tbuckley/cabot-search huggingface dataset:
Comparison of epoetin alfa (EPO) and darbepoetin alfa (DARB) utilization in cancer chemotherapy patients treated in a hospital outpatient setting
Authors: F. Vekeman, M. LaFeuille, R. Bailey, C. Tak Piech, R. S. McKenzie, P. Lefebvre
Journal: Journal of Clinical Oncology (2009)

e17524 Background: With recent changes in erythropoiesis-stimulating agent (ESA) labeling and coverage limitations by the Centers for Medicare and Medicaid Services, it is important to examine the evolution of EPO and DARB real-world utilization in cancer patients receiving chemotherapy in a hospital outpatient setting. Methods: Electronic outpatient records (2006–2007) from &gt;500 hospitals in the Premier Perspective Comparative Hospital Database were analyzed. Subjects were ≥18 years, had ≥1 cancer diagnosis, received chemo during newly initiated ESA therapy, and ≥2 doses during the treatment episode (classified by quarter of ESA initiation). Mean cumulative dose and dose ratio of EPO:DARB were calculated. 2% of patients with extreme doses were excluded. Results: 7,259 outpatient treatment episodes were identified (EPO 3,568;DARB 3,691). EPO patients were slightly younger (years; EPO 62.7;DARB 64.0, p&lt;.0001), had lower proportion of women (EPO 62.2%;DARB 65.4%, p=0.0044), and had slightly longer mean treatment duration (EPO 3.1 months; DARB 2.9 months, p=0.0009) compared to DARB patients. Mean cumulative dose (SD) per treatment episode was EPO 263,582 (210,167) Units and DARB 1,005 (678) mcg, corresponding to a dose ratio of 262:1 (Units EPO: mcg DARB). Over time, mean cumulative dose, mean treatment duration, and dose ratio reflected a downward trend for both groups ( Table ). Conclusions: This analysis reported a mean dose ratio of 262:1 (Units EPO: mcg DARB) in cancer chemotherapy patients from a hospital outpatient setting. Recent changes in ESA prescribing information and coverage appear to have decreased ESA utilization and the EPO: DARB dose ratio over time. [Table: see text] [Table: see text]
Yttrium-90 ibritumomab tiuxetan radioimmunotherapy in primary cutaneous B-cell lymphomas: first results
Authors: M. Steinhoff, S. Gellrich, S. Maza, C. Assaf, H. Orawa, D. L. Munz, W. Sterry
Journal: Journal of Clinical Oncology (2008)

19525 Background: Radioimmunotherapy with Yttrium-90 ibritumomab tiuxetan (YIT), a radio-labelled anti-CD20 antibody, was shown to be highly effective in systemic B-cell lymphomas. We for the first time evaluated the outcome and complications of YIT therapy in patients with primary cutaneous B-cell lymphomas (PCBCL), a distinct group of non-Hodgkin lymphomas. Methods: Ten patients, all but one, with relapsed PCBCL were included and treated according to the standard protocol with rituximab (250mg m-2/body surface) on day 1 and 8 followed by a single dose of YIT (11–15 MBq kg-1). The median follow up period was 19 months (range 9–29 months). Results: The overall response rate was 100%. The complete response rate was 100%. The median time to complete response was 4.5 weeks. The median time to relapse (TTR) was 12 months. Ongoing remission was achieved in 4 patients. Transient and reversible myelosuppression in 80% of patients was the primary toxicity. Conclusions: Radioimmunotherapy with YIT is an effective treatment in PCBCL. Further investigations in controlled randomized clinical trials evaluating the role of radioimmunotherapy with YIT versus rituximab in PCBCL are needed. No significant financial relationships to disclose.
Abstract 9973: Late Revealing ECG abnormalities in Patients With Idiopathic Ventricular Fibrillation and Unknown Cause Ventricular Tachycardia Undergoing Implantable Cardioverter Defibrillator
Authors: Ki Hong Lee, Jeong Gwan Cho, Hyung Wook Park, Nam Sik Yoon, Don Han Kim, Jong Hyun Ryu, Youngkeun Ahn, Myung Ho Jeong, Jong chun PARK, Jung Chaee Kang, Young Joon Hong, Ju Han Kim, Min Goo Lee, Keun Ho Park, Doo Sun Sim, Kye Hoon Kim, Hyun Ju Yoon
Journal: Circulation (2012)

Backgroud: Despite of meticulous evaluation to reveal the cause of sudden cardiac death, some patients have been implanted Implantable Cardioverter Defibrillator (ICD) without definitive cause. However, they might have certain electrocardiogram (ECG) abnormalities during follow up. Methods: We analyzed 145 patients (55.8±16.6 years old, 95 males) who underwent ICD implantation in single center from January 1999 to March 2012. 43 patients (29.7%) were designated as idiopathic ventricular fibrillation (VF) or unknown cause ventricular tachycardia (VT) without organic nor ECG abnormalities. ECG abnormalities including early repolarization (ER) were analyzed during 3.7±2.4 years median follow-up duration. Appropriate shock and electrophysiologic inducibility of recurrent VF/VT were analyzed in patients with late revealing ECG abnormalities. Results: 32 patients (77.4%) showed ECG abnormalities during long-term follow-up after ICD implantation. 3 patients (7.0%) revealed Brugada type 2 ECG abnormalities, and 29 patients (67.4%) revealed ER. In patients with ER, 16 patients (37.2%) showed notching J point elevation, whereas 13 patients (30.2%) showed slurred J point elevation. Also 9 patients (20.9%) showed rapidly upsloping ST segment elevation (STE), whereas 20 patients (46.5%) showed horizontal/descending STE. Appropriate shock was dominantly delivered in patients with horizontal/descending STE compared with in patients without horizontal/descending STE (40.4% vs. 17.4%, Odd Ratio [OR] 3.17, 95% Confidence Interval [CI] 0.78-6.86, p=0.09). In patients undergoing electrophysiology before ICD implantation, recurrent VF/VT were significantly induced in patients with horizontal/descending STE compared with upsloping STE (71.4% vs. 25.0%, p=0.035). In subgroup analysis, only patients with inferior leads ER received significantly higher appropriate shock than other leads ER (43.5% vs. 10.0%, p=0.015). Conclusions: Considerable patients had ECG abnormalities after ICD implantation, although initial meticulous evlaution did not reveal any structural or ECG abnormalities. Also, Horizontal/descending STE in inferior leads might predict further appropriate ICD shock.
A model to optimize health care assistance for women with breast cancer: The Núcleo Mama Porto Alegre Project
Authors: M. Caleffi, J. P. Viegas-Butzke, F. D. Baldisserotto, A. Bedin-Junior, B. Weber, D. Duarte-Filho, G. P. Skonieski, M. Graudenz, R. A. Ribeiro
Journal: Journal of Clinical Oncology (2009)

e17526 Background: The promptness of breast cancer (BC) diagnosis and treatment is cornerstone in reducing the disease's mortality. In Brazil, the main problem to achieve this is lack of access to the insufficient referral centers, which in turn are not used to perform early diagnosis and treatment. To address this problem in our city, we created the Núcleo Mama Porto Alegre (NMPOA) model, through a partnership among the private, public and third sectors. The cohort is composed by 9,218 women, of which 4,500 are in the 40–69 age group and have annual clinical examination and mammography (MMG) at NMPOA, and the remainder (&lt;40 and &gt;=70) have clinical follow-up at primary care facilities. All clinical visits, exams and treatment are conducted in the NMPOA center. Our aim is to demonstrate the effectiveness of a model for underserved population to shorten the time between 1st medical appointment and the start of BC treatment. Methods: We analyzed all BC cases diagnosed up to now. We evaluated 3 time periods of the patient's care: median time (MT) between the medical appointment and MMG, MT between MMG and biopsy, and MT between biopsy and the first treatment as indicated: definitive surgery, neoadjuvant chemo- or hormone therapy. Results: 48 cases were evaluated. Clinical staging were the following: stage 0: 16.6%; I: 37.5%; IIA: 18.8%; IIB: 12.5%; IIIA: 10.4%; and IV: 4.1%. MT between the first visit and MMG was 0 days; between MMG and biopsy, 3 days; and between biopsy and first treatment, 23 days. Conclusions: Our model shows much faster results than the usual delay time in Brazil (4–6 months between first visit and treatment). A nationwide BC screening program in Brazil must be implemented with efficient infrastructure and well trained personnel in order to rapid investigate breast lesions, assuring quick access to treatment and therefore diminishing BC mortality. No significant financial relationships to disclose.
Mega Ovarian Cancer Screening Trial Shows Modest Reduction in Mortality
Authors: Anita Slomski
Journal: JAMA (2016)

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Examination of the Follicular Lymphoma International Prognostic Index (FLIPI) in the National LymphoCare Study (NLCS): A U.S. patient cohort treated predominantly in community practices.
Authors: A. K. Nooka, N. J. DeJoubner, C. Nabhan, X. Zhou, M. Taylor, M. Byrtek, T. P. Miller, J. W. Friedberg, A. D. Zelenetz, B. K. Link, J. R. Cerhan, H. Dillon, D. Levy, J. Hirata, C. Flowers
Journal: Journal of Clinical Oncology (2011)

8036 Background: FLIPI uses five prognostic factors to define 3 risk groups. Limited data exists regarding the role of FLIPI in the era of rituximab (R) and R-chemo as initial therapy Methods: NLCS, a prospective, observational cohort study, collected demographic and clinical outcome data. Cox proportional hazards models were constructed to examine FLIPI strata as predictors for PFS, time to next therapy (TTNT) and OS. Results: Among the 1,069 male and 1,124 female patients (pts) with FL 52% were > 60 years, 69% stage III-IV, 22% had Hb <12 g/dL, 37% >4 nodal areas, and 22% LDH >ULN. Most pts were white (91%), treated in U.S. community practices (79%), had ECOG PS of 0/1 (67%/29%), and treated with single agent R (14%) or a R-containing regimen (54%). 771 pts (35%) were FLIPI low risk (LR), 666 (30%) intermediate (IR), and 756 (35%) high (HR). Statistically significant differences were seen between the 3 risk groups among pts receiving non-R containing regimens in OS, PFS and TTNT concordant with prior studies. FLIPI risk groups were significant predictors of PFS and OS for patients treated with R-alone, R-CHOP, and R-CVP. Conclusions: FLIPI remains a useful prognostic index in pts treated in US community practices with non-R and R-containing regimens. Stratifying pts into FLIPI risk groups, generally predicts better outcomes for the LR group > IR > HR in terms of PFS, TTNT and OS. TTNT PFS OS IR Haz (95% CI) HR Haz (95% CI) IR Haz (95% CI) HR Haz (95% CI) IR Haz (95% CI) HR Haz (95% CI) All (n=2,191) 1.4 (1.1, 1.6) 1.6 (1.4, 2.0) 1.6 (1.3, 1.9) 2.3 (2.0, 2.8) 2.5 (1.7, 3.7) 6.7 (4.8, 9.5) R or R-containing (n=1,480) 1.3 (1.0, 1.6) 1.7 (1.4, 2.1) 1.6 (1.3, 2.1) 3.0 (2.4, 3.7) 2.6 (1.5, 4.5) 8.4 (5.3, 13.6) R-CVP (n=263) 1.3 (0.6, 2.5) 2.2 (1.2, 3.9) 1.2 (0.6, 2.4) 3.4 (2.0, 6.0) 1.6 (0.4, 5.6) 6.8 (2.4, 19.0) R-alone (n=297) 1.0 (0.6, 1.6) 1.9 (1.3, 2.9) 1.7 (1.1, 2.7) 2.7 (1.8, 4.2) 6.1 (1.7, 21.1) 13.8 (4.3, 44.5) R-CHOP (n=584) 1.2 (0.8, 1.7) 1.4 (0.9, 1.9) 1.5 (1.0, 2.2) 2.3 (1.6, 3.4) 2.3 (0.9, 6.1) 6.8 (2.9, 15.8) Watchful waiting (n=374) 1.5 (1.1, 2.1) 1.4 (1.0, 2.1) 1.7 (1.3, 2.4) 1.8 (1.3, 2.6) 2.6 (1.2, 5.7) 4.6 (2.1, 9.7) Abbreviation: Haz, hazards ratio.
Abstract 17042: Transapical Aortic Valve Implantation: Analysis of Risk Factors and Learning Experience in 299 Patients
Authors: Joerg Kempfert, Ardawan Rastan, David Holzhey, Axel Linke, Gerhard Schuler, Arnaud van Linden, Johannes Blumenstein, Friedrich W Mohr, Thomas Walther
Journal: Circulation (2010)

Background: Transapical aortic valve implantation (TA-AVI) has evolved as an established therapeutic option for high risk patients with aortic stenosis. We performed multivariate analysis of outcom...
Abstract 12665: Impaired Resting Myocardial Annular Velocities are Independently Associated with Mental-stress Induced Ischemia in Patients with Coronary Heart Disease
Authors: Mads Ersboll, Fawaz A Enezi, Zainab Samad, Brenda Sedberry, Stephen H Boyle, Christopher O'Connor, Wei Jiang, Eric J Velazquez
Journal: Circulation (2013)
Abstract 18677: The ACEF Risk Score Exhibits Superior Predictive Ability for Adverse Clinical Outcomes in Women Undergoing PCI
Authors: Jason C Kovacic, Atul M Limaye, Nilusha Gukathasan, Samantha Sartori, Biana Trost, Birju Narechania, Roja Thapi, Michael C Kim, Pedro Moreno, Usman Baber, George Dangas, Roxana Mehran, Samin K Sharma, Annapoorna Kini
Journal: Circulation (2012)

Objectives: Women are known to experience worse clinical outcomes than men following percutaneous coronary intervention (PCI). Rather than a gender-specific effect, this is believed to be due to a greater burden of baseline cardiovascular risk factors. We therefore sought to identify which of the commonly used risk scores identify female patients at particular risk for adverse clinical events following PCI. Methods: Patients with triple vessel and/or LM disease with 12 month follow-up were studied from our single center PCI registry (n=584; mean age 69.8±12.3). Exclusion criteria included STEMI presentation, prior revascularization, and shock. Clinical events at 12 months were compared to baseline risk scores, based on area under the receiver operating characteristic curves (AUC; all comparisons females vs. males, respectively). The following scores were evaluated and compared: SYNTAX risk score (SRS), ACEF, modified ACEF (ACEFmod), NCDR, Clinical SYNTAX score (CSS), and NY State Risk Score (NYSRS). Results: Women (n=179, 30.7%), were older (75.8±10.6 vs. 67.2±12.2; p≤0.0001) and more often presented with CCS class III/IV angina. The SRS was the only risk score for which women and men had similar scoresvalues; for all other scores women had significantly higher scores values than men. For mortality, the ACEF score was the only score to show significantly better predictive ability in females (AUC 0.85 vs. 0.70; p&lt;0.05) (Figure). For myocardial infarction, both the ACEF (0.79 vs. 0.49; p&lt;0.005) and NYSRS (0.75 vs. 0.48; p&lt;0.05) showed superior predictive ability in females. No score demonstrated gender specificity for TLR. For overall MACE (mortality+MI+TLR), the ACEF score was the only score with greater predictive ability in females versus males (0.69 vs. 0.56; p&lt;0.05) (Figure). Conclusions: The ACEF score is simple to calculate (using only Age, Creatinine and Ejection Fraction) and offers superior clinical outcome prediction in females undergoing PCI.
Prediction of preclinical myocardial damage utilizing cardiac biomarkers and ultrasound myocardial tissue characterization by integrated backscatter in patients with breast cancer treated with postoperative adjuvant radiotherapy.
Authors: Yong Zhang
Journal: Journal of Clinical Oncology (2012)

169 Background: To evaluate whether cardiac biomarkers, ultrasonic integrated backscatter (IBS) can predict early myocardial damage in breast cancer patients treated with postoperative adjuvant radiotherapy. Methods: Forty-eight left-sided breast cancer patients treated with modified radical mastectomy and non-anthracycline containing chemotherapy regimen were examined. Baseline blood samples were drawn for cardiac markers analysis, including Troponin T (TnT), C-reactive protein (CRP), and brain natriuretic peptide (BNP). Calibrated myocardial IBS (CMIBS, assessed by comparison of the anterior wall (AW), inferior wall (IW), anteroseptum (AS) and posterior wall (PW) with pericardial IBS intensity), cyclic variation of IBS (CVIBS) and conventional echocardiography parameters (LVIDd: the left ventricular internal diameter at end-diastole; IVSTd: the intraventricular septal thickness at end-diastole; PWTd: the posterior wall thickness at end-diastole; LVDs: the left ventricular end-systolic dimension; EF: the left ventricular ejection fraction; FS: the left ventricular fractional shortening. The peak velocity of early (E) and late ventricular filling (A) were also determined for calculating the ratio E/A) were investigated before the initiation of radiotherapy (group A), during (group B, 3 weeks after the initiation, the cumulative dose was about 30Gy) and after radiotherapy (group C, 5 weeks, the cumulative dose was about 50Gy). At each time point, blood was drawn to measure TnT, CRP, and BNP. Results: TnT, CRP, and BNP did not change over time. CMIBS of AW and AS were significantly increased after radiotherapy both during (group B, p&lt;0.05) and at the end of treatment (group C, p&lt;0.01) and meanwhile CVIBS and E/A were decreased significantly throughout the treatment period (group B, p&lt;0.05 for both; group C, p&lt;0.01 for both) compared with the beginning (group A). Conclusions: Myocardial IBS offers a promising approach for early clinical detection and characterization of evolution of cardiomyopathy induced by radiotherapy in breast cancer patients.
The BMJ's Nuremberg issue
Authors: G J Addis, D London
Journal: BMJ (1997)

CONSORT statement on the reporting standards of clinical trials Recommendations are inappropriate for trial reportsEditor-In his editorial on the CONSORT statement Douglas G Altman states that since "only randomised trials have the potential directly to affect patient care ... it is ... reasonable to require higher standards for papers reporting randomised trials than those describing other types of study." 1 But although randomised trials are usually the preferred approach for the unbiased evaluation of treatments, non-randomised observational studies also influence treatment.Because the correct interpretation of observational studies is much more difficult, largely due to uncontrollable biases, their description and analysis call for at least as much care as do randomised trials.Sometimes, of course, randomised comparisons are unnecessary-for example, to determine the value of fetoprotein screening for neural tube defects.CONSORT is the product of deliberations conducted almost entirely through North American journals. 2Journal editors and statisticians are well represented among those involved, but clinicians and others with experience in actually conducting trials less so.Experience of the procedures recommended seems to be limited and not wholly positive.The authors of one trial report who had been persuaded to rewrite it 3 in the structured format expressed mixed feelings: the paper was rendered less readable with "ideas that are logically linked together (such as point estimates with 95% confidence intervals) torn asunder." 4 Inflexibility and a lengthier manuscript were other reported disadvantages.The editor stated that a journal "should change the way it structures articles only when there is good agreement on the new format in the communities we serve" 4 ; this includes writers and readers of trial reports as well as editors.Feedback from the test case 3 or from other commentators does not seem to have materially altered the final version of CONSORT.By announcing its decision, less than a fortnight after publication of CONSORT, the BMJ pre-empted input from many with experience of planning, conducting, and reporting trials.Few will dispute the need for improvements in the reporting of all studies with implications for patient care, whatever their design.But without appropriate consultation, the BMJ seems to have made its decision on CONSORT prematurely.The requirement that randomised trials report the numbers of patients excluded is generally pointless, 5 and making authors indicate where a large number of checklist items are dealt with would be unduly prescriptive.The CONSORT recommendations should not be imposed unilaterally.Others with experience of trial conduct should be consulted on the nature of any guidelines for the reporting of randomised trials and, more importantly, of observational studies of treatments.
End-of-Life Care Intensity for Physicians, Lawyers, and the General Population
Authors: Joel S. Weissman, Zara Cooper, Joseph A. Hyder, Stuart Lipsitz, Wei Jiang, Michael J. Zinner, Holly G. Prigerson
Journal: JAMA (2016)

Care at the end of life must balance intensity of treatment with quality of life.Previous research has not determined whether physicians, the group most familiar with end-of-life care, receive higher or lower intensity end-of-life treatments compared with nonphysicians.
Mutagenic Activity of Tryptophan Metabolites Produced by Rat Intestinal Microflora23
Authors: P. Bowden, King-Thom Chung, A. W. Andrews
Journal: JNCI Journal of the National Cancer Institute (1976)

The catabolism of tryptophan by rat intestinal microflora was studied for the production of mutagenic metabolites that might be involved in the etiology of colon cancer. Various tryptophan metabolites were assayed for mutagenic and comutagenic activity in the Ames bacterial test system. These included metabolites that were identified by thin-layer chromatography in cultures of rat fecal bacteria, other compounds structurally related to tryptophan, whole unfractionated mixed fecal bacteria culture filtrates, and concentrated solvent extracts. A total of 27 materials were tested with 5 Salmonella strains in the mutagenesis assay. Most substances were inactive, and only one compound, o-aminoacetophenone, which was unlikely to be produced in the intestine, showed weak comutagenic activity. Our results did not support the hypothesis that tryptophan metabolites produced by intestinal microflora are major etiologic factors in cancer of the colon.