tbuckley/cabot-search huggingface dataset:
Enzalutamide monotherapy: Extended follow-up of a phase II study in hormone-naive prostate cancer patients.
Authors: Bertrand Tombal, Michael Borre, Per Rathenborg, Patrick Werbrouck, Hendrik Van Poppel, Axel Heidenreich, Peter Iversen, Johan Braeckman, Jiri Heracek, Edwina Baskin-Bey, Taoufik Ouatas, Frank Perabo, De Phung, Matthew R. Smith
Journal: Journal of Clinical Oncology (2014)

62 Background: The efficacy and safety of enzalutamide (ENZA) monotherapy was assessed in hormone-naive men with prostate cancer (PC; any stage) eligible for androgen-deprivation therapy (ADT). The primary end point of prostate-specific antigen (PSA) response rate (80% or more decline), assessed at 25 weeks (wks), was 92.5% with a median (range) maximum decrease of –99% (–100, –86.5) (Tombal et al. ASCO-GU 2013). Here we present data from the extended follow-up at 49 wks. Methods: In an open-label, single-arm phase II study, men age 18 or older with histologically confirmed PC requiring ADT, non-castrate testosterone (8 nmol/L or more), PSA 2 ng/mL or more at screening and a life expectancy of 12 months or more, received 160 mg ENZA once daily (NCT01302041). Treatment continued until disease progression or unacceptable toxicity. Secondary end points included changes in endocrine levels, metabolic parameters, bone mineral density (BMD), quality of life, and safety. Results: Sixty seven men were enrolled. Median (range) age was 73 (48 to 86); 38.8% had prior metastases; 35.8% and 23.94% had undergone prior prostatectomy and radiotherapy, respectively. Fifty nine men continued treatment beyond wk 25, and 54 completed wk 49. PSA response rate (80% or more reduction from baseline) at wk 49 was 80.6%, with a median (range) maximum decrease of –100% (–100, –86.5). Luteinizing hormone and testosterone were increased from baseline to wk 49 by 215.2% and 101.7%, respectively. Mean changes from baseline for metabolic outcomes at wk 49 were: +5.02% (total cholesterol), +8.86% (triglycerides), –3.54% (HbA1c), and +19.72% (HOMA-IR). Total body BMD was maintained at 49 wks (–0.30% from baseline). The most frequently reported treatment-emergent adverse events (AEs) were gynecomastia (47.8%) and fatigue (38.8%). Seven men had serious AEs, none of which were drug related. Data on patient reported outcomes will be presented. Conclusions: ENZA monotherapy was associated with significant PSA reductions after 49 wks of treatment in men with hormone-naive PC. Endocrine changes and AEs were consistent with potent AR inhibition. Outcomes for all end points at 49 wks were consistent with those reported at 25 wks. Clinical trial information: NCT01302041.
Randomized Trial of Fludarabine Versus Fludarabine and Idarubicin as Frontline Treatment in Patients With Indolent or Mantle-Cell Lymphoma
Authors: Pier Luigi Zinzani, Massimo Magagnoli, Luciano Moretti, Amalia De Renzo, Raffaele Battista, Alfonso Zaccaria, Luciano Guardigni, Patrizio Mazza, Roberto Marra, Fioravante Ronconi, Vito Michele Lauta, Maurizio Bendandi, Filippo Gherlinzoni, Patrizia Gentilini, Fabrizio Ciccone, Claudia Cellini, Vittorio Stefoni, Francesco Ricciuti, Marco Gobbi, Sante Tura
Journal: Journal of Clinical Oncology (2000)

PURPOSE: A first comparative trial of fludarabine (FLU) alone versus FLU plus idarubicin (FLU-ID) for indolent or mantle-cell lymphomas. PATIENTS AND METHODS: From September 1995 to July 1998, 199 patients aged 25 to 65 years (median, 54 years) with newly diagnosed stages II to IV indolent or mantle-cell lymphomas (standard risk according to the International Prognostic Index) were enrolled onto a multicenter, 1:1 randomized study. Of the 199 patients who were able to be assessed, 101 were assigned to the FLU group (six monthly cycles of FLU 25 mg/m 2 /d on days 1 through 5) and 98 to the FLU-ID group (six monthly cycles of FLU 25 mg/m 2 /d on days 1 through 3 and idarubicin 12 mg/m 2 on day 1). RESULTS: In the FLU group, complete response (CR) and partial response rates were 47% and 37%, respectively, whereas in the FLU-ID group, they were 39% and 42%, respectively. In-depth analysis of the CR rate with respect to histologic type showed that FLU seemed to be superior to FLU-ID in treating follicular lymphomas (60% v 40%, respectively), whereas FLU-ID seemed to be more effective than FLU in treating nonfollicular lymphomas (small lymphocytic, 43% v 29%, respectively; immunocytoma, 38% v 23%, respectively; P = not significant), excluding the mantle-cell subset (in which there was no difference between the two groups). No striking differences were observed between the two protocols in terms of overall response or toxicity, which was generally mild. However, with a median follow-up of 19 months, only 29 patients (62%) who received FLU alone have maintained their initial CR, compared with 32 (84%) of those who received FLU-ID therapy (P = .021). CONCLUSION: Although the FLU-ID regimen may not significantly improve the induction of CR in most indolent-lymphoma patients, our preliminary data do suggest that, with respect to FLU alone, it may be capable of conferring a longer-lasting CR and that it might be superior in terms of CR rate in small lymphocytic and immunocytoma subtypes.
Alterations in estrogen-associated proliferation markers in histologically-normal endometrium of obese women
Authors: R. A. Lacour, S. N. Westin, L. A. Meyer, P. T. Soliman, E. R. Keeler, S. G. Boyd-Rogers, D. L. Urbauer, R. R. Broaddus, D. S. Loose, K. H. Lu
Journal: Journal of Clinical Oncology (2008)

16503 Background: Estrogen induces both pro- and anti-proliferative genes in the endometrium. Our group has previously described EIG121 as a relevant pro-proliferation biomarker and RALDH2 and SFRP4 as anti-proliferation biomarkers in the endometrium. In addition, we have shown that there is dysregulation of these pro- and anti-proliferation markers in endometrial cancer. In this study, our goal was to examine these markers in prospectively collected, timed endometrial biopsies from obese women, an at-risk cohort, and to compare them to endometrial cancers from obese women. Methods: A prospective study was carried out to evaluate endometrium of obese women (BMI >30 kg/m2). Premenopausal women between 30 and 55 years of age were enrolled. A timed endometrial biopsy was performed between day 5 and 10 of the proliferative phase of the menstrual cycle. Quantitative, real-time PCR analysis was performed to evaluate endometrial samples for the EIG121, RALDH2 and SFRP4 transcripts. Endometrial cancer tissue of 43 patients with BMI >30 kg/m2 was obtained from the tumor bank and evaluated for the same transcripts. Statistical analysis was performed using Kruskal-Wallis and Fisher’s exact tests. Results: Endometrial tissue of 65 patients with BMI >30 kg/m2 has been evaluated thus far. Median age was 40 years and median BMI was 36.6 kg/m2. Histologically, 1 case of complex atypical hyperplasia was discovered. Endometrial cancer tissue from obese patients exhibited higher levels of EIG121 than benign endometrium of obese patients (p=.0022). Levels of RALDH2 and SPFR4 transcripts were significantly lower in obese endometrial cancers compared to obese normal endometrium (p<.0001). Conclusions: Estrogen-induced pro- and anti-proliferation biomarkers were more significantly altered in obese cancers compared to obese normal endometrium. Evaluation of these markers in a series of endometrial tissues from thin women is ongoing. These molecular alterations may represent biomarkers of endometrial cancer risk in obese women. No significant financial relationships to disclose.
Troller fuel exhaust and respiratory impairments; a cross sectional study in Indian fishermen
Authors: Subhabrata Moitra, Santi Gopal Maity, Prasun Haldar, Asis Pandit, Subhashis Sahu
Journal: European Respiratory Journal (2012)

Introduction:  The fishermen of India are exposed regularly to the fuel exhausts of the trollers. No study has been reported on the respiratory health of the fishermen.  Aim:  The study aimed to see whether there is a relationship between troller fuel exhaust and respiratory impairments among the fishermen in India.  Methods:  A total of 259 male fishermen participated in the study among which 152 were regularly exposed to troller fuel exhaust (mean age 58±9.8 years) and 107 were never exposed to that (mean age 53±10.3 years). Evaluation of the examined subjects included ECRHS questionnaire for the assessment of respiratory symptoms and lung function test. Data were analysed using odds ratio with 95% confidence interval and independent 9t9 test adjusting for age, smoking status, parental asthma and second hand smoke exposure at home or work.  Results:  Fishermen exposed to troller fuel exhaust had higher prevalence of respiratory symptoms for chronic phlegm (OR = 3.4, 95% CI = 1.2-8.3), morning cough with sputum (OR = 2.3, 95% CI = 1.1-4.6), prolonged cough (OR = 2.5, 95% CI = 1.4-6.2), whistling in chest (OR = 2.8, 95% CI = 1.4 = 7.3) and breathing trouble (OR = 2.6, 95% CI = 1.2-6.2) compared to the those unexposed to troller fuel exhaust. Spirometric parameters showed that the mean values of FVC, FEV1, FEV1/FVC, FEF25%, FEF50%, FEF75% and FEF25-75% were lower in the subjects exposed to fuel exhausts but statistically significance (p  Conclusion:  The study suggests that occupational exposure to troller fuel exhaust is associated with higher prevalence of respiratory symptoms and lung function impairment among fishermen of India.
Abstract 138: Procollagen I Carboxyterminal Propeptide Levels in Friedreich Ataxia and Its Relation to Subclinical Myocardial Disease
Authors: Paul Chacko, James Jin, Tam Tran, Thomas W Prior, Gunjan Agarwal, Subha V Raman
Journal: Circulation Research (2012)

Background: Friedreich ataxia (FA) is the most common recessive hereditary ataxia. Triplet expansion (GAA) of the frataxin gene leads to intramitochondrial iron accumulation, and cardiomyopathy is the leading cause of death in FA. Histopathologic analysis of autopsy hearts has shown myocardial fibrosis and concentric left ventricular (LV) thickening, which our group has previously shown in vivo in FA patients using cardiac magnetic resonance with late gadolinium enhancement (LGE-CMR). Procollagen I carboxyterminal propeptide (PICP) is a serum marker of collagen synthesis, suggesting potential utility as a biomarker of myocardial fibrosis and remodeling. Objectives: The aims of this work were to 1) determine PICP levels in FA patients compared to similar-aged healthy controls, 2) evaluate PICP levels relative to GAA repeat length, 3) evaluate PICP in the context of cardiac remodeling and 4) compare serum PICP levels to presence or absence of fibrosis by LGE-CMR. Methods: 30 FA patients (34.2±11.8 years) underwent measurement of serum PICP using sandwich ELISA as well as CMR examination with cine and LGE acquisitions. Southern blot analysis was performed to measure GAA repeats, recording the minimum of 2 values for each FA patient. 5 healthy volunteers (37.6±8.4 years) served as controls for PICP measurement. Cine images were analyzed at end-diastole to compute relative wall thickness (RWT), a marker of concentric remodeling. Results: PICP values were markedly elevated in FA patients compared to normal controls (1034±76 vs. 657±89 ng/mL, p=0.004). Minimum GAA repeat length was moderately correlated with greater RWT (r=0.40, p=0.041) but did not predict PICP level. Higher PICP level modestly predicted worse concentric remodeling (r=0.39, p=0.033). However, PICP did not distinguish between 15 patients with evident myocardial fibrosis by LGE vs. 15 LGE-negative FA patients (1042±128 vs 1027±87 ng/mL, p=0.925). Conclusions: PICP, a serum marker of collagen synthesis, is significantly elevated in FA patients with higher values indicating adverse LV remodeling. PICP may provide complementary information to direct myocardial fibrosis imaging, and warrants further evaluation as a biomarker of disease severity and treatment response.
Abstract 13347: Exercise Counseling in Low-income Ethnic Minority Individuals With Heart Failure: A Pilot Study
Authors: Margaret M McCarthy, Victoria V Dickson, Stuart D Katz, Deborah A Chyun
Journal: Circulation (2013)

Background: A primary symptom of heart failure (HF) is exercise intolerance. Unfortunately, many patients are not referred to cardiac rehabilitation, nor counseled about exercise. The positive effects of exercise training on functional status and quality of life (QOL) have been established in patients with HF, with some evidence on improvement in flow-mediated dilation (FMD). However, few ethnic minority individuals of low socio-economic status have been included in these studies. The purpose of this quasi-experimental study was to pilot a brief exercise counseling intervention in a low-income ethnic minority HF clinic, and to assess preliminary efficacy in improving functional status, physical activity, mood, QOL and FMD. Methods: Adults with HF (n=20) were enrolled from an urban HF clinic and completed a 6-minute walk test (6MWT) and standardized reliable instruments. Each subject participated in brief (15 minutes) exercise counseling based upon the principles of motivational interviewing (MI) to discus...
A randomized phase II study of BAY 43–9006 in combination with gemcitabine in metastatic pancreatic carcinoma: A California Cancer Consortium study (CCC-P)
Authors: S. Iqbal, H. J. Lenz, D. Yang, R. K. Ramanathan, N. Bahary, S. Shibata, R. J. Morgan, D. R. Gandara
Journal: Journal of Clinical Oncology (2008)

11082 Background: BAY 43–9006 is a multi-targeted tyrosine kinase inhibitor of c and b-Raf, VEGFR 2/3 and PDGFR. Mutations of K-ras oncogene are noted in 80%- 90% of pancreatic adenocarcinoma. The CCC-P performed a randomized phase II study of BAY 43–9006 vs. BAY 43–9006 with gemcitabine in metastatic pancreatic cancer. The primary objective was to determine the response rate (RR), secondary objectives were to determine 6 month overall survival (OS), 3 month progression free survival (PFS) and toxicity. Methods: Chemo-naive patients (pts) were randomized to receive (Arm A) single agent BAY 43–9006 400 mg po BID for 3 weeks on/1 week off or (Arm B) same regimen BAY 43–9006 with gemcitabine 1,000 mg/m2 at 10 mg/m2/minute weekly for 3 weeks/1 week off. Pts progressing on single agent BAY 43–9006 (Arm A) were crossed-over to Arm B. Response was assessed every 8 weeks. Results: 52 pts were accrued. Of the 15 pts in Arm A, 7 pts crossed over to Arm B. The median number of cycles was 2.3 for Arm A and 2.9 for Arm B. One pt responded in Arm B. Median PFS and 3-month (mo) PFS were: 2.3 mos (1.2 to 5.7) and 0.36±0.13 in Arm A, and 2.9 mos (2.1 to 4.3) and 55 ± 0.08 in Arm B. Median OS and 6-mo OS were: 4.3 mos and 0.47 ± 0.13 in Arm A, and 6.5 mos and 0.55 ± 0.08 in Arm B. There were more grade 3+ toxicities in Arm B vs. Arm A including hematologic toxicity (11/ 2), liver function abnormalities (3/16) and fatigue (7/1). Conclusions: The addition of BAY43–90006 to gemcitabine did not demonstrate significant activity in pts with metastatic pancreatic cancer. Supported by NO1 CM-62209. Arm A (n=15) Arm B (n=37) Age Median 66 yrs (55-82) 65 yrs (43-83) Sex 6 Female, 9 Male 15 Female, 22 Male ECOG Peformance Status ECOG 0: 6 pts ECOG 0: 22 pts ECOG 1: 9 pts ECOG 1: 15pts Response PR 0 1 SD 2 15 PD 11 14 Not evaluated 2 7 No significant financial relationships to disclose.
Multicentric, epidemiological study of the prevalence of sleep apnea in patients with nocturnal hypertension in the Czech Republic and the difference between its prevalence in two Czech regions (Bohemia, Moravia)
Authors: Milada Hobzova, Karel Sonka, Martin Pretl, Jana Zapletalova, Martina Placková, Vitezslav Kolek
Journal: European Respiratory Journal (2014)

Introduction and objective : The aim of this study was to assess the percentage of patients with nocturnal hypertension (assessed by 24 hour ambulatory pressure monitoring- ABPM) and as yet non-diagnosed and non-treated with SAS and to asses the difference between two regions in the Czech Republic (Bohemia, Moravia).    Subjects and methods  : 188 patients (125 males) average age 57.8± 10.6 with nocturnal hypertension according to ABPM (    Results  : In the full sample of patients (Bohemia , Moravia) with nocturnal hypertension, treated arterial hypertension was present in 96.8 (100; 95.5)%.SAS was newly diagnosed in 72.9 (74.1; 72.4)% and apnea- hypopnea (AHI) index ³ 15 was present in 43.6 ( 38.9; 45.5)%. We have not found a statistically significant difference between the prevalence in Bohemia and Moravia in age (p=0.187), number of men (p=0.500), treated arterial hypertension (p= 0.185), newly diagnosed SAS (p=0.858), AHI ³ 15 (p=0.422).   Conclusion:  This study has shown a high prevalence of non-diagnosed and non-treated SAS in patients with resistant nocturnal hypertension. It is important to evaluate clinical signs of SAS in patients with nocturnal hypertension and to refer them to a sleep centre for further investigation.  Acknoledgements: Supported by MH CZ – DRO (FNOl,00098892), Grant CARO 2009.
A phase I study of docetaxel and 5-fluorouraciI in patients with advanced solid malignancies
Authors: T. Petit, C. Aylesworth, H. Burris, P. Ravdin, G. Rodriguez, L. Smith, N. Peacock, L. Smetzer, R. Bellet, D.D. Von Hoff, E.K. Rowinsky
Journal: Annals of Oncology (1999)
Human immunodeficiency virus/acquired immunodeficiency syndrome–related cancer in the pre- and post-highly active antiretroviral therapy era in a national cancer center of a resource-limited country: 1988 to 2007
Authors: L. E. Cuéllar Ponce de León, L. M. Miranda Rosales, C. Biminchumo Zagástegui, R. Rosales Cusichaqui, C. Flores, L. Mas López, J. León Chong
Journal: Journal of Clinical Oncology (2009)

e20550 Background: The introduction of the highly active antiretroviral therapy (HAART) has changed the clinical course of acquired immune deficiency syndrome (AIDS) related to cancer. The goals were to describe the the characteristics of AIDS related to cancer before and after HAART in patients in a Hospital of a resource-limited country. Methods: This was an observational, retrospective and cross sectional study. Comparisons analyzed with X2 test. Survival estimated with Kaplan-Meier estimates. Results: The population included 426 (52.2%) patients. The mean age was 39 y.o. The main group was heterosexual 51.1%. The number of invasive cervical cancer (CC) and AIDS-related lymphomas (ARLs) increased in the Post HAART era; the number on non-HIV/AIDS related to cancer has decreased. During the first period none of patients had antiretroviral therapy, living patients was 62% in the Post HAART era (p&lt; 0.01). Conclusions: The introduction of HAART has reduced the number of non-VIH/AIDS related cancer, but have increased the CC and LNH and improved the survival of patients. [Table: see text] No significant financial relationships to disclose.
New Option for Bleeding Disorder
Authors: Rebecca Voelker
Journal: JAMA (2016)

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RNA sequencing reveals the consequences of a novel insertion in dedicator of cytokinesis-8
Authors: Shaheen Khan, Merin Kuruvilla, David Hagin, Benjamin Wakeland, Chaoying Liang, Kasthuribhai Vishwanathan, Richard A. Gatti, Troy R. Torgersen, Roshini S. Abraham, Edward K. Wakeland, Nicolai S.C. van Oers, M. Teresa de la Morena
Journal: Journal of Allergy and Clinical Immunology (2016)
Initial clinical study of indium-111-labeled clone 110 anticarcinoembryonic antigen antibody in patients with colorectal cancer.
Authors: T W Griffin, A B Brill, S Stevens, J A Collins, F Bokhari, H Bushe, M C Stochl, M Gionet, M Rusckowski, S D Stroupe
Journal: Journal of Clinical Oncology (1991)

A murine monoclonal antibody directed against carcinoembryonic antigen (CEA) was labeled with indium-111 (111In) by means of a benzylisothiocyanate derivative of diethylenetriamine penta-acetic acid (DTPA) and used for clinical radioimmunodetection studies. Twenty-one patients having a history of surgically resected colorectal cancer and rising serum CEA levels suggestive of tumor recurrence were studied. Patients were infused over 20 minutes with 5, 10, or 20 mg of the monoclonal antibody labeled with 5 mCi of 111In. The mean radiochemical purity was greater than 96%. No toxicity was seen. The stability of the radiolabel on antibody in patient serum was demonstrated by high-performance liquid chromatography (HPLC), sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) with autoradiography, and immunoprecipitation for up to 96 hours after infusion. Tumor sites were identified in 20 of 21 patients. Sites of antibody accumulation in 20 patients were confirmed as tumor either by resection at laparotomy (16 patients) or fine-needle biopsy (four patients). Nine patients who had the identified lesion resected or irradiated showed return of the serum CEA antigen level to normal or near normal values. In the absence of high levels of circulating CEA (greater than 500 ng/mL), the disappearance of radioactivity from patient serum demonstrated first order elimination kinetics, with a mean half-life of 38 hours. The serum half-life was not affected by the dose of antibody administered or by serum CEA titers below 500 ng/mL. Despite a mean liver uptake of 18% injected dose (ID) 24 hours after administration, hepatic metastases were easily visualized as areas of increased uptake of radioactivity. Radioimmunodetection of recurrent colorectal cancer, not detected by computed tomographic (CT) scans, appears achievable with this agent. This may allow successful clinical intervention in selected patients.
The roles of PCDH1 on epithelial barrier function in the airway
Authors: Yutaka Kozu, Yasuhiro Gon, Akiko Sekiyama, Masahiro Terakado, Ikuko Takeshita, Shuichiro Maruoka, Shu Hashimoto
Journal: European Respiratory Journal (2012)

[Background]  PCDH1 is recently identified as a susceptibility gene of bronchial hypersensitivity (BHR). Although PCDH1 seems to be involved in the differentiation of the airway, the roles of PCDH1 on epithelial barrier functions have not been determined.  [Methods]  A human airway epithelial cell line, 16HBE, cells were cultured on Transwell chamber for 5days. Barrier function was evaluated by Trans Electric Resistance and dextran permeability. Expression of inflammatory cytokine was measured by RT-PCR. Morphology of cell junctions was analyzed by immunostaining using anti-PCDH1, anti-ZO-1, anti-Ocludin and an anti-E-cadherin antibody.  [Results]  The paracellular barrier function of 16HBE cell monolayer increased over time in culture. Similarly, the expression of PCDH1 increased for the period. The knockdown of PCDH1 significantly inhibited the paracellular barrier function. In addition, it inhibited the dsRNA-induced inflammatory cytokines expressions. Immunocytostaining revealed that PCDH might coexist with E-cadhein at the cell-cell contact sites.  [Conclusion]  Our results indicated that a susceptibility gene of PCDH1 plays an important roles on the immunological and physiological barriers of airway epithelium.