Medical Specialties Commons^™

The Authors Reply., Mindy M Pike, Aseel Alsouqi, Samuel A E Headley, Katherine Tuttle, Elizabeth Elspeth Evans, Charles M Milch, Kelsey Anne Moody, Michael Germain, Thomas G Stewart, Loren Lipworth, Jonathan Himmelfarb, T Alp Ikizler, Cassianne Robinson-Cohen

Articles, Abstracts, and Reports

No abstract provided.

Predicting Breast Cancer Response To Neoadjuvant Treatment Using Multi-Feature Mri: Results From The I-Spy 2 Trial., Wen Li, David C Newitt, Jessica Gibbs, Lisa J Wilmes, Ella F Jones, Vignesh A Arasu, Fredrik Strand, Natsuko Onishi, Alex Anh-Tu Nguyen, John Kornak, Bonnie N Joe, Elissa R Price, Haydee Ojeda-Fournier, Mohammad Eghtedari, Kathryn W Zamora, Stefanie A Woodard, Heidi Umphrey, Wanda Bernreuter, Michael Nelson, An Ly Church, Patrick Bolan, Theresa Kuritza, Kathleen Ward, Kevin Morley, Dulcy Wolverton, Kelly Fountain, Dan Lopez-Paniagua, Lara Hardesty, Kathy Brandt, Elizabeth S Mcdonald, Mark Rosen, Despina Kontos, Hiroyuki Abe, Deepa Sheth, Erin P Crane, Charlotte Dillis, Pulin Sheth, Linda Hovanessian-Larsen, Dae Hee Bang, Bruce Porter, Karen Y Oh, Neda Jafarian, Alina Tudorica, Bethany L Niell, Jennifer Drukteinis, Mary S Newell, Michael A Cohen, Marina Giurescu, Elise Berman, Constance Lehman, Savannah C Partridge, Kimberly A Fitzpatrick, Marisa H Borders, Wei T Yang, Basak Dogan, Sally Goudreau, Thomas Chenevert, Christina Yau, Angela Demichele, Don Berry, Laura J Esserman, Nola M Hylton

Articles, Abstracts, and Reports

Dynamic contrast-enhanced (DCE) MRI provides both morphological and functional information regarding breast tumor response to neoadjuvant chemotherapy (NAC). The purpose of this retrospective study is to test if prediction models combining multiple MRI features outperform models with single features. Four features were quantitatively calculated in each MRI exam: functional tumor volume, longest diameter, sphericity, and contralateral background parenchymal enhancement. Logistic regression analysis was used to study the relationship between MRI variables and pathologic complete response (pCR). Predictive performance was estimated using the area under the receiver operating characteristic curve (AUC). The full cohort was stratified by hormone receptor (HR) and …

The Effect Of Mock Code Blue Simulations And Dedicated Advanced Cardiac Life Support Didactics On Resident Perceived Competency., Dallis Q Ngo, Christina Vu, Thien Nguyen, Patricia Sotolongo, Manika Talati, Nikki Zahabi, Katrina Platt

Articles, Abstracts, and Reports

In-hospital cardiac or pulmonary arrest is associated with high mortality. In the USA, approximately 200,000 of these events occur and are associated with overall survival rates of 18%-20%. Despite advances in resuscitative methods, the probability of intact survival also remains unfavorable. Though many factors play a role, we believe a large portion of a patient's survival is dependent on the competency of the leader of the code blue or resuscitative team's efforts. Newly minted physicians who enter medical training in their respective residencies are equipped with a wide range of clinical competency in regards to hands-on experience and aptitude with …

Breast Cancer Distant Recurrence Lead Time Interval By Detection Method In An Institutional Cohort., Henry G Kaplan, Judith A Malmgren, Mary K Atwood

Articles, Abstracts, and Reports

BACKGROUND: Lead time, the interval between screen detection and when a disease would have become clinically evident, has been cited to explain longer survival times in mammography detected breast cancer cases (BC).

METHODS: An institutional retrospective cohort study of BC outcomes related to detection method (mammography (MamD) vs. patient (PtD)). Cases were first primary invasive stage I-III BC, age 40-74 years (n = 6603), 1999-2016. Survival time was divided into 1) distant disease-free interval (DDFI) and 2) distant disease-specific survival (DDSS) as two separate time interval outcomes. We measured statistical association between detection method and diagnostic, treatment and outcome variables …

Metabolic Network Analysis Reveals Altered Bile Acid Synthesis And Metabolism In Alzheimer's Disease., Priyanka Baloni, Cory C Funk, Jingwen Yan, James T Yurkovich, Alexandra Kueider-Paisley, Kwangsik Nho, Almut Heinken, Wei Jia, Siamak Mahmoudiandehkordi, Gregory Louie, Andrew J Saykin, Matthias Arnold, Gabi Kastenmüller, William J Griffiths, Ines Thiele, Alzheimer’S Disease Metabolomics Consortium, Rima Kaddurah-Daouk, Nathan D Price

Articles, Abstracts, and Reports

Increasing evidence suggests Alzheimer's disease (AD) pathophysiology is influenced by primary and secondary bile acids, the end product of cholesterol metabolism. We analyze 2,114 post-mortem brain transcriptomes and identify genes in the alternative bile acid synthesis pathway to be expressed in the brain. A targeted metabolomic analysis of primary and secondary bile acids measured from post-mortem brain samples of 111 individuals supports these results. Our metabolic network analysis suggests that taurine transport, bile acid synthesis, and cholesterol metabolism differ in AD and cognitively normal individuals. We also identify putative transcription factors regulating metabolic genes and influencing altered metabolism in AD. …

Safety And Tolerability Of Srx246, A Vasopressin 1a Antagonist, In Irritable Huntington's Disease Patients-A Randomized Phase 2 Clinical Trial., Michael J Brownstein, Neal G Simon, Jeffrey D Long, Jon Yankey, Hilda T Maibach, Merit Cudkowicz, Christopher Coffey, Robin A Conwit, Codrin Lungu, Karen E Anderson, Steven M Hersch, Dixie J Ecklund, Eve M Damiano, Debra E Itzkowitz, Shifang Lu, Marianne K Chase, Jeremy M Shefner, Andrew Mcgarry, Brenda Thornell, Catherine Gladden, Michele Costigan, Padraig O'Suilleabhain, Frederick J Marshall, Amy M Chesire, Paul Deritis, Jamie L Adams, Peter Hedera, Kelly Lowen, H Diana Rosas, Amie L Hiller, Joseph Quinn, Kellie Keith, Andrew P Duker, Christina Gruenwald, Angela Molloy, Cara Jacob, Stewart Factor, Elaine Sperin, Danny Bega, Zsazsa R Brown, Lauren C Seeberger, Victor W Sung, Melanie Benge, Sandra K Kostyk, Allison M Daley, Susan Perlman, Valerie Suski, Patricia Conlon, Matthew J Barrett, Stephanie Lowenhaupt, Mark Quigg, Joel S Perlmutter, Brenton A Wright, Elaine Most, Guy J Schwartz, Jessica Lamb, Rosalind S Chuang, Carlos Singer, Karen Marder, Joyce A Moran, John R Singleton, Meghan Zorn, Paola V Wall, Richard M Dubinsky, Carolyn Gray, Carolyn Drazinic

Articles, Abstracts, and Reports

SRX246 is a vasopressin (AVP) 1a receptor antagonist that crosses the blood-brain barrier. It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials. The present study was a 3-arm, multicenter, randomized, placebo-controlled, double-blind, 12-week, dose escalation study of SRX246 in early symptomatic Huntington's disease (HD) patients with irritability. Our goal was to determine whether SRX246 was safe and well tolerated in these HD patients given its potential use for the treatment of problematic …

A Pilot Study Comparing The Efficacy Of Lactate Dehydrogenase Levels Versus Circulating Cell-Free Micrornas In Monitoring Responses To Checkpoint Inhibitor Immunotherapy In Metastatic Melanoma Patients., Matias A Bustos, Rebecca Gross, Negin Rahimzadeh, Hunter Cole, Linh T Tran, Kevin Tran, Ling Takeshima, Stacey L Stern, Steven O'Day, Dave Hoon

Articles, Abstracts, and Reports

Serum lactate dehydrogenase (LDH) is a standard prognostic biomarker for stage IV melanoma patients. Often, LDH levels do not provide real-time information about the metastatic melanoma patients' disease status and treatment response. Therefore, there is a need to find reliable blood biomarkers for improved monitoring of metastatic melanoma patients who are undergoing checkpoint inhibitor immunotherapy (CII). The objective in this prospective pilot study was to discover circulating cell-free microRNA (cfmiR) signatures in the plasma that could assess melanoma patients' responses during CII. The cfmiRs were evaluated by the next-generation sequencing (NGS) HTG EdgeSeq microRNA (miR) Whole Transcriptome Assay (WTA; 2083 …

Fall Prevention In A Neurosurgery Clinic, Beth Ann Bremer, Brenda Senger, Jonathan Dennis Carlson, Teresa Bigand, Deborah Smith

Articles, Abstracts, and Reports

No abstract provided.

Discovery Of Driver Non-Coding Splice-Site-Creating Mutations In Cancer., Song Cao, Daniel Cui Zhou, Clara Oh, Reyka G Jayasinghe, Yanyan Zhao, Christopher J Yoon, Matthew A Wyczalkowski, Matthew H Bailey, Terrence Tsou, Qingsong Gao, Andrew Malone, Sheila Reynolds, Ilya Shmulevich, Michael C Wendl, Feng Chen, Li Ding

Articles, Abstracts, and Reports

Non-coding mutations can create splice sites, however the true extent of how such somatic non-coding mutations affect RNA splicing are largely unexplored. Here we use the MiSplice pipeline to analyze 783 cancer cases with WGS data and 9494 cases with WES data, discovering 562 non-coding mutations that lead to splicing alterations. Notably, most of these mutations create new exons. Introns associated with new exon creation are significantly larger than the genome-wide average intron size. We find that some mutation-induced splicing alterations are located in genes important in tumorigenesis (ATRX, BCOR, CDKN2B, MAP3K1, MAP3K4, MDM2, SMAD4, STK11, TP53 etc.), often leading …

Heroism And Hypocrisy: Seeing Our Reflection With 2020 Vision., Ira Byock

Articles, Abstracts, and Reports

No abstract provided.

An Atypical Case Of Necrotizing Fasciitis Secondary To Perforated Cecal Cancer., Laura S Heidelberg, Erica Pettke, Teresa E Wagner, Lauren Angotti

Articles, Abstracts, and Reports

Necrotizing fasciitis is an aggressive, life threatening soft tissue infection that requires high index of suspicion for diagnosis. Diagnosis is clinical with management including broad spectrum antibiotics and emergent operative debridement. The majority of cases are secondary to underlying medical processes, local tissue damage, abscess, or inciting procedure, with a paucity of data correlating causation with colon cancer. We describe the case of an 84-year-old man presenting with sepsis of unknown origin who was diagnosed with an atypical presentation of necrotizing fasciitis secondary to a perforated cecal malignancy. His case is unique in that a less virulent polymicrobial infection was …

Semiautomated Glasgow-Blatchford Bleeding Score Helps Direct Bed Placement For Patients With Upper Gastrointestinal Bleeding., Drew B Schembre, Robson E Ely, Janice M Connolly, Kunjali T Padhya, Rohit Sharda, John J Brandabur

Articles, Abstracts, and Reports

OBJECTIVE: The Glasgow-Blatchford Bleeding Score (GBS) was designed to identify patients with upper gastrointestinal bleeding (UGIB) who do not require hospitalisation. It may also help stratify patients unlikely to benefit from intensive care.

DESIGN: We reviewed patients assigned a GBS in the emergency room (ER) via a semiautomated calculator. Patients with a score ≤7 (low risk) were directed to an unmonitored bed (UMB), while those with a score of ≥8 (high risk) were considered for MB placement. Conformity with guidelines and subsequent transfers to MB were reviewed, along with transfusion requirement, rebleeding, length of stay, need for intervention and death. …

Cardio-Renal-Metabolic Care Models: Toward Achieving Effective Interdisciplinary Care., Janani Rangaswami, Katherine Tuttle, Muthiah Vaduganathan

Articles, Abstracts, and Reports

No abstract provided.

An Exploratory Pilot Study With Plasma Protein Signatures Associated With Response Of Patients With Depression To Antidepressant Treatment For 10 Weeks., Eun Young Kim, Hee-Sung Ahn, Min Young Lee, Jiyoung Yu, Jeonghun Yeom, Hwangkyo Jeong, Hophil Min, Hyun Jeong Lee, Kyunggon Kim, Yong Min Ahn

Articles, Abstracts, and Reports

Major depressive disorder (MDD) is a leading cause of global disability with a chronic and recurrent course. Recognition of biological markers that could predict and monitor response to drug treatment could personalize clinical decision-making, minimize unnecessary drug exposure, and achieve better outcomes. Four longitudinal plasma samples were collected from each of ten patients with MDD treated with antidepressants for 10 weeks. Plasma proteins were analyzed qualitatively and quantitatively with a nanoflow LC-MS/MS technique. Of 1153 proteins identified in the 40 longitudinal plasma samples, 37 proteins were significantly associated with response/time and clustered into six according to time and response by …

Targeting Breast Cancer Metabolism With A Novel Inhibitor Of Mitochondrial Atp Synthesis., Myoung Sook Kim, Ramkishore Gernapudi, Yessenia Cedeño Cedeño, Brian M Polster, Ramon Martinez, Paul Shapiro, Santosh Kesari, Elmar Nurmemmedov, Antonino Passaniti

Articles, Abstracts, and Reports

Inhibitors of mitochondrial respiration and ATP synthesis may promote the selective killing of respiration-competent cancer cells that are critical for tumor progression. We previously reported that CADD522, a small molecule inhibitor of the RUNX2 transcription factor, has potential for breast cancer treatment. In the current study, we show that CADD522 inhibits mitochondrial oxidative phosphorylation by decreasing the mitochondrial oxygen consumption rate (OCR) and ATP production in human breast cancer cells in a RUNX2-independent manner. The enzyme activity of mitochondrial ATP synthase was inhibited by CADD522 treatment. Importantly, results from cellular thermal shift assays that detect drug-induced protein stabilization revealed that …

Tp53 Abnormalities Correlate With Immune Infiltration And Associate With Response To Flotetuzumab Immunotherapy In Aml., Jayakumar Vadakekolathu, Catherine Lai, Stephen Reeder, Sarah E Church, Tressa Hood, Anbarasu Lourdusamy, Michael P Rettig, Ibrahim Aldoss, Anjali S Advani, John E Godwin, Matthew J Wieduwilt, Martha Arellano, John Muth, Tung On Yau, Farhad Ravandi, Kendra Sweet, Heidi Altmann, Gemma A Foulds, Friedrich Stölzel, Jan Moritz Middeke, Marilena Ciciarello, Antonio Curti, Peter J M Valk, Bob Löwenberg, Ivana Gojo, Martin Bornhäuser, John F Dipersio, Jan K Davidson-Moncada, Sergio Rutella

Articles, Abstracts, and Reports

Somatic TP53 mutations and 17p deletions with genomic loss of TP53 occur in 37% to 46% of acute myeloid leukemia (AML) with adverse-risk cytogenetics and correlate with primary induction failure, high risk of relapse, and dismal prognosis. Herein, we aimed to characterize the immune landscape of TP53-mutated AML and determine whether TP53 abnormalities identify a patient subgroup that may benefit from immunotherapy with flotetuzumab, an investigational CD123 × CD3 bispecific dual-affinity retargeting antibody (DART) molecule. The NanoString PanCancer IO360 assay was used to profile 64 diagnostic bone marrow (BM) samples from patients with TP53-mutated (n = 42) and TP53-wild-type (TP53-WT) …

Tp53 Abnormalities Correlate With Immune Infiltration And Associate With Response To Flotetuzumab Immunotherapy In Aml., Jayakumar Vadakekolathu, Catherine Lai, Stephen Reeder, Sarah E Church, Tressa Hood, Anbarasu Lourdusamy, Michael P Rettig, Ibrahim Aldoss, Anjali S Advani, John E Godwin, Matthew J Wieduwilt, Martha Arellano, John Muth, Tung On Yau, Farhad Ravandi, Kendra Sweet, Heidi Altmann, Gemma A Foulds, Friedrich Stölzel, Jan Moritz Middeke, Marilena Ciciarello, Antonio Curti, Peter J M Valk, Bob Löwenberg, Ivana Gojo, Martin Bornhäuser, John F Dipersio, Jan K Davidson-Moncada, Sergio Rutella

Articles, Abstracts, and Reports

Somatic TP53 mutations and 17p deletions with genomic loss of TP53 occur in 37% to 46% of acute myeloid leukemia (AML) with adverse-risk cytogenetics and correlate with primary induction failure, high risk of relapse, and dismal prognosis. Herein, we aimed to characterize the immune landscape of TP53-mutated AML and determine whether TP53 abnormalities identify a patient subgroup that may benefit from immunotherapy with flotetuzumab, an investigational CD123 × CD3 bispecific dual-affinity retargeting antibody (DART) molecule. The NanoString PanCancer IO360 assay was used to profile 64 diagnostic bone marrow (BM) samples from patients with TP53-mutated (n = 42) and TP53-wild-type (TP53-WT) …

Navigating The Paradox Of Scarcity: The Case For Radiologist-Driven Care., Daniel A Ortiz, Kevin M Cregan, Join Y Luh, Taj M Kattapuram

Articles, Abstracts, and Reports

No abstract provided.

Enhanced Detection Of Community-Acquired Pneumonia Pathogens With The Biofire® Pneumonia Filmarray® Panel., David Gilbert, James E Leggett, Lian Wang, Shirin Ferdosian, Gita D Gelfer, Michael L Johnston, Brent Footer, Kathryn W Hendrickson, Hiromichi Park, Emma White, John Heffner

Articles, Abstracts, and Reports

Background: Although most observational studies identify viral or bacterial pathogens in 50% or less of patients hospitalized with community-acquired pneumonia (CAP), we previously demonstrated that a multi-test bundle (MTB) detected a potential pathogen in 73% of patients. This study compares detection rates for potential pathogens with the MTB versus the Biofire® Pneumonia FilmArray® panel (BPFA) multiplex PCR platform and presents an approach for integrating BPFA results as a foundation for subsequent antibiotic stewardship (AS) activities.

Methods: Between January 2017 to March 2018, all patients admitted for CAP were enrolled. Patients were considered evaluable if all elements of the MTB and …

No Time To Die: The Consensus Immunoscore For Predicting Survival And Response To Chemotherapy Of Locally Advanced Colon Cancer Patients In A Multicenter International Study., Paolo A Ascierto, Francesco M Marincola, Bernard A Fox, Jérôme Galon

Articles, Abstracts, and Reports

The multicenter international Society for Immunotherapy of Cancer (SITC) study of the consensus Immunoscore demonstrated the prediction of survival and response to chemotherapy in 763 Stage III colon cancer (CC) patients. Similar Immunoscore groups were found in elderly patients, and densities of immune cells and intratumoral T-cell repertoire were not decreasing with age in the tumor microenvironment. In two independent cohorts, Immunoscore significantly predicted time to recurrence (TTR), disease-free survival (DFS), and overall survival (OS), including within high-risk (T4 or N2) and low-risk (T1-3, N1) patients. In stratified Cox multivariable analysis for TTR, DFS, and OS, Immunoscore's association to outcomes …

Feasibility Of Treating High Grade Gliomas In Children With Tumor-Treating Fields: A Case Series., John Crawford, Marlon G Saria, Girish Dhall, Ashley Margol, Santosh Kesari

Articles, Abstracts, and Reports

Children diagnosed with high grade gliomas (HGG) have dismal prognoses and treatment options remain limited. Tumor treating fields (TTFields) in combination with temozolomide (TMZ) is approved for the treatment of newly diagnosed and recurrent glioblastoma (GBM) in adult patients. However, clinical experience with TTFields in the pediatric HGG population is lacking. This retrospective review of four clinical cases was undertaken to evaluate the feasibility of treating children diagnosed with HGG off-label with TTFields. Patients were evaluated for device compliance, safety, and outcome. Treatment with TTFields was delivered via four transducer arrays placed on the shaved scalp, which were connected to …

Prediction Of Opioid-Induced Respiratory Depression On Inpatient Wards Using Continuous Capnography And Oximetry: An International Prospective, Observational Trial., Ashish K Khanna, Sergio D Bergese, Carla R Jungquist, Hiroshi Morimatsu, Shoichi Uezono, Simon Lee, Lian Kah Ti, Richard D Urman, Robert Mcintyre, Carlos Tornero, Albert Dahan, Leif Saager, Toby N Weingarten, Maria Wittmann, Dennis Auckley, Luca Brazzi, Morgan Le Guen, Roy Soto, Frank Schramm, Sabry Ayad, Roop Kaw, Paola Di Stefano, Daniel I Sessler, Alberto Uribe, Vanessa Moll, Susan J Dempsey, Wolfgang Buhre, Frank J Overdyk, Marianne Tanios, Eva Rivas, Miluska Mejia, Kavita Elliott, Assad Ali, Juan Fiorda-Diaz, Ruben Carrasco-Moyano, Ana Mavarez-Martinez, Alicia Gonzalez-Zacarias, Cory Roeth, January Kim, Alan Esparza-Gutierrez, Carleara Weiss, Chiahui Chen, Arata Taniguchi, Yuko Mihara, Makiko Ariyoshi, Ichiro Kondo, Kentaro Yamakawa, Yoshifumi Suga, Kohei Ikeda, Koji Takano, Yuuki Kuwabara, Nicole Carignan, Joyce Rankin, Katherine Egan, Lakeisha Waters, Ming Ann Sim, Lyn Li Lean, Qi En Lydia Liew, Lawrence Siu-Chun Law, James Gosnell, Salina Shrestha, Chisom Okponyia, Mohammed H Al-Musawi, María José Parra Gonzalez, Claudia Neumann, Vera Guttenthaler, Olja Männer, Achilles Delis, Anja Winkler, Bahareh Marchand, Frauke Schmal, Fuad Aleskerov, Mohammedumer Nagori, Muhammad Shafi, Gloria Mcphee, Cynthia Newman, Elizabeth Lopez, Sabrina Ma Har, Moumen Asbahi, Kim Nordstrom Mccaw, Maurice Theunissen, Valerie Smit-Fun

Articles, Abstracts, and Reports

BACKGROUND: Opioid-related adverse events are a serious problem in hospitalized patients. Little is known about patients who are likely to experience opioid-induced respiratory depression events on the general care floor and may benefit from improved monitoring and early intervention. The trial objective was to derive and validate a risk prediction tool for respiratory depression in patients receiving opioids, as detected by continuous pulse oximetry and capnography monitoring.

METHODS: PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) was a prospective, observational trial of blinded continuous capnography and oximetry conducted at 16 sites in the United States, Europe, and …

Untargeted Longitudinal Analysis Of A Wellness Cohort Identifies Markers Of Metastatic Cancer Years Prior To Diagnosis., Andrew T Magis, Noa Rappaport, Matthew P Conomos, Gilbert S Omenn, Jennifer C Lovejoy, Leroy Hood, Nathan D Price

Articles, Abstracts, and Reports

We analyzed 1196 proteins in longitudinal plasma samples from participants in a commercial wellness program, including samples collected pre-diagnosis from ten cancer patients and 69 controls. For three individuals ultimately diagnosed with metastatic breast, lung, or pancreatic cancer, CEACAM5 was a persistent longitudinal outlier as early as 26.5 months pre-diagnosis. CALCA, a biomarker for medullary thyroid cancer, was hypersecreted in metastatic pancreatic cancer at least 16.5 months pre-diagnosis. ERBB2 levels spiked in metastatic breast cancer between 10.0 and 4.0 months pre-diagnosis. Our results support the value of deep phenotyping seemingly healthy individuals in prospectively inferring disease transitions.

Full-Thickness Resection Device (Ftrd) For Treatment Of Upper Gastrointestinal Tract Lesions: The First International Experience., Kaveh Hajifathalian, Yervant Ichkhanian, Qais Dawod, Alexander Meining, Arthur Schmidt, Nicholas Glaser, Kia Vosoughi, David L Diehl, Ian S Grimm, Theodore James, Adam W Templeton, Jason B Samarasena, Nabil El Hage Chehade, John G Lee, Kenneth J Chang, Meir Mizrahi, Mohammed Barawi, Shayan Irani, Shai Friedland, Paul Korc, Abdul Aziz Aadam, Mohammad Al-Haddad, Thomas E Kowalski, George Smallfield, Gregory G Ginsberg, Norio Fukami, Michael Lajin, Nikhil A Kumta, Shou-Jiang Tang, Yehia Naga, Stuart K Amateau, Franklin Kasmin, Martin Goetz, Stefan Seewald, Vivek Kumbhari, Saowanee Ngamruengphong, Srihari Mahdev, Saurabh Mukewar, Kartik Sampath, David L Carr-Locke, Mouen A Khashab, Reem Z Sharaiha

Articles, Abstracts, and Reports

Background and study aims The Full-Thickness Resection Device (FTRD) provides a novel treatment option for lesions not amenable to conventional endoscopic resection techniques. There are limited data on the efficacy and safety of FTRD for resection of upper gastrointestinal tract (GIT) lesions. Patients and methods This was an international multicenter retrospective study, including patients who had an endoscopic resection of an upper GIT lesion using the FTRD between January 2017 and February 2019. Results Fifty-six patients from 13 centers were included. The most common lesions were mesenchymal neoplasms (n = 23, 41 %), adenomas (n = 7, 13 %), and …

Nivolumab In Advanced Hepatocellular Carcinoma: Safety Profile And Select Treatment-Related Adverse Events From The Checkmate 040 Study., Karen Julien, Hiu Tung Leung, Carmen Fuertes, Megumi Mori, Miao-Jen Wang, Jocelyn Teo, Lisa Weiss, Sara Hamilton, Holly Difebo, Yoon Jin Noh, Aralee Galway, Jane Koh, Edith Brutcher, Huanyu Zhao, Yun Shen, Marina Tschaika, Yue-Yun To

Articles, Abstracts, and Reports

BACKGROUND: CheckMate 040 assessed the efficacy and safety of nivolumab in patients with advanced hepatocellular carcinoma (HCC). Understanding the safety profile of nivolumab is needed to support the management of treatment-related adverse events (TRAEs). This analysis assessed the safety of nivolumab monotherapy in the phase I/II, open-label CheckMate 040 study.

MATERIALS AND METHODS: Select TRAEs (sTRAEs; TRAEs with potential immunologic etiology requiring more frequent monitoring) occurring between first dose and 30 days after last dose were analyzed in patients in the dose-escalation and -expansion phases. Time to onset (TTO), time to resolution (TTR), and recurrence of sTRAEs were assessed, and …

The Society For Immunotherapy Of Cancer (Sitc) Clinical Practice Guideline On Immunotherapy For The Treatment Of Acute Leukemia., Michael M Boyiadzis, Ivan Aksentijevich, Daniel A Arber, John Barrett, Renier J Brentjens, Jill Brufsky, Jorge Cortes, Marcos De Lima, Stephen J Forman, Ephraim J Fuchs, Linda J Fukas, Steven D Gore, Mark R Litzow, Jeffrey S Miller, John M Pagel, Edmund K Waller, Martin S Tallman

Articles, Abstracts, and Reports

Acute leukemia is a constellation of rapidly progressing diseases that affect a wide range of patients regardless of age or gender. Traditional treatment options for patients with acute leukemia include chemotherapy and hematopoietic cell transplantation. The advent of cancer immunotherapy has had a significant impact on acute leukemia treatment. Novel immunotherapeutic agents including antibody-drug conjugates, bispecific T cell engagers, and chimeric antigen receptor T cell therapies have efficacy and have recently been approved by the US Food and Drug Administration (FDA) for the treatment of patients with acute leukemia. The Society for Immunotherapy of Cancer (SITC) convened a panel of …

Society For Immunotherapy Of Cancer Clinical And Biomarkers Data Sharing Resource Document: Volume I-Conceptual Challenges., Sergio Rutella, Michael A Cannarile, Sacha Gnjatic, Bruno Gomes, Justin Guinney, Vaios Karanikas, Mohan Karkada, John M Kirkwood, Beatrix Kotlan, Giuseppe V Masucci, Els Meeusen, Anne Monette, Aung Naing, Vésteinn Thorsson, Nicholas Tschernia, Ena Wang, Daniel K Wells, Timothy L Wyant, Alessandra Cesano

Articles, Abstracts, and Reports

The sharing of clinical trial data and biomarker data sets among the scientific community, whether the data originates from pharmaceutical companies or academic institutions, is of critical importance to enable the development of new and improved cancer immunotherapy modalities. Through data sharing, a better understanding of current therapies in terms of their efficacy, safety and biomarker data profiles can be achieved. However, the sharing of these data sets involves a number of stakeholder groups including patients, researchers, private industry, scientific journals and professional societies. Each of these stakeholder groups has differing interests in the use and sharing of clinical trial …

Classifying Complications: Assessing Adult Spinal Deformity 2-Year Surgical Outcomes., Eric O Klineberg, Peter G Passias, Gregory W Poorman, Cyrus M Jalai, Abiola Atanda, Nancy Worley, Samantha Horn, Daniel M Sciubba, D Kojo Hamilton, Douglas C Burton, Munish Chandra Gupta, Justin S Smith, Alexandra Soroceanu, Robert A Hart, Brian Neuman, Christopher P Ames, Frank J Schwab, Virginie Lafage

Articles, Abstracts, and Reports

STUDY DESIGN: Retrospective review of prospective database.

OBJECTIVE: Complication rates for adult spinal deformity (ASD) surgery vary widely because there is no accepted system for categorization. Our objective was to identify the impact of complication occurrence, minor-major complication, and Clavien-Dindo complication classification (Cc) on clinical variables and patient-reported outcomes.

METHODS: Complications in surgical ASD patients with complete baseline and 2-year data were considered intraoperatively, perioperatively (<6 >weeks), and postoperatively (>6 weeks). Primary outcome measures were complication timing and severity according to 3 scales: complication presence (yes/no), minor-major, and Cc score. Secondary outcomes were surgical outcomes (estimated blood loss [EBL], …

Lenvatinib Plus Pembrolizumab In Patients With Advanced Endometrial Cancer., Vicky Makker, Matthew H Taylor, Carol Aghajanian, Ana Oaknin, James Mier, Allen L Cohn, Margarita Romeo, Raquel Bratos, Marcia S Brose, Christopher Disimone, Mark Messing, Daniel E Stepan, Corina E Dutcus, Jane Wu, Emmett V Schmidt, Robert Orlowski, Pallavi Sachdev, Robert Shumaker, Antonio Casado Herraez

Articles, Abstracts, and Reports

PURPOSE: Patients with advanced endometrial carcinoma have limited treatment options. We report final primary efficacy analysis results for a patient cohort with advanced endometrial carcinoma receiving lenvatinib plus pembrolizumab in an ongoing phase Ib/II study of selected solid tumors.

METHODS: Patients took lenvatinib 20 mg once daily orally plus pembrolizumab 200 mg intravenously once every 3 weeks, in 3-week cycles. The primary end point was objective response rate (ORR) at 24 weeks (ORR

RESULTS: At data cutoff, 108 patients with previously treated endometrial carcinoma were enrolled, with a median follow-up of 18.7 months. The ORR

CONCLUSION: Lenvatinib plus pembrolizumab showed …

Functional Outcome Of Traumatic Spinopelvic Instabilities Treated With Lumbopelvic Fixation., Emre Yilmaz, Martin F Hoffmann, Alexander Von Glinski, Christiane Kruppa, Uwe Hamsen, Cameron K Schmidt, Ahmet Oernek, Matthias Koenigshausen, Marcel Dudda, Thomas A Schildhauer

Articles, Abstracts, and Reports

The aim of this study was to assess the functional outcome after lumbopelvic fixation (LPF) using the SMFA (short musculoskeletal functional assessment) score and discuss the results in the context of the existing literature. The last consecutive 50 patients who underwent a LPF from January 1st 2011 to December 31st 2014 were identified and administered the SMFA-questionnaire. Inclusion criteria were: (1) patient underwent LPF at our institution, (2) complete medical records, (3) minimum follow-up of 12 months. Out of the 50 recipients, 22 questionnaires were returned. Five questionnaires were incomplete and therefore seventeen were included for analysis. The mean age …