tbuckley/cabot-search huggingface dataset:
Impact of value frameworks on the magnitude of clinical benefit: Evaluating a decade of randomized trials for systemic therapy in solid malignancies.
Authors: Ellen Cusano, Chelsea Wong, Marcus Vaska, Nancy Alice Nixon, Safiya Karim, Tasnima Abedin, Patricia A. Tang, Daniel Yick Chin Heng, Doreen Anuli Ezeife
Journal: Journal of Clinical Oncology (2020)

e19410 Background: In the era of rapid development of new, expensive cancer therapies, value frameworks were developed to quantify clinical benefit. We assessed the evolution of the magnitude of clinical benefit since the 2015 introduction of the ASCO and ESMO value frameworks. Methods: Randomized phase II and III clinical trials assessing systemic therapies for solid malignancies from January 2010 to July 2019 were evaluated. Study characteristics were recorded, and magnitude of clinical benefit (Δ) was calculated for the endpoints overall survival (OS), progression-free survival (PFS), response rate (RR), and quality of life (QoL). Multivariable analyses compared ΔOS, ΔPFS, and ΔRR in 2010-2014 [pre-value frameworks (PRE)] to 2015-2019 [post-value frameworks (POST)]. Results: In the 290 studies analyzed [60 (21%) PRE and 230 (79%) POST], the most common primary endpoint was PFS (46%), followed by OS (20%), RR (16%), and QoL (8%), with a non-significant increase in OS and decrease in RR as a primary endpoint in the POST era (Table). Studies evaluating immunotherapy and palliative therapy significantly increased POST [0 (0%) v 39 (17%), Fisher’s exact p&lt;0.01 and 25 (42%) v 142 (62%), Chi squared p=0.01, respectively]. Studies reporting improvement in QoL doubled POST [3 (5%) v 22 (10%) Fisher’s exact p=0.56], however not statistically significant. Median ΔOS was significantly greater POST (N= 140 evaluable studies, 1.3 v -0.2 months, Wilcoxon p=0.005) but there was no significant difference in median ΔPFS or ΔRR. Multivariable analyses revealed significant improvement in ΔOS POST (OR 3.08, 95% CI 0.54-5.62, p=0.02) while adjusting for drug mechanism of action, line of therapy, disease setting, and primary endpoint. Conclusions: After the development of value frameworks, median OS improved minimally. The impact of value frameworks has yet to be fully realized in randomized clinical trials. Efforts to include endpoints shown to impact value, such as QoL, into clinical trials are warranted. [Table: see text]
Prevalence of acute kidney injury in myeloma patients visiting U.S. emergency departments: A nationwide analysis.
Authors: Umar Zahid, Preethi Ramachandran, Lutfi Alasadi, Puneet Bedi, Sergiy Shurin, Jen C. Wang, Faiz Anwer, Samuel Spitalewitz
Journal: Journal of Clinical Oncology (2020)

e20548 Background: Patients diagnosed with multiple myeloma (MM) frequently visit emergency departments (ED) with complications, commonly with kidney disease. However, data regarding the prevalence of acute kidney injury (AKI) and its effects on patient outcome, economic burden, length of hospital stay and mortality among these patients are lacking. Methods: From the Nationwide Emergency Department Sample, we obtained 7-year (2010-2016) data of myeloma patients who visited ED. Baseline characteristics of these patients with and without AKI were compared. The multivariable regression model was used to estimate hospital admission, length of stay, healthcare burden and in-hospital mortality in patients with and without AKI. Results: Between 2010-2016, 657,392 adult myeloma patients visited ED at an increased rate from 35 to 45 per 100,000 census population. The prevalence of AKI was 22.5% (n = 147,743) with a stable trend over the study period. AKI was more common in patients with relapsed MM (33.5%) than those in remission (18.6%) or never achieving remission (22.4%) (P &lt; 0.001), male (24.1 vs 20.6% in female, P &lt; 0.001), age ≥65 years (24.1%) vs 18-44 years (12.9%), or 45-64 years (19.3%)(P &lt; 0.001) and urban (23.3%) vs non-urban residents (17.9%)(P &lt; 0.001). The majority patients with AKI were hospitalized (96.5%) compared with those without AKI (69.6%) (P &lt; 0.001). In multivariable analysis, odds of hospitalization was higher in patients with AKI (OR: 8.8, P &lt; 0.001) after adjusting age, gender, co-morbidities and other demographics. Median hospital stay was longer in patients with AKI compared to those without (6 vs 4 days, P &lt; 0.001). Median ED and total hospitalization charges were higher in patients with AKI (ED: $2,057; total: $45,414) vs without AKI (ED: $1,853; total: $29,299) (P &lt; 0.001). In the multivariable adjusted-model, odds of in-hospital mortality was significantly higher in patients not in remission (OR: 1.8), patients with relapse (OR: 2.3), AKI (OR: 2.2), age ≥ 65 years (OR: 1.4), male (OR: 1.1) and urban residents (OR:1.2). Conclusions: In this largest national study of MM patients visiting ED, patients with AKI had higher in-hospital admission, ED and total charges, length of hospital stays, and mortality, both by univariate and multivariate analysis. Prevalence of AKI and mortality were highest in patients with MM relapse.
Daratumumab (Dara) and hyperfractionated cyclophosphamide (HyperCy)/dexamethasone (Dex) with and without carfilzomib (Car) for the treatment of relapsed/refractory multiple myeloma (RRMM).
Authors: Brandon R. Shank, Brian Primeaux, Sandra B. Horowitz, Erin K. Yeung, Irene Y. Lee, Gregory Peter Kaufman, Hans Chulhee Lee, Elisabet Esteve Manasanch, Krina K. Patel, Robert Z. Orlowski, Donna M. Weber, Sheeba K. Thomas
Journal: Journal of Clinical Oncology (2020)

e20528 Background: RRMM can be associated with high disease burden and/or end organ damage requiring rapid disease control. Our group has previously published data with hyperCy-bortezomib (bor)-doxorubicin-dex (Tabchi et al. 2019) for such patients (pts). Dara, a monoclonal antibody targeting CD38, has limited overlapping toxicities with cytotoxic chemotherapy, making it an attractive partner for hyperCy-dex. We report our retrospective experience of pts treated with dara-hyperCy-dex ± car. Methods: Between 5/2016-8/2019, 53 pts were treated with dara (16 mg/kg IV d1,8,15,22)-hyperCy (300-350 mg/m 2 IV q12h x 6-8 doses d1-3/4)-dex (20-40 mg IV/PO d1-4, 8-11, 15-18, 22-23) alone (27 records), or with car (20 mg/m 2 IV d1-2, 27-36 mg/m 2 IV d8-9, 15-16) (32 records) on 28 day cycles. Pts received growth factor, anti-fungal, anti-bacterial, anti-viral, and peptic ulcer prophylaxis. High-risk MM (HRMM) was defined by t(4;14), t(14;16), and/or del 17p. Response was assessed by International Myeloma Working Group Uniform Criteria. Overall response rate (ORR) and disease control rate (DCR) were defined as ≥ partial response and ≥ stable disease, respectively. Each instance of treatment (tx) started &gt; 60 days from the previous cycle start date was counted as a separate record. Patient characteristics, progression-free survival (PFS) and overall survival (OS) were assessed per pt, based on earliest administration date. Results: Median age of pts was 61 (26-77) years. Median number of prior therapies was 4 (1-18). Previous exposure to both lenalidomide and pomalidomide (93%), both bor and car (83%), and dara (64%) was frequent. HRMM was present in 20/42 evaluable pts. After a median of 1 cycle (1-5), ORR was 63%, with ≥ very good partial response in 24%. DCR was 86%. Median PFS was 4.3 months. Median OS was 9.7 months. Grade 3-4 hematologic toxicities included 66% neutropenia, 66% anemia, and 68% thrombocytopenia. Grade 3-4 non-hematologic toxicities included 42% febrile neutropenia, 19% bacteremia, and 15% pneumonia. Within 60 days of tx, 7 pts underwent autologous stem cell transplant (ASCT), and 7 pts died. Conclusions: Dara-hyperCy-dex ± car demonstrates a high ORR and DCR in heavily treated and HRMM, allowing bridging of some pts to ASCT. High rates of hematologic toxicity and risk of infection are manageable with twice weekly monitoring for transfusion support, as well as early detection and intervention for infections. Rates of end organ damage reversal will be presented.
Quantitative assessment of proprioceptive dysfunction in cancer survivors post oxaliplatin-containing chemotherapy.
Authors: Allison B. Wang, Stephen Nick Housley, Timothy C. Cope, Ann Marie Flores, Eric J. Perreault
Journal: Journal of Clinical Oncology (2020)

e24071 Background: Oxaliplatin (OX) is commonly used for gastrointestinal cancers but can cause chronic neurotoxicity with long-term motor impairments (e.g. dexterity loss, poor balance, and falls). These impairments are often attributed to OX-induced sensory neuropathy that disrupts touch, vibration, and proprioception in distal limbs. However, some cancer survivors report motor impairments even in the absence of sensory neuropathy. Recent animal studies suggest OX induces global signaling dysfunction in muscle proprioceptors that may account for the motor impairments in the absence of sensory neuropathy. However, this mechanism has yet to be investigated in cancer survivors. We hypothesize that cancer survivors will display impaired proprioceptive function compared to age-matched healthy controls using quantitative techniques that are more sensitive than current clinical measures. Methods: We assessed use of proprioception for controlling upper extremity position, force, and posture using target reaching, force matching, and postural stability tasks, respectively. A haptic robot quantified motor performance in all tasks, performed with and without visual feedback to disambiguate proprioceptive from vision. The dominant hand and wrist were fixed in an orthosis emphasizing elbow and shoulder use since these joints are less likely to have sensory neuropathy. Self-reported symptoms and functional limitations were measured with the QLQ-CIPN20 questionnaire. Accuracy and trial-to-trial variability for each task were compared between cancer survivors and controls using linear mixed effect models. Results: Thirteen cancer survivors (0 – 20 months post OX-treatment) and 7 controls completed the study. Without visual feedback, cancer survivors had significantly decreased accuracy (p &lt; 0.001) and increased trial-to-trial variability (p &lt; 0.05) in all tasks compared to controls. Deficits in force matching were correlated with self-reported motor dysfunction on the QLQ-CIPN20 (r = 0.87, p &lt; 0.001). Conclusions: Proprioceptive deficits occur in cancer survivors who received OX-treatment and are associated with motor dysfunction. This identified mechanism of motor impairment may present opportunities for targeted interventions.
Changes in black-white disparity in receipt of guideline concordant treatment for women with early-stage breast tumors.
Authors: Hasan Nadeem, John Romley, Shaneda Warren-Andersen
Journal: Journal of Clinical Oncology (2020)

e19089 Background: Racial disparities are well documented in the treatment of women with breast cancer. Whereas clinical treatment guidelines are established for early stage breast tumors, disparities in guideline-concordant (GC) treatment may influence variation in breast cancer outcomes. As such, we investigated differences in the receipt of GC treatment for black and white women with early-stage breast cancer between 2008 and 2016. Methods: We evaluated the Surveillance, Epidemiology, and End Results Registry (SEER) Incidence database for black and white women aged 20-64 years with stage I / stage II breast tumors. Primary analyses investigated associations between race and receipt of GC treatment in three chronological periods. Potential driving factors for trends in receipt of guideline-concordant treatment were also assessed. Results: Among 145,561 women diagnosed with early stage breast tumors, overall receipt of GC care decreased from 84.58% in 2008 to 83.89% in 2016. In period 1 (2008-2010), there was a prominent disparity between black and white women (81.89% black vs 86.24% white; p &lt; 0.001). By period 3 (2014-2016), GC care increased for black women (84.29%) but decreased for white women (84.82%), eliminating the disparity (p = 0.276). Multivariate logistic regression on changes in the black-white disparity across the study period showed increased receipt of GC treatment for black women relative to white women in period 2 (2011-2013, odds ratio [OR], 1.202; 95% confidence interval [CI], 1.075 – 1.344) and period 3 (OR, 1.376; 95% CI, 1.212 – 1.505). For black women undergoing breast conserving surgery, administration of radiation therapy increased from 44.01% in period 1 to 50.64% in period 3 (p &lt; 0.001) and was a prominent driver for increased GC care. Conclusions: Overall receipt of guideline-concordant treatment decreased from 2008-2016. Black women experienced a substantial increase in receipt of guideline-concordant care in period 2 (2011-2013) and period 3 (2014-2016) relative to white women. Delivery and completion of radiation therapy with breast conserving surgery increased the likelihood of receipt of guideline-concordant treatment.
Report of one patient of cerebral infarction associated with methamphetamine and a review of pertinent literature
Authors: Meijuan Xiao, Hai Zou
Journal: BMJ (2014)

A case of methamphetamine-related cerebral infarction was reported and the relevant databases of CBMdisc and Medline were searched.Among 14 cases of ischemic stroke, the ratio of male: female was 9∶5 and the age range 19-45 years.There were anterior circulation lesions (n=13, 92.8%) and 10 of them (71.3%) had cerebral vascular occlusion or stenosis.And the predominant manifestation was hemiplegia (85.7%); among 34 cases of hemorrhagic stroke, the ratio of male: female was 12∶5 and the age range 16-60 years.And 28 cases (82%) were ≤45 years.Cerebral hemorrhage was the most common (85%). The major manifestations were headache (n=26, 76%) and disturbance of consciousness (n=21, 62%). The methamphetamine-related stroke occurs frequently in young males.And ischemic stroke tends to involve anterior circulation and cause hemiplegia.Yet hemorrhagic stroke has extensive attack sites and headache and disturbance of consciousness are quite common.


Key words: 
Methamphetamine; Cerebrovascular accident
A prospective trial of standard versus multimedia counseling in patients undergoing endometrial cancer surgery.
Authors: Katherine Tucker, Stephanie Sullivan, Katie Allman, Luz Cuaboy, Paola A. Gehrig
Journal: Journal of Clinical Oncology (2020)

2067 Background: A patient’s understanding of surgery is often limited, especially in the setting of complex oncologic procedures. A recent review found that interventions such as the use of written materials, videos, and websites, improve patients’ knowledge of the procedure and their satisfaction with decision making. We sought to determine if a video-based approach in patients undergoing robotic endometrial cancer staging improves satisfaction with perioperative counseling. Secondary objectives were physician satisfaction, patient comprehension, and visit length. Methods: From 2018-2019, patients were randomized to standard physician education or multimedia-based education, which included watching two novel animated videos followed by focused physician counseling. Basic demographic information was collected. Patient satisfaction was assessed using the Client Satisfaction Questionnaire-8 (CSQ-8, a validated satisfaction survey, scored 8-32) and a global satisfaction score (10-point scale). Physician satisfaction was assessed using a global satisfaction score. Comprehension was assessed with a 9 question survey at 3 time points. Descriptive statistics were used to compare groups. Results: Of 76 patients randomized, the majority were Caucasian (68%), 50-70 years old (70%), and had at least some college education (75%). Most patients had undergone prior surgery (83%) and one fourth had a prior cancer diagnosis. Demographic variables and surgical history were similar between groups. The video patients reported higher satisfaction on the CSQ-8 (31.57 ± 1.02 vs 30.62 ± 2.09, p &lt; 0.05) and global satisfaction score (9.95 ± 0.23 vs 9.74 ± 0.55, p &lt; 0.05). There was no difference in comprehension scores between groups at either the initial or postoperative visit. At the time of surgery, comprehension scores were higher in the standard education group compared to the video group (p &lt; 0.01). There was no difference in physician satisfaction between groups. Among the video group, there was improvement in physician satisfaction between the first and second half of patients enrolled (p &lt; 0.05). There was no difference in visit length. Conclusions: While multimedia education improved patient satisfaction in the preoperative setting, this was not clinically significant. Provider satisfaction improved over time with the use of a video aid. Multimedia education may be implemented in perioperative counseling based on provider preference and consideration should be made for further study of satisfaction after the initial implementation period. Clinical trial information: NCT03899441.
Clinical decision support tools (CDST) provide education at the point-of-care to assist provider treatment choices.
Authors: Aimee Ginsburg, Lalan S. Wilfong, Neelima Denduluri, Josh Howell, Andrea Dickens, Kelly Leigh Casey, Angela Hsieh, John M. Burke, Charles Lance Cowey, J. Russell Hoverman, Lynne M. Knowles, Kartik Konduri, Tim Larson, Andrew Scott Paulson, Ian D. Schnadig, David Jacob Andorsky, Marcus A. Neubauer, Debra A. Patt
Journal: Journal of Clinical Oncology (2020)

e19165 Background: Cancer care is complex and requires synthesis of increasing amounts of clinical and financial data to optimize treatment decisions. The heightened differentiation of individual cancers, therapy sequencing, and increasing number of treatment options make it more challenging for oncologists to stay current. A survey showed that 82% of Network providers validated the utility of clinical evidence and decision-making assistance at the point-of-care. Providing education on efficacy, toxicity, and cost in the form of evidence tables (ET) as CDST may assist in value-based decision-making. Methods: We retrospectively reviewed utilization of ET developed to provide clinical and financial data about regimens included within the Value Pathways powered by NCCN. Thirty ET were embedded in the electronic health record (EHR) and posted on our intranet between June-December 2019, covering over 90% of cancers. Utilization was queried from roll out through January 2020. ET include a summary of primary literature (primary/secondary endpoints, adverse events) and monthly Medicare allowable reimbursement rates. ET are updated with each change to pathways and quarterly for cost updates. We also conducted a survey to understand provider ET utilization patterns. Results: Utilization was evaluated for 1,200 physicians across 470 sites that have access to ET. ET have been accessed 1178 times by 586 providers within the EHR and accessed 1363 times by 260 providers via intranet. Our rate of repeat users of the ET is 35% in the EHR and 97% on the intranet. A survey of 200 physicians after ET release showed that 19% of physicians use ET with every new chemotherapy start and an additional 50% refer to ET only if they are uncertain about the best option. Conclusions: Utilization patterns underscore the importance of ET as a CDST within the EHR and on the intranet. While early ET use is high, continued tracking of utilization and addition of content to assist in complex clinical decisions is a priority. Providers surveyed found that clinical informatics tools like ET are useful to enhance decision-making in complex cancer care. [Table: see text]
主动脉夹层的早期诊断与治疗价值临床分析
Authors: 杨发, 刘雪梅, 方俊平, 于新丽
Journal: BMJ (2007)

对28例确诊为主动脉夹层的住院患者的临床资料进行分析.结果显示该病的重要表现和诊断线索包括:突发胸背疼痛,但心电图及心肌酶学检查不支持急性心肌梗死;患者呈休克样表现,但血压反而增高或正常;四肢血压、脉搏不对称;新出现主动脉瓣反流杂音以及主动脉分支受累致相应脏器(脑、心、肾等)缺血和功能改变.X线检查、CT、B超、MRI可提供主动脉夹层诊断的可靠证据.提示提高对主动脉夹层的早期认识、早期诊断和及时处理,是降低其病死率的关键。
Application of mixed assessment of competence of general practitioners in Shanghai suburban communities
Authors: Xiaoqing Gu, Haiying Chen, Meijuan Yuan, Qing Lu, Lei Zhang, Jie Gu, Shanzhu Zhu, Xingqian Xie
Journal: BMJ (2020)

A pilot mixed assessment method was used to evaluate the clinical and teaching ability of general practitioners (GPs) in a suburban district of Shanghai. In December 2018, 29 GPs from 20 community health centers in a suburban district of Shanghai were assessed by a mixed method consisting of 3 domains and 8 stations for one day. The average age of GPs was (37.8±4.7) years and 22 were females (75.9%). In 3 domains, the average score (66.8±9.7) and qualified rate (75.9%) of clinical thinking abilities were the lowest. In 8 stations, the average score [(53.8+13.4) points] and qualified rate (34.5%) of adult SOAP medical record writing station were the lowest. The average score of pediatric outpatients consult station of GPs with 15 years of work experience [(68.6+10.2) vs. (58.5+9.4), t=2.787, P<0.05]. There was no significant difference in the scores among GPs with different teaching years and titles. The average scores of clinical thinking ability domain (t=2.115) and adult outpatient consult station (t=3.410); in the clinical operation ability domain the ophthalmoscopy and readings (t=3.816) and otoscopy and reporting station (t=2.286); clinical teaching abilities (t=2.618) and simulated educational situation station (t=2.452) and mini lectures station (t=2.802) of GPs in the community teaching base were higher than those in non-community teaching base (all P<0.05). Mixed assessment method can be used as one of the important means for GPs′ ability assessment. The community teaching bases have effectively improved the clinical and teaching abilities of GPs in suburban areas, however, the clinical thinking abilities of them are still weak.

Key words: 
General practitioner; Clinical and teaching ability; Mixed assessment
ApricityRx companion digital therapeutic for evidence-based mitigation and phenotype-linked molecular characterization of irAEs in patients receiving immune checkpoint therapy (ICT).
Authors: Matthew T Campbell, Tian Zhang, Lynda Chin, Allison Betof Warner, Matthen Mathew
Journal: Journal of Clinical Oncology (2020)

TPS2089 Background: Presentation of immune-related adverse events (irAEs) is heterogeneous and unpredictable in patients receiving immune checkpoint therapy (ICT). ICT has been approved for cancer patients as single agent, combination of dual ICT, ICT plus chemotherapy, and ICT plus targeted therapy. Given the ever increasing complexity in recognizing and managing irAEs, coupled with the lack of skilled resources and clinical experience in real world practice, there is increasing demand for digital solutions that can detect early toxicity and support evidence-based interventions in real world practice. To this end, we have developed ApricityRx, a companion digital therapeutic for end-to-end irAE management. In addition to (i) teaching patients about immune-related toxicities and (ii) empowering them to monitor key symptoms and vital signs, ApricityRx continuously analyzes the combined patient-reported data and longitudinal EMR data to (iii) detect symptom-triggers and lab test-triggers of irAEs, and (iv) activate the clinical team to triage, evaluate and treat in a timely fashion, while (v) providing access to synthesized longitudinal patient information and expert guidance on evidence-based management and care. In a feasibility trial conducted in a community setting, we demonstrated two-thirds of the study participants completed on average 5 eCheck-ins per calendar week (overall average 4 times per week), with 5% of the check-ins resulting in notifications alerting the clinical team to evaluate for the early signs of an irAE. Methods: To accelerate translational research in irAEs and to develop predictive biomarkers for risk stratification, we are launching a single-arm, open-label study that utilizes ApricityRx in patients receiving ICT alone or in combination. The objectives of the study will include (i) defining the operative characteristics of ApricityRx as an irAE mitigation strategy; (ii) identifying patients and time points for phenotype-triggered biospecimen collection and molecular characterization. The study aims to enroll initially up to 100 participants per site, with a total target of 1,000.