tbuckley/cabot-search huggingface dataset:
Outcomes of the patients with pT0 on first protocol biopsy during active surveillance for early prostate cancer: From the PRIAS-JAPAN study.
Authors: Takuma Kato, Mikio Sugimoto, Yoshiyuki Kakehi, Akito Yamaguchi, Akira Yokomizo, Nobuo Shinohara, Ryuji Matsumoto, Koji Mitsuzuka, Haruki Kume, Masaki Nakamura, Shin Egawa, Hiroshi Sasaki
Journal: Journal of Clinical Oncology (2019)

20 Background: We assessed the outcomes of the patients with pT0 on first protocol biopsy during active surveillance(AS) from the analysis Japanese cohort forming part of the Prostate Cancer Research International: Active Surveillance (PRIAS) study. Methods: PRIAS-JAPAN started in January 2010. 39 institutions are participating in this study. The inclusion criteria for the PRIAS study are as follows: clinical stage T1c/T2, PSA ≤ 10 ng/ml, PSA density (PSAD) &lt; 0.2 ng/ml per milliliter, one or two positive biopsy cores, and Gleason score (GS) ≤ 6 at initial diagnostic biopsy.In this analysis, we defined the patients presenting no reclassification with cancer after first protocol biopsy as NR-CA group and the patients presenting no reclassification showing pT0 as NR-noCA group. We compared AS remaining rate, pathological outcomes in extra biopsy and second protocol biopsy at 4 years between two groups. Results: First protocol biopsy was performed on 514 patients. 191 patients were in NR-noCA group and 199 patients were in NR-CA group. Patients background of NR-noCA group was as follows: Median age was 68, median PSA was 5.6ng/ml, and median prostate volume was 38.4cc. T1c were in 183 and T2a were in 8. At the time of first protocol biopsy, there was no significant differences about PSA parameters and pathological factors between NR-noCA group and NR-CA group. Also, extra biopsy performing rate (NR-noCA group vs NR-CA group; 5.75% vs 7.53%) and implementation rate of second protocol biopsy at 4 years (75.6% vs 63.6%) showed no significant differences. On second protocol biopsy, number of cancer positive cores were significantly smaller and rate of pT0 was higher in NR-noCA group. After five years, both group showed comparable AS remaining rate (76.9 vs 75.3%). Thirty eight patients of NR-noCA group selected definitive therapy and surgery was the most frequently chosen treatment option. Conclusions: Although rate of pT0 on second biopsy was higher in NR-noCA group, there was no significant difference between both groups in AS remaining rate. The patients in NR-noCA group tended to choose surgery as a definitive therapy. Clinical trial information: UMIN000002874.
Abstract 019: Changes in Gut Microbial Metabolites and Risk of Coronary Heart Disease in US Women: the Nurses’ Health Study
Authors: Yoriko Heianza, Wenjie Ma, Joseph A DiDonato, Qi Sun, Eric B Rimm, Frank B Hu, Kathryn M Rexrode, JoAnn E Manson, Lu Qi
Journal: Circulation (2019)

Introduction: Circulating levels of gut microbial metabolites, trimethylamine N-oxide (TMAO) and its nutrient precursors of choline and L-carnitine, have been suggested as risk factors for coronary heart disease (CHD). Whether changes in gut microbial metabolites are associated with the CHD incidence remains unknown. Hypothesis: We assessed the hypothesis that long-term (over 10 years) changes in plasma levels of TMAO, choline, and L-carnitine would be associated with the risk of CHD. Methods: This prospective nested case-control study included a total of 768 women (385 incident cases of fatal CHD and nonfatal myocardial infarction and 383 controls) who had data on blood concentrations of TMAO, choline, and L-carnitine at 2 time points, 10 years apart (1989-90, and 2000-01). We identified incident cases of CHD from the date of the second blood collection through 2014. Results: Higher TMAO levels at the second collection were associated with higher risk of CHD (relative risk (RR) 1.22 [95% CI: 1.05, 1.42] per 1 SD increment in log-transformed TMAO) in multivariate analyses controlling for traditional risk factors. Compared with women with low TMAO levels (lower two tertiles) at both time points, the RR was 1.74 (95% CI: 1.05, 2.89) for those with elevated levels of TMAO (the highest tertile) at both time points. Regardless of metabolite levels at the first collection, increases in TMAO or L-carnitine from the first to second collections were significantly associated with an increased risk of CHD (Fig. panels A-B). Women who had increases in both TMAO and L-carnitine had a particularly elevated risk of CHD (RR 2.12, 95% CI: 1.25, 3.59), as compared to those with decreases in both metabolites. Adherence to healthy dietary habits attenuated the associations of TMAO with CHD risk (Fig. panel C). Conclusions: Long-term increases in TMAO were significantly predictive of subsequent risk for CHD among women. The associations may be modified by the nutrient metabolite precursor, L-carnitine, and adherence to healthy dietary habits.
Abstract P142: Heart Healthy Behaviors in Young Women: What Prevents Teens From Going Red?
Authors: Courtney A Brown, Anna C Revette, Sarah D de Ferranti, Jingyi Liu, Catherine Stamoulis, Holly C Gooding
Journal: Circulation (2019)

Introduction: Ideal cardiovascular health behaviors are the foundation of primordial prevention as health behaviors initiated in adolescence track into adulthood. Adolescent and young adult (AYA) women may experience unique barriers to and facilitators of heart healthy behaviors. Using an explanatory sequential mixed methods design, we examined how AYA women perceive cardiovascular health. Methods: We surveyed a random convenience sample of 331 AYA women ages 15-24 years presenting for care at an urban academic medical center and a community health center using the AHA National Women’s Health Study survey. Survey data guided development of the qualitative guide used during eight online, semi-structured focus groups with 32 young women. We report descriptive statistics performed using Matlab (Mathworks, Inc.) and thematic analyses conducted to synthesize data from the online focus groups using NVivo 11. Results: A total of 280 young women (84.6%) performed at least one preventive behavior in the past year. Actions taken included visiting a doctor [261 (78.9%)], exercising [247 (74.6%)], and reducing stress [174 (52.6%)]. AYA’s most commonly reported barriers to heart healthy actions were a failure to perceive oneself at risk for heart disease [130 (39.3%)] and stress [108 (32.6%)]. Focus group participants discussed several barriers including time constraints (“we just don’t have time to worry about our hearts”), lack of access to affordable gyms and healthy food (“improving health would be easier if healthy food weren’t expensive”), and mental health (“working on depression or anxiety so one doesn’t stop exercising or stop eating healthy because of life stresses”). Most [237 (71.6%)] participants identified a desire to improve their health as a reason for performing preventive behaviors, with 62.5% [n=207] wanting to live longer and 61.9% [n=205] wanting to feel better. Many AYA women surveyed were encouraged to take action by a family member [151 (45.6%)], a health care professional [113 (34.1%)], or a friend [106 (32.0%)]. Most participants [241 (72.8%)] felt that increased access to healthy food would help facilitate a heart healthy lifestyle. Focus group participants reported interpersonal connections (“having a strong support system to encourage you”), personal motivation (“I finally get fed up with myself and force myself to go back to the gym”), celebrities (“contact the Kardashians and tell them to promote”), and music as facilitators of preventive behaviors. Conclusions: Our results emphasize the competing concerns AYA women face - including time constraints, access to resources, and mental health issues - and how these factors impact their ability to perform preventive behaviors. Future campaigns should address stressors experienced by young women and capitalize on personal support systems, celebrities and music to encourage heart healthy behaviors.
Long-term fatigue and quality of life among epithelial ovarian cancer survivors: a GINECO case/control VIVROVAIRE I study
Authors: F. Joly, D. Ahmed-Lecheheb, E. Kalbacher, N. Heutte, B. Clarisse, J.M. Grellard, F. Gernier, D. Berton-Rigaud, O. Tredan, M. Fabbro, A.M. Savoye, J.E. Kurtz, J. Alexandre, P. Follana, V. Delecroix, N. Dohollou, C. Roemer-Becuwe, G. De Rauglaudre, A. Lortholary, K. Prulhiere, A. Lesoin, A. Zannetti, S. N’Guyen, S. Trager-Maury, L. Chauvenet, S. Abadie Lacourtoisie, A. Gompel, C. Lhommé, A. Floquet, P. Pautier
Journal: Annals of Oncology (2019)
Long-term effect of chemotherapy on ovarian function in premenopausal breast cancer.
Authors: Dalia S. Kamel, Mohammed A Moneam Osman, William Grogan, Oscar S. Breathnach, Patrick G. Morris, Arnold D. Hill, Colm Power, Michael J Allen, Maciej Milewski, Michelle Griffin, Elizabeth Summersby, Marie Gilchrist, Bryan Hennessy
Journal: Journal of Clinical Oncology (2015)

e17682 Background: To assess effect of chemotherapy on ovarian function (defined as regular menses plus at least 1 hormone within premenopausal range) in premenopausal BC after follow up 24-month period. Methods: In prospective study from Oct 2011 to Sept 2014, clinical and biochemical premenopausal new ESBC were enrolled. From start of chemotherapy, date of menses, oestradiol, FSH, Inhibin A, B were recorded at baseline, mid, end of chemotherapy, every 3 months till 24-month period. Results: 26 patients reached 24-month period, mean age 42.6 (see table). Risk of CRA was 73%, oestradiol, FSH, Inhibin A, B consistent with menopause in 73%, 69%, 69%, 85% respectively. There was concordance between CRA and serological indicators of menopause. Of 7 patients (27%) with regular menses at 24-month, 3 (12%) retained regular menses throughout 24 months. Patients < 45 yrs at diagnosis were more likely to have regular menses (27% vs. 0%, p = 0.004), oestradiol (23% vs. 4%, p = 0.07), Inhibin A (31% vs. 0%, p = 0.01), Inhibin B (15% vs. 0%, p = 0.09) within premenopausal range compared with patients > 44 yrs at diagnosis. Trastuzumab did not have significant impact on ovarian function. Patients on Tamoxifen have premenopausal oestradiol (19% vs. 8%, p = 0.07), FSH (27% vs. 4%, p = 0.02), Inhibin B (15% vs. 0%, p = 0.09). At baseline, only oestradiol levels were significantly different between patients with retained/recovered ovarian function after 24 months vs. patients without ovarian function after 24 months (209.5 ± 95% CI vs. 494.2 ± 95% CI pg/ml, respectively; p = 0.04). Conclusions: Younger age and lower oestradiol at diagnosis are significant predictor of retained ovarian function at 2 years after chemotherapy for early BC. Determination of comparative impact of different adjuvant chemotherapy regimens on ovarian function requires enrollment of more patients. In most patients, serological marker of menopausal status taken in serial fashion during/after chemotherapy correlate with patient’s menstrual status at that time. Age 33-44 16 45-49 10 Ethnic Caucasian 21 Non 5 ER status +ve 17 -ve 9 HER2 status +ve 6 -ve 20 GnRH analogue No 25 Yes 1 Chemo type Adjuvant 19 Neoadjuvant 7 Chemo regimen ACT 16 ACTH 3 TC 3 TCH 3 CMF 1 Trastuzumab Yes 6 No 20 Tamoxifen Yes 17 No 9
Methotrexate‐Associated Lymphoproliferative Disorder: A Rare Case of Large Liver Tumors
Authors: Saori Watanabe, Kazuya Takahashi, Kazuhiro Funakoshi, Shuji Terai
Journal: Hepatology (2019)

Watanabe, Saori1; Takahashi, Kazuya*,1,2; Funakoshi, Kazuhiro1; Terai, Shuji2 Author Information
First prospective, open-label, phase 2 study of sipuleucel-T (sip-T) in European men with metastatic, castration-resistant prostate cancer (mCRPC).
Authors: Maria De Santis, Peter Mulders, Karim Fizazi, Todd E. Gray, Candice McCoy, Andrew Stubbs, Thomas Powles
Journal: Journal of Clinical Oncology (2015)

e16015 Background: Sip-T is approved in the European Union (EU) and US for the treatment of certain patients (pts) with asymptomatic or minimally symptomatic mCRPC. P11-1 (NCT01477749) is a phase 2, open-label, multicenter trial and the first trial of sip-T conducted in the EU. Data from the primary analysis are reported here. Methods: Sip-T is an autologous cellular immunotherapy consisting of peripheral blood mononuclear cells, including antigen presenting cells (APCs), cultured with PA2024 (a recombinant protein composed of prostatic acid phosphatase linked to GM-CSF). Treatment consists of 3 sip-T infusions, each administered at ~2-week intervals. Primary endpoint is summary of product parameters (APC activation measured by CD54 upregulation, total nucleated cell [TNC] count, and APC count) of sip-T produced in an EU manufacturing facility. Secondary endpoint is safety. Exploratory endpoint is quality of life (QOL) assessed by FACT-P and EQ-5D-3L questionnaires. Results: From SEP 2012 to MAR 2014, 47 pts were enrolled across 4 sites in Austria, France, the Netherlands and the United Kingdom. All pts completed 3 infusions; most (91.5%) only required 1 leukapheresis per infusion, and median treatment time was 28 d (range 27–49). APC activation was observed after infusion 1, indicating an immunological prime boost. TNC and APC counts were relatively stable across infusions. Adverse events (AEs) occurred in 40 pts (85.1%), the most frequent being fatigue, back pain, chills, dizziness, and nausea. No events Grade > 3 occurred. Mild to moderate AEs within 1 d of infusion occurred in 29 pts (61.7%), and most (75.9%) resolved in ≤ 2 d. Five serious AEs (urinary calculus, fatigue, gastroenteritis radiation, pain, and urinary tract obstruction) occurred in 3 pts (6.4%); none were considered related to treatment. QOL data generally showed no change from baseline. Conclusions: Data show that sip-T can be successfully produced in an EU facility servicing multiple nations. The pattern of APC activation indicates an immunological prime boost, consistent with all sip-T trials. AEs were transient and mild to moderate in severity. QOL appeared to be maintained during treatment. Clinical trial information: NCT01477749.
Abstract MP25: Longitudinal Assessment of Sleep Patterns During Early Childhood and Their Association With Obesity
Authors: Jill L Kaar, Sarah Schmiege, Heidi Kalwarf, Jessica G Woo, Stephen Daniels, Stacey L Simon
Journal: Circulation (2019)

Objective: To identify sleep patterns in early childhood and examine the influence of these patterns on health behaviors and obesity. Methods: Prospective cohort study of healthy 3-year old children (n=301) measured annually through age 6. Parent-reported total sleep duration (TSD) was calculated as night-time sleep plus daytime naps . Insufficient sleep was defined as TSD &lt;10 hours/day. A latent growth curve model was estimated to establish the trajectory of TSD over four years. At each time period, univariate regression models were estimated to: (a) identify modifiable and demographic (i.e., race/ethnicity, gender) predictors of insufficient sleep and (b) test the association of insufficient sleep with health behaviors (i.e., diet, screen time) and obesity status (adjusting for time-specific daily energy intake, screen time, and moderate-vigorous physical activity (MVPA)). Results: The analytical cohort was 49% female, predominately white (82%) with 36% reporting household incomes below $50,000. At age 3, 21% were defined as overweight or obese and at age 6, 32% of the cohort were defined as overweight or obese. Children had a similar bed and wake time across the four-year study with an average bedtime at 9:27PM and waketime at 8:01AM. Growth curve modeling showed decreases of 39.6 minutes in TSD from age 3 to age 6; though statistically significant (p&lt;0.001), this may be due to the developmental expected decrease in daytime naps over this age range. The most consistent modifiable predictors of insufficient sleep from ages 4-6 years were bedtimes after 9PM (age 4 OR: 27.3 (95%CI: 3.7, 201); age 5 OR: 37.3 (95% CI: 5.1, 274); age 6 OR: 13.2 (95% CI: 3.1, 55)) and insufficient sleep the prior year (age 4 OR: 11.4 (95%CI: 3.8, 34); age 5 OR: 5.9 (95% CI: 3.0, 11.6); age 6 OR: 6.5 (95% CI: 3.4, 12.4)). Children reported as “non-white” were more likely to be classified with insufficient sleep at ages 4-6 years (age 4 OR: 2.6 (95%CI: 1.3, 5.2); age 5 OR: 2.39 (95% CI: 1.2, 4.7); age 6 OR: 2.2 (95% CI: 1.1, 4.3)). Children at ages 5-6 years with insufficient sleep reported 29 and 36 minutes more screen time per day compared to those with sufficient sleep (p &lt; 0.05). Insufficient sleep did not predict diet and MVPA behaviors. Insufficient sleep status was also significantly associated with obesity status as children with insufficient sleep at age 5 were 2.22 times (95% CI: 1.20,4.1) more likely to be overweight and obese compared than children with adequate sleep (p = 0.01). Conclusions: Sleep patterns appear to be established by age 3 years with little change throughout young childhood, and with implications for early obesity development. Early intervention to improve sleep may be necessary during this time, especially for children from racial/ethnic minority backgrounds, prior to the establishment of sleep patterns, to prevent negative consequences of insufficient sleep.
Abstract P172: Association of Interleukin 6 With Hypertension in HIV Positive Participants in the Strategic Timing of Antiretroviral Treatment (START) Trial
Authors: Lama Ghazi, Jason V Baker, Shweta Sharma, Mamta K Jain, Adrian Palfreeman, Coca Necsoi, Daniel Murray, James D Neaton, Paul E Drawz
Journal: Circulation (2019)

Introduction: The association between hypertension (HTN) and inflammation [e.g., estimated via interleukin 6 (IL-6)] in HIV positive persons who have a CD4+ count greater than 500 cells/mm 3 has not been well established. Methods: We studied HTN in the START trial, a randomized study of immediate vs. deferred antiretroviral therapy (ART) in HIV-positive adults who were ART naïve and had a CD4+ count greater than 500 cells/mm 3 . Our analysis included 4249 of the 4,684 HIV positive persons enrolled in START who had no history of cardiovascular disease and had IL-6 measured at baseline. HTN (prevalence at baseline or incidence) was defined as having a systolic BP ≥140 mm Hg, or a diastolic BP ≥90 mm Hg, or use of BP-lowering therapy. Logistic regression and discrete Cox proportional hazard models were used to test the association between IL-6 and HTN prevalence and incidence. Sensitivity analysis were used to test the association between systolic and diastolic BP and IL-6 levels. Results: HTN was prevalent in 18.9% of the cohort at entry. The median age of participants was 36 years, 27% were female, median CD4 + cell count at entry was 651 cells/mm 3 and median HIV RNA level was 13090 copies/mL. In univariate analysis, HTN was significantly associated with higher IL-6 levels at baseline [OR per doubling of IL-6:1.28, 95%CI (1.18, 1.39)]. This association was attenuated and no longer significant after adjusting for race, age, gender, BMI, diabetes, smoking, RNA and CD4+ levels [OR per doubling of IL-6:1.10, 95%CI (0.99, 1.20)]. The reduced OR was primarily due BMI and age, both which were strongly related to HTN. Overall incidence of HTN was 6.9 cases per 100 person year. Baseline IL-6 was not associated with risk of incident HTN in the crude and fully adjusted model [HR per doubling of IL-6:0.98, 95%CI (0.90, 1.10) in adjusted analysis]. This association did not differ by treatment group (p for interaction=0.21). Risk factors such as age, black race, BMI, and male gender were associated with incident HTN. Continuous systolic and diastolic BP were not significantly associated with IL-6 at baseline or in follow-up analyses. Conclusions: IL-6 was not associated with HTN in HIV positive participants with CD4+ counts greater than 500 cells/mm 3 after adjusting for factors known to be associated with HTN and inflammation. Furthermore, baseline IL-6 level was not associated with incident HTN, nor with continuous BP measures. Rather, HTN development was associated with traditional risk factors such as age, race, gender and BMI.
Third party assessment of resection margin status in head and neck cancer.
Authors: Amy Ransohoff, Douglas Wood, Solomon Henry, Vasu Divi, A. Dimitrios Colevas
Journal: Journal of Clinical Oncology (2015)

e17011 Background: Definitive status of primary site margin following resection of head and neck cancer is necessary for prognostication, treatment determination and qualification for clinical trials. We have noticed that definitive determination of margin status is not always possible from chart review. The goal of this retrospective analysis was to determine how often an independent reviewer can definitively assess primary tumor margin status of head and neck cancer resection based on review of the pathology report, surgical operative report, and first follow-up note alone. Methods: Pathology reports, operative reports, and follow-up notes from head and neck cancer resections performed from 2011 through 2013 at Stanford Hospital were extracted from the electronic medical record (EMR) under an IRB-approved protocol, based on ICD-9 codes. Margin status was classified as definitive or not. We called any pathology report clearly indicating a positive, negative, or close (< 5mm) margin as definitive. For each non-definitive pathology report, the operative note and first follow-up note were reviewed in an attempt to clarify margin status. We also looked for associations between non-definitive status and clinical features such as primary site. Results: Pathology reports, operative reports, and follow-up notes from 467 unique cases of head and neck cancer resection were extracted; 159 cases were discarded as non-head and neck cancer cases, or did not involve a definitive resection of a primary tumor site. The main findings are shown in Table 1. Margin status of 22% of resections could not be definitively established by independent review of the EMR. We found no association between margin status determination and primary tumor site. Conclusions: A substantial fraction of primary site surgical margins could not be definitively determined via independent EMR review. This could have implications for subsequent patient care decisions and clinical trial options. Pathology Report Operative Report Follow-Up Note Definitive Margin Determination (%) 235 (76) 2 (3) 2 (3) Non-Definitive Margin Determination (%) 73 (24) 71 (97) 69 (97) Total cases considered 308 73 71