tbuckley/cabot-search huggingface dataset:
Neoadjuvant XELOX vs. XELIRI in combination with concomitant boost 3D-conformal radiotherapy in locally advanced rectal cancer (LARC)
Authors: G. Privitera, C. Spatola, G. Acquaviva, G. Di Franco, L. Raffaele, V. Salamone, G. C. Ettorre
Journal: Journal of Clinical Oncology (2006)

3570 Background: While several randomized trials have shown that preoperative chemoradiation reduces local recurrence in LARC, there is no standard chemoradiation schedule. The aim of this study was to compare capecitabine + oxaliplatin (XELOX) vs. capecitabine + irinotecan (XELIRI) in association with high-dose radiotherapy. Methods: Patients (pts) with histologically proven uT3–4 N-/+ or uT2 N+ LARC were randomized to receive capecitabine 1250mg/m 2 bid d1–14 before chemoradiation and then 825mg/m 2 bid d22–55 plus either oxaliplatin 130mg/m 2 d1,22&amp;43 (18 pts) or irinotecan 180mg/m 2 d1,22&amp;43 (18 pts). On d22 pts also received radiotherapy administered to the whole pelvis (maximum 45Gy; 1.8Gy/fraction), with a concomitant boost to the CTV (maximum 9Gy; 1.5Gy/fraction) during the last 6d of treatment with a 6h inter-fraction interval. Surgery was carried out 6–8w after chemoradiation by the same surgical team. Results: 36 pts (23M/13F, median age 59 years, ECOG PS 0–1) were enrolled between Jan03 and Jun05. No pt had systemic disease at the time of diagnosis. One pt in the XELIRI group discontinued chemoradiation because of GI toxicity; the other 35 pts (18 XELOX, 17 XELIRI) received 95% and 92% of the planned chemotherapy doses, respectively. The most common adverse event was grade 3/4 diarrhea (6% XELOX, 18% XELIRI). There was no relevant neurotoxicity. 12 pts (67%) on XELOX and 12 pts (71%) on XELIRI had clinical and pathological downstaging. There were no treatment-related deaths. A complete pathological remission was seen in 4 pts (22%) on XELOX and 5 pts (29%) on XELIRI. 25 pts (71%; 13 XELOX, 12 XELIRI) underwent sphincter-saving surgery and 10 pts had Miles abdomino-perineal resection. All pts are alive after a median follow-up of 20 months (range 7–36 months), but 4 (2 in each group) have developed distant metastases. Conclusions: XELOX and XELIRI are feasible and effective, with high efficacy comparable to that observed with other neoadjuvant regimens. XELOX was better tolerated, as diarrhea was seen more frequently in the XELIRI arm. Further studies of these regimens are warranted in this setting. No significant financial relationships to disclose.
P1058 : Increased epicardial fat and early signs of impaired diastolic and systolic left ventricular function in non-diabetic, non-dyslipidemic, normotensive patients with Nonalcoholic Fatty Liver Disease
Authors: E. Vanni, A. Marengo, R. Faletti, M. Morello, L. Mezzabotta, G. Battisti, S. Frea, M. Cannillo, E. Mosso, C. Rosso, L. Bergamasco, M. Rizzetto, E. Bugianesi
Journal: Journal of Hepatology (2015)
Psychiatric illness in homicide victims
Authors: M Herjanic, D A Meyer
Journal: American Journal of Psychiatry (1976)

The authors studied the demographic characteristics and history of psychiatric treatment of 214 homicide victims and 67 suicide victims. Thirty-two (15%) of the homicide victims and 12 (18%) of the suicide victims had a record of psychiatric care; these rates were higher than the treatment rate of the general population. The authors suggest that there may be a connection between the occurrence of homicide and the increased frequency of psychiatric disorders among victims of this crime.
Lenalidomide maintenance after transplantation for myeloma.
Authors: M. Attal, C. Cristini, G. Marit, D. Caillot, T. Facon, C. Hullin, P. Moreau, C. Mathiot, H. Avet-Loiseau, J. L. Harousseau
Journal: Journal of Clinical Oncology (2010)

8018 Background: High-dose therapy with autologous stem cell transplantation (ASCT) is a standard treatment for myeloma patients. However, a residual disease (RD) responsible for relapse is always present. Effective maintenance treatment would be required. However, such treatment is still to be defined. We previously reported that thalidomide reduced RD. However, neuropathy was a major limiting factor. Lenalidomide, a thalidomide analog devoid of neurological toxicity, was thus attractive to investigate. Methods: Patients, under 65 years of age, with non-progressive disease after a first line ASCT (performed within the last 6 months) were randomized to receive a consolidation with lenalidomide (25 mg/d, 21 days/month, for 2 months) followed by a maintenance with either placebo until relapse (Arm A) or lenalidomide (10 to 15 mg/d) until relapse (Arm B). From July 2006 to August 2008, 614 patients were randomized. Patient's characteristics of each group were similar and no significant differences were found with regard to age (57 years), ISS stage, FISH analysis, induction regimen (VAD/bortezomib-dex/thalidomide-dex/others=49%/44%/3%/2%), diagnosis-randomization interval (10 months), and response at time of randomization. Results: In December 2009, with a median follow up of 24 months from randomization, the first pre-planned interim analysis was performed. The independent data and safety monitoring committee recommended to unblind the trial due to the PFS superiority of arm B (primary end point). Consolidation improved the response in 20% of patients. Maintenance with LEN improved the 3-year PFS from randomization: 35% in arm A versus 68% in arm B (HR=0.46, p<10-6). This benefit was observed both among patients achieving or not a complete response after ASCT. In multivariate analysis, PFS was related to response after consolidation, beta-2 microglobulin at diagnosis, and treatment arm. A strong interaction (p<0.04) was found between the efficacy of arm B and beta 2-microglobulin (HR=0.3, p <10-4 for beta-2 m <=3 mg/l; HR=0.58, p<0.003 for beta-2 m > 3 mg/l). The 2-year survival was similar in both treatment arms (95%) Conclusions: Lenalidomide is an effective maintenance treatment which prolongs PFS after ASCT. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Celgene, Janssen-Cilag, Janssen-Ortho Celgene, Janssen-Cilag, Janssen-Ortho
Abstract 10057: Predicting Cardiac Complications during Pregnancy in Women with Congenital Heart Disease
Authors: Laura Thomason, Emir Veledar, Martina Badell, Anurag Sahu, Maan Jokhadar, Michael E McConnell, Brian Kogon, Dan Sorescu, Wendy M Book
Journal: Circulation (2012)

Background: Women with congenital heart disease (CHD) have an increased risk of complications during pregnancy including heart failure (HF), arrhythmias, and thromboembolic events (TEC). In 2010, Drenthen proposed a maternal risk score (MRS) to predict maternal complications, but this score has yet to be verified in a prospective population. Methods: We reviewed 78 pregnancies in 70 women, mean age 26.97 ± 5.71 years (range 17.12 - 41.8). CHD defect classification was simple in 5 (6.4%), moderate in 48 (61.5%), complex in 20 (25.6%), and other in 5 (6.4%) with mean MRS of 1.45 (range 0- 9). Results: Maternal cardiac complications defined as clinically significant arrhythmia, HF, or TEC occurred in 17 pregnancies (28.8%). Risk distribution and maternal complications rates are shown in the table. There was a statistically significant trend towards a higher rate of adverse cardiac events with a higher MRS (p = 0.023). All complications in two lowest risk categories (0-1.50) were arrhythmias. A logistic model...
Evaluating carcinoembryonic antigen (CEA) and tumor size as predictors of outcome in patients receiving capecitabine (X) plus oxaliplatin for metastatic colorectal cancer (MCRC): findings from a retrospective analysis
Authors: F. Jonsson, C. Twelves, J. Tabernero, P. Schoffski, A. Sobrero, E. Van Cutsem, E. Díaz-Rubio, J. Cassidy, L. Claret, K. Zuideveld
Journal: Journal of Clinical Oncology (2006)

13534 Background: The oral fluoropyrimidine X has superior efficacy and improved safety compared with bolus 5-FU/LV in CRC. Twice-daily oral X is replacing 5-FU as the backbone of combination regimens. The combination of X and 3-weekly oxaliplatin (XELOX regimen) has demonstrated similar efficacy to FOLFOX with some safety advantages and enhanced convenience in phase II/III clinical trials. The objective of this retrospective study was to investigate the use of CEA as an early predictor of outcome. Methods: The data used in this analysis came from a previously published large phase II study (n=96) of XELOX as first-line treatment for patients with MCRC [Cassidy et al. J Clin Oncol 2004]. A population-based pharmacodynamic analysis of CEA and tumor size progressions was performed. The resulting data were linked to hazard models for the secondary clinical endpoints: time to disease progression (TTP) and overall survival. As we were interested in early prediction, model-predicted time courses of CEA and tumor size (up to 10 weeks) were examined as covariates in the hazard models. The resulting predictions for TTP and survival based on either measure were tested and compared using stochastic simulations. Results: An indirect effect model provided the best description of CEA progression. For tumor size, a similar indirect effect model with an added resistance term gave the best description. CEA performed marginally better than tumor size in predicting survival and less well in predicting TTP. For survival the misclassification rate decreased from 0.426 to 0.404 when using tumor size and to 0.396 when using CEA as predictors. Conclusions: CEA and tumor size were found to have clinically equivalent power as early phase predictors of clinical outcome. [Table: see text]
Abstract 15764: Coronary Vasomotor Dysfunction Indicates Remodeling Type of Epicardial Vasculopathy and Microvasculopathy in Biopsy of Cardiac Transplant Recipients
Authors: Nicola E Hiemann, Rudolf Meyer, Stephan Dreysse, Christoph Klein, Peter Breit, Roland Hetzer, Ernst Wellnhofer
Journal: Circulation (2012)

Coronary vasomotor dysfunction precedes the development of vasculopathy after heart transplantation (HTx). Longitudinal analysis of vasomotor function in epicardial vasculopathy and microvasculopat...
Abstract 18860: Cardiorespiratory Fitness Affects the Rate of Decline of Maximal Heart Rate with Age
Authors: Cemal Ozemek, Mitchell H Whaley, Holmes W Finch, Leonard A Kaminsky
Journal: Circulation (2014)

Introduction: There is a general consensus that an individual’s cardiorespiratory fitness (CRF) does not affect the rate of decline of maximal heart rate (HRmax) with age. This consensus was developed primarily from large cross-sectional studies performing symptom limited exercise tests, which lack cardiometabolic data to confirm the achievement of true maximal effort and are limited to predicting CRF. Methods: Maximal cardiopulmonary exercise test (CPET) results, with directly measured CRF, from participants (1161 men, 1070 women) of a university based health-assessment/fitness program were examined. Participants’ data were included if they performed a CPET on a treadmill, achieved a respiratory exchange ratio ≥1.0 and were not taking HR altering medications. Only subjects having completed ≥2 CPETs with ≥1 year between test dates were included in the longitudinal analysis (282 men, 172 women). Subjects were categorized into CRF categories (high, moderate, and low) relative to age and gender normative cla...
Outcome of patients with an initial presentation of brain metastases.
Authors: Lawrence Berk, Bryan Stevens
Journal: Journal of Clinical Oncology (2014)

133 Background: Many studies have looked at the survival of patients with brain metastases but few studies have determined if the survival of patients initally presenting with brain metastases is the same as patients who subsequently develop brain metastases. Methods: Patients with no known history or a malignancy who presented to the hospital with brain metastases were retrospectively revieweed for survival. The survival data were collected from the hospital's tumor registryand the Social Security Index. The years 2010-2011 were studied as of 5/31/2013. Results: Ninety-four patients met the inclusion criteria in 2010 and eight-two patients in 2011. Sixty five percent of the patients in 2010 were male and fifty-five percent were male in 2011. The median age was approximately 60. In 2010 53% of the patients had lung cancer and 12% had breast cancer and in 2011 45% had lung cancer and 13% had breast cancer. zThus the median survival is equivalent to the median survival of the lung cancer patients, which was 71 days in 2010 and 37 days in 2011. the median survival of the breast cancer patients were 153 days in 2010 and 35 days in 2011. Sixty three percent of the patients received radiation therapy as some part of their treatment and eighteen percent received no treatment. The median survival time of patients receiving radiation therapy only as treatment was 84 days and the patients with no treatment had a survival of 34 days. Conclusions: The survival of patients presenting with brain metastases falls within the range expected from previous studies of patients with brain metastases. The survival of patients presenting with lung cancer was much poorer than patients with breast cancer. Patients for no treatment appear to be appropriately selected, with a median surival of approximately one month.
Utilization and cost of CPT-11 (C) in elderly previously treated metastatic colorectal cancer (MCRC) patients (pts)
Authors: C. Eng, L. Zhao, Y.-C. T. Shih
Journal: Journal of Clinical Oncology (2004)

3587 Background: The topoisomerase I inhibitor, irinotecan (CPT-11), is widely available for pts with progressive disease despite first-line therapy with 5-fluorouracil (5-FU). Potential adverse toxicities of CPT-11 [C] include treatment-related diarrhea and myelosuppression which may impact treatment decisions in elderly pts (≥ 65 y/o). Cost analysis and actual use has not been previously reported in this pt population. Methods: A sample of MCRC pts was selected from the 1996–1999 SEER-Medicare database. MCRC pts were identified by cancer site, histology codes, and AJCC stage. Chemotherapy regimens were identified from the Medicare claims via ICD-9-CM and HCPCS codes. A multivariate logistic model was used to examine factors associated with C among Medicare beneficiaries. Two types of costs were estimated for each 6-week period: 1) Medicare payment for chemotherapy and 2) Medicare payment incurred during each 6 weeks. T-test was used to compare cycle-specific costs across regimens. Results: The study sample included 3,449 MCRC pts; 1,538 (44.6%) were treated with chemotherapy; 1,140 (74%) had identifiable chemotherapy regimens. C-based regimens were used in 12% of pts. The logistic model showed no gender or racial difference; the estimated odds ratio (OR) between male and female and non-white and white was 0.998 (P=0.95) and 0.912 (P=0.69), respectively. Cost comparisons across regimens are presented in Table 1. Conclusions: CPT-11 resulted in higher chemotherapy-related and overall costs. Higher overall costs may be due to a greater incidence of treatment-related adverse events. Future studies are needed to explore whether the higher costs of C can be outweighed by the added survival in the elderly population. Table 1: Average Costs per 6-week Treatment Cycle by Chemotherapy Regimens Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer Pfizer
Abstract 149: The Method Matters: Community Consultation Methods Influence Attitudes and Understanding of Proposed Trial Using Exception from Informed Consent for Research in Emergency Settings
Authors: Victoria Mah, Neal W Dickert, Michelle H Biros, Deneil Harney, Robert E Silbergleit, Jeremy Sugarman, Kevin P Weinfurt, David W Wright, Rebecca D Pentz
Journal: Circulation (2012)

Background- Resuscitation research often requires an exception from informed consent (EFIC). EFIC regulations require community consultation (CC) during development and approval. CC is conducted ma...
Effect of Bile Acids and Neutral Sterols on Benzo[ a ]pyrene-Induced Tumorigenesis in Skin of Mice: Brief Communication 2
Authors: Kenshi Watanabe, Tomio Narisawa, C. Q. Wong, John H. Weisburger
Journal: JNCI Journal of the National Cancer Institute (1978)

The effect of neutral sterols and bile acids were determined in the classic mouse skin tumor induction system by applying each sterol or acid with benzo[a]pyrene to the skin of Swiss mice three times per week for 60 weeks. The mice were killed 63 weeks after the experimenta was begun. Most of the chemicals had an inhibitory effect on skin tumor formation by benzo[a]pyrene. Unconjugated bile acids had higher inhibitory action than did conjugated bile acids. The inhibition decreased in the following order of acids: chenodeoxycholic, lithocholic, deoxycholic, and clinic. Within the group of conjugated acids, taurine conjugates were more effective inhibitors than were glycine conjugates. The neutral sterols cholesterol, coprostanol, and coprostanone showed relatively similar, moderate inhibitory effects.
Abstract 17449: Angiotensin II Induces Wnt/{beta}-catenin Signaling and Cellular Proliferation in Mouse Mitral Valves
Authors: Nassir M Thalji, Michael A Hagler, Bin Zhang, Carolyn M Roos, Rakesh M Suri, Jordan D Miller
Journal: Circulation (2013)

Myxomatous mitral valve degeneration (MMVD) is a prominent cardiac disease characterized by cellular proliferation, matrix remodeling, and leaflet prolapse. While much emphasis has been placed on i...
Pre-transfusion hemoglobin (PT-Hb) levels in erythropoiesis-stimulating agent (ESA)-treated patients with chemotherapy-induced anemia (CIA): Results from randomized controlled trial (RCT) and observational data.
Authors: E. Apgar, T. M. Burton, K. Larholt, C. L. Pashos, D. H. Henry, W. Langholff, L. Ellis, R. S. McKenzie, M. Senbetta, C. T. Piech
Journal: Journal of Clinical Oncology (2010)

e16559 Background: Cancer patients often experience CIA and may be treated with ESAs. Recent observational data on PT-Hb levels in ESA-treated patients with CIA have not been reported. This analysis evaluated PT-Hb levels for this population from RCTs and the DOSE registry, a prospective, observational study of real-world ESA treatment patterns and hematologic outcomes. Methods: Data from ESA-treated cancer patients with CIA were obtained from 3 RCTs (Waltzman/Oncologist 2005; Henry/Curr Med Res Opin 2006; Glaspy/Cancer 2009) and from the DOSE registry (Larholt/Clin Drug Inv 2008). Transfused patients with PT-Hb measurements were identified. PT-Hb levels were defined according to RCT protocols or as the most recent Hb value 7 days before the transfusion episode (DOSE registry). Descriptive statistics summarize the analyses. Results: Of the 834 ESA-treated CIA patients from RCTs, 150 received a total of 257 transfusions, of which 245 (95.3%) had PT-Hb levels available. Of 1,810 ESA-treated CIA registry patients (enrolled 12/2003-5/2009), 364 received a total of 596 transfusions, of which 508 (85.2%) had PT-Hb levels available. The PT-Hb was significantly lower in RCT patients compared to registry patients (mean±sd: RCT 8.0±1.0 g/dL, registry 8.9±1.1 g/dL, p<0.0001). The PT-Hb range was wide for both groups (RCT: 4.7-13.1 g/dL; registry: 5.1-12.9 g/dL). In RCT patients, 42.4% of transfusions occurred at PT-Hb levels <8.0 g/dL and 1.9% at ≥10.0 g/dL. In registry patients, 15.8% of transfusions occurred at PT-Hb levels of <8.0 g/dL and 13.1% at ≥10.0 g/dL. Conclusions: Wide variance of PT-Hb levels in ESA-treated patients with CIA was reported from RCT and observational data. Mean PT-Hb was significantly lower in the RCT compared to observational data. Patient characteristics or site-specific transfusion policies that may contribute to the latter represent an area of future research. Group Transfusions based on PT-Hb range (g/dL), n (%) <7.0 7.0-7.9 8.0-8.9 9.0-9.9 >10.0 Missing RCTs 21 (8.2) 88 (34.2) 105 (40.9) 26 (10.1) 5 (1.9) 12 (4.7) Registry 13 (2.2) 81 (13.6) 192 (32.2) 144 (24.2) 78 (13.1) 88 (14.8) Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Centocor Ortho Biotech Centocor Ortho Biotech Johnson & Johnson Centocor Ortho Biotech
Efficacy of weekly low-dose chemotherapy in elderly women with advanced ovarian cancer: is there an antiangiogenic effect?
Authors: S. Darwish, G. Bronte, A. Ignoto, D. Piazza, S. Rizzo, S. Russo, I. Carreca
Journal: Journal of Clinical Oncology (2006)

13133 Background: In elderly patients decreased functionality of multiple organ systems may affect pharmacokinetics and pharmacodynamics of drugs. For this reason elderly cancer patients experience enhanced susceptibility to common chemotherapy-related adverse events. A way to prevent these effects could be metronomic chemotherapy, which is a variation of dose-dense therapy, with a cumulative dose significantly lower than maximum tolerated dose. Methods: 27 advanced ovarian cancer patients, median age 67 (range 60–86), received low dose weekly continuous chemotherapy until disease progression. All patients were treated with CBDCA AUC 2 mg/ml/min and Docetaxel 35 mg/sqm (adjusted according with Kintzel &amp; Dorr formula) i.v. weekly. Primary endpoints were response rate (RR) and time to treatment failure (TTF). Moreover we considered as secondary endpoints toxicity profile, VEGF values and Quality of Life (QoL) score. RR and TTF were evaluated with RECIST criteria and Kaplan-Meyer formula respectively, toxicity was assessed according to the NCI-CTC. VEGF concentrations were analyzed by ELISA, QoL score was determined using the ADL/IADL and EORTC QLQ-C30 questionnaires, at baseline (T0) and at the end of therapy (T1). Results: median duration of treatment was 39 weeks. 2 Complete Responses (CR) and 5 Partial Responses (PR) were achieved for a 26% RR. Stable Disease was achieved in 18 pts (67%) with a total Clinical Benefit (CB) of 93%. Overall toxicity was very low: haematological G1/2 - 6 pts; gastrointestinal G1 - 8 pts; neurological G1/2 - 5 pts; cutaneous G3 - 1 pt; renal G1 - 1 pt. A mean TTF of 17.4 months was reached. Mean VEGF values (T0): 527 ± 35 pg/ml, (T1): 335 ± 18 pg/ml (p = 0,003). QoL score (T0): 45.2 ± 12, (T1): 47.5 ± 25 (p = 0,06). Conclusions: first results seem to be very encouraging, even if the number of responses is too small and we need to enrol more pts to reach a good statistical evaluation. Nevertheless the use of this “metronomic” schedule shows that VEGF values decrease strongly during the treatment and is maintained also when treatment is discontinued. Thus it suggests a preminent antiangiogenic role of this schedule according with the most recent preclinical and clinical studies. No significant financial relationships to disclose.