tbuckley/cabot-search huggingface dataset:
PALBOCOMP: Retrospective observational analysis of palbociclib treatment in patients with advanced breast cancer within a compassionate use program in Spain
Authors: L. Manso, B. Bermejo, I. Delgado, E. Aguirre, A. Oltra, M. Gonzalez, D. Malón, J.E. Ales, C. Rodriguez, F. Moreno
Journal: Annals of Oncology (2019)

Background: The combination of palbociclib with hormone therapy significantly increases progression free survival (PFS) compared with hormone therapy in first and second treatment line of HR+ HER2- metastatic breast cancer (MBC). However, the activity and security of palbociclib in MBC patients progressing after multiple treatment lines, has not been tested in clinical trials. Methods: Spanish compassionate use program of palbociclib enabled drug access to patients with HR+/HER2- MBC previously treated with at least 4 treatments for advanced disease and adequate organ function (bone marrow reserve, QTc interval and renal/liver function). Patients received palbociclib 125 mg once daily for 3 weeks followed by 1 week off alone or in combination with endocrine therapy (tamoxifen, fulvestrant, aromatase inhibitor and LHRH-agonists in premenopausal patients). Results: Between February 2015 and November 2017, 385 patients received treatment with palbociclib. Considering the dispersion of the centers that hindered the analysis, PALBOCOMP study has considered only those that included ≥ 3 patients in the compassionate use program. We report the results of the 70 first patients analyzed. The median age was 46.1 years (range 33.5–58.7 years) at the time of inclusion. 67 (95.7%) and 65 (92.9%) patients had received previous hormonal treatment and chemotherapy for advanced disease respectively. Concomitant hormonal therapy was fulvestrant in 55.7% patients and aromatase inhibitors in 34.3%. Best objective response was partial or complete response in 3 patients (4.3%), stable disease in 25 patients (35.7%) and progressive disease in 33 patients (47.1%) Evaluation of response was not available in 9 patients (12.9%) at the moment of the analysis. Median progression free survival was 5 months (95% CI 3.2-6.8 months). Conclusions: Palbociclib in combination with endocrine therapy shows encouraging activity in heavily pretreated endocrine-resistant HR+ MBC. Legal entity responsible for the study: Fundación para la Investigación Biomédica Hospital Clínico San Carlos. Funding: Pfizer. Disclosure: L. Manso: Consultant or advisory role: Pfizer, Tesaro, AstraZeneca, Roche, Novartis, Celgene; Research funding: Tesaro. Speaking: Roche, AstraZeneca, Novartis. M. Gonzalez: Advisory role: BMS, Pierre Fabre; Speaker: AstraZeneca. D. Malón: Advisory role: Roche, Novartis, Ipsen, Pfizer, BMS, MSD, Eisai; Travel expenses: Roche, Novartis, MSD, BMS. J.E. Ales: Travel expenses: Pfizer. F. Moreno: Advisory role: Roche, Pfizer, Novartis, AstraZeneca, Eisai; Travel expenses: Roche, Pfizer. All other authors have declared no conflicts of interest.
The early changes of ΔSUV is a predictive marker of response and outcome in everolimus treated patients with mBC
Authors: M.M. Sirico
Journal: Annals of Oncology (2019)

Background:18F-FDG PET/CT is regarded as one of the essential imaging for establish the efficacy of breast cancer therapy and the measures of tumor burden showed promises to predict OS in patients with mBC. Everolimus leads to decreased protein synthesis, cell metabolism and cell proliferation in solid tumors. Identification of predictive markers for everolimus-based treatment remains a major issue, but to date, no predictive markers have been established. The aim of this study is to evaluate an optimal ΔSUV% [(SUV baseline-SUV 3 months)/SUV baseline] as a predictive factor of OR and DFS in patients with mBC cancer receiving everolimus and exemestane in 1^ line treatment. Methods: The study included 31 patients with a new diagnosed luminal B phenotype mBCs treated with everolimus and exemestane in ASST of Cremona and INT of Milano between May 2013 and March 2018. The 18F-FDG PET/CT and glycemia were performed at baseline and after three months of treatment. Patients who stopped treatment before 10 months were considered as in a progressive disease (PD), otherwise a duration of therapy > 10 months was scored as no PD. ROC analysis was performed to determine the optimal cut-off value of ΔSUV% to differentiate PD from non-PD women using Youden Index. Time to progression survival (TTP) was estimated by Kaplan-Mayer method. Spearman's rank correlation coefficient (rho) was calculated to describe correlation between ΔSUV% and Δglycemia. Results: An optimal cut-off ΔSUV% value of 29% was proposed for discriminate patients with PD from those without PD: patients with ΔSUV%<29% had a median TTP of 3.11 months versus 9.29 months for patients with ΔSUV%>29% (p = 0.0036) and more frequently had PD within 10 months: 100% vs 53%, respectively (p = 0.005). There was a negative correlation between ΔSUV% and Δglycemia (rho=-0.32, p = 0.15). Conclusions: Our results showed that ΔSUV> 30% tested with 18F-FDG PET/CT after 3 months of treatment identified patients who had benefit from the everolimus-exemestane combination in term of response and TTP (>10 months). Moreover we have observed an inverse correlation between ΔSUV and Δglycemia. These results warrant further validation with a potential integration with molecular biomarkers related to tumor metabolism and mTOR signalling. Legal entity responsible for the study: Breast Cancer Unit and Translational Research Unit, Azienda Socio-Sanitaria Territoriale Cremona, Italy. Funding: Has not received any funding. Disclosure: The author has declared no conflicts of interest.
Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study
Authors: Josef S Smolen, Aileen L Pangan, Paul Emery, William Rigby, Yoshiya Tanaka, Juan Ignacio Vargas, Ying Zhang, Nemanja Damjanov, Alan Friedman, Ahmed A Othman, Heidi S Camp, Stanley Cohen
Journal: The Lancet (2019)
Love Poem Without Wheat
Authors: Theresa Burns
Journal: JAMA (2019)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA HomeNew OnlineCurrent IssueFor Authors Podcasts Clinical Reviews Editors' Summary Medical News Author Interviews More Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA journal
ESD OF CIRCUMFERENTIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA, “MUCOSAL BRIDGE TRACTION TECHNIQUE”
Authors: H Uchima, L Torrealba, D Busquets, G Mateu, M Figa, M Pujadas, C Huertas, M Hombrados, V Piñol, C López, R Louvriex, S Arjona, C Coll, S Marta, X Aldeguer
Journal: Endoscopy (2019)

We present the case of a circumferential oesophageal submucosal endoscopic dissection in a 56-year-old patient who presented a squamous esophageal squamous carcinoma of 10 cm in superficial length, without evidence of lymph node involvement by EUS, CT and PET-Scan. ESD was decided as the preferred first-line treatment according to the patient decision.
Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial
Authors: Giorgio V Scagliotti, Rabab Gaafar, Anna K Nowak, Takashi Nakano, Jan van Meerbeeck, Sanjay Popat, Nicholas J Vogelzang, Federica Grosso, Rasha Aboelhassan, Marko Jakopovic, Giovanni L Ceresoli, Paul Taylor, Francisco Orlandi, Dean A Fennell, Silvia Novello, Arnaud Scherpereel, Kozo Kuribayashi, Susana Cedres, Jens Benn Sørensen, Nick Pavlakis, Martin Reck, Derek Velema, Ute von Wangenheim, Miyoung Kim, José Barrueco, Anne S Tsao
Journal: The Lancet Respiratory Medicine (2019)
A MULTICENTER RANDOMIZED TRIAL OF LASER VERSUS ELECTROHYDRAULIC LITHOTRIPSY FOR DIFFICULT BILE DUCT STONES
Authors: DH Koh, J Lee, SH Moon, S Jung, JH Moon, HJ Choi, IS Lee, CS Shim, TY Lee, JK Lee, JH Han, JH Cho, HG Kim, SH Lee, DW Seo, HJ Jang
Journal: Endoscopy (2019)

Firstly, difficult bile duct stones were removed by mechanical lithotripsy. But, If this fail, the electrohydrulic (EHL) or laser lithotripsy (LL) could be performed. We performed the first prospective randomized controlled study to compare the efficiency and safety of LL and EHL in multicenter of South Korea.
Short- and Long-term Effects of a Mobile Phone App in Conjunction With Brief In-Person Counseling on Physical Activity Among Physically Inactive Women
Authors: Yoshimi Fukuoka, William Haskell, Feng Lin, Eric Vittinghoff
Journal: JAMA Network Open (2019)

<h3>Importance</h3> Mobile phone applications (apps) and activity trackers allow researchers to remotely deliver an intervention and monitor physical activity but have not been rigorously evaluated for longer periods. <h3>Objective</h3> To determine whether a mobile phone–based physical activity education app, in conjunction with brief in-person counseling, increases and then maintains levels of physical activity. <h3>Design, Setting, and Participants</h3> In this parallel randomized clinical trial, community-dwelling physically inactive women recruited between May 2011 and April 2014 were randomized in equal proportions into the control (n = 69), regular (n = 71), and plus (n = 70) groups. Data were analyzed using intention to treat from September 16, 2016, through June 30, 2018. <h3>Interventions</h3> The regular and plus groups were instructed to use the app on their mobile phone and an accelerometer every day for 3 months and attend brief in-person counseling. During the 6-month maintenance period, the plus group continued to use the app and accelerometer, while the regular group stopped using the app but continued using the accelerometer. The control group used the accelerometer throughout. <h3>Main Outcomes and Measures</h3> The primary and secondary outcomes were daily accelerometer-measured total steps and time spent in moderate to vigorous physical activity (MVPA). <h3>Results</h3> The 210 participants had a mean (SD) age of 52.4 (11.0) years. At baseline, the mean (SD) daily total steps by accelerometer in the control, regular, and plus groups were 5384 (2920), 5063 (2526), and 5837 (3235), respectively. During the 3-month intervention period, daily steps and MVPA increased in the combined regular and plus groups compared with the control group (between-group differences, 2060 steps per day; 95% CI, 1296-2825 steps per day;<i>P</i> &lt; .001 and 18.2 min/d MVPA; 95% CI, 10.9-25.4 min/d MVPA;<i>P</i> &lt; .001). During the subsequent 6-month maintenance period, mean activity level remained higher in the combined plus and regular groups than among controls (between-group difference, 1360 steps per day; 95% CI, 694-2026 steps per day;<i>P</i> &lt;. 001), but trends in total daily steps and MVPA were similar in the plus and regular groups. <h3>Conclusions and Relevance</h3> In this trial, the intervention groups substantially increased their physical activity. However, use of both the app and accelerometer for an additional 6 months after the initial 3-month intervention did not help to maintain increases in physical activity compared with continued use of the accelerometer alone. <h3>Trial Registration</h3> ClinicalTrials.gov identifier:NCT01280812
La Résection Muqueuse Endoscopique (RME) pour le traitement du Reflux Gastro-Oesophagien (RGO) en l'absence de hernie hiatale: étude pilote
Authors: A Laquière, F Trottier-Tellier, L Lecomte, C Boustière
Journal: Endoscopy (2019)

Le traitement endoscopique du RGO a fait l'objet de nombreuses études qui ont montré des résultats peu concluants. La seule étude pilote sur la RME de la jonction oeso-gastrique (1) a montré une diminution significative des symptômes du RGO. Le but de notre étude était de montrer l'efficacité et la tolérance de la RME pour le traitement du RGO.
Have Treatment Studies of Depression Become Even Less Generalizable? Applying the Inclusion and Exclusion Criteria in Placebo-Controlled Antidepressant Efficacy Trials Published over 20 Years to a Clinical Sample
Authors: Mark Zimmerman, Caroline Balling, Iwona Chelminski, Kristy Dalrymple
Journal: Psychotherapy and Psychosomatics (2019)

&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; Antidepressants are amongst the most frequently prescribed medications. More than a decade ago, our clinical research group applied a prototypic set of inclusion/exclusion criteria used in an antidepressant efficacy trial (AET) to patients presenting for treatment in our outpatient practice and found that most patients would not qualify for the trial. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we apply the psychiatric inclusion/exclusion criteria used in 158 placebo-controlled studies to a large sample of depressed patients who presented for outpatient treatment to determine the range and extent of the representativeness of samples treated in AETs and whether this has changed over time. &lt;b&gt;&lt;i&gt;Method:&lt;/i&gt;&lt;/b&gt; We applied the inclusion and exclusion criteria used in 158 AETs to 1,271 patients presenting to an outpatient practice who received a principal diagnosis of major depressive disorder. The patients underwent a thorough diagnostic evaluation. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; Across all 158 studies, the percentage of patients that would have been excluded ranged from 44.4 to 99.8% (mean = 86.1%). The percentage of patients that would have been excluded was significantly higher in the studies published in 2010 through 2014 compared to the studies published from 1995 to 2009 (91.4 vs. 83.8%, &lt;i&gt;t&lt;/i&gt;(156) = 3.74, &lt;i&gt;p&lt;/i&gt; &amp;#x3c; 0.001). &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; Only a minority of depressed patients seen in clinical practice are likely to be eligible for most AETs. The generalizability of AETs has decreased over time. It is unclear how generalizable the results of AETs are to patients treated in real-world clinical practice.
Fracture Risk After Roux-en-Y Gastric Bypass vs Adjustable Gastric Banding Among Medicare Beneficiaries
Authors: Elaine W. Yu, Seoyoung C. Kim, Daniel J. Sturgeon, Katherine G. Lindeman, Joel S. Weissman
Journal: JAMA Surgery (2019)

<h3>Importance</h3> Roux-en-Y gastric bypass (RYGB) is associated with significant bone loss and may increase fracture risk, whereas substantial bone loss and increased fracture risk have not been reported after adjustable gastric banding (AGB). Previous studies have had little representation of patients aged 65 years or older, and it is currently unknown how age modifies fracture risk. <h3>Objective</h3> To compare fracture risk after RYGB and AGB procedures in a large, nationally representative cohort enriched for older adults. <h3>Design, Setting, and Participants</h3> This population-based retrospective cohort analysis used Medicare claims data from January 1, 2006, to December 31, 2014, from 42 345 severely obese adults, of whom 29 624 received RYGB and 12 721 received AGB. Data analysis was performed from April 2017 to November 2018. <h3>Main Outcomes and Measures</h3> The primary outcome was incident nonvertebral (ie, wrist, humerus, pelvis, and hip) fractures after RYGB and AGB surgery defined using a combination of<i>International Classification of Diseases, Ninth Edition</i>and<i>Current Procedural Terminology 4</i>codes. <h3>Results</h3> Of 42 345 participants, 33 254 (78.5%) were women. With a mean (SD) age of 51 (12) years, recipients of RYGB were younger than AGB recipients (55 [12] years). Both groups had similar comorbidities, medication use, and health care utilization in the 365 days before surgery. Over a mean (SD) follow-up of 3.5 (2.1) years, 658 nonvertebral fractures were documented. The fracture incidence rate was 6.6 (95% CI, 6.0-7.2) after RYGB and 4.6 (95% CI, 3.9-5.3) after AGB, which translated to a hazard ratio (HR) of 1.73 (95% CI, 1.45-2.08) after multivariable adjustment. Site-specific analyses demonstrated an increased fracture risk at the hip (HR, 2.81; 95% CI, 1.82-4.49), wrist (HR, 1.70; 95% CI, 1.33-2.14), and pelvis (HR, 1.48; 95% CI, 1.08-2.07) among RYGB recipients. No significant interactions of fracture risk with age, sex, diabetes status, or race were found. In particular, adults 65 years and older showed similar patterns of fracture risk to younger adults. Sensitivity analyses using propensity score matching showed similar results (nonvertebral fracture: HR 1.75; 95% CI, 1.22-2.52). <h3>Conclusions and Relevance</h3> This study of a large, US population–based cohort including a substantial population of older adults found a 73% increased risk of nonvertebral fracture after RYGB compared with AGB, including increased risk of hip, wrist, and pelvis fractures. Fracture risk was consistently increased among RYGB patients vs AGB across different subgroups, and to a similar degree among older and younger adults. Increased fracture risk appears to be an important unintended consequence of RYGB.
ESR1 mutations are similarly prevalent in newly metastatic and loco-regional recurrence of endocrine-treated breast cancer patients and carry worse prognosis
Authors: E. Nili Gal Yam, A. Zundelevich, M. Dadiani, A. Itay, T. Sela, M. Gadot, S. Kahana, A. Pavlovsky, I. Barshack, B. Kaufman
Journal: Annals of Oncology (2019)

Background: Mutations in the ESR1 gene that evolve under endocrine treatment are associated with resistance to therapy and with worse prognosis of HR positive metastatic breast cancer patients. Here we aimed to study the incidence and clinical implication of these mutations in local recurrence events and newly diagnosed metastases. Methods: A total of 130 archived tumor samples were collected from 103 endocrine-treated breast cancer patients having long-term follow-up. The cohort consisted of 41 patients having at least one loco-regional recurrence sample and 62 patients with metastatic samples, of which 41 samples were from newly diagnosed metastasis and 28 samples from advanced metastatic patients. The 5 ESR1 hotspot mutations (D538G, L536R, Y537S/N/C) were analyzed. Results: The prevalence of ESR1 mutations was 5/41 (12%) for newly diagnosed metastasis and 5/28 (18%) for advanced metastases, at allele frequency >1%. In contrast to advanced metastases, most mutations in newly diagnosed metastases (4/5) emerged under Tamoxifen treatment alone. Progression free survival was significantly shorter in metastatic patients with ESR mutations treated with AI. For loco-regional recurrence events, ESR1 mutations were identified in 15/41 (36%) patients with 4/41 (10%) at allele frequency >1%. Again, most mutations (3/4) emerged under Tamoxifen treatment. Disease free survival and distant recurrence free survival were significantly shorter in patients that had ESR1 mutations (>1%) in their loco-regional recurrent tumor. Conclusions: ESR1 mutations are prevalent in breast cancer local recurrence to a similar extent as newly metastatic hormone receptor positive breast cancer patients. The results may have important implications for choosing the optimal adjuvant treatment for these patients. Legal entity responsible for the study: Breast Cancer Translational Research Group, Sheba Medical Center. Funding: Israel Cancer Association. Disclosure: All authors have declared no conflicts of interest.
EVALUATION OF FREQUENCY OF VOMITING AND THE NEED FOR HOSPITAL SUPPORT AFTER PLACEMENT OF THE INTRAGASTRIC BALLOON (IGB)
Authors: S Barrichello, GC Nunes, AC Hoff, JR Fernandes Fittipaldi, T Ferreira de Souza, J Waisberg, M Galvão Neto, A Fabio Teixeira, E Nobuki Usuy, J Scarparo, E Guimaraes Hourneax de Moura
Journal: Endoscopy (2019)

One of the most widely used treatment options in Brazil is the implantation of a silicone intragastric balloon (IGB).
BOUGIE CAP IN THE TREATMENT OF ESOPHAGEAL PEPTIC STRICTURE
Authors: J Cortez Pinto, S Mão de Ferro, A Dias Pereira
Journal: Endoscopy (2019)

Various methods are available for endoscopic treatment of benign stenosis in the upper gastrointestinal tract. The most common is the sequential use the of Savary-Gillard bougies after passing a guide-wire through the stenosis. The main problem of this method is the lack of direct visual control of the bougienage procedure. The Bougie caps are single use caps of different sizes that can be attached to an endoscope. The bougienage is carried out by advancing the endoscope through the stenosis while allowing good visualization of the surrounding tissue.
Neurocardiac Injury Assessed by Strain Imaging Is Associated With In-Hospital Mortality in Patients With Subarachnoid Hemorrhage
Authors: Nobuyuki Kagiyama, Masataka Sugahara, Elizabeth A. Crago, Zhi Qi, Theodore F. Lagattuta, Khalil M. Yousef, Robert M. Friedlander, Marilyn T. Hravnak, John Gorcsan
Journal: JACC. Cardiovascular imaging (2019)
Transient Confinement of CaV2.1 Ca2+-Channel Splice Variants Shapes Synaptic Short-Term Plasticity
Authors: Jennifer Heck, Pierre Parutto, Anna Ciuraszkiewicz, Arthur Bikbaev, Romy Freund, Jessica Mitlöhner, Maria Andres-Alonso, Anna Fejtova, David Holcman, Martin Heine
Journal: Neuron (2019)