HR+/HER2- breast cancer (BC) despite high risk scoring on multigene sequencing analysis for OncotypeDX (ODX) or MammaPrint (MP), in which the survival benefit of chemotherapy is clear. PATIENTS AND METHODS: Patients with HR+/HER2- BC and high risk scoring on ODX (score >26) or MP were selected from the National Cancer Database (2004-2017). Only those who refused to get chemotherapy despite their physician's recommendations were included. Univariate frequency and proportion statistics were used to describe the patient cohort. Bivariate Chi-square analysis evaluated the association between refusal of recommended chemotherapy and sociodemographic characteristics. Significant variables (P < .05) were included in a multivariable logistic regression model. RESULTS: N = 43,533 patients were included (88.7% ODX, 11.3% MP). A total of n = 4415 (10.1%) patients declined chemotherapy despite recommendation by the patient's primary oncologist. Age >70 (OR: 3.46, 95% CI: 2.96-4.04, P < .001), black race (OR: 1.20, 95% CI: 1.07-1.36, P = .01), non-private insurance, lobular carcinoma histology (OR: 1.21, 95% CI: 1.09-1.35, P < .001), and tumor grade of I significantly predicted chemotherapy decline. CONCLUSION: Identifying and addressing many of the factors that contribute to under-treatment in minorities is to be key to reducing cancer disparity and improving equity in cancer care and outcome.

Temporary vs. permanent stoma: factors associated with the development of complications and costs for rectal cancer patients.

OBJECTIVE: To compare in-hospital complication rates and treatment costs between rectal cancer patients receiving permanent and temporary stomas. Surgical complications and costs associated with permanent stoma formation are still poorly understood. While choosing between the two stoma options is usually based on clinical and technical factors, disparities exist. METHODS: Patients with rectal cancer, stoma formation, complications, and cost of care were identified from the Florida Agency for Health Care Administration Discharge Database. Rectal cancer patients who underwent elective surgery and received a permanent or temporary stoma were identified using ICD-10 codes. Patients who underwent colostomy with resection were included in the "Permanent stoma" group, and those who underwent "resection with ileostomy" were included in the "temporary stoma" group. Multivariable models compared patients receiving temporary vs. permanent stomas. RESULTS: Regression models revealed no difference in the odds of having a complication between patients who obtained permanent versus temporary stoma (OR 0.96, 95% CI: 0.70-1.32). Further, after adjusting for the number of surgeries, demographic variables, socioeconomic and regional factors, comorbidities, and type of surgery, there was a significant difference between permanent and temporary stomas for rectal cancer (ß - 0.05, p = 0.03) in the log cost of creating a permanent stoma. CONCLUSION: Our findings suggest there are no differences associated with complications, and reduced cost for permanent compared to temporary stomas. Increased costs are also associated with receiving minimally invasive surgery. As a result, disparities associated with receipt of MIS could ultimately influence the type of stoma received.

Metastasectomy versus radiation of secondary sites in stage IV breast cancer: Analysis from a national cancer registry.

PURPOSE: Locoregional therapy at primary or secondary sites in breast cancer may be associated with improved survival as compared to systemic therapy alone. We explored the sociodemographic and clinicopathologic factors associated with the use of radiation versus surgical resection of metastatic sites (metastasectomy) in patients with de novo stage IV breast cancer, followed by the associated overall survival. METHODS: We sampled the National Cancer Database for patients with de novo stage IV breast cancer, (2010-2017) and described cohort's characteristics using univariate analyses. We identified 5 subgroups based on malignant site involvement: 1. Bone only, 2. Brain only, 3. Liver only, 4. Lung only, and 5. Metastasis involving >1 site. Kaplan-Meier modeling with log-rank testing and multivariate Cox Regression analysis were used to explore differences in overall survival between those that received radiation at secondary sites and those that underwent metastasectomy. RESULTS: N = 22,749patients were included in this analysis. Radiation (81.2%) was used more commonly than metastasectomy (28.8%). Metastasectomy was associated with better median overall survival across all 5 cohorts (p < .001), with the survival benefit being the most pronounced with lung only (OS: 56.9 months; HR 0.8, 95% CI 0.7-0.9, p = .032), or liver only (OS: 41.6 months; HR: 0.9; 95% CI: 0.7-1.1, p < .001) metastasis. CONCLUSION: Metastasectomy in patients with de novo stage IV breast cancer may be associated with improved overall survival as compared to radiation of secondary lesions, particularly in those with only liver or lung involvement. Prospective randomized controlled trials investigating surgical resection of metastatic sites in patients with breast cancer are warranted.

Survival benefit of a combined surgical approach in patients with metastatic breast cancer.

BACKGROUND: We previously reported survival benefit of surgery in patients with stage IV breast cancer (BC); prospective trials yielded inconclusive results. METHODS: We sampled the National Cancer Database (2004-2016) for de novo stage IV BC patients undergoing both primary site resection and metastasectomy. A multivariate Cox-regression survival model investigated the overall survival (OS) of this surgical approach as compared to lumpectomy/mastectomy alone, metastasectomy alone, or no surgery. The Kaplan-Meier method was used to demonstrate the utility of surgery when metastasis were confined to 1 site stratifying by tissue type. RESULTS: A total of n = 55,125 patients were included. As compared to lumpectomy/mastectomy alone (43 months), lumpectomy/mastectomy + metastasectomy exhibited the best OS (50 months, p = 0.012), metastasectomy alone showed slightly worse OS (30 months, p < 0.0001), and no surgery had the worst OS (21 months, p < 0.0001). In metastasis confined to 1 site, superior OS with combined lumpectomy/mastectomy and metastasectomy versus lumpectomy/mastectomy alone was observed with liver (72.8 vs. 48.1 months, p < 0.001) or lung (49.2 vs. 36.8 months, p < 0.001) metastasis but not bone (52.2 vs. 49.9 months, p < 0.001) or brain (16.2 vs. 15.5 months, p < 0.001). CONCLUSION: Patients with metastatic BC undergoing primary site resection and metastasectomy exhibited optimal OS, particularly when metastasis involved only the liver or lung.

Permanent stoma: a quality outcome in treatment of rectal cancer and its impact on length of stay.

BACKGROUND: This study aimed to identify socioeconomic predictors of permanent stoma in rectal cancer treatment and examine its association with length of stay at the treatment facility. METHODS: Rectal cancer patients who underwent elective surgery between January 2015 and December 2018 were identified from the Agency for Health Care Administration Florida Hospital Inpatient Discharge Dataset. Multivariate regression models were utilized to identify demographic and socioeconomic factors associated with receiving a permanent stoma as well as the associated length of stay of these patients. RESULTS: Of 2630 rectal cancer patients who underwent surgery for rectal cancer, 21% had a permanent stoma. The odds of receiving permanent stoma increased with higher Elixhauser score, metastatic disease, advanced age, having open surgery, residence in Southwest Florida, and having Medicaid insurance or no insurance/self-payers (p < 0.05). Patients with a permanent stoma had a significantly extended stay after surgery (p < 0.001). CONCLUSIONS: Patients with a permanent stoma following cancer resection were more likely to have open surgery, had more comorbidities, and had a longer length of stay. Having permanent stoma was higher in patients living in South West Florida, patients with Medicaid insurance, and in the uninsured. Additionally, the payer type significantly affected the length of stay.

Factors associated with worse outcomes for colorectal neuroendocrine tumors in radical versus local resections.

BACKGROUND: Colorectal neuroendocrine tumors (NETs) are the most common NETs of the gastrointestinal tract. Due to the rarity, colorectal NETs are understudied and are not clearly understood. Our study sought to identify the factors associated with worse outcomes for colorectal NETs following resection. METHODS: We identified patients diagnosed with colorectal NETs [2004-2014] who underwent resection from the National Cancer Data Base. Non-NETs were excluded. Overall survival (OS) was evaluated using the Kaplan Meier method. Cox proportional hazards and logistic regression models were used to assess factors associated with radical versus local resection, OS and LOS. RESULTS: A total of 7,967 colon and 11,929 rectal NETs were analyzed. The majority of colon (93.4%) and rectal (89.1%) NETs underwent radical and local resection respectively. The 5-year OS was 69% and 92% for colon and rectal NETs respectively. Older age (OR 1.45, CI 1.37-1.53) and clinical stage 4 (OR 9.91, CI 4.56-21.52) were associated with higher odds for colonic radical resection. Lowest median income quartile (OR 1.41, CI 1.21-1.64) and African Americans (OR 1.26, CI 1.07-1.49) experienced higher mortality for colon and rectal NETs respectively. CONCLUSIONS: Racial minority and low-income patients experience worse outcomes for colorectal NETs following resection.