tbuckley/cabot-search huggingface dataset:
Randomized study of docetaxel (D) and dexamethasone (DX) with low or high dose estramustine (E) for patients with advanced hormone-refractory prostate cancer (HRPC)
Authors: T. Nelius, T. Klatte, F. Reiher, S. Filleur, R. Yap, E. P. Allhoff
Journal: Journal of Clinical Oncology (2006)

4653 Background: D-based chemotherapy is a burgeoning option for men with advanced HRPC. Alone or in combination with E, D has been shown to improve median survival. In this study we tested the combination of D with two different doses of E in patients (pts) with HRPC to improve response rates and to lower side effects. Methods: 72 metastatic HRPC pts were randomly assigned to receive D (70 mg/m 2 IV, d2, q3w) and E (3 × 280 mg/d PO starting 1 day prior to D, for 5 consecutive days) for arm A or E (3 x 140 mg/d PO starting 1 day prior to D, for 3 consecutive days) for arm B. Premedication with oral DX at a total daily dose of 16 mg, in divided doses two times a day was administered in arm A on day 1 to 5 and in arm B on day 1 to 3. Initially, 6 cycles were administered and repeated after significant PSA rise. Pts were monitored for PSA response, time to progression (TTP), survival and toxicity. Results: PSA declines of ≥75%, ≥50% and ≤50% were 36.8%, 55.3% and 44.7% in arm A and 38.2%, 67.6% and 32.4% in arm B, respectively (P = .442). TTP in Arm A and Arm B were 11 months (95% CI, 7–14) versus 14 months (95% CI, 8–19), P = .6911) and overall survival 21 months (95% CI, 6–35) versus 22 months (95% CI, 18–27), respectively, (P = .4149). The primary treatment-related side effects observed in arm A and arm B were granulocytopenia (34% and 29%, P = .663) and thrombotic complications caused by E (four pts (11%) and one pt (3%), respectively, P = .206). Associated baseline factors with overall survival in univariate analysis were ECOG performance status (P &lt; .001), hemoglobin level (P &lt; .001), bone pain (P &lt; .001), and PSA (P &lt; .097) and in multivariate analysis ECOG performance status (95% CI, 2.9–13.9) and bone pain (95% CI, 3.2–20.1), (P &lt; .001). Conclusions: In this randomized phase II study the combination of D and E had substantial activity in HRPC. We did not find a statistically significant difference of higher dose of E in combination with D compared to a lower dose of E and D regarding PSA response, TTP and survival. However, there was a tendency of higher toxicity in the high dose E group. These treatment-related toxicities were mainly hematologic and manageable. The results of this study support the assertion that estramustine is not necessary in docetaxel-based treatment regimens. No significant financial relationships to disclose.
Abstract 16204: Longitudinal Data Analysis of Echocardiographic Allograft Valve Function
Authors: Mostafa M Mokhles, Jeevanantham Rajeswaran, Gerard Borsboom, Jolien Roos-Hesselink, Ewout Steyerberg, Ad J Bogers, Eugene H Blackstone, Johanna J Takkenberg
Journal: Circulation (2012)

Obective: The assessment of allograft valve performance is complicated by several factors (e.g. unequal number of records per patient, different time intervals between sequential measurements, corr...
Tumor Growth Rate as a Validated Early Radiological Biomarker Able to Reflect Treatment-Induced Changes in Neuroendocrine Tumors: The GREPONET-2 Study
Authors: Angela Lamarca, Maxime Ronot, Salma Moalla, Joakim Crona, Marta Opalinska, Carlos Lopez Lopez, Daniela Pezzutti, Pavan Najran, Luciana Carvhalo, Regis Otaviano Franca Bezerra, Philip Borg, Naik Vietti Violi, Hector Vidal Trueba, Louis de Mestier, Niklaus Scaefer, Eric Baudin, Anders Sundin, Frederico Costa, Marianne Pavel, Clarisse Dromain
Journal: Clinical Cancer Research (2019)

Tumor growth rate (TGR) represents the percentage change in tumor volume per month (%/m). Previous results from the GREPONET study showed that TGR measured after 3 months (TGR3m) of starting systemic treatment (ST) or watch and wait (WW) was an early biomarker predicting progression-free survival (PFS) in neuroendocrine tumors (NET).Patients from 7 centers with advanced grade (G) 1/2 NETs from the pancreas (P)/small bowel (SB) initiating ST/WW were eligible. Computed tomography (CT)/MRI performed at prebaseline, baseline, and 3(±1) months of study entry were retrospectively reviewed. Aim-1: explore treatment-induced changes in TGR (ΔTGR3m-BL; paired T test), and Aim-2: validate TGR3m (<0.8%/m vs. ≥0.8%/m) as an early biomarker in an independent cohort (Kaplan-Meier/Cox regression).Of 785 patients screened, 127 were eligible. Mean (SD) TGR0 and TGR3m were 5.4%/m (14.9) and -1.4%/m (11.8), respectively. Mean (SD) ΔTGR3m-BL paired-difference was -6.8%/m (19.3; P < 0.001). Most marked ΔTGR3m-BL [mean (SD)] were identified with targeted therapies [-11.3%/m (4.7); P = 0.0237] and chemotherapy [-7.9%/m (3.4); P = 0.0261]. Multivariable analysis confirmed the absence of previous treatment (OR = 4.65; 95% CI, 1.31-16.52; P = 0.018) and low TGR3m (continuous variable; OR 1.09; 95% CI, 1.01-1.19; P = 0.042) to be independent predictors of radiologic objective response. When the multivariable survival analysis for PFS (Cox regression) was adjusted to grade (P = 0.004) and stage (P = 0.017), TGR3m ≥ 0.8 (vs. <0.8) maintained its significance as a prognostic factor (P < 0.001), whereas TGR0 and ΔTGR3m-BL did not. TGR3m ≥ 0.8%/m was confirmed as an independent prognostic factor for PFS [external validation; Aim-2; multivariable HR 2.21 (95% CI, 1.21-3.70; P = 0.003)].TGR has a role as a biomarker for monitoring response to therapy for early identification of treatment-induced changes and for early prediction of PFS and radiologic objective response.
Meta-analysis of pemetrexed (P) plus gemcitabine (G) in first-line, advanced (adv) non-small cell lung cancer (NSCLC)
Authors: Z. Ye, J. A. Treat
Journal: Journal of Clinical Oncology (2007)

18015 Background: Clinical trials with varying schedules and doses of P and G have demonstrated anti-tumor activity in NSCLC. Methods: This report summarizes best response and toxicity data of 4 clinical trials using PG regimens in 1st-line, adv NSCLC. Pt populations were similar and included measurable or evaluable Stage IIIB-IV disease. Results: *Excludes 1 pt considered inevaluble for neutropenia **One pt died due to thrombocytopenia. Conclusion: Based on the results of these 4 trials, PG was efficacious and well tolerated as 1st-line therapy for pts with adv NSCLC. A low incidence of alopecia and Gr 4 thrombocytopenia are noted. [Table: see text] [Table: see text]
Sepsis alters the transcriptional and translational landscape of human and murine platelets
Authors: Elizabeth A. Middleton, Jesse W. Rowley, Robert A. Campbell, Colin K. Grissom, Samuel M. Brown, Sarah J. Beesley, Hansjörg Schwertz, Yasuhiro Kosaka, Bhanu K. Manne, Krystin Krauel, Neal D. Tolley, Alicia S. Eustes, Li Guo, Robert Paine, Estelle S. Harris, Guy A. Zimmerman, Andrew S. Weyrich, Matthew T. Rondina
Journal: Blood (2019)
Randomized phase II trial of the biweekly schedule of adjuvant chemotherapy with carboplatin plus paclitaxel versus carboplatin plus gemcitabine in patients with non-small cell lung cancer (NSCLC)
Authors: K. Sugio, A. Nagashima, R. Nakanishi, A. Uchiyama, M. Inoue, T. Osaki, T. Yoshimatsu, M. Takenoyama, T. Hanagiri, K. Yasumoto
Journal: Journal of Clinical Oncology (2009)

7562 Background: Carboplatin plus paclitaxel and carboplatin plus gemcitabine chemotherapy have shown a good response and an improved survival against advanced NSCLC. This phase II trial assessed the feasibility, safety and efficacy of a bi-weekly schedule for adjuvant chemotherapy. Methods: Patients with completely resected stage IB-IIIB NSCLC were randomized to either carboplatin (AUC3) plus paclitaxel (90mg/m2) (arm A) or carboplatin (AUC3) plus gemcitabine (1000 mg/m2) (arm B), q2w for 8 cycles within 8 weeks after surgery. The main inclusion criteria were no prior chemotherapy or radiotherapy, ECOG PS 0–1, an age of less than 80 years, and an adequate organ function. The primary endpoint was compliance, and secondary endpoints were the disease free survival (DFS) and toxicity. The patients were stratified by gender, histology (adenoca vs. non-adenoca) and disease stage. Results: Between 07/2005 and 06/2007, 76 patients were randomized and 75 were eligible (including 48 males, 27 females; median age 66 years) for intent-to-treat analysis (39 in arm A, 36 in arm B). The histologic types included adenocarcinoma (n=51), squamous cell carcinoma (n=18), large cell carcinoma (n=5), and adenosquamous cell carcinoma (n=1). The pathological stages were IB/IIA/IIB/IIIA/IIIB: 22/10/13/29/1. Twenty-one of 39 pts (54%) in arm A and 25 of 36 pts (69%) in arm B completed 8 cycles, and 59% in arm A and 81% in arm B completed ≥6 cycles. Grade 3/4 hematologic toxicities (%) in arms A/B were respectively; neutropenia 36/53, anemia 0/17, thrombocytopenia 3/0, nausea 3/3. No treatment related deaths were observed. Up to 12/2008, 11 of 39 pts in arm A and 13 of 36 pts in arm B had recurrent disease, but no significant difference was observed. Conclusions: This adjuvant bi- weekly scheduled chemotherapy in both arms resulted in a good compliance and feasible with acceptable levels of toxicity in completely resected NSCLC. No significant financial relationships to disclose.
Abstract P023: Association of Sickle Cell Trait with Common Electrocardiographic Abnormalities in The REasons for Geographic and Racial Differences in Stroke (REGARDS) Study
Authors: Daniel Douce, Elsayed Z Soliman, Rakhi P Naik, Hyacinth I Hyacinth, Mary Cushman, Cheryl A Winkler, George Howard, Neil A Zakai
Journal: Circulation (2017)

Introduction: Sickle cell disease (SCD) arises from an autosomal recessive mutation that leads to progressive vascular obstruction and early death. Sickle cell trait (SCT), the carrier status, is present in ~8% of African-Americans (AA) and is thought to be a benign condition, although evidence now suggests an association with worse cardiovascular and renal outcomes. Electrocardiogram (ECG) changes have been documented in SCD patients; however, similar studies in SCT individuals are lacking. We hypothesized that left ventricular hypertrophy (LVH), atrial fibrillation (AF) and QTc prolongation would be more common in SCT carriers than non-carriers. Methods: SCT was genotyped in 10,731 AA participants in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study. Baseline risk factors were recorded from 2003-7. LVH was determined using Sokolow-Lyon criteria for all participants, and Cornell criteria in those with 12 lead ECGs (n = 8,690). AF was based on both self-report and ECG criteria. We assessed the association of SCT with LVH, AF, and QTc using multivariable logistic regression adjusting for age, sex, income, education, self-reported history of stroke, myocardial Infarction, diabetes, hypertension, and chronic kidney disease. Results: Among AA participants with ECG data and genotyping, 787 of 10,553 were SCT carriers (7.5%). AF was present in 814 (7.8%), LVH in 1,556 (14.7%) and QTc prolongation in 357 (3.4%). SCT status was associated with AF with an adjusted OR of 1.36 (95% CI 1.05, 1.76). SCT was not associated with LVH by Cornell criteria or Sokolow-Lyon (OR 1.16; 95% CI 0.94, 1.42). There was a significant age (continuous) by SCT interaction (p=0.02) with SCT associated with increased risk of LVH in younger but not older individuals. When stratified by the mean age of the cohort (65 years), younger individuals with SCT had an OR of 1.50 (95% CI 1.14, 1.97) for LVH, an association not seen in older individuals (OR 0.86; 95% CI 0.63-1.18). QTc prolongation was not associated with SCT (OR 0.97, 95% CI 0.64-1.47). Conclusions: SCT was associated with increased prevalence of AF in all individuals and with LVH in younger but not older individuals and was not associated with QTc prolongation. These data suggest SCT is not benign, and for the first time report the association of SCT with common ECG abnormalities. The association with AF and LVH is concerning with respect to increased stroke risk, especially the increased prevalence of LVH seen at younger ages in SCT. These data raise the question of whether individuals with SCT need more intensive monitoring and/or hypertension control than the general population.
Commensal Neisseria Kill Neisseria gonorrhoeae through a DNA-Dependent Mechanism
Authors: Won Jong Kim, Dustin Higashi, Maira Goytia, Maria A. Rendón, Michelle Pilligua-Lucas, Matthew Bronnimann, Jeanine A. McLean, Joseph Duncan, David Trees, Ann E. Jerse, Magdalene So
Journal: Cell Host & Microbe (2019)
Abstract 4005: Glycemic microenvironment and ovarian cancer risk in underserved minority populations
Authors: Desmond Henry, Crystal Washington, Marley Rashad, Guihong Fan, Veena Rao, Monica Frazier
Journal: Cancer Research (2019)

Abstract Studies have shown that ovarian cancer risk is associated with diabetes mellitus (DM). Moreover, the notion that cancer growth and progression is linked to obesity is also widely accepted. However, the impact of the glycemic and adipose microenvironment is often overlooked. Epidemiologic studies of these microenvironments in medically underserved populations are also overlooked. The aim of this study was to determine the relationship between DM and ovarian cancer incidence and progression in underserved minority populations. A retrospective study of ovarian cancer patients diagnosed over at 10 year period (2008 – 2018) at one location was performed. Data abstracted for this study included demographic, pathologic, glycemic, DM and BMI data of 142 women with ovarian cancer. Pearson chi-square (p&amp;lt;0.05) was used to compare variables. 26 (18%) of 141 patients had a DM diagnosis and 128 (91%) of the 141 were from an underserved minority group. There was an inverse relationship between tumor size and stage. Patients in later stages had significantly smaller tumors than those in earlier stages of ovarian cancer. There was also a direct correlation between hemoglobin a1c (HbA1c) levels and tumor staging in patients with more advanced disease having slightly higher HbA1c levels (5.2, 5.5, 5.3 and 5.8 HbA1c levels Stages 1 - 4, respectively) And although there continues to be discussion on the best glycemic indicator for determining risk, we did find a similar correlation between staging and blood glucose levels. Lastly, when investigating the relationship between BMI and ovarian cancer staging, it appears that stage 1 occurrence was irrespective of BMI measurements (range 16.3 – 63.2). However, in stages 2 (range 17 – 22.8), 3 (range 21.5 – 33.9) and 4 (range 20.9 – 41.2), there was a positive correlation between BMI and staging. This result suggests that ovarian cancer progression is associated with BMI. Overall, when using cancer stage as an indicator of ovarian cancer progression, this data suggests that while tumor size is inversely related to progression, the glycemic microenvironment along with the increased presence of adipose tissue is positively correlated with ovarian cancer progression. Citation Format: Desmond Henry, Crystal Washington, Marley Rashad, Guihong Fan, Veena Rao, Monica Frazier. Glycemic microenvironment and ovarian cancer risk in underserved minority populations [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 4005.
Global Longitudinal Shortening
Authors: Frank A. Flachskampf, Ron Blankstein, Paul A. Grayburn, Christopher M. Kramer, Raymond Y.K. Kwong, Thomas H. Marwick, Eike Nagel, Partho P. Sengupta, William A. Zoghbi, Y. Chandrashekhar
Journal: JACC. Cardiovascular imaging (2019)
Phase II study of combination chemotherapy with docetaxel and carboplatin for elderly patients with advanced non-small cell lung cancer
Authors: B. Kim, H. Kim, T. Kim, H. Lee, B. Lee, J. Kim, S. Nam
Journal: Journal of Clinical Oncology (2009)

e19073 Background: More than 50% of advanced non-small cell lung cancer (NSCLC) are diagnosed in patients older than age 65 years. Cisplatin-based chemotherapy has been used in patients with advanced NSCLC as standard treatment, and we investigated the efficacy and safety of combination chemotherapy with docetaxel and carboplatin for elderly patients with advanced non- small cell lung cancer. Methods: Chemotherapy-naïve patients (age ≥ 65 years) with stage IIIB or IV NSCLC were enrolled. Patients received docetaxel (75 mg/m 2 on D1) and carboplatin (AUC of 5 mg/ml/min on D1) every 3 weeks. End points included response, time to progression, overall survival, and toxicity. Results: Total 37 patients were enrolled between March 2005 and August 2008. Median age was 75 years old (range, 65 to 84 years), and 33 patients (89.2%) had ECOG PS 0 or 1. Twenty two patients (59.5%) had increased Charlson comorbidity index score (CCI ≥1). The median number of treatment cycles was five (range, 1–8), and relative dose intensity was 95.6% in docetaxel and 95.8% in carboplatin. Overall response rate was 51.3% (95% CI 34.9–67.1) with one complete response, and 18 partial responses. The median time to progression was 6.7 months and median overall survival was 12.3 months. In 164 cycles, grade 3 or 4 hematologic toxicities included neutropenia (10.4%), anemia (1.8%), and thrombocytopenia (1.2%). Non-hematologic toxicities were tolerable. Conclusions: The combination chemotherapy with docetaxel and carboplatin was effective with tolerable toxicities in elderly patients with advanced non-small cell lung cancer. No significant financial relationships to disclose.
Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial
Authors: Michael G Hanna, Umesh A Badrising, Olivier Benveniste, Thomas E Lloyd, Merrilee Needham, Hector Chinoy, Masashi Aoki, Pedro M Machado, Christina Liang, Katrina A Reardon, Marianne de Visser, Dana P Ascherman, Richard J Barohn, Mazen M Dimachkie, James A L Miller, John T Kissel, Björn Oskarsson, Nanette C Joyce, Peter Van den Bergh, Jonathan Baets, Jan L De Bleecker, Chafic Karam, William S David, Massimiliano Mirabella, Sharon P Nations, Hans H Jung, Elena Pegoraro, Lorenzo Maggi, Carmelo Rodolico, Massimiliano Filosto, Aziz I Shaibani, Kumaraswamy Sivakumar, Namita A Goyal, Madoka Mori-Yoshimura, Satoshi Yamashita, Naoki Suzuki, Masahisa Katsuno, Kenya Murata, Hiroyuki Nodera, Ichizo Nishino, Carla D Romano, Valerie S L Williams, John Vissing, Lixin Zhang Auberson, Min Wu, Ana de Vera, Dimitris A Papanicolaou, Anthony A Amato
Journal: The Lancet Neurology (2019)
Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices
Authors: Rita F. Redberg, Sanket S. Dhruva
Journal: JAMA (2019)

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Validation of the Vanderbilt Head and Neck Symptom Survey Version 2.0.
Authors: Kenneth J. Niermann, Mary S. Dietrich, Sheila H Ridner, Leanne Kolnick, Lauren Azure Zatarain, Jill Gilbert, Barbara A. Murphy
Journal: Journal of Clinical Oncology (2013)

6049 Background: We previously reported the development and preliminary testing of the Vanderbilt Head and Neck Symptoms Survey version 2.0 (VHNSS 2.0 ) for assessment of symptom burden in head and neck cancer (HNC) patients who are undergoing or completed primary or adjuvant radiation based therapy (Cooperstein et al., Head and Neck, 2012, 24(6): 797-804). In addition to expanding items on existing domains, version 2.0 includes new domains such as dental health, mucosal sensitivity, and joint range of motion. Herein we report the results of initial validation of the instrument. Methods: 159 unique patients with HNC completed the 50 item VHNSS 2.0 as a part of one of three supportive care studies. Since each of these studies was prospective and longitudinal with repeated application of the VHNSS 2.0, we chose to utilize the first complete questionnaire for each patient for this analysis. Results: Patient characteristics: median age 57 (range 28-81 years), male 74.8%, Caucasian 91.8%, T3 or T4 46.5%, N2 or N3 66%, Site: pharynx 57.9%, oral cavity 15.1%, larynx 11.3%, 15.7%. Analysis identified 10 distinct clusters with 3 single items. The internal consistency of the clusters was good to excellent. Cronbach’s alpha coefficient, a statistical measure of reliability is shown in the Table. Conclusions: The VHNSS 2.0 is a robust, reliable measure of acute and late toxicities in patients undergoing radiation for HNC. These results provide a platform for administering appropriate interventions, which would ultimately provide for effective management of adverse oral health outcomes. [Table: see text]
EML4-ALK mutation in Austrian patients with NSCLC: A multicenter study.
Authors: Maximilian J. Hochmair, Ulrike Setinek, Thomas Efstathiades, Klaus Kirchbacher, Andrea Mohn-Staudner, Britt-Madeleine Arns, Melina Gulesserian, Nina Dworan, Marie Breyer, Kurt Patocka, Otto Burghuber
Journal: Journal of Clinical Oncology (2013)

e19093 Background: EML4 (echinoderm microtubule-associated protein-like 4) - ALK (anaplastic lymphoma kinase) fusion-type tyrosine kinase, an oncoprotein found in a subgroup of non-small-cell lung cancer (NSCLC) predicts the response to ALK inhibitors. In general, AML4-ALK mutation is found in 2 to 7% of Caucasian patients with NSCLC and occurs more often in never and former smokers, adenocarcinomas, and younger, male patients. However, the frequency of EML4-ALK mutation in Austrian patients with NSCLC is unknown. The aim of the study was to evaluate the prevalence of EML4-ALK mutation in Austrian patients with NSCLC. Methods: From September 2011 to October 2012 tumour tissue from bronchoscopy, CT- and ultrasound guided biopsies and surgical specimen with histological type of adenocarcinoma and NSCLC NOS (Not Otherwise Specified) excluding squamous cell carcinoma, large cell carcinoma and neuroendocrine carcinoma were analysed for EML4-ALK mutations from 4 hospitals in Austria with high expertise in the management of lung cancer. Mutation detection was performed with a two-step procedure. First an immunhistochemical staining was done (ALK confirm/Ventana) and further on positive cases were tested by ALK FISH (dual colour breakapart FISH/Abbott Vysis). Results: In total 639 patients were analysed. EML4-ALK positive immunohistochemical staining was found in 35 patients (5,48%). 14 of these patients (2,19%) showed positive ALK FISH analysis. Conclusions: Frequency of EML-ALK mutations in Austrian patients with NSCLC was similar to other Caucasian peers.