tbuckley/cabot-search huggingface dataset:
Intravenous Iron Therapy Prevents Heart Failure Rehospitalizations
Authors: Anita Slomski
Journal: JAMA (2021)

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Predictors of intubation in COVID-19 patients treated with out-of-ICU continuous positive airway pressure
Authors: N. De Vita, L. Scotti, G. Cammarota, F. Racca, C. Pissaia, C. Maestrone, D. Colombo, C. Olivieri, F. Della Corte, F. Barone-Adesi, P. Navalesi, R. Vaschetto
Journal: Pulmonology (2021)

As delayed intubation may worsen the outcome of coronavirus disease 2019 (COVID-19) patients treated with continuous positive airway pressure (CPAP), we sought to determine COVID-specific early predictors of CPAP failure.In this observational retrospective multicentre study, we included all COVID-19 patients treated with out-of-ICU CPAP, candidates for intubation in case of CPAP failure. From these patients, we collected demographic and clinical data.A total of 397 COVID-19 patients were treated with CPAP for respiratory failure, with the therapeutic goal of providing intubation in case of CPAP failure. Univariable analysis showed that, age, lactate dehydrogenase (LDH) and white cell counts were all significantly lower in patients with successful CPAP treatment compared to those failing it and undergoing subsequent intubation. The percentage changes between baseline and CPAP application in the ratio of partial pressure arterial oxygen (PaO2) and fraction of inspired oxygen (FiO2), PaO2, respiratory rate and ROX index were higher in patients experiencing successful CPAP compared to those failing it. FiO2 and male gender were also significantly associated with intubation. Multivariable analysis adjusting for age, gender, Charlson comorbidity index, percentage change in PaO2/FiO2 or PaO2 and FiO2 separately, lactate, white blood cell count, LDH and C-reactive protein levels led to an area under the curve of 0.818 and confirmed that age, LDH and percentage increase in PaO2/FiO2 are predictors of intubation.In COVID-19 patients requiring CPAP, age, LDH and percentage change in PaO2/FiO2 after starting CPAP are predictors of intubation.
Abstract MP025: Unfavorable Perceptions of Neighborhood Environment are Associated With Greater Sedentary Time - Data From the Washington, D.C. Cardiovascular Health and Needs Assessment
Authors: Chaarushi Ahuja, Colby Ayers, Jacob Hartz, Joel Adu-Brimpong, Valerie Mitchell, Marlene Peters-Lawrence, Dana Sampson, Alyssa Brooks, Gwenyth Wallen, Faren Grant, Joshua Rivers, Samantha Thomas, Leah Yingling, Allan Johnson, Lennox Graham, Avis Graham, Tiffany Powell-Wiley
Journal: Circulation (2017)

Background: Sedentary time (ST) and unfavorable perceptions of neighborhood environment (NE) are independently associated with poor cardiovascular (CV) health. However, little is known about ST’s relationship to NE perceptions. Methods: We examined associations between ST and NE perception in the Washington, DC CV Health and Needs Assessment.(NCT01927783) Participants underwent a CV health evaluation designed using community-based participatory research principles and conducted in faith-based organizations in lower socioeconomic (SES) areas in DC. Participants responded, on a 5-point Likert scale, to questions about NE perceptions of sidewalks, recreational areas, crime, etc. Factor analysis was conducted to explore associations with overall NE perception. The factor sums were combined as the Total Perception Score (TPS). For ST, participants reported amount of time (in hours/minutes) “spent sitting or reclining on a typical day”. Linear regression analyses were performed to determine the relationship between TPS (range 15-75, higher score=more favorable perception) and ST for the 1) overall population, 2) Wards 5, 7, and 8 and 3) other DC wards/Maryland (MD) areas. Results: For the study sample (N=99, 99% African American, 78% female), DC Wards 5, 7, and 8 had a significantly higher percentage of households with yearly income of &lt;$60,000 (p&lt;0.05) and lower mean TPS than residents of other areas (p &lt; 0.001).Three factors (neighborhood violence, physical and social environment, and social cohesion) were associated with overall NE perception. Among those living in the lower SES Wards 5, 7, and 8, there was a negative association between TPS and ST that remained after adjusting for age, sex, and income (Table). This relationship was not observed for those in higher SES DC/ MD areas. Conclusions: Poorer NE perception is associated with greater ST for those living in lower SES areas of DC. Targeted interventions to improve perceptions of physical and social environment in these areas may decrease ST and improve CV health.
Phase Ib/II study of pembrolizumab with lanreotide depot for advanced, progressive gastroenteropancreatic neuroendocrine tumors (PLANET).
Authors: Michael Morse, Daniel M. Halperin, Hope Elizabeth Uronis, David S. Hsu, Herbert Hurwitz, Emily Bolch, Dana Warren, Sherri Haley, Lisa John, Ashley Moyer, Christel N. Rushing, Donna Niedzwiecki
Journal: Journal of Clinical Oncology (2021)

369 Background: Pembrolizumab has antitumor activity in a subset of GEP-NETs patients. We hypothesized that the lanreotide, by its antitumor effects and reduction of serotonin, a modulator of immunity, would synergize with pembrolizumab in low/intermediate grade GEPNETs. Methods: GEP-NETs patients who had progressed on a prior somatostatin analogue received lanreotide 90mg sq and pembrolizumab 200mg IV every 3 weeks until progressive disease or intolerable toxicity. The primary endpoint was ORR at any time on study and secondary endpoints were PFS and OS. Results: 22 patients were treated (F/M 10/12; Caucasian/AA/other 10/7/5; GI/pancreatic 14/8; median Ki67 5%, median time since diagnosis 5.3 yrs (IQR 2.3-7.9 yrs)). Prior octreotide LAR/lanreotide/both was administered to 20/1/1. Patients had a median of 2 prior systemic therapies (range 1-9) and six had prior locoregional therapy and 3 external beam radiotherapy. Of the 12 tumors analyzed thus far, 4 had detectable PD-L1 expression and 11 had detectable TILs. A median of 6 pembrolizumab doses (range 2-15) and 7 lanreotide doses (range 2-15) were administered. Six patients experienced treatment related SAEs (abdominal pain, pneumonitis, colitis, and hyperglycemia, all related to the pembrolizumab). Selected treatment related adverse events included: Hypothyroidism 23%, colitis 9%, hyperglycemia 14%, and pneumonitis 5%. Best response by RECIST 1.1 was SD/PD/Not available:39/52/9% and by irRECIST was 43/48/9%. Median PFS was 5.4 months (95% CI 1.7-8.3 mo). The median overall survival at a median follow-up of 15 months was not reached. Peripheral blood immunologic correlates will be reported subsequently. Conclusions: In a population of GEP-NET patients, progressing on a median of 2 prior therapies, including prior somatostatin analogue therapy, a minority of whom had PD-L1 expressing tumors, the combination of lanreotide and pembrolizumab produced stable disease in approximately 40% of patients. No new safety signals were identified. Clinical trial information: NCT03043664.
Factors associated with treatment duration from start of second-line ramucirumab plus paclitaxel or nab-PTX for advanced gastric cancer: real-world evidence from Japanese Claim Database.
Authors: Shuichi Hironaka, Yoshito Komatsu, Yoshinori Tanizawa, Zhihong Cai, Yongzhe Piao, Narikazu Boku
Journal: Journal of Clinical Oncology (2021)

177 Background: Recently, the value of RWE has been recognized to be important. We investigated the first line(1L)-2L therapy(Tx) sequence for AGC and factors associated with whole treatment period after RAM plus(+) (nab-)PTX therapy using RWE in Japan. Methods: This study used a hospital-based claims database in Japan. Patients who were diagnosed with GC and started 1L Tx between Jun 2015 and Jul 2019 were selected. The 1L Tx was defined as fluoropyrimidine(FP)+platinum (with or without trastuzumab[Tmab]), and defined to be discontinued when it was suspended for &gt;90 days or switched to different antitumor drugs (2L Tx). In patients who started RAM+(nab-)PTX as 2L Tx, factors associated with overall Tx duration (from start of 2L Tx to the last dose of chemotherapy including subsequent Tx) were explored by Cox regression analysis. Results: 10581 patients (mean age 67.9 years, male 73.9%) received 1L Tx (9024 patients without Tmab and 1557 patients with Tmab). In patients who discontinued 1L Tx, the proportion of 1L-2L Tx transition was 61% (4509/7443) without Tmab and 68% (849/1245) with Tmab. Among 5358 patients who received 2L Tx, 3650 patients (68%) received RAM+(nab-)PTX. The median overall Tx duration was 6.7 months after initiation of 2L Tx with RAM+(nab-)PTX. Factors positively associated with the overall Tx duration from initiation of 2L Tx with RAM+(nab-)PTX were Tmab use before data cutoff (Sep 2019; hazard ratio [95% CI] 0.9 [0.79-1.00]), previous oral FP (0.7 [0.54-0.89]), duration of 1L Tx &gt;150 days (0.8 [0.74-0.87]). Factors negatively associated were peritoneal metastasis or ascites (1.3 [1.17-1.40]), comorbidities e.g., edema (1.3 [1.07-1.45]), renal disease (1.1 [1.01-1.30]), diabetes (1.1 [1.01-1.22]), previous oxaliplatin (1.2 [1.09-1.30]), and rehabilitation (1.9 [1.67-2.24]) or nutritional intervention (1.5 [1.34-1.68]) within 1 month before and after starting 2L Tx. Conclusions: Many of the patients received RAM+(nab-)PTX as 2L Tx regardless of Tmab. This large-scale RWE demonstrated that Tmab use, oral FP, and long 1L Tx duration were associated with longer treatment course from start of 2L RAM+(nab-)PTX therapy.
Conflicts in Managed Care
Authors: M A Rodwin
Journal: New England Journal of Medicine (1995)

Managed care changes traditional indemnity insurance and fee-for-service practice by integrating the financing and delivery of medical services, with the aim of controlling costs and improving quality. Both the patient and the physician are managed through policies that restrict the patient's choice of providers and medical options and that limit the clinical autonomy of doctors.Managed-care organizations use a variety of approaches to change the decisions of doctors and providers.1 They may use case managers to coordinate medical care in expensive cases, financial incentives to encourage physicians to make medical decisions that conserve resources, gatekeepers to control referrals for specialty . . .
Cost-effectiveness of cetuximab + FOLFIRI versus bevacizumab + FOLFIRI in the first-line treatment of <i>RAS</i> wild-type metastatic colorectal cancer in China.
Authors: Ilse Van Oostrum, Yannan Hu, Zijiao Yuan, Michael Schlichting, Libo Tao, Chris P. Pescott
Journal: Journal of Clinical Oncology (2021)

133 Background: Adding cetuximab to FOLFIRI chemotherapy (cet+CT) as first-line (1L) treatment for RAS wild-type (wt) metastatic colorectal cancer (mCRC) has been reported as cost-effective vs bevacizumab + FOLFIRI (bev+CT) in multiple jurisdictions. This study determined the cost-effectiveness (CE) of cet+CT for patients with mCRC in China. Methods: A published 3–health-state (nonprogressive, progressive, death) CE model was adapted to reflect Chinese patient characteristics, health state utilities, unit costs, and discounting rates, applying FIRE-3 trial–based resource utilization and adverse event rates. Progression-free and overall survival estimates were based on published FIRE-3 trial simulations to statistically adjust for available later-line treatment modalities in China vs those observed in FIRE-3. [1] Cetuximab and bevacizumab costs were based on up-to-date prices after the 2019 national reimbursement drug listing negotiations. Incremental CE ratios (ICERs) are given as cost (Chinese Yuan [¥]) per life-year (LY) and quality-adjusted LY (QALY) gained. The willingness-to-pay (WTP) threshold was ¥193,931, equivalent to 3 times the gross domestic product per capita, following WHO guidance. Results: Overall costs/costs restricted to 1L treatment were ¥483,771/¥249,619 (cet+CT) and ¥366,036/¥156,802 (bev+CT). Health effects were 3.32/2.68 (cet+CT) and 2.39/1.94 (bev+CT) LYs/QALYs gained. Discounted ICERs for cet+CT vs bev+CT were ¥148,311 and ¥186,517 per LY and QALY gained in deterministic analysis. cet+CT had a 71.8% (LY) and 52.5% (QALY) probability of being cost-effective. Treatment duration with a biologic in 1L, utilities in 3L treatment, and duration of 2L treatment were the main outcome drivers. Conclusions: Projections suggest that cet+CT is cost-effective vs bev+CT for 1L treatment of patients with RAS wt mCRC in China, with ICERs below the current WTP threshold in deterministic and probabilistic sensitivity analyses. [1] Van Oostrum I, et al. Value Health. 2020;23(Suppl 1): S8.
Impact of NAFLD on clinical outcomes in hepatocellular carcinoma treated with sorafenib: An international cohort study.
Authors: Jessica Howell, Amit Samani, Binish Mannan, Saur Hajiev, Leila Motedayan Aval, Rebecca Abdelmalak, Vincent C. Tam, Dominik Bettinger, Robert Thimme, Tamar Hamosh Taddei, David Edward Kaplan, Max Seidensticker, Rohini Sharma
Journal: Journal of Clinical Oncology (2021)

289 Background:The incidence of non-alcoholic fatty liver disease (NAFLD)-associated hepatocellular carcinoma (HCC) is increasing. The impact of NAFLD on overall survival (OS), treatment response and toxicity in patients with HCC treated with sorafenib is unknown. We examined the impact of NAFLD on OS and toxicity in an international cohort of patients receiving sorafenib. Methods:Clinical and demographic data were collected from patients consecutively treated at specialist centres in Europe and North America. The impact of NAFLD on OS, sorafenib-specific survival and sorafenib-related toxicity compared to other aetiologies of liver disease using multivariable Cox-proportional hazards and logistic regression modelling was assessed. Results:5201 patients were treated with sorafenib; 183 (3.6%) had NAFLD-associated HCC. NAFLD-associated HCC patients were more likely to be older women(median age 65.8 vs 63.0 years, p &lt; 0.01 and 10.4% vs 2.3%, &lt; 0.01), with a median BMI of 29.4. After controlling for known prognostic factors, no difference in OS in patients with or without NAFLD was observed(adjusted HR 0.94 (95% CI 0.76 -1.16), p = 0.57). NAFLD-associated patients had more advanced stage HCC when they commenced sorafenib (BCLC C/D 70.9% vs 58.9%, p &lt; 0.01) and were more likely to be commenced on a lower starting dose of sorafenib (51.4 vs. 36.4%, p &lt; 0.01). However, there was no difference in sorafenib-specific survival between NAFLD and other aetiologies(HR 0.99, 95% CI (0.85 – 1.16, p=0.92). Adverse events were similar between NAFLD and non-NAFLD HCC groups, including rates of ≥ grade 2 hypertension(6.3 vs. 5.8%, p = 1.00). A lower rate of severe hand foot syndrome was observed in the NAFLD population(3.8 vs. 12.4%, p = 0.03). Conclusions: OS in HCC does not appear to be influenced by the presence of NAFLD. NAFLD-associated HCC derive similar clinical benefit from sorafenib compared to other aetiologies.
Covid-19: Three quarters of UK doctors have had first vaccine dose, BMA survey finds
Authors: Abi Rimmer
Journal: BMJ (2021)

Covid-19: Three quarters of UK doctors have had first vaccine dose, BMA survey finds Abi RimmerThree quarters of doctors (75%) have received their first dose of the covid-19 vaccine, a survey conducted by the BMA has found.The association polled 41 000 doctors, including medical students and returning retired doctors, from 16 to 17 January.It received 5197 responses.Of the doctors who responded, 75% (3816) said that they had received a single dose of the vaccination, and 12% (624) had now received two doses.The Pfizer vaccine was most commonly used, as 94% (4140) of those doctors had received it.Among respondents who were still waiting for their first dose of the vaccine, 66% (377 of 572) said that they had not yet been notified as to when they would receive it.Just under a quarter (23%; 873 of 3806) of doctors reported having been notified of a cancelled second vaccine dose.The BMA said that this probably reflected the prioritisation of single doses in the vaccine rollout at this stage. Workforce strainCommenting on the survey findings, David Wrigley, BMA council deputy chair, said that progress was being made but that more than one in 10 doctors around the UK had still not received their first dose of the vaccine."The majority of these are still unsure when they are set to have it," he said."These are doctors who need their vaccine as soon as possible."He added that around 50 000 NHS workers were off work owing to covid-19, which was compounding the immense strain already on the workforce during the second wave."If we don't act quickly to give these doctors protection it runs the risk of even more falling ill and being taken away from the front line," he said."The BMA has been absolutely clear that all health and social care workers need to have received at least their first dose of the vaccine by the end of January, particularly those at greatest risk from infection."It is therefore crucial that these remaining doctors receive their first dose urgently to give them protection against this deadly disease."Wrigley also called for a renewed effort to give a second dose of the vaccine to doctors as soon as possible to provide maximum protection from the virus."The BMA will continue to lobby hard for this to happen," he said.
THU0115 Nocturnal melatonin serum level rhythm in rheumatoid arthritis
Authors: A Sulli, GJ Maestroni, C Pizzorni, E Hertens, C Craviotto, A Bisso, C Prete, M Grosso, M Briata, B Seriolo, M Cutolo
Journal: Annals of the Rheumatic Diseases (2001)

<h3>Background</h3> The pineal hormone melatonin (MLT) exerts a variety of effects on the immune system. MLT activates Th1 lymphocytes and monocytes; moreover MLT enhances the production of inflammatory cytokines, like IL-1, IL-6, IL-12 and TNFa, as well as nitric oxide production. <h3>Objectives</h3> Several symptoms of rheumatoid arthritis (RA), i.e. morning gelling, stiffness and swelling, are more evident in the early morning and might be related to the neuroimmunomodulatory effects exerted by MLT on synovitis. On the other hand, it is well known that MLT reaches its physiological serum peak level during the first hours of the morning. <h3>Methods</h3> Nocturnal MLT serum levels (8 pm, 12 pm, 2 am, 4 am, 6 am, 8 am o’clock) were evaluated in ten RA patients (pts) (mean age 57 ± 13 SD ys) and in six healthy controls (cnts) (mean age 50 ± 18 SD ys). RA pts were taking only nonsteroidal antiinflammatory drugs and the mean disease duration was 4 ± 2 SD ys. MLT assay was performed by RIA and statistical analysis was carry out by nonparametric tests. <h3>Results</h3> MLT serum levels at 8 pm and 8 am o’clock resulted higher in RA pts than in cnts (p &lt; 0.05). The differences were more evident in the older RA pts (age &gt; 60 ys) when compared to the younger ones (age &lt; 60 ys). In both RA pts and cnts, MLT progressively increased from 8 o’clock pm to the first hours of the morning, reaching the peak level that gradually decreased (p &lt; 0.02). However, MLT serum level reached the peak at least three hours before in RA pts than in cnts (p &lt; 0.05); subsequently, in RA pts, MLT concentration showed a plateau lasting two-three hours. After 2 am o’clock MLT levels decreased similarly in both RA pts and cnts. MLT levels progressively decreased with ageing in all subjects; nevertheless, MLT serum levels resulted significantly lower only in RA pts at 4 am and 6 am o’clock (p &lt; 0.05). <h3>Conclusion</h3> The results of this study confirm the existence of a nocturnal rhythm of MLT also in RA pts, with the peak level in the early morning. However, RA pts showed higher mean MLT serum levels, that reached earlier the peak of concentration, and maintained the high levels for longer time when compared to cnts. The imbalance between cortisol serum levels (notably lower in RA pts) and MLT serum levels (higher in RA pts) might explain several clinical aspects related to the neuroimmunomodulatory effects on RA synovitis, such as morning gelling, stiffness and swelling.
Clinical correlation of cadherin-17 (CA17 aka CDH17) marker with advanced tumor stages and poor prognosis of cholangiocarcinoma in a retrospective cohort of 180 patients.
Authors: Bohao Zheng, Sheng Shen, Tony K Wong, Zi-Jun Gong, Wentao Sun, Xiaojian Ni, Jiwen Wang, Mei-yu Hu, Han Liu, Xiaoling Ni, Houbao Liu, Moon Ching Luk, Tao Suo
Journal: Journal of Clinical Oncology (2021)

344 Background: Aberrant expression of cadherin-17 (CA17, aka CDH17) cancer marker is often observed in major gastrointestinal (GI) cancers. In this retrospective study, we examined the CA17 tissue expression and analyzed its clinical significance in cholangiocarcinoma (CCA). Methods: A total of 180 patients with detailed demographic and clinical data were enrolled in this study and randomly divided into a training cohort (N = 120) and a validation cohort (N = 60). Biopsy samples (tumor and adjacent normal tissue) collected for tissue microarray were examined by immunohistochemistry using a mouse anti-CA17 monoclonal antibody (Clone 7C5). Image pro plus was applied to score the staining intensity and expression level of CA17 marker. Kaplan-Meier analysis, Cox's proportional hazards regression, and nomogram were applied to evaluate the prognostic significance of CA17. Results: CA17 cancer biomarker over-expression was significantly observed in CCA compared to their non-tumor counterparts (P &lt; 0.001), and positively correlated with aggressive tumor phenotypes, like larger tumor size (P = 0.004), lymph node metastasis (P &lt; 0.001), and advanced TNM stage (P &lt; 0.001). Meanwhile, patients with high expression of CA17 correlated with worse postoperative overall survival (OS)(P = 0.002) and recurrence-free survival (P = 0.03). Besides, multivariate analysis identified that CA17 expression was an independent prognostic factor for cholangiocarcinoma patients (Training cohort: HR:1.716, 95% CI:1.116-2.638; P = 0.014; Validation cohort: HR: 1.811, 95%CI:1.028-3.892; P = 0.035), which indicated that the CA17 is much more efficient than serum CA19-9 (Training cohort: HR: 1.000, 95%CI: 1.000-1.001; P = 0.006; Validation cohort: HR: 1.000,95%CI:1.000-1.001; P = 0.013) in predicting the OS of CCA patients. Notably, the nomogram integrating CA17 expression had a better prognostic performance as compared with current TNM staging systems. Conclusions: CA17 cancer biomarker was aberrantly expressed in CCA tumor tissues, and its high expression level positively correlated with aggressive tumor phenotypes. Furthermore, CA17 was an independent adverse prognostic factor for CCA patients’ survival, which may serve as a potential drug target for CCA patients.