tbuckley/cabot-search huggingface dataset:
Randomized phase II study of AKT blockade with ipatasertib (GDC-0068) and abiraterone (Abi) vs. Abi alone in patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel chemotherapy (A. MARTIN Study).
Authors: Johann S. De Bono, Ugo De Giorgi, Christophe Massard, Sergio Bracarda, Ivo Kocak, Albert Font, Jose Angel Arranz Arija, Kent C. Shih, George Daniel Radavoi, Wei Yu, Wai Y. Chan, Jian Huang, Luna C. Musib, Steven Gendreau, Raymond D. Meng, Premal H Patel, Daniel J. Maslyar, Viorel Jinga
Journal: Journal of Clinical Oncology (2016)

5017 Background: mCRPC commonly has hyperactivated PI3K/Akt signaling, usually via PTEN loss; androgen receptor (AR) blockade activates Akt, supporting mCRPC cell survival. We hypothesized that co-inhibition of Akt with Ipatasertib (Ipat), a potent novel oral ATP-competitive inhibitor of Akt, and of AR by Abi would improve outcome in mCRPC. Methods: Patients (pts) with mCRPC, previously treated with docetaxel, were double-blinded randomized 1:1:1 to three arms: Ipat-400, Ipat-200, or placebo (pbo), all in combination with Abi 1000 mg and prednisone 10 mg, daily (NCT01485861). Pts were stratified by prior enzalutamide (yes or no), number of chemotherapies (one vs more), and progression by PSA only vs other. Primary endpoint was radiographic progression-free survival (rPFS), with key secondary endpoint of overall survival (OS). Exploratory endpoints included assessment of the effect of PI3K/Akt pathway alterations in archival tumor tissue on rPFS. Results: 253 patients (pts) were randomized with 173 rPFS events (68%) at the primary analysis. Compared to pbo, Ipat-400 showed increased rPFS (median 8.2 vs 6.4 m; HR = 0.75; p= 0.17) with consistent trends in subgroup analyses. At 41% OS events, analysis showed an increased OS for Ipat-400 vs pbo (median 18.9m vs 15.6m; HR = 0.72; p= 0.22). Results for the Ipat-200 vs pbo showed less robust HR (rPFS HR = 0.94, p= 0.75; OS HR = 0.96, p= 0.87) - a potential dose effect for this combination. mCRPC with PTEN loss had superior rPFS benefit from Ipat-400 over pbo. AEs more common with Ipat were generally consistent with PI3K/Akt pathway inhibitor class and included diarrhea, nausea, vomiting, asthenia, rash, decreased appetite, and hyperglycemia. These AEs were dose-dependent, manageable, and reversible with Abi dose intensity maintained. Conclusions: This study provides evidence that Ipat in combination with Abi may improve rPFS and OS in pts with mCRPC post docetaxel, with potentially increased benefit in patients with decreased PTEN expression. Clinical trial information: NCT01485861.
Phase 1 study of ipatasertib (AKT inhibitor) for investigating safety, tolerability, pharmacokinetics (PK), efficacy, and biomarkers in Japanese patients (pts) with solid tumors including castration-resistant prostate cancer (CRPC)
Authors: S. Takahashi, Y. Fujiwara, N. Matsubara, J. Tomomatsu, S. Iwasa, A. Yamasaki, C. Endo, S. Yokoyama, T. Doi
Journal: Annals of Oncology (2017)
Human Induced Pluripotent Stem Cell (hiPSC)-Derived Cells to Assess Drug Cardiotoxicity: Opportunities and Problems
Authors: Tarek Magdy, Adam J.T. Schuldt, Joseph C. Wu, Daniel Bernstein, Paul W. Burridge
Journal: The Annual Review of Pharmacology and Toxicology (2017)

Billions of US dollars are invested every year by the pharmaceutical industry in drug development, with the aim of introducing new drugs that are effective and have minimal side effects. Thirty percent of in-pipeline drugs are excluded in an early phase of preclinical and clinical screening owing to cardiovascular safety concerns, and several lead molecules that pass the early safety screening make it to market but are later withdrawn owing to severe cardiac side effects. Although the current drug safety screening methodologies can identify some cardiotoxic drug candidates, they cannot accurately represent the human heart in many aspects, including genomics, transcriptomics, and patient- or population-specific cardiotoxicity. Despite some limitations, human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) are a powerful and evolving technology that has been shown to recapitulate many attributes of human cardiomyocytes and their drug responses. In this review, we discuss the potential impact of the inclusion of the hiPSC-CM platform in premarket candidate drug screening.
Development of automated quantitative multiparameter immunocytochemical profiling of circulating tumor cells (CTCs) in breast cancer (BC).
Authors: Brandon L. Miller, Clayton Deighan, Jeffrey J. Chalmers, Maryam B. Lustberg
Journal: Journal of Clinical Oncology (2012)

e21124 Background: The currently accepted definition of a CTC is a nucleated cell that is positive by qualitative fluorescence for EpCAM, expresses cytokeratin, and is negative for the pan-hematopoietic marker CD45. Such approach has limitations such as operator bias, difficulty distinguishing true signal from autofluoresence or filter bleed-through, and most importantly, it cannot differentiate expression levels that are low, intermediate or high. This is a problem because CTCs are in fact heterogeneous with respect to phenotypic expression of various markers. Methods: Peripheral blood samples were subjected to our previously described, negative depletion technology. Cytospins of enriched samples were stained with 3 to 5 antibodies conjugated to various Alexa Fluor dyes plus a nuclear dye and then analyzed with both confocal microscopy and a traditional epifluorescence microscope equipped with a Nuance (CRi) multispectral imaging camera and associated software. This imaging system allows not only fluorescent signals to be quantified between specific excitation and emission filters, but also the spectral structure between these boundaries through the use of a liquid crystal that takes images in as little as 10nm increments. Such imaging allows spectra from specific dyes to identify from the contributions of other dyes, filter leakage, and auto fluorescence. Results: Using this technology, and appropriate controls, we are developing continuous variable quantification of the expression of: cytokeratins, vimentin, CD45, Her2, CD44, EpCAM and EGFR in negatively enriched, peripheral blood samples from metastatic breast cancer patients. To date, over 10 metastatic patient samples have been quantified and the study is ongoing. Initial quantification indicates that significant variability in expression levels exists in multiple markers including Her2 neu. Conclusions: Using multispectral technology, we have shown that CTCs are heterogeneous, with different CTCs having varying expression levels of EpCAM, HER2 neu, vimentin and EGFR. Further multiparameter quantitative characterization with up to 6 color analysis on the same cell is in progress.
Neutrophil lymphocyte ratio (NLR) as a predictive biomarker for PD-1/PD-L1 directed therapy in metastatic non-small cell lung cancer (NSCLC).
Authors: Naresh Bumma, Ghayathri Jeyakumar, Seongho Kim, Cathy Galasso, Manish K. Thakur, Shirish M. Gadgeel, Ulka N. Vaishampayan, Antoinette J. Wozniak
Journal: Journal of Clinical Oncology (2017)

e20633 Background: PD-1/PD-L1 directed therapy is approved in the second and first-line treatment of metastatic NSCLC. While PD-L1 expression can be predictive of outcomes with such therapy, there remains a need for additional biomarkers to guide patient (pt) selection. NLR is an easy to use biomarker that was predictive for clinical outcomes in the treatment of kidney cancer and melanoma. This study evaluated NLR as a predictor of response rate (RR), PFS and OS in metastatic NSCLC pts treated with PD-1/PD-L1 inhibitors as second line therapy. Methods: A retrospective chart review of NSCLC pts treated with PD-1/PD-L1 inhibitors was conducted. Data were collected on pt demographics, smoking status [&lt;10 pack years (PY) and ≥10 PY], histology, NLR pre-therapy and NLR post 3 doses. Correlation with RR, PFS and OS was evaluated by univariate and multivariate analyses. Results: 58 pts with NSCLC were included in the analyses. Median age was 62.5 yrs (39-85) and 34(59%) were male. 36 (62%) were Caucasian, 16(28%) African American and 6(10%) Asian. 39 (63%) had adenocarcinoma histology, 23 (40%) patients smoked &lt;10 PY and 35(60%) ≥10 PY. On Day 1, 33 (57 %) had NLR &lt;4 and 28 (48%) had NLR &lt;4 after cycle 3. 43 (74%) pts had disease control with 2 (3%) complete remissions, 22 (38%) partial responses. Pre-therapy NLR ≥4 was associated with shorter PFS (HR = 1.79 p=0.10) and shorter OS (HR =2.57; p=0.04). NLR≥4 post 3doses was associated with shorter PFS (HR= 2.14,p=0.04) and shorter OS (HR= 3.11; p=0.04). In multivariate analysis, heavy smoking (≥10 PPY) was associated with longer PFS; HR=0.50 (95% CI 0.25-1.01; p=0.05); but had no effect on OS with a HR 0.58(95%CI 0.21-1.56; p=0.28). Squamous histology appeared to have longer PFS HR=0.62 (95% CI 0.61-2.35: p =0.61), though not statistically significant. Conclusions: Pretherapy NLR ≥4 was found to be associated with shorter OS in NSCLC pts treated with PD-1/PD-L1 therapy. This suggests that NLR may be a predictive factor for benefit with PD1/PDL1 therapy. A larger sample study is warranted to validate this observation. [Table: see text]
CAMKIIγ suppresses an efferocytosis pathway in macrophages and promotes atherosclerotic plaque necrosis
Authors: Amanda C. Doran, Lale Ozcan, Bishuang Cai, Ze Zheng, Gabrielle Fredman, Christina C. Rymond, Bernhard Dorweiler, Judith C. Sluimer, Joanne Hsieh, George Kuriakose, Alan R. Tall, Ira Tabas
Journal: Journal of Clinical Investigation (2017)

Atherosclerosis is the underlying etiology of cardiovascular disease, the leading cause of death worldwide. Atherosclerosis is a heterogeneous disease in which only a small fraction of lesions lead to heart attack, stroke, or sudden cardiac death. A distinct type of plaque containing large necrotic cores with thin fibrous caps often precipitates these acute events. Here, we show that Ca2+/calmodulin-dependent protein kinase γ (CaMKIIγ) in macrophages plays a major role in the development of necrotic, thin-capped plaques. Macrophages in necrotic and symptomatic atherosclerotic plaques in humans as well as advanced atherosclerotic lesions in mice demonstrated activation of CaMKII. Western diet-fed LDL receptor-deficient (Ldlr-/-) mice with myeloid-specific deletion of CaMKII had smaller necrotic cores with concomitantly thicker collagen caps. These lesions demonstrated evidence of enhanced efferocytosis, which was associated with increased expression of the macrophage efferocytosis receptor MerTK. Mechanistic studies revealed that CaMKIIγ-deficient macrophages and atherosclerotic lesions lacking myeloid CaMKIIγ had increased expression of the transcription factor ATF6. We determined that ATF6 induces liver X receptor-α (LXRα), an Mertk-inducing transcription factor, and that increased MerTK expression and efferocytosis in CaMKIIγ-deficient macrophages is dependent on LXRα. These findings identify a macrophage CaMKIIγ/ATF6/LXRα/MerTK pathway as a key factor in the development of necrotic atherosclerotic plaques.
Inotuzumab ozogamicin (IO) combined with mini-hyper-CVD as salvage therapy for patients (pts) with R/R acute lymphoblastic leukemia (ALL).
Authors: Rita Assi, Hagop M. Kantarjian, Farhad Ravandi, Susan Mary O'Brien, Partow Kebriaei, Deborah A. Thomas, Guillermo Garcia-Manero, Issa F. Khouri, Richard E. Champlin, Tapan M. Kadia, Jorge E. Cortes, Nitin Jain, Marina Konopleva, Rita Khouri, Zeev Estrov, Koichi Takahashi, Koji Sasaki, Jovitta Jacob, Rebecca Garris, Elias Jabbour
Journal: Journal of Clinical Oncology (2017)

7025 Background: Outcome of pts with R/R ALL is poor. IO, a CD22 monoclonal antibody bound to a toxin, calicheamicin, has single-agent activity in R/R ALL with response rate of 80% and median survival of 7.7 months. Adding IO to low-intensity chemotherapy might further improve clinical outcomes. Methods: Pts ≥18 years with R/R ALL were eligible. Chemotherapy was of lower intensity than standard hyper-CVAD and referred to as mini-hyper-CVD (cyclophosphamide and dexamethasone at 50% dose reduction (DR), no anthracycline, methotrexate at 75% DR, cytarabine at 0.5 g/m 2 x 4 doses). Rituximab (if CD20+ blasts) and intrathecal chemotherapy were given for first 4 courses. IO was given on day 3 of each of the first 4 courses at a dose of 1.8 mg/m2 for cycle 1 then 1.3 mg/m2 for subsequent cycles. After the occurrence of veno-occlusive disease (VOD), IO was modified to 1.3 mg/m2 for cycle 1 followed by 1.0 mg/m2 for subsequent cycles. Results: Sixty pts with a median age of 35 years (range 18-87) were treated. Overall, 47 pts (80%) responded, 32 of them (54%) achieving complete response. The overall minimal residual disease negativity rate among responders was 82%. Grade 3-4 toxicities included prolonged thrombocytopenia (79%), infections during induction and consolidations (52%, and 73% respectively), and hyperbilirubinemia (13%). VOD of any grade occurred in 9 patients (15%). At a median follow-up of 19 months, the median relapse-free survival (RFS) and overall survival (OS) were 9 and 11 months, respectively. The 2-year RFS and OS rates were 33% and 38%. The 2-year OS rates for patients treated in salvage (S)1, S2, and S3 and beyond were 53%, 0%, and 34%, respectively (p = 0.005). When compared to IO monotherapy in a similar pts population, a significant improvement in OS was observed (11 and 6 months, respectively; p = 0.003). Conclusions: The combination of IO with low-intensity mini-hyper-CVD chemotherapy is effective in pts with R/R ALL. Results are encouraging and appear superior to those obtained with IO alone, particularly in pts treated in S1. The risk of VOD should be considered carefully for transplant candidates and pts with previous liver damage. Lower dose of weekly schedules of IO are being explored Clinical trial information: NCT01371630.
Erratum: Influence of coronary heart disease on morbidity and mortality after carotid endarterectomy: A population-based study in Olmsted County, Minnesota [1970-1988] (J Am Coll Cardiol (1992), 19 (1254-60)
Authors: C. S. Rihal, B. J. Gersh, J. P. Whisnant
Journal: Journal of the American College of Cardiology (1992)
YOSEMITE: A 3 arm double-blind randomized phase 2 study of gemcitabine, paclitaxel protein-bound particles for injectable suspension, and placebo (GAP) versus gemcitabine, paclitaxel protein-bound particles for injectable suspension and either 1 or 2 truncated courses of demcizumab (GAD)
Authors: A. Cubillo Gracian, A. Dean, A. Muñoz, M. Hidalgo, R. Pazo-Cid, M. Martin, T. Macarulla Mercade, L. Lipton, M. Harris, J.L. Manzano-Mozo, J. Maurel, C. Guillen-Ponce, N. Tebbutt, P. Cooray, D. Sohal, M. Zalupski, T. Kolevska, R. Stagg, D. Goldstein
Journal: Annals of Oncology (2017)
Calendriers vaccinaux dans les pays de l'Union Européenne
Authors: N Guérin, C Roure
Journal: Eurosurveillance (1995)

Les pays de l'UE participent aux reunions des responsables nationaux desprogrammes de vaccination organisees par le bureau regional del'OMS pour l'Europe et lui adressent leurs donnees concernantl'incidence des maladies et la couverture vaccinale. Les calendriers vaccinauxont ete analyses a partir des informations inclusesdans les plans nationaux elabores par chacun des pays. Cependantil est difficile de tenir ces informations a jour, car les politiquesvaccinales sont souvent modifiees en fonction des changementsepidemiologiques et de l'apparition de nouveaux vaccins sur lemarche. De plus, les politiques peuvent varier d'une subdivision administrative a l'autre au sein d'un meme pays.
BREAKOUT: A cross-sectional, prospective, observational study of germline BRCA mutation (gBRCAm) prevalence and real-world outcomes among patients (pts) with HER2-negative (HER2-ve) metastatic breast cancer (mBC)
Authors: T. Dalvi, K.A. Gelmon, R. Dent, M. Pegram, S. Loibl, Y. Tazir, A. Milner, J. Lewis
Journal: Annals of Oncology (2017)
Shortage or Surplus of Physicians in the United States
Authors: Adeel Ajwad Butt
Journal: JAMA (2017)

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A phase II trial of palbociclib in metastatic grade 1/2 pancreatic neuroendocrine tumors: The PALBONET study on behalf of the Spanish Taskforce Group of Neuroendocrine Tumors (GETNE)
Authors: E. Grande Pulido, A. Teule, T. Alonso-Gordoa, P. Jiménez-Fonseca, M. Benavent, J. Capdevila, A. Custodio, R. Vera, J. Munarriz, A. La Casta-Muñoa, R. Garcia-Carbonero
Journal: Annals of Oncology (2017)
Genomic analyses reveal potential recurrence markers of locally advanced triple negative breast cancer treated by combined neoadjuvant EGFR targeting and chemotherapy
Authors: N. Radosevic-Robin, E. Cocco, H.H. Won, M.F. Berger, M. Privat, C. Abrial, F. Penault-Llorca, M. Scaltriti
Journal: Annals of Oncology (2017)
Prognostic relevance of immune-related gene expression signatures (irGES) in patients (pts) with ovarian clear cell carcinomas (OCCC)
Authors: V. Heong, D. Lim, T.Z. Tan, J. Ye, Y.W. Lim, S.E. Lim, J. Ng, A. Ilancheran, J. Loh, R. Soong, D. SP. Tan, R. Huang
Journal: Annals of Oncology (2017)
Abstract 16396: Characteristics, Indications and Outcomes of Pacemaker Use for Treatment of Conduction Abnormalities in Patients With Infective Endocarditis Requiring Valve Replacement
Authors: Gbolahan O Ogunbayo, Odunayo Olorunfemi, Ayman Elbadawi, Deola Saheed
Journal: Circulation (2016)

Introduction:  Conduction abnormalities secondary to Infective Endocarditis are associated with increased morbidity and mortality. Our study describes the frequency, indications and outcomes of pacemaker use in patients with Infective Endocarditis needing valve replacement.   Methods:  We queried the Nationwide Inpatient Survey Database from 1998 to 2013. Our study population was patients with a primary diagnosis of Infective Endocarditis undergoing valve replacement. In this cohort,we describe baseline characteristics and predictors of mortality in patients that underwent pacemaker insertion. We performed logistic regression analysis with mortality as the primary outcome. Our conduction disorders of interest were Right Bundle Brach Block, Left Bundle Branch Block, First Degree AV Block, Second Degree AV Block (Mobitz type II), Complete Heart Block and Sinus Node Dysfunction.   Results:  A total of 19% (n=6,261) of patients with a primary diagnosis of Infective endocarditis (n=52,998) required valve surgery. 776 (12.4%) patients undergoing surgery had conduction abnormalities. Of these, 560 (72.2%) were male. There was a statistically significant difference in pacemaker use in favor of all the conduction abnormalities studied except in trifascicular block (n=3). Pacemakers were implanted in 489(7.8%) of patients undergoing valve replacement. Among patients who had any of the conduction abnormalities studied, patients that received a pacemaker were also more likely to have a longer length of hospital stay (p=.001) and be discharged to a skilled nursing facility. Mortality was however lower in patients that received a pacemaker (4% vs 8% p=.035). When adjusted for type of valve replaced and adverse post-procedural events (TIA/Stroke, Respiratory failure, acute renal failure, cardiogenic shock, cardiac arrest/ventricular fibrillation), pacemaker placement was associated with lower mortality [OR= .457 95% CI= .236-.883; p value= .02]. This was mainly driven by pacemaker insertion for complete heart block [OR .310 95% CI .145-.666; p value 0.003].   Conclusions:  In patients undergoing valve replacement for Infective endocarditis, pacemaker placement in patients with complete heart block was associated with odds for lower mortality.
A phase I dose-escalation trial of ublituximab (TG-1101), a novel anti-CD20 monoclonal antibody (mAb), for rituximab relapsed/refractory B-cell lymphoma patients.
Authors: Changchun Deng, Jennifer Effie Amengual, Marshall T. Schreeder, Sean Clark-Garvey, Molly Patterson, Hari Miskin, Peter Sportelli, Owen A. O'Connor
Journal: Journal of Clinical Oncology (2013)

8575 Background: Anti-CD20 therapy (rituximab or RTX) in treating patients (pts) with B-cell lymphomas has resulted in significant improvement in treatment response and clinical outcomes. Despite advances, pts continue to relapse from, or are refractory to, RTX-based regimens. Ublituximab (UTX) is a novel, chimeric mAb targeting a unique epitope on the CD20 antigen. UTX has been glycoengineered to enhance affinity for all variants of FcγRIIIa receptors, and therefore demonstrates greater ADCC activity than RTX (Le Garff-Tavernier, 2011). UTX displayed greater antitumor activity compared to RTX in NHL in vivo models and in low CD20 expressing tumors (ASH 2011). A phase I trial with UTX used as a single agent in pts with relapsed/refractory CLL reported a response rate of 45%. Herein we report on the phase I dose-escalation of UTX in pts with RTX relapsed/refractory B-cell lymphoma. Methods: Eligible pts have B-cell lymphoma relapsed or refractory to a RTX containing regimen. Pts are required to have measurable/evaluable disease, ECOG PS &lt; 2 and no active hepatitis B/C. The phase I dose-escalation uses a sequential 3+3 design in dose cohorts of 450mg, 600mg and 900mg respectively. UTX is administered once weekly for 4 infusions followed by monthly maintenance therapy. PK and correlative PD data are being collected. Primary endpoint: Maximum Tolerated Dose (MTD) and Dose Limiting Toxicities (DLT). Efficacy is a secondary endpoint. Results: Nine pts (5 FL, 3 MZL, 1 MCL) have been enrolled (3 each cohort). Median age 63; 3/6 (M/F). Median prior Rx = 4 (2-6). RTX refractory (44%). 8/9 pts are evaluable for safety; no DLT’s observed and no Grade 3/4 AE’s to date. 7/9 pts have had at least one response assessment (8 wk scan), which includes: 1 CR (rituximab refractory MZL); 2 PR’s (1 MZL, 1 FL); 2 SD (FL) and 2 PD (1 transformed FL, 1 MCL). PK analysis is ongoing. Conclusions: UTX has been well tolerated to date with no G 3/4 AE’s with demonstrated early clinical activity at all doses. 7/9 patients continue to receive UTX treatment (range 1–25 wks). Enrollment in the 900mg expansion cohort is now open with an emphasis on RTX relapsed/refractory indolent or low CD20-expressing lymphomas. Clinical trial information: NCT01647971.
Genome-wide association analysis identifies 30 new susceptibility loci for schizophrenia
Authors: Zhiqiang Li, Jianhua Chen, Hao Yu, Lin He, Yifeng Xu, Dai Zhang, Qizhong Yi, Changgui Li, Xingwang Li, Jiawei Shen, Zhijian Song, Weidong Ji, Meng Wang, Juan Zhou, Boyu Chen, Yahui Liu, Jiqiang Wang, Peng Wang, Ping Yang, Qingzhong Wang, Guoyin Feng, Benxiu Liu, Wensheng Sun, Baojie Li, Guang He, Weidong Li, Chunling Wan, Qi Xu, Wenjin Li, Zujia Wen, Ke Liu, Fang Huang, Jue Ji, Stephan Ripke, Weihua Yue, Patrick F Sullivan, Michael C O'Donovan, Yongyong Shi
Journal: Nature Genetics (2017)