Eligible Patients Research Articles

Evaluating the feasibility of prehospital point-of-care EEG: The prehospital implementation of rapid EEG (PHIRE) study.

Point-of-care electroencephalography (EEG) devices can be rapidly applied and do not require specialized technologists, creating new opportunities to use EEG during prehospital care. We evaluated the feasibility of point-of-care EEG during ambulance transport for 911 calls. This mixed-methods study was conducted between May 28, 2022 and October 28, 2023. Emergency Medical Services (EMS) clinicians identified eligible individuals, provided emergent treatment, applied EEG, and obtained an EEG recording during ambulance transport. Eligible patients were aged 6 years or older and evaluated for seizure, stroke, or altered mental status. EMS clinicians completed a survey and a brief phone interview following every enrollment. Two epileptologists reviewed EEG recordings for interpretability and artifact. There were 34 prehospital encounters in which EEG was applied. Patients had a mean age of 69 years, and 15 (44%) were female. EEG recordings had a median duration of 10 min 30 s. It took EMS clinicians an average of 2.5 min to apply the device and begin EEG recording. There were 14 (47%) recordings where clinicians achieved a high-quality connection for all 10 electrodes and 32 (94%) recordings that were sufficient in quality to interpret. There were 24 (71%) recordings with six or more channels free of artifact for 5 min or more. All clinicians agreed or strongly agreed that the device was easy to use. Among real-world prehospital encounters for patients with neurologic symptoms, point-of-care EEG was rapidly applied and yielded EEG recordings that could be used for clinical interpretation, demonstrating the feasibility of point-of-care EEG in future prehospital care.

Changes in Use of Migraine Medications, Healthcare Resource Utilization, and Associated Direct Costs Over 12Months Following Initiation of Erenumab: A US Retrospective Real-World Analysis.

Erenumab-aooe is approved for the preventive treatment of migraine in adults. Recent publications have evaluated migraine medication use during the 6 months after starting erenumab, but longer-term follow-up data are limited. The objective of this study was to describe 12-month medication use and changes in healthcare resource utilization (HRU) and associated direct costs among patients initiating erenumab. We identified adult patients with an erenumab claim in the Merative MarketScan Commercial and Medicare Databases from May 2018 through September 2019. Eligible patients had ≥ 12months of continuous medical and pharmacy coverage before (pre-index period) and after (post-index period) the index date (first erenumab claim) in addition to pre-index evidence of migraine. Patients were stratified by post-index-period adherence to erenumab, defined as ≥ 80% of days covered (adherent) or < 80% of days covered (non-adherent). Outcomes were measured pre- and post-index, and differences between these periods were described. Among 7528 eligible patients, the mean (standard deviation) age was 45.1 (11.4) years and 85.4% were female; 38.5% of patients were adherent to erenumab. Most patients used acute or traditional migraine-preventive medications pre-index, with reductions in use observed post-index (acute medication was used by 95.6% of patients pre-index, compared to 92.3% post-index; traditional preventive medication was used by 89.6% of patients pre-index, compared to 81.9% post-index). Reductions were observed for HRU of emergency room visits (-3.8%) and brain- and other head-imaging studies (-7.5%). Overall costs associated with acute and traditional preventive medications were reduced (-$764), but costs for HRU increased slightly ($76). When stratifying by adherence and combining costs for acute and traditional preventive medications and HRU, adherent patients had cost decreases (-$1947), while non-adherent patients had cost increases ($101). Most patients initiating erenumab had prior use of acute and traditional migraine-preventive therapies. The reduction in acute and traditional migraine-preventive medication use and HRU over the 12-month follow-up supports the long-term clinical benefits of erenumab in the real-world setting.

Undermining the Translational Potential of Clinical Research With Adolescents and Young Adults: Differential Enrollment in Randomized Clinical Trials During COVID-19.

COVID-19 stay-at-home orders and research restrictions halted recruitment and follow-up of clinical research patients. Although clinical research has resumed, it is an open question whether research participation has returned to levels similar to those before COVID-19. We used data from the TECH-PN (NCT No. NCT03828994) study, a single-center randomized controlled trial enrolling 13- to 25-year-olds with mild-moderate pelvic inflammatory disease (PID) receiving ambulatory care. We examined enrollment patterns before COVID-19 and during/after COVID-19 among those assessed for eligibility by estimating the average rate of recruitment visits for each period. We focused on this monthly rate by pandemic status, the length of stay (LOS) by pandemic status, as well as the relationship between the LOS and patient demographics. Descriptive analyses were conducted, including Student t test to compare rates between time periods and a χ2 test to compare the proportion refusing enrollment. The monthly enrollment rate during/after the pandemic was significantly lower than before COVID-19 (4.8 per month compared with 7.4 per month, P < 0.001). However, eligible participants' age, race, and insurance type were similar before and during/after the pandemic. Among eligible patients, LOS for receiving PID care was slightly increased, from a median of 5.4 to 6.4 hours ( P = 0.650), and the rate of refusal to participate among those eligible was similar (23% vs. 27%, P = 0.362). There were a similar number of ineligible patients because of inpatient admissions during both periods. COVID-19 pandemic restrictions negatively impacted recruitment into this randomized controlled trial. Enrollment differences may reflect ongoing perceptions of restrictions in care access or a hesitancy to use health services. More research is needed to stabilize access to ambulatory sexually transmitted infection/PID care and access to clinical trials.

Validation of necrotising infection clinical composite endpoint in a retrospective cohort of patients with necrotising soft tissue infections.

Rapidly progressive necrotising soft tissue infections (NSTIs) are associated with high mortality and morbidity. Low incidence and disease heterogeneity contribute to low event rates and inadequately powered studies. The Necrotising Infections Clinical Composite Endpoint (NICCE) provides a binary outcome with which to assess interventions for NSTIs. Partly with a view towards studies of hyperbaric oxygen treatment in NSTIs we aimed to validate NICCE in a retrospective cohort of NSTI patients. Eligible patients were admitted between 2012 and 2021 to an adult major referral hospital in Victoria, Australia with surgically confirmed NSTI. The NICCE and its constituents were assessed in the whole cohort (n = 235). The cohort was divided into two groups using the modified sequential organ failure assessment (mSOFA) score, with an admission mSOFA score ≥ 3 defined as high acuity. Baseline characteristics of the whole (n = 235), the high (n = 188) and the low acuity cohorts (n = 47) were similar. Survival rates were high (91.1%). Patients with an admission mSOFA ≥ 3 were less likely to meet NICCE criteria for 'success' compared to the lower acuity cohort (34.1% and 64.7% respectively). Meeting NICCE criteria was significantly associated with lower resource utilisation, measured by intensive care unit days, ventilator days, and hospital length of stay for all patients and for those with high acuity on presentation. The NICCE provides greater discriminative ability than mortality alone. It accurately selects patients at high risk of adverse outcomes, thereby enhancing feasibility of trials. Adaptation of NICCE to include patient-centred outcomes could strengthen its clinical relevance.

Abstract B040: Building a lung cancer awareness event

Abstract Introduction: Lung cancer is the top cancer killer in the United States. Lung cancer screening (LCS) can decrease mortality of lung cancer, but current uptake is low. Concentrated effort during lung cancer awareness month has potential to positively impact uptake. Patient engagement and education are meaningful ways for medical students to make an impact. Methodology: We created a lung cancer awareness event during November (Lung Cancer Awareness Month) that aims to educate and engage regarding lung cancer and LCS. Prior to event day: 1. We secured buy-in from LCS leadership at the hospital, nurse navigators of the LCS program, leaders of nonprofit organizations and lung cancer support group leadership. 2. We recruited medical students to assist with creating informational materials, promoting the event and staffing day-of. All students attended a 1-hour training session on priority messages regarding lung cancer and LCS, engaging people in surveys and connecting eligible patients with LCS. 3. Informational materials and promotional flyers were sent to the lung cancer screening leadership to ensure messaging was in-line with messaging by the hospital and nonprofit organizations. Day-of event prep: 4. Tables with lung cancer educational materials were placed at the hospital entrances where foot traffic was greatest and staffed by medical students, nurse navigators and representatives from the nonprofits and lung cancer support groups. Educational and engagement materials at the table included lung cancer informational pamphlets, smoking cessation pamphlets and surveys to determine LCS eligibility. 5. Each table had a lung cancer and LCS trivia wheel with small give away items to attract and engage people at the tables. Event: 6. Medical students greeted people who approached the table and explained the purpose of the event (e.g. increasing lung cancer and LCS awareness and education). High priority messages regarding lung cancer and LCS (e.g. lung cancer is the top cancer killer, LCS can lower risk of dying from lung cancer, many eligible patients may not be getting screened) was conveyed by the student to the participant. 7. Participants were invited to complete the survey to determine LCS eligibility. 8. Participants were invited to answer a trivia question to win a lung cancer awareness t-shirt prize. After event: 9. Eligible patients identified by event surveys were followed-up by the nurse navigators to connect to LCS. Results: This lung cancer awareness event was successful in engaging people with lung cancer and lung cancer screening education. 73 people were recorded to have stopped by the table; 58 completed the survey in full. This event is within the power of medical students to do and can be set up easily with buy-in from faculty, hospital staff and local nonprofits. Conclusion: A student-run lung cancer awareness event is a feasible and impactful method to quickly engage patients in lung cancer screening. This event model can be translatable to future years and potentially expanded to other institutions and centers. Citation Format: Michelle Gomez-Guevara, Kristine Chin, Anthony Smith Jr., Masashi Azuma, Grace X. Ma, Cherie P Erkmen. Building a lung cancer awareness event [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B040.

Abstract A161: Racial and ethnic differences in receipt of guideline-recommended hepatocellular carcinoma surveillance in a high Risk, diverse primary care patient population: A study in two large integrated healthcare systems in California and Hawai‘i

Abstract Guideline-recommended ultrasounds for hepatocellular carcinoma (HCC) surveillance target patients with cirrhosis and certain liver conditions, yet uptake remains low, particularly among racial/ethnic minority groups. Underuse may be attributed to factors at the patient, provider, healthcare system, and neighborhood levels. However, in-depth analyses identifying contributory factors are lacking. We investigated the presence of racial/ethnic disparities in receipt of recommended surveillance among high-risk patients as a retrospective analysis of electronic health record (EHR) data from Kaiser Permanente Hawai‘i (KPHI) and Sutter Health in California, both of which serve numerous Asian American, Hispanic, Native Hawaiian (NH), other Pacific Islander (PI), and multiracial/ethnic patients. We included patients with ≥1 in-person encounter (2000-2017), no history of liver cancer, and a clinical indication of surveillance eligibility (cirrhosis, chronic hepatitis B or C, or a high FIB-4 score ≥2.67) with a minimum EHR follow-up of 18 months post-eligibility. Recommended surveillance is biannual abdominal imaging (ultrasound, CT, MRI) or alpha-1 fetoprotein tests. We categorized eligible patients as 'ever surveilled' if conducted at least once during follow-up and by the proportion of follow-up time they were up-to-date with surveillance (PTUDS). The cohort includes 54,597 patients (9,488 from KPHI; 45,109 from Sutter); current results are for the KPHI subset only. Among N=9,488 patients (median age: 52; 46% female; 26% NHW, 14% NH, 11% Filipino, 10% multiracial/ethnic) median follow-up was 91 months and 82% were surveilled at least once, with a mean PTUDS of 14% (SD=19%) overall and 19% (SD=21%) among the surveilled. We used sex- and age-adjusted log-risk regression for risk ratio (RR) of ‘ever surveilled’ vs. not and linear regression for PTUDS; NHW is the reference group in all models. We found that NH (RR=0.96, 95%CI 0.93-1.00), PI (RR=0.91, 95%CI 0.97-0.95) and multiracial/ethnic (RR=0.95, 95%CI 0.91-0.99) patients were significantly less likely to be ever surveilled, and that PI (beta=-0.02, 95% CI -0.04-0.01) race/ethnicity was significantly associated with lower PTUDS, while Chinese (beta=0.04, 95% CI 0.02-0.06), Korean (beta=0.04, 95%CI 0.01-0.07), Vietnamese (beta=0.05, 95%CI 0.02-0.09), and other Asian (beta=0.03, 95%CI 0.00-0.07) ethnicities were significantly associated with higher PTUDS. Although not statistically significant, surveillance rates were lower for American Indian/Alaska Native and Black groups, and higher for Japanese and Non-Hispanic Other race/ethnicity groups. Continued analyses will incorporate Sutter data, employ fully adjusted models with clustering by health system, and examine patient, provider, and neighborhood drivers of these disparities. Our findings indicate racial/ethnic disparities in HCC surveillance receipt, particularly noting the heterogeneity within Asian populations, and underscore the importance of analyzing disaggregated data for Asian American groups to fully understand and address these disparities. Citation Format: Enyao Y. Zhang, Mindy DeRouen, Alison J. Canchola, Aly M. Cortella, Pushkar Inamdar, Janet N. Chu, Sixiang Nie, Mai Vu, Ma Somsouk, Michele M. Tana, Anna D. Rubinsky, Iona Cheng, Mi-Ok Kim, Mark Segal, Chanda Ho, Yihe G. Daida, Su-Ying Liang, Hashem B. El-Serag, Scarlett L. Gomez, Salma Shariff-Marco, Caroline A. Thompson. Racial and ethnic differences in receipt of guideline-recommended hepatocellular carcinoma surveillance in a high Risk, diverse primary care patient population: A study in two large integrated healthcare systems in California and Hawai‘i [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A161.

Outcomes of COVID-19 in 24 hospitalized liver transplant recipients: an observational study

BackgroundAlthough liver transplant (LT) recipients are considered a population at risk of severe features of coronavirus disease 2019 (COVID-19), data in this regard are scarce and controversial. In this study, we reported the outcome of 24 cases of LT recipients who were hospitalized due to COVID-19 and investigated the role-playing factors in the severity of the disease.MethodsIn this single-center, analytic case-series study, eligible patients were among LT recipients who were hospitalized due to the diagnosis of COVID-19 based on positive results of polymerase chain reaction. Participants were categorized as severe COVID-19 if they were admitted to the intensive care unit, experienced respiratory failure demanding mechanical ventilation, or eventually died. Demographic and clinical data, COVID-19 symptoms and specific treatments, laboratory biomarkers, and immunosuppressive regimens and their alteration during the admission were recorded. Analysis was done using SPSS software.ResultsTwenty-four hospitalized LT patients were included, of which nine had severe and fifteen had non-severe COVID-19. Out of 9 patients with severe COVID-19, four sadly died. The analysis and comparison between the two groups revealed longer hospital stays (P = 0.02), lower lymphocyte counts (P = 0.002), and higher levels of C-reactive protein (CRP) (P = 0.006) in patients with severe COVID-19. Patients with non-severe COVID-19 had higher doses of tacrolimus and mycophenolate in their baseline immunosuppressive regimen (both P = 0.02).ConclusionLymphopenia and high CRP levels are associated with more severe forms of COVID-19 in LT patients. Mycophenolate may have protective properties against severe COVID-19. The role of severity indicators in LT patients with COVID-19 needs to be systematically recognized.

Comparison of side-hole and step-tip catheters for patients requiring continuous renal replacement therapy in intensive care units: study protocol for a randomised controlled trial

IntroductionIn addition to various techniques involved in catheter insertion, catheter placement location, lumen diameter and operation and management during continuous renal replacement therapy (CRRT), the design of the tip and...

Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non-valvular atrial fibrillation: protocol for a prospective, randomised, open-label, blinded endpoint trial (APIDP2)

IntroductionSeveral randomised controlled trials have demonstrated that novel oral anticoagulants are safer compared with vitamin K antagonists for the management of non-valvular atrial fibrillation (NVAF) to prevent thromboembolic events in...

Digital ray: enhancing cataractous fundus images using style transfer generative adversarial networks to improve retinopathy detection

Background/aimsThe aim of this study was to develop and evaluate digital ray, based on preoperative and postoperative image pairs using style transfer generative adversarial networks (GANs), to enhance cataractous fundus...

The cost-of-illness of multiple sclerosis in Jordan

ABSTRACT Background Multiple Sclerosis (MS) is a chronic neurological autoimmune disease that imposes a significant financial burden on healthcare systems. This study aims to determine the cost of illness for MS in Jordan, a country where data on the economic impact of MS are scarce. The objective of this study is to assess both direct and indirect costs associated with MS care in Jordan’s public healthcare system. Methods Data were collected during the year 2020–2021, annual cost of illness was estimated using a cross-sectional snowball sampling design. Eligible patients completed a self-reported questionnaire to provide sociodemographic, physician visit, and diagnostic and laboratory test data. We estimated indirect costs using an adjusted Human Capital Approach. Results This study included 383 people with MS (PwMS), 73.1% of whom were female and 61.4% between 26 and 45. Nearly 79.6% of PwMS took Disease Modifying Therapies (DMTs), and 40% had relapses in the year 2020-2021. One-third use non-DMTs and equipment for assistance like canes and walkers. The average annual cost per patient was 11,719 USD, with direct costs amounting to 11,252 USD and indirect costs at 467 USD. The total cost for all participants was 748,299 USD. The estimated cost of non-DMT, medical tools, diagnostic tests, and hospitalization per patient was 53 USD, 51 USD, 99 USD, and 235 USD respectively. Conclusion The high costs for Disease Modifying Therapies (DMTs) state the necessity of resource optimization in Jordan public healthcare facilities. Such findings yield policy-informing actionable insights, suggesting strategic investments in more cost-effective DMTs with potential improvement in accessibility and reduction in the overall economic burden faced by both patients and governments.

Humoral Immunity and Antibody Responses against Diphtheria, Tetanus, and Pneumococcus after Immune Effector Cell Therapies: A Prospective Study

Patients undergoing immune effector cell therapy (IECT) are at high risk for infections. We assessed seropositivity against pneumococcus, tetanus, and diphtheria in patients before and after IECT and the patients’ response to vaccination. We enrolled patients who underwent IECT from January 2020 to March 2022. Antibody levels for diphtheria, tetanus, and pneumococcus were measured before IECT, at 1 month, and 3–6 months after. Eligible patients were vaccinated after IECT. In non-seroprotected patients, we discontinued testing. Before IECT, most patients had seroprotective antibody levels against tetanus (68/69, 99%) and diphtheria (65/69, 94%), but fewer did against pneumococcus (24/67, 36%). After IECT, all patients had seroprotective antibody levels for tetanus at 1 month (68/68) and 3–6 months (56/56). For diphtheria, 65/65 patients (100%) had seroprotective antibody levels at 1 month, and 48/53 (91%) did at 3–6 months. For pneumococcus, seroprotective antibody levels were identified in 91% (21/23) of patients at 1 month and 79% (15/19) at 3–6 months following IECT. Fifteen patients received a pneumococcal vaccine after IECT, but none achieved seroprotective response. One patient received the tetanus-diphtheria vaccine and had a seroprotective antibody response. Because some patients experience loss of immunity after IECT, studies evaluating vaccination strategies post-IECT are needed.

Elevated serum albumin-to-creatinine ratio as a protective factor on clinical outcomes among critically ill patients with sepsis: a retrospective study

BackgroundThe aim of this study was to examine the prognostic significance of serum albumin-to-creatinine ratio (ACR) in critically ill patients with sepsis.MethodsThis retrospective study analyzed sepsis cases admitted to the Affiliated Hospital of Jiangsu University between January 2015 and November 2023. The patients were divided into four groups based on their ACR upon admission to the intensive care unit (ICU). Laboratory data were collected at the time of ICU admission, and the primary outcome measure was in-hospital all-cause mortality. Kaplan–Meier survival curves were generated to illustrate the differences in 30−/60-day mortality among the various groups. Multivariate Cox regression models and restricted cubic splines (RCS) were utilized to explore the association between ACR and all-cause mortality in sepsis patients. Subgroup analyses were conducted to examine the impact of other covariates on the relationship between ACR and all-cause mortality.ResultsA total of 1,123 eligible patients were included in the study, with a median ACR of 0.169. The in-hospital mortality rate was 33.7%, the ICU mortality rate was 31.9%, and the 30-day mortality rate was 28.1%. Kaplan–Meier survival analysis demonstrated that patients with higher ACR had a significantly lower risk of 30−/60-day mortality (log-rank p &amp;lt; 0.001). Multivariable Cox proportional hazards analyses revealed that ACR was an independent predictor of in-hospital death (HR: 0.454, 95% CI 0.271–0.761, p = 0.003), ICU death (HR: 0.498, 95% CI 0.293–0.847, p = 0.010), and 30-day death (HR: 0.399, 95% CI 0.218–0.730, p = 0.003). For each 1-unit increase in ACR, there was a 1.203-fold decrease in the risk of death during the hospital stay. The RCS curve illustrated a non-linear negative correlation between ACR and in-hospital mortality (p for non-linear =0.018), ICU mortality (p for non-linear =0.005), and 30-day mortality (p for non-linear =0.006). Sensitivity analysis indicated consistent effect sizes and directions in different subgroups, confirming the stability of the results.ConclusionLow ACR levels were identified as independent risk factors associated with increased in-hospital, ICU, and 30-day mortality in sepsis patients. ACR can serve as a significant predictor of the clinical outcome of sepsis.

Real-world evaluation of multimodal treatment practice in older oesophageal cancer patients

Abstract OBJECTIVES Elderly-specific data for multimodal treatment of oesophageal cancer (EC) is lacking. This study aimed to evaluate the safety and efficacy of multimodal treatment in older EC patients and to compare the impact of neoadjuvant chemotherapy (NCT) and neoadjuvant chemoradiotherapy (NCRT). METHODS Patients diagnosed with oesophageal squamous cell carcinoma or adenocarcinoma who received NCT/NCRT were identified in the National Cancer Database (NCDB, 2004–2015). First, we compared baseline and post-treatment characteristics between younger (&amp;lt;70 years) and older patients (≥70 years). Logistic regression was used to investigate risk factors of postoperative mortality. Second, we evaluated the effect of neoadjuvant chemotherapy on postoperative mortality and overall survival in the older cohort. Inverse probability of treatment weights (IPTW) and multivariable analyses were used to compensate for differences in baseline covariates. RESULTS We first compared outcomes of neoadjuvant therapy plus oesophagectomy in 14778 eligible EC patients. The older group experienced higher rates of postoperative mortality at 30 days (5.8%) and 90 days (13.5%) compared to younger patients. Postoperative mortality was significantly related to the Charlson-Deyo score and treatment-related factors including NAT type and minimally invasive technique. Second, among the 3,141 older patients (with a median follow-up of 57.8 months and 2029 deaths), those receiving NCT obtained significantly lower postoperative mortality and improved overall survival compared with NCRT (IPTW-Adjusted P = 0.05; HR, 0.85; 95% Cl, 0.72–0.99). CONCLUSIONS Neoadjuvant therapy plus oesophagectomy carries increased short-term mortality risk in older EC patients. NCT in older EC patients showed lower postoperative mortality but no statistically significant differences in overall survival with a point estimate favoring NCT compared to the NCRT group, making NCT a potential option for consideration in specific cases.

Sintilimab plus GemOx is an effective salvage therapy in patients with refractory/relapsing nodal peripheral T cell lymphomas

PurposeThe retrospective study was to explore the effectiveness and safety of GemOx (gemcitabine, oxaliplatin) plus sintilimab (belongs to the class of drugs known as immune checkpoint inhibitors, particularly targeting the PD-1 receptor) in relapse or refractory nodal PTCLs.MethodsPatients with nodal PTCL who initiated salvage therapy with sintilimab and GemOx between January 2020 to September 2021 were identified from the database of the hematology department of the Second Affiliated Hospital of Zhejiang University School of Medicine. All patients received 2–4 cycles (3 weeks/cycle) of treatment of sintilimab (200 mg, I.V, D1) in combination with GemOx. Treatment response was assessed every six weeks during the salvage treatment phase. Eligible patients received maintenance therapy according to the investigator’s decision. Follow-ups were routinely conducted every three months.Results31 patients with r/r nodal PTCLs were enrolled, including 23 PTCL-NOS, 4 AITL, and 4 ALCL. 21 (67.7%) patients received at least two lines of therapy. 71.0% (95% CI, 53.4%-83.9%) of patients documented objective response of 2–4 cycles of sintilimab plus GemOx therapy, including 9 complete response and 13 partial response. 21 (67.7%) patients received consolidation therapy, including 5 autologous stem-cell transplantation and 12 histone deacetylase inhibitors. After a median 25.6 months follow-up, the median PFS was 22.0 (95% CI,11.8–24.7) months, and the median OS was 26.2 (95% CI, 24.4 –NA) months. 29 (93.5%) patients experienced at least one adverse event, and 26 (83.9% patients only had mild (grade 1–2) AEs.Univariable Cox regression showed the progression risk of AITL is 22.7 (3.9- 131.0, p < 0.01) times of PTCL-NOS, while the HR of ALCL was 1.14 (0.33–3.96,p = 0.833).ConclusionSintilimab plus GemOx showed encouraging activity and manageable toxicity for patients with r/r PTCL.

Racial Disparities in Nasopharyngeal Carcinoma Characteristics and Survival

Objective: To investigate and compare the distribution of histological subtypes, stage at presentation, and survival outcomes among Chinese American, Non-Hispanic White, and African American patients with nasopharyngeal carcinoma (NPC). Materials and methods: We identified Chinese American, Non-Hispanic White, and African American patients with NPC who were diagnosed between 2010 and 2017. Statistical analyses were conducted using the chi-square test, propensity score matching, Kaplan-Meier analysis, and multivariate Cox proportional hazards models. Results: A total of 1646 eligible patients with NPC were included. Non-Hispanic White accounted for 1049 (63.7%), African Americans for 265 (16.1%), and Chinese Americans for 332 (20.2%), and their median age at diagnosis was 59, 55, and 53 years, respectively ( P &lt; .001). Chinese Americans most frequently harbored undifferentiated non-keratinizing squamous cell carcinoma subtype (n = 134, 40.4%) than Non-Hispanic White (n = 164, 15.6%) or African American patients (n = 44, 16.7%) ( P &lt; .001). Histological subtype distribution was similar between Non-Hispanic White and African American patients ( P = .338). African American patients had the highest rate of stage III to IV disease (n = 206, 77.7%) compared to Non-Hispanic White (n = 704, 67.1%) and Chinese American patients (n = 210, 63.2%) ( P = .009). No significant difference in stage distribution was observed between Chinese American and Non-Hispanic White patients ( P = .494). Non-Hispanic White patients [hazard ratio (HR) 1.344, 95% confidence interval (CI) 1.007-1.479, P = .045] and African American patients (HR 2.314, 95% CI 1.405-3.813, P &lt; .001) had significantly worse overall survival compared to Chinese American patients. However, race was not associated with NPC-specific survival in the multivariate analysis. Similar results were found after propensity score matching. Conclusions: Race influences the distribution of histological subtypes, stage at presentation, and survival outcomes in NPC.

Repeated rebiopsy for detection of EGFR T790M mutation in patients with advanced-stage lung adenocarcinoma: Associated factors and treatment outcomes of Osimertinib

Objectives This study was performed to investigate the detection rate of EGFR T790M mutation by repeated rebiopsy, to identify the clinical factors related to repeated rebiopsy, and to assess survival outcomes according to the methods and numbers of repeated rebiopsies in patients with lung adenocarcinoma who received sequential osimertinib after failure of previous 1st or 2nd generation EGFR-tyrosine kinase inhibitors. Methods This retrospective study included patients with advanced-stage lung adenocarcinoma who were confirmed to have EGFR T790M mutation and to have received osimertinib from January 2020 to February 2021 at Samsung Medical Center. The presence of T790M mutation was assessed based on either plasma circulating tumor DNA (ctDNA) or tissue specimens. Results A total of 443 patients underwent rebiopsy, with 186 (42.0%) testing positive for the T790M mutation by the sixth rebiopsy. The final analysis included 143 eligible patients. Progression-free survival was not significantly different in terms of the methods (tissue: 13.3 months, 95% confidence interval [CI]: [9.4, 23.5] vs plasma: 11.1 months, 95% CI: [8.1, 19.4], p = 0.33) and numbers (one: 13.4 months, 95% CI: [9.4, 23.5] vs two or more: 11.0 months, 95% CI: [8.1, 14.8], p = 0.51) of repeated rebiopsies. Longer overall survival (OS) was found in patients in whom T790M was detected by tissue specimens rather than by plasma ctDNA (2-year OS rate: 81.7% for tissue vs 63.9% for plasma, p = 0.0038). Factors related to the lower numbers of rebiopsies included age and bone metastasis. Factor associated with T790M detection in tissue rather than in plasma was pleural metastasis, while advanced tumor stage was related to T790M confirmation in plasma rather than in tissue. Conclusions Repeated rebiopsy for T790M detection in patients with NSCLC can increase the detection rate of the mutation. Detection of T790M by plasma ctDNA might be related to poor survival outcomes.

Frequency of KRAS and BRAF mutations in colorectal carcinoma and their association with clinical-pathological characteristics in a tertiary hospital in Kenya

IntroductionColorectal carcinoma is a leading cause of cancer morbidity and mortality globally. Its management includes the use of targeted therapy which require assessment for biomarkers to choose eligible patients. KRAS and BRAF mutations are biomarkers predictive of response to anti-EGFR therapy. This study aimed at determining the frequency of BRAF V600E and KRAS exon 2,3,4 mutations in colorectal carcinoma patients at the Aga Khan University Hospital Nairobi, Kenya.MethodsStudy participants were patients who had colectomy for colorectal carcinoma. They were identified from the laboratory information system. The patients age, gender and tumor location were determined from the medical records. The histological diagnosis, pathological tumor and nodal stage were confirmed by examining hematoxylin and eosin-stained slides prepared from the colectomy specimen. DNA was extracted from the specimens using Qiagen QIAamp DNA FFPE Tissue Kit and PCR performed using EntroGen KRAS/BRAF mutation analysis kit following manufacturer’s protocol.ResultsOne hundred fourteen patients were enrolled. Colorectal carcinoma was significantly more common in males than females. The mean age at diagnosis was 58 years. Majority of the tumors were in the right colon, were of pathological tumor stage T3 and had nodal involvement. Forty six percent (46%) of the cases had KRAS mutations while 5.3% had BRAF V600E mutation. KRAS mutation was associated with a high pathological tumor stage and nodal involvement.ConclusionColorectal carcinoma in our patients is more common in males and tend to occur at a younger age. The patients tend to have a high tumor pathological stage and nodal involvement at diagnosis. The high frequency of KRAS exon 2,3,4 mutation and low frequency of BRAF V600E mutations is similar to what has been reported in literature.

Mainstream Germline Genetic Testing with Expanded Eligibility for Early Breast Cancer Patients in a Large Integrated Health System.

This study evaluated a new mainstream genetic testing pathway for hereditary cancer, with expanded eligibility for early-stage breast cancer patients. The study compared multigene panel (62 genes) germline testing uptake and results for breast cancer patients at 4 pilot sites (n = 502 patients) and 10 non-pilot sites (n = 1792 patients) within Kaiser Permanente Northern California from December 2020, to June 2021. At the pilot sites, breast care coordinators (BCCs) offered and consented patients for testing, with eligibility expanded to include all patients age 65 years or younger. At the non-pilot sites, eligible patients were referred to genetics for pre-test counseling, ordering, and follow-up evaluation with the standard guideline that included all patients age 45 years or younger. Demographic and disease characteristics were similar at the pilot and non-pilot sites. At the pilot verses non-pilot sites, a higher percentage of patients was tested overall (61.6% vs 31.7%) and across all age groups. The median time from breast biopsy to test result also was reduced (22 vs 33 days, respectively). A higher percentage of patients at the pilot sites was identified as having a pathogenic/likely pathogenic variant (PV/LPV) in a breast cancer-related gene (3.6% vs 1.6%). Although the percentage of total patients tested was nearly twofold higher at the pilot sites than at the non-pilot sites, the percentage of total patients seen by genetics was estimated to be similar (33.7% vs 31.7%). Mainstream genetic testing of breast cancer patients facilitated by BCCs makes it feasible for a large health care system to expand germline genetic testing to early breast cancer patients age 65 years or younger.

In-Hospital Mortality and Treatment in Patients With Acute Coronary Syndrome With and Without Standard Modifiable Cardiovascular Risk Factors: Findings From the CCC-ACS Project.

Patients with acute coronary syndrome without standard modifiable cardiovascular risk factors (SMuRFs; hypertension, smoking, dyslipidemia, diabetes) have not been well studied, with little known about their characteristics, quality of care, or outcomes. We sought to systematically analyze patients with ACS without SMuRFs, especially to evaluate the effectiveness of guideline-directed medical therapy for these patients. In the CCC-ACS (Improving Care for Cardiovascular Disease in China-Acute Coronary Syndrome) project (2014-2019), we examined the presence and absence of SMuRFs and features among 89 462 patients with initial acute coronary syndrome. The main outcome was in-hospital all-cause mortality. Among eligible patients, 11.0% had none of the SMuRFs (SMuRF-less). SMuRF-less patients had higher in-hospital mortality (unadjusted hazard ratio [HR], 1.49 [95% CI, 1.19-1.87]). After adjustment for clinical characteristics and treatments, the associations between SMuRF status and in-hospital mortality persisted (adjusted HR, 1.35 [95% CI, 1.07-1.70]). Guideline-directed optimal medical therapy (receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, β-blockers, and statins) was not associated with lower mortality (adjusted HR, 0.98 [95% CI, 0.58-1.67]) in SMuRF-less patients, unlike the association in patients with SMuRFs (adjusted HR, 0.80 [95% CI, 0.66-0.98]). Sensitivity analyses were consistent with these results. SMuRF-less patients were associated with an increased risk of in-hospital mortality. Guideline-directed medical therapy was less effective in SMuRF-less patients than in patients with SMuRFs. Dedicated studies are needed to confirm the optimal therapy for SMuRF-less patients. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02306616.