tbuckley/cabot-search huggingface dataset:
A randomized phase III study of neoadjuvant chemotherapy with docetaxel(D), oxaliplatin(O), and S-1(S) (DOS) followed by surgery and adjuvant S-1 vs. surgery and adjuvant S-1 for resectable advanced gastric cancer (PRODIGY).
Authors: Yoon-Koo Kang, Jeong Hwan Yook, Min-Hee Ryu, Jong Seok Lee, Youngkyu Park, Ik-Joo Chung, Minkyu Jung, Young Woo Kim, Mi-Jung Kim, Sang Cheul Oh, Samyong Kim, Jong Gwang Kim, Hong-Suk Song, Seung Wan Ryu, Sang Young Roh, Myeong-Cherl Kook, Kyoo Jung Shim, Jeehyun Lee, Gyunji Kim, Sung Hoon Noh
Journal: Journal of Clinical Oncology (2015)

TPS4136 Background: Although adjuvant chemotherapy with S-1 is now considered a standard after D2 resection in stage II or III locally advanced gastric cancer (LAGC) in Asia, many patients still experience recurrence of disease. Addition of neoadjuvant chemotherapy can be one method to further improve outcomes in LAGC. A previous phase II study of neoadjuvant DOS triplet regimen followed by surgery and adjuvant S-1 in LAGC demonstrated promising outcome with 98% of R0 resection rate, 90% of 2-year disease-free survival and manageable toxicity (Park et al, Cancer Chemother Pharmacol. 2013;72:815). On this background, a phase III randomized study has been initiated. Methods: Since Jan 2012, patients with newly diagnosed resectable gastric or gastroesophageal junction(GEJ) adenocarcinoma at clinical stage T2,3/N(+) or T4/N(any) by AJCC 7th edition have been recruited. Key exclusion criteria are Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2, history of any malignancy other than gastric or GEJ cancer, or patients who have difficulties in oral ingestion/digestion/absorption. Patients are randomized 1:1 in open label to neoadjuvant DOS chemotherapy, surgery and then adjuvant chemotherapy (CSC) arm vs surgery and chemotherapy (SC) arm. Neoadjuvant DOS regimen consists of D 50mg/m2 i.v. on day 1, O 100mg/m2 i.v. on day 1 and S 40mg/m2 twice orally on days 1-14 every 3 weeks for 3 cycles. Surgical method is D2 dissection. Adjuvant chemotherapy is S 40mg/m2 twice orally on days 1-28 every 6 weeks for 8 cycles. Primary endpoint is 3 year progression free survival (PFS). Secondary endpoints include overall survival (OS), pathologic stage, R0 resection rate and safety profiles compared in two arms. With power of 80% and two-sided α- level of 5%, 244 events are required to detect 70% of 3 year PFS in CSC arm compared to 60% in SC arm (HR = 0.698). Considering 10% of drop-out rate, target enrollment is 530 subjects from 17 sites in Korea until July 2016. The first Independent Data Monitoring Committee meeting was held in October 2014 and the committee recommended continuing the study as planned. NCT01515748 Clinical trial information: NCT01515748.
Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
Authors: Marc S. Sabatine, Robert P. Giugliano, Anthony C. Keech, Narimon Honarpour, Stephen D. Wiviott, Sabina A. Murphy, Julia F. Kuder, Huei Wang, Thomas Liu, Scott M. Wasserman, Peter S. Sever, Terje R. Pedersen
Journal: New England Journal of Medicine (2017)

Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain.
PROGNOSTIC UTILITY OF CORONARY COMPUTED TOMOGRAPHIC ANGIOGRAPHY BEYOND CORONARY ARTERY CALCIUM SCORE IN DIABETIC PATIENTS WITH NO SYMPTOMS OR NON-TYPICAL CHEST PAIN: THE CONFIRM REGISTRY
Authors: Mahn Won Park, Ji Hyun Lee, Briain O. Hartaigh, Asim Rizvi, Donghee Han, Hadi Mirhedayati Roudsari, Subhi Al'Aref, Khalil Anchouche, Ashley Beecy, Yao Lu, Heidi Gransar, Jessica Pena, James Min, Fay Lin
Journal: Journal of the American College of Cardiology (2017)
A Prospective, Randomized Study of Cyclosporine or Corticosteroids As an Adjunct to Plasma Exchange for the Treatment of Thrombotic Thrombocytopenic Purpura
Authors: Spero Cataland, Shangbin Yang, Camila Masias Castanon, Michael McGookey, Haiwa Wu, Susan Geyer, James N. George, Lauren Jay, Haifeng M Wu
Journal: Blood (2016)
COMPARISON OF IN-HOSPITAL OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN MEN AND WOMEN
Authors: Sahil Agrawal, Lohit Garg, Tanush Gupta, Aakash Garg, Abdullah Quddus, Pedro Villablanca, Nirmanmoh Bhatia, Divyanshu Mohananey, John Kostis, Jamshid Shirani
Journal: Journal of the American College of Cardiology (2017)
Use of chemotherapy with IMRT reirradiation: MDACC experience.
Authors: Mark A. Edson, Adam S. Garden, Vinita Takiar, Gary Brandon Gunn, Clifton David Fuller, David Ira Rosenthal, Merrill S. Kies, Jack Phan
Journal: Journal of Clinical Oncology (2015)

6065 Background: The benefits of adding chemotherapy to radiation, combined with the ability to spare more normal tissue with conformal radiation techniques have led to an increased interest in reirradition of head and neck cancers (HNC). However, similar to the use of chemotherapy in unirradiated patients with HNC, the use and delivery of systemic therapy in the reirradiation setting is not standardized. We evaluated our 15-year institutional experience using intensity modulated radiation therapy (IMRT) for reirradiation of recurrent HNC, focusing on chemotherapy-related outcomes. Methods: We retrospectively reviewed the records of 206 patients treated between 1999-2014 with IMRT reirradiation to definitive doses ( > 60 Gy). The Kaplan-Meier method was used to estimate locoregional control (LRC), progression-free survival (PFS), and overall survival (OS). The log-rank test was used to compare variables of interest. Results: Median follow-up was 25 months. Of the 134 patients (65%) who received chemotherapy (CT), 124 (93%) received concurrent chemotherapy (CCT), and 50 (37%) received induction chemotherapy (iCT). The use of CT was associated with worse OS (5Y 35% vs 49%; P = 0.04), but not LRC (N.S.) or PFS (N.S.). The use of CCT was associated with improved LRC (5Y OS 55% vs 69%; P = 0.05) but not PFS (N.S.) or OS (N.S.). Sub-group analysis of patients who received CCT showed that the use of platinum-containing doublets (n = 24) was associated with improved LRC (5Y 82% vs 57%; P < 0.05). The use of iCT did not impact clinical outcomes. However, patients who experienced a radiographic complete response after iCT had improved 5-year PFS (5Y 43% vs 9%; P < 0.01) and OS (5Y 44% vs 18%; P < 0.01) but not LRC (N.S.). CT use was associated with increased grade 3 toxicity (5Y 59% vs 345; P = 0.02), and for those receiving concurrent chemotherapy platinum-based CCT was associated with increased grade 4-5 toxicity (28% vs 8%; P < 0.05). Prior CT use, and type or number of cycles did not affect clinical outcome or toxicity after reirradiation. Conclusions: Chemotherapy given concurrently with IMRT-based reirradiation for HNC appears to improve LRC but not OS. The potential for increased toxicity associated with combined modality treatment warrants careful patient selection.
AORTIC VALVE CALCIFICATION PREDICTS PARAVALVULAR AORTIC REGURGITATION AFTER SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT
Authors: Ahmad Agha, Nisreen Ali, Shermeen Memon, Lara Bakhos, Khaled Dajani, Mark Rabbat, Ferdinand Leya, Mushabbar Syed
Journal: Journal of the American College of Cardiology (2017)
PREDICTORS OF EARLY DISCHARGE HOME AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION
Authors: Sagar Mallikethi-Reddy, Naveen Trehan, Shanker Kundumadam, Aditya Sood, Rajeev Sudhakar, Melvyn Rubenfire, Mazhar Khan, Luis Afonso, Cindy Grines
Journal: Journal of the American College of Cardiology (2017)
Symptom assessment in small cell lung cancer (SCLC) in a randomized trial: A psychometric analysis of Patient Symptom Assessment in Lung Cancer (PSALC)
Authors: L. Chen, L. Antras, M. Duh, M. Neary, B. Dharan, M. E. O’Brien
Journal: Journal of Clinical Oncology (2007)

18101 Background: Lung symptoms may be very burdensome for patients (pts) with SCLC. PSALC is a symptom scale that was developed for use in pts with SCLC for assessment of 9 symptoms (shortness of breath, cough, chest pain, hemoptysis, appetite loss, sleep interference, hoarseness, fatigue, interference with daily activities) scored from 1 (not at all) to 4 (very much), but has not been formally validated. The objective of this study is to evaluate the validity of the PSALC through a psychometric analysis of trial data. Methods: Data were analyzed from a randomized, open-label, multicenter trial with 141 pts with SCLC receiving either oral topotecan with best supportive care (BSC) or BSC alone. PSALC and EQ-5D were administered to pts at baseline and at 3-week intervals at subsequent visits. Endpoints for psychometric analysis included statistics for internal consistency, construct validity, reliability, and responsiveness to change in clinical status. Results: Factor analysis (n=131) indicated that there was only one factor, therefore PSALC total score (PSALC-TS) could be used for psychometric analysis. Weighted Cronbach’s alpha from all visits was 0.78. Construct validity was supported by association with established measures: higher baseline PSALC-TS (worse symptoms) was associated with worse ECOG (12.31, 16.37, 17.49 for ECOG score=0, 1, 2, respectively, p=0.0002); baseline PSALC-TS was significantly correlated with EQ-5D utility index (Pearson correlation coefficient [CC] =-0.493, p&lt;0.0001, n=125) and EQ-5D VAS score (Pearson CC=-0.495, p&lt;0.0001, n=122). Reliability was supported by intraclass CC of 0.68 for PSALC-TS evaluated before any change in clinical status, and concordance CC of 0.65, calculated using PSALC-TS at baseline and before first visit. PSALC-TS was responsive to change in clinical status from baseline to tumor response (responsiveness statistic (RS) =-0.99) and to tumor progression (RS=0.94). Conclusions: Retrospective analysis of trial data suggests that PSALC is a reliable, valid, and responsive scale for measuring SCLC symptoms. If feasible in SCLC population, a prospective validation study could be used to further evaluate the validity of this symptom scale. No significant financial relationships to disclose.
EFICACY AND SAFETY OF FLECAINIDE TO REDUCE EXERCISE-INDUCED VENTRICULAR ARRHYTHMIAS AND THE ARRHYTHMIC WINDOW IN PATIENTS WITH CATECHOLAMINERGIC POLYMORPHIC VENTRICULAR TACHYCARDIA
Authors: María del Val Groba Marco, Fernando Wangüemert Pérez, Julio Salvador Hernandez Afonso, Eduardo Caballero Dorta, Luis Alvarez Acosta, Oscar Campuzano Larrea, Guillermo Javier Pérez, Josep Brugada, Ramon Brugada-Terradellas
Journal: Journal of the American College of Cardiology (2017)
A Phase II Trial of Bendamustine, Carboplatin and Dexamethasone (BCD) for Refractory or Relapsed Peripheral T-Cell Lymphoma (BENCART): A Consortium for Improving Survival of Lymphoma (CISL) Trial
Authors: Byeong-Bae Park, Won Seog Kim, Cheolwon Suh, Dok Hyun Yoon, Jong-Ho Won, Deok-Hwan Yang, Young-Rok Do, Won Sik Lee, Jeong-A Kim, Min Kyoung Kim, Jae-Cheol Jo, Youngil Koh
Journal: Blood (2016)
Phase II trial of goserelin and exemestane combination therapy in premenopausal women with locally advanced or metastatic breast cancer.
Authors: Jiayu Wang, Binghe Xu, Peng Yuan, Fei Ma, Qing LI, Pin Zhang, Yang Luo, Ruigang Cai, Ying Fan, Qiao Li
Journal: Journal of Clinical Oncology (2015)

e11525 Background: A promising option as the treatment of choice for premenopausal patients with locally advanced or metastatic breast cancer (MBC) could be the combination of a luteinising hormone-releasing hormone analog and an aromatase inhibitor. However, no prospective studies on the efficacy of goserelin with exemestane in locally advanced or MBC premenopausal breast cancer patients have been reported. Methods: We present the phase II trial of goserelin plus exemestane in a total of 44 premenopausal women with locally advanced or MBC. All patients received a subcutaneous injection of 3.6 mg of goserelin every 4 weeks along with exemestane 25 mg daily. The primary end point was progression-free survival (PFS). The second end point included overall survival (OS), objective rate of response (RR), duration of response (DOR), and clinical benefit rate (CBR) based on complete response (CR), partial response (PR), or stable disease (SD) for ≥ 6 months. Results: The median PFS was 13 months (range: 2–42 months). The median DOR was 8 months (range: 2–40 months). Two patients achieved CR (4.5%), and 15 patients experienced PR (34.1%). Fifteen patients (34.1%) had SD ≥ 6 months. The ORR was 38.6%, and the CBR was 65.9%. Primary progressive disease occurred in 15 patients (34.1%). Five patients (11.4%) died during the study period. Cause of few patients had died, the median OS have not be reached. Drug therapy was well tolerated,The most frequent grade-3 adverse events were arthralgia (18.2%), skin rash (6.8%), and myalgia (4.5%). No participants withdrew from the study due to drug toxicity. Conclusions: This study suggested that goserelin and exemestane might be an highly efficacious and well-tolerated regimen in premenopausal women with hormone-responsive locally advanced and MBC. Clinical trial information: ChiCTR-ONC-13003946.
Long-term stability of RNA from FFPE brian tissue post-sectioning on slides.
Authors: Donald James Witt, Steven M. Anderson, Briana King, Christina Borrego, Marcia Eisenberg, Li Cai
Journal: Journal of Clinical Oncology (2013)

e22142 Background: Analysis of nucleic acids (NA) from formalin fixed paraffin embedded (FFPE) tissue can provide detailed information about gene sequence mutational status, which may be important for oncology treatment decisions. FFPE specimens also have utility for retrospective analyses. Potential degradation of NA during formalin fixation, paraffin embedding processes and possible continued deterioration during subsequent storage may diminish utility of FFPE tissue for these purposes. Using real-time PCR, this study investigated the functional stability of RNA from brain FFPE tissue sections on slides over an extended time period after sectioning. Methods: Brain biopsy specimens obtained from glioblastoma patients with informed consent were used to prepare blocks with standard formalin fixation and paraffin embedding techniques. Slides were made from the FFPE blocks and stored at room temperature until testing. RNA was extracted from sequential slides within one week of sectioning for a zero time and then at 4, 8 and 12 months. Reverse transcription PCR was performed, and real-time PCR was analyzed on the ABI7900 to detect EGFRvIII mutation and cABL gene. RNA Integrity Analysis was performed with an Agilent Bioanalyzer. Results: Consistent qualitative results were obtained with EGFRvIII mutant positive specimens (n =10) and wild type (wt) specimens (n =10) from slides stored up to twelve months at room temperature compared to the initial testing (95% agreement). One wt specimen showed negative results for the first three time points but a low positive result at 12 months, possibly due to tumor content change in the different sections of the FFPE block. Ct values for EGFR (wt and mutant) and cABL genes did not increase during the storage period. RNA integrity number (RIN) indicated the degradation of RNA during FFPE processing, although no further significant degradation occurred during the course of the experiment. Conclusions: The results of this study indicated that although the RNA was impacted by the tissue preparation, fixation, and processing steps, for the brain FFPE slide specimens, target genes with amplicon size up to 124bp could be detected with minimum degradation for up to 12 months when slides were stored at room temperature.
Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients
Authors: Michael J. Reardon, Nicolas M. Van Mieghem, Jeffrey J. Popma, Neal S. Kleiman, Lars Søndergaard, Mubashir Mumtaz, David H. Adams, G. Michael Deeb, Brijeshwar Maini, Hemal Gada, Stanley Chetcuti, Thomas Gleason, John Heiser, Rüdiger Lange, William Merhi, Jae K. Oh, Peter S. Olsen, Nicolo Piazza, Mathew Williams, Stephan Windecker, Steven J. Yakubov, Eberhard Grube, Raj Makkar, Joon S. Lee, John Conte, Eric Vang, Hang Nguyen, Yanping Chang, Andrew S. Mugglin, Patrick W.J.C. Serruys, Arie P. Kappetein
Journal: New England Journal of Medicine (2017)

Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk.We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement.A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group.TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).
YOUNGER AGE, POSITIVE FAMILY HISTORY AND REVERSE CURVE MORPHOLOGY PREDICT INFORMATIVE RESULTS FROM GENE PANEL ANALYSIS FOR HYPERTROPHIC CARDIOMYOPATHY (HCM)
Authors: Akriti Naraen, Victoria McKay, Wern Yew Ding, Debar Rasoul, Matthew Shaw, Archana Rao, David Wright, Timothy Fairbairn, John Somauroo, Rod Stables, Simon Modi, Saagar Mahida, Derick Todd, Robert Cooper
Journal: Journal of the American College of Cardiology (2017)
Gold nanoparticles, radiations and the immune system: Current insights into the physical mechanisms and the biological interactions of this new alliance towards cancer therapy
Authors: Nikolaos M. Dimitriou, George Tsekenis, Evangelos C. Balanikas, Athanasia Pavlopoulou, Melina Mitsiogianni, Theodora Mantso, George Pashos, Andreas G. Boudouvis, Ioannis N. Lykakis, Georgios Tsigaridas, Mihalis I. Panayiotidis, Vassilios Yannopapas, Alexandros G. Georgakilas
Journal: Pharmacology & Therapeutics (2017)
Results of a Phase II Trial Testing Interferon Alpha 2b and Cytarabine in Children with Chronic Myelogenous Leukemia.
Authors: Frédéric Millot, Joelle Guilhot, Brigitte Nelken, Jean-Pierre Lamagnère, Thierry Leblanc, Guy Leverger, Anne Notz, Dominique Plantaz, Frédéric Bernard, Pierre Bordigoni, Karima Yacouben, Catherine Behar, Antoine Thyss, Cornu Guy, Sylvain Duchène, François Guilhot
Journal: Blood (2004)
A RETROSPECTIVE DESCRIPTIVE ANALYSIS OF PCI PATIENTS BY INDICATION FOR TREATMENT, COMORBIDITIES, AND LIPID THERAPY USING REAL-WORLD, LINKED NCDR REGISTRY AND PHARMACY CLAIMS DATA
Authors: Keri L. Monda, John Acquavella, David Smith, Patrick Stewart, Thomas Maddox, Steven Bradley, Gregory Hess
Journal: Journal of the American College of Cardiology (2017)
A phase I safety and PK study of the novel vascular targeting agent (VTA), Exherin, in patients with refractory solid tumors stratified according to N-cadherin expression
Authors: D. J. Jonker, L. Avruch, D. J. Stewart, R. Goel, G. Goss, S. Dent, M. N. Reaume, T. A. Spencer, W. P. Peters
Journal: Journal of Clinical Oncology (2004)

3078 Background: Exherin is a novel angiolytic VTA which specifically targets existing tumor vessels. Exherin is a cyclic pentapeptide (CHAVC) which competitively inhibits N-cadherin mediated endothelial cell, pericyte and tumor cell binding. Exherin caused highly-specific tumor angiolysis in multiple murine and xenograft tumor models. We report here preliminary data from the first human safety and pharmacokinetics (PK) study on Exherin. Methods: 13 patients (pts) with refractory solid tumors received 24 cycles of Exherin by bolus injection at 4 dose levels from 50 to 225 mg/m2to define the toxicities (AE) and maximum tolerated dose (MTD) for patients with N-cadherin positive or negative tumors. Dynamic MRI was performed in cohorts 3 to 5 where feasible to assess for changes in tumor perfusion and intra-tumoral hemorrhage. Results: Dose escalation has proceeded without reaching MTD. AE > grade 2 considered possibly drug related include tumor pain (n=3) and 1 coronary syndrome in a patient with a previously unknown 99% LCX occlusion. Low grade (≤2) considered probably drug related included fatigue (n=4), hot flushes (n=4), and dysgeusia (n=3). PK data show that the AUC and Cmaxincrease linearly with dose and that the mean terminal t1/2is 84 minutes. Conclusions: Exherin has been well tolerated at the doses given. MTD has not been reached. Further dosage escalation, molecular target expression measurement by immunohistochemistry, and MRI data will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Adherex Technologies, Inc. Adherex Technologies Ltd. Adherex Technologies, Inc. Adherex Technologies Ltd.