tbuckley/cabot-search huggingface dataset:
Insomnia in cancer patients.
Authors: Sara Ashraf, Mohammad Ali Syed Jafri, Mohamed Farouq Alsharedi
Journal: Journal of Clinical Oncology (2021)

e18651 Background: Insomnia is a prevalent, debilitating problem that is faced by a growing number of patients with cancer. These patients are at higher risk of excessive fatigue, anxiety, depression, less immunity and poor adherence to treatment. A recommendation by the National Comprehensive Cancer Network (NCCN) Guidelines is to routinely screen patients for sleeps issues. We sought to analyze the screening for insomnia and its management at a cancer center in Appalachia. We also evaluated referrals for cognitive behavioral therapy, which is recommended as first line therapy in patients with chronic insomnia by the American College of Physicians (ACP). Methods: We performed an anonymous survey related to sleep at our cancer center which included 312 patients diagnosed with a solid tumor malignancy divided into early stage (stage I or II) or advanced stage (stage III or IV). Three questions were directly from NCCN guidelines screening for sleep disturbances in patients with cancer. We also added questions regarding if the patients’ medical oncologists ever asked about or addressed their sleep difficulties and if any treatment was offered. The institutional review board of the cancer center approved this study. Results: Our results showed that 67.9% (212 patients) reported either having difficulty falling asleep, staying asleep, or waking up too early. 14.7% (46 patients) reported excessive sleepiness, while 64.7% (202 patients) reported that someone else told them that they snore frequently or stop breathing while sleeping. Of the patients who reported difficulty with sleep, only 4.7% (10 patients) reported that their medical oncologist ever addressed it, with 7 patients being started on medication. No patients were referred for cognitive behavioral therapy. Patients with advanced stage disease were four times more likely to report disturbances with sleep than early stage disease. Conclusions: Patients with cancer have difficulty with sleep, which profoundly affects their quality of life and may negatively impact their response to treatment. We wanted to use this survey to see how we can improve efforts to routinely screen patients and identify those in need of assistance and therapy. Routine screening and initiation of treatment must be implemented nationwide in all cancer centers. We aim to start referrals for cognitive behavioral therapy and continue to address patients’ sleep disturbances on a routine basis.
Polatuzumab vedotin-bendamustine-rituximab (PBR) versus tafasitamab-lenalidomide (TafaL) in ASCT-transplant ineligible relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL): Economic evaluation including novel metrics.
Authors: Matthias Calamia, Ali McBride, Ivo Abraham
Journal: Journal of Clinical Oncology (2021)

e19535 Background: PBR and TafaL are two recently regulatory approved regimens that offer treatment options for R/R DLBCL patients who are ASCT ineligible or choose not to undergo ASCT. PBR is administered over 6 cycles, whereas TafaL is sustained until disease progression or death. We report here on an independent, naïve comparative, pharmacoeconomic evaluation of both regimens. Methods: Cost effectiveness and cost utility analyses were performed using a Markov model with 3 health states (progression free survival (PFS), post progression survival (PPS), death) parametrically extrapolated over a 5-year (y) time horizon (US payer perspective; 2020 USD). Cost inputs included main treatment, premedication, drug administration, adverse event management, and physician and laboratory fees. Incremental cost effectiveness ratios (ICER) and cost-utility ratios (ICUR) estimated the incremental costs to gain 1 unadjusted (LY) or quality adjusted life years (QALY), respectively. A novel metric of the incremental cost per 1% gain in probability of achieving objective response (OR), PFS and overall survival (OS) at trial follow up (̃2y) and PFS and OS at 5y with TafaL over PBR were estimated. Deterministic (DSA) and probabilistic (PSA) sensitivity analyses complemented base case analyses (BCA). Willingness to pay (WTP) thresholds were estimated. Results: At trial follow up (̃2y), PFS and OS rates were 38% and 63% for TafaL vs rates of 18% and 27.5% for PBR. The corresponding 5y PFS and OS rates were 13% and 32.7% for TafaL vs 5.2% and 11.3% for PBR. In BCAs, 5y TafaL costs ($470,949) exceeded PBR’s ($251,615) by $219,334 for incremental gains of 0.71 LY and 0.32 QALY. This yielded BCA ICER of $307,840/LYg and ICUR of $689,314/QALYg attenuated in PSA estimates of ICER of $280,042/LYg and ICUR of $589,215/QALYg. In DSAs, TafaL PFS utility value and PBR treatment costs were the most influential parameters. In PSAs, TafaL had a 50% probability of being cost effective at WTPs of $278,050/LYg and $560,360/QALYg. The incremental cost per 1% gain in probability to achieve OR, PFS and OS at follow up were $7,714, $5,785 and $3,259; and $28,120 and $10,249 for PFS and OS at 5 years. Conclusions: Considering that economic evaluations are intended to inform (but not set) policy, this independent analysis demonstrated that sustained TafaL treatment is associated with better survival outcomes than PBR though at greater cost. The incremental costs to gain a 1% improvement in 2y and 5y survival outcomes with TafaL over PBR were modest, underscoring the longer-term benefit of TafaL over PBR in pts ineligible for or opting out of ASCT.
Trends in Use of Prescription Nonsteroidal Anti-inflammatory Medications Before vs After Implementation of a Florida Law Restricting Opioid Prescribing for Acute Pain
Authors: Shailina Keshwani, Ivanna Grande, Michael Maguire, Amie Goodin, Scott M. Vouri, Juan M. Hincapie-Castillo
Journal: JAMA Network Open (2021)

<h3>Importance</h3> Previous research has shown an immediate reduction in new opioid users and use after implementation of the opioid supply restriction laws. Assessment of the association between opioid restrictions and alternative treatment options, such as nonsteroidal anti-inflammatory drugs (NSAIDs), is needed to evaluate potential unintended consequences for patients requiring analgesia. <h3>Objective</h3> To evaluate the association between an opioid restriction law in Florida and use of prescription NSAIDs. <h3>Design, Setting, and Participants</h3> This quality improvement study used interrupted time series analyses accounting for autocorrelation to estimate immediate and trend changes in the prescribing and use of prescription NSAIDs in Florida before and after implementation of a state law limiting opioid prescriptions to a 3-day supply. Participants were enrollees in a single private health plan of a large university and health system employer in Florida from January 2015 to June 2019. <h3>Exposures</h3> Prescriptions for NSAIDs, ascertained from pharmacy claims data. <h3>Main Outcomes and Measures</h3> The following outcomes were calculated monthly per 1000 plan enrollees: (1) number of NSAID users; (2) mean days' supply of NSAIDs per prescription; and (3) mean number of NSAID prescriptions. Individuals were classified as NSAID users if they had at least 1 NSAID prescription in a given month. Analysis was stratified by route of NSAID administration (oral or nonoral). <h3>Results</h3> Among 46 783 NSAID users with 79 089 NSAID prescriptions during the study period, the median age was 47 years (interquartile range, 35-57 years). After implementation of the opioid restriction law, the number of NSAID users immediately increased, but the difference was not significant (change, 0.82 per 1000 patients; 95% CI, −0.67 to 2.30 per 1000 patients). No significant change in the days' supply of oral NSAID users occurred (change, 0.21 days per prescription; 95% CI, −1.66 to 2.08 days per prescription). Before implementation of the law, there was a nonsignificant decreasing trend in NSAID prescriptions (rate of change, −0.03 per month per 1000 enrollees; 95% CI, −0.13 to 0.07 per month per 1000 enrollees; after implementation, there was a nonsignificant increase in the number of oral and nonoral NSAID prescriptions (change, 1.49 per 1000 enrollees; 95% CI, −3.38 to 6.37 per 1000 enrollees). <h3>Conclusions and Relevance</h3> In this quality improvement study, prescribing and use of prescription NSAIDs did not increase after implementation of a law restricting opioid analgesic prescriptions in Florida. These findings suggest possible greater use of over-the-counter NSAIDs after implementation of the law, but further research is needed to evaluate changes in the use of nonopioid analgesics and alternative pain therapies.
Implications of Biomarker Discordance After Coronary Artery Revascularization
Authors: Björn Redfors, John Gregson, Ori Ben-Yehuda, Patrick W. Serruys, Arie Pieter Kappetein, Joseph F. Sabik, Stuart J. Pocock, Gregg W. Stone
Journal: Journal of the American College of Cardiology (2021)
Structural Cardiac Remodeling in Atrial Fibrillation
Authors: Christoph Beyer, Lyudmyla Tokarska, Markus Stühlinger, Gudrun Feuchtner, Florian Hintringer, Sarah Honold, Lukas Fiedler, Marie-Sophie Schönbauer, Robert Schönbauer, Fabian Plank
Journal: JACC. Cardiovascular imaging (2021)
OMIC-02. COGNITIVE DEFICITS AND ALTERED FUNCTIONAL BRAIN NETWORK ORGANIZATION IN PEDIATRIC BRAIN TUMOR PATIENTS
Authors: Benjamin Seitzman, Hari Anandarajah, Alana McMichael, Hongjie Gu, Dennis Barbour, David Limbrick, Joshua Shimony, Joshua Rubin, Stephanie Perkins
Journal: Neuro-Oncology (2021)

Abstract Pediatric brain tumor survivors experience significant cognitive sequelae from their diagnosis and treatment. The exact mechanisms of cognitive injury are poorly understood, and validated predictors of long-term cognitive outcome are lacking. Large-scale, distributed brain systems provide a window into brain organization and function that may yield insight into these mechanisms and outcomes. We evaluated functional network architecture, cognitive performance, and brain-behavior relationships in pediatric brain tumor patients. Patients ages 8–18 years old with diagnosis of a brain tumor underwent awake resting state functional Magnetic Resonance Imaging during regularly scheduled clinical visits and were tested with the National Institutes of Health Toolbox Cognition Battery. Age- and sex-matched typically developing children were used as controls. We observed that functional network organization was significantly altered in patients compared to controls (p &amp;lt; 0.001), with the integrity of the dorsal attention network particularly affected (p &amp;lt; 0.0001). Moreover, patients demonstrated significant impairments in multiple domains of cognitive performance, including attention (p &amp;lt; 0.0001). Finally, a significant amount of variance (R squared = 0.52, F = 3.2, p &amp;lt; 0.05) of age-adjusted total composite scores from the Toolbox was explained by changes in segregation between the dorsal attention and default mode networks. Our results suggest that changes in functional network organization may provide insight into long-term changes in cognitive function in pediatric brain tumor patients.
Plasma ascorbic acid and risk of heart disease and cancer [1] (multiple letters)
Authors: Naveed Sattar, Donald McMillan, Kay Tee Khaw, Alessandra Tavani, Carlo La Vecchia, David Lightsey, Michael Burr, Paul Appleby, Timothy Key, Margaret Thorogood, R. A. Riemersma, K. F. Carruthers, R. A. Elton, K. A A Fox
Journal: The Lancet (2001)
Dermatologic diagnoses in oncology patients of color on anticancer therapy: Five-year retrospective review of outpatient dermatology consultations.
Authors: Britney N. Wilson, Mary Sun, Mario E. Lacouture, Sarah Noor
Journal: Journal of Clinical Oncology (2021)

12084 Background: Dermatologic toxicities from cancer treatments affecting patients from racial and ethnic minority backgrounds or skin of color (SOC) patients is an understudied area of research. These patients are also significantly underrepresented in therapeutic clinical trials, limiting complete understanding of toxicities associated with cancer therapies. Current treatment algorithms for dermatological adverse events (dAE) also do not take into account possible biologic differences in different skin types affecting toxicity presentation and treatment response. In this study we summarize the demographic, clinical, and treatment characteristics of oncology patients from racial and ethnic minority backgrounds who developed dermatologic adverse events related to cancer therapies. Methods: We performed a retrospective review of all SOC patients (Asian, Black, Hispanic) on active cancer therapy who received outpatient dermatology consultation at Memorial Sloan Kettering Cancer Center from January 1, 2014 to December 31, 2019. Electronic health record information for 2917 patients was obtained. A computational keyword-based text analysis of medical chart text, developed in consultation with a board-certified dermatologist, was performed to determine dermatologic diagnoses categories for each patient. All analyses were conducted using R statistical programming software, version 4.2.06. Results: There were 2917 outpatient dermatology consultations. Our population consisted of 1992 (68.29%) females and 925 (31.71%) males with a mean age of 53 (range 0-97). There were 35.55% Black, 41.28% Asian, 1.02% (30) Native American or Alaskan Native, 0.17% (5) Native Hawaiian or Other Pacific Islander. 729 were Hispanic ethnicity of which 641 were Caucasian. A total of 4,026 dermatologic diagnoses occurred in the study population. Bacterial infections were the most commonly observed, occurring in 15% of patients. Nail disorders were the second most common dAE, occurring in 14% of the study population, followed by eczema/eczematous reactions at 9%. In all racial groups, eczema/eczematous reactions, nail disorders, and dermatomyositis were in the top five most common observed dAEs. Asian patients made up the largest proportion of those who had morbilliform rash dAEs (55%) while Black patients made up the largest proportion of those with hyperpigmentation dAEs (54%) and vascular insufficiency dAEs (47%). Conclusions: The findings from our study indicate that pigmentary changes, bacterial infections, eczema/eczematous reactions, and nail disorders are the most common dAE types that occurred in our group of SOC patients. We hope to use this information to aid in the development of specific management strategies within the field of supportive oncodermatology to meet the needs of minority patient populations.
Anlotinib alone or in combination with temozolomide in recurrent high-grade glioma: A retrospective study.
Authors: Qun-ying Yang, Cheng-Cheng Guo, Zhenqiang He, Fuhua Lin, Ji Zhang, Xiaoyu Guo, Yinsheng Chen, Xiaobing Jiang, Chao Ke, Zhongping Chen, Yonggao Mou
Journal: Journal of Clinical Oncology (2021)

e14019 Background: High-grade glioma (HGG) is the most common malignant brain tumor and lacks effective treatment regimen. Anlotinib is a multikinase inhibitor blocking angiogenesis and tumor cell proliferation simultaneously. This study was performed to evaluate the efficacy and safety of anlotinib alone or in combination with temozolomide (TMZ) in the treatment of recurrent HGG. Methods: This is a single-center, retrospective study. Eligible patients (pts) were diagnosed with pathologically confirmed high grades (WHO III/IV) glioma and had recurrent or progressive disease on or after prior treatment. Other key eligibility criteria included Karnofsky Performance Status (KPS) ≥ 40, aged 16 ̃75 years and having at least one measurable lesion (RANO criteria). Pts were administrated with anlotinib once daily for 14 days every 3 weeks till disease progression, intolerable toxicities or death. The initial dose was 12mg for younger pts ( &lt; 40 years old) with KPS ≥ 60 and 10 mg for others. Combination treatment was allowed if previous TMZ was effective and tolerable. TMZ was administered on dose-dense schedule (150mg/m 2 , QD, d1-d7 and d15-d21 every 28 days) or metronomic schedule (25-50mg/m 2 QD). The primary endpoint was progression-free survival at 6 months (PFS 6m ) accessed according to RANO criteria. The second endpoints included overall survival (OS), objective response rate (ORR) and disease control rate (DCR). Results: Between August 2019 and June 2020, 23 pts with HGG (15 grade IV; 8 grade III; 12 males, 11 females) were enrolled. The median age and median KPS was 42 years and 60. 16 pts have multifocal or disseminated disease. 18 pts received ≥2 lines previous treatment. At the data cutoff date on September 2020, the median duration of treatment was 9 weeks (range: 3-33). The PFS 6 m was 39.1% and the median PFS was 4.2 months (95% CI: 2.8, 5.6). The median OS was not reached (95% CI: NE, NE) and the OS at 12 months (OS 12m ) was 54.8%. 8 pts observed tumor response and 9 pts had stable disease. The ORR and DCR were 34.8% and 73.9% respectively. The results of survival analysis for subgroups were summarized in table below. Grade 1 or 2 treatment-related adverse events (TRAEs) occurred in 65.2% pts. No ≥ grade 3 TRAE was found. All hematological TRAEs occurred in patients received combination regimen. No TRAE-induced treatment termination occurred. The lower incidence of TRAE may partly attributed to that most pts (18/23) received lower initial dose (10mg) of anlotinib and the relatively shorter treatment duration. Conclusions: This study showed treatment with anlotinib alone or in combination with TMZ had promising efficacy and favorable tolerability in patients with recurrent HGG.[Table: see text]
Endocrine therapy-based strategies with different endocrine sensitivity statuses for hormone receptor positive/HER2 negative metastatic breast cancer: A network meta-analysis.
Authors: Jiani Wang, Yiqun Han, Jiayu Wang, Binghe Xu
Journal: Journal of Clinical Oncology (2021)

1062 Background: Novel endocrine therapies (ETs) and targeted therapeutic regimens have been developed to dramatically improve the outcome of hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer (MBC). Since the absence of direct head-to-head comparisons for all regimens, decision-making guidelines are urgently needed for different endocrine sensitivity statuses. This study is to evaluate the efficacy of ET-based regimens in patients with HR+/HER2- MBC and to assess the heterogeneity among different compounds with a particular focus on their ability to improve survival outcomes. Methods: This network meta-analysis of phase II/III randomized controlled trials (RCTs) with at least one ET in HR+/HER2- MBC were enrolled. Based on the endocrine responses, participants were stratified into endocrine therapy sensitivity (ETS) and endocrine therapy resistance (ETR) groups. Primary endpoints, including progression-free survival (PFS) and overall survival (OS), were assessed by bayesian algorithms and primarily measured as surface under the cumulative ranking curve (SUCRA). Results: A total of 42 trials (22917 patients) were included. Regarding PFS, cyclin-dependent kinases 4/6 inhibitors (CDK4/6i) +fulvestrant 500mg (F500) was recommended for the ETS group (SUCRA = 76.92%), while chemotherapy was considered as the most effective option for the ETR group (SUCRA = 73.47%). For visceral metastases, CDK4/6i +aromatase inhibitors (AIs) could provide the extreme efficacy for the ETS group (SUCRA = 63.27%) while the CDK4/6i +F500 (SUCRA = 76.17%) as the prior regimen for the ETR group. For bone-only disease, CDK4/6i+F500 was preferred for both the ETS (SUCRA = 67.04%) and the ETR (SUCRA = 70.24%) group. Concerning OS, CDK4/6i+tamoxifen was estimated as the first-rank regimen for the ETS subgroup (SUCRA = 67.04%) and chemotherapy for the ETR subgroup (SUCRA = 60.02%). Regarding resistance category, abemaciclib +F500 was likely the best option with PFS, for both primary (SUCRA = 69.19%) and secondary ETR (SUCRA = 69.09%) settings, as well as primary ETR associated with OS improvement (SUCRA = 67.67%). Pictilisib +F500 could be the optimal treatment with OS for secondary ETR (SUCRA = 60.50%)group. Conclusions: The results showed that CDK4/6i + F500 was probably the most promising option in ETS, visceral ETR and bone-only disease settings in terms of PFS. OS subgroup analysis showed that different endocrine sensitivity statuses required various optimal treatment strategies.
Optimal treatment duration of bevacizumab (BEV) combined with carboplatin and paclitaxel in patients (pts) with primary epithelial ovarian (EOC), fallopian tube (FTC) or peritoneal cancer (PPC): A multicenter open-label randomized 2-arm phase 3 ENGOT/GCIG trial of the AGO Study Group, GINECO, and NSGO (AGO-OVAR 17/BOOST, GINECO OV118, ENGOT Ov-15, NCT01462890).
Authors: Jacobus Pfisterer, Florence Joly, Gunnar Kristensen, Joern Rau, Sven Mahner, Patricia Pautier, Ahmed El-Balat, Jean Emmanuel Kurtz, Ulrich Canzler, Jalid Sehouli, Martin L. Heubner, Andreas D. Hartkopf, Klaus Baumann, Annette Hasenburg, Lars Ch. Hanker, Antje Belau, Barbara Schmalfeldt, Dominik Denschlag, Tjoung-Won Park-Simon, Philipp Harter
Journal: Journal of Clinical Oncology (2021)

5501 Background: GOG-0218 established the addition of BEV 15 mg/kg every 3 weeks (q3w) for 15 months to standard front-line chemotherapy for advanced ovarian cancer, but the optimal BEV duration remained unknown. We report primary results from a randomized phase 3 trial designed to address this question. Methods: Eligible pts with FIGO stage IIB–IV EOC, FTC, or PPC and ECOG PS ≤2 underwent primary cytoreductive surgery followed by 6 cycles of chemotherapy (paclitaxel 175 mg/m 2 + carboplatin AUC 5 q3w) and BEV (15 mg/kg q3w). Pts were randomized to receive BEV for either 15 months (standard arm BEV15) or 30 months (experimental arm BEV30), stratified by FIGO stage/residual tumor (stage IIB–IIIC/no residual tumor vs stage IIB–IIIC/residual tumor or stage IV). The primary endpoint was investigator-assessed progression-free survival (PFS) according to RECIST v1.1. Secondary endpoints were overall survival (OS), objective response rate, quality of life, safety, and tolerability. The trial was designed with 80.2% power to detect a hazard ratio (HR) of 0.66 favoring BEV30 (2-sided log-rank test, 5% significance level, 10% dropout rate) after 697 PFS events. The trial was funded by F. Hoffmann-La Roche Ltd., performed according to ENGOT model A. Results: From Nov 2011 to Aug 2013, 927 women (83% with EOC) from 161 centers were randomized. Baseline characteristics were balanced between arms; median age was 61 years, 96% had ECOG PS 0/1, 58% had no residual tumor, and 77% had high-grade serous histology. Serious adverse events of special interest for BEV occurred in 51/448 pts (11%) vs 61/442 pts (14%) receiving BEV15 vs BEV30, respectively: hypertension (2.7%/4.5%), thromboembolic event (2.2%/3.2%), fistula (3.1%/1.1%), gastrointestinal perforation (0.2%/0.9%), proteinuria (0.7%/1.4%), hemorrhage (0.2%/0.9%), and myocardial infarction (0%/1.1%). Efficacy is shown in the table. Conclusions: Longer treatment with BEV for up to 30 months improves neither PFS nor OS in pts with primary EOC, FTC, or PPC. Therefore BEV treatment duration of 15 months remains standard of care. Clinical trial information: NCT01462890. [Table: see text]