bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical outcome of patients with implantation of second‐generation drug‐eluting stents in the right coronary ostium: Insights from 2‐year follow‐up of the TWENTE trial
Authors: Lam Ming Kai , Sen Hanim , Tandjung Kenneth , Löwik Marije M. , Basalus Mounir W.Z. , Mewes Janne C. , Stoel Martin G. , van Houwelingen K. Gert , Linssen Gerard C.M. , Ijzerman Maarten J. , Doggen Carine J.M. , von Birgelen Clemens 
Published: April 2014

ObjectivesThe aim of the present study was to assess the impact on clinical outcome of right coronary artery (RCA) ostial coverage with second‐generation drug‐eluting stents (DES).BackgroundTreatment of the aorta‐ostial (AO) region of the RCA with bare metal stents and first‐generation DES has been associated with a higher risk of target‐lesion revascularization (TLR).MethodsOf the 1,391 patients of the prospective TWENTE trial, we identified 321 (23%) with single‐vessel RCA treatment, who were categorized into stenting with AO stent coverage (AOC) versus stenting without AOC. The AO region was defined as 3 mm from the aortic orifice.ResultsThe 67 (20.9%) patients with AOC showed more severe lesion calcifications than the 254 patients without AOC (31.3% vs. 12.6%; P < 0.01). In the AOC group, there was a higher prevalence of hypercholesterolemia and family history of coronary disease (75.4% vs. 61.6%, and 68.7% vs. 53.5%, respectively; P = 0.03). During 2‐year follow‐up, patients in the AOC group had a higher incidence of TLR (7.5% vs. 1.6%; P = 0.02). Following adjustment for confounders, AOC independently predicted TLR with an adjusted hazard ratio of 4.1 (95% CI: 1.17–14.39; P = 0.03).ConclusionAO treatment of the RCA with second‐generation DES is feasible, but our data suggest that stent coverage of the right AO segment remains a predictor of TLR. © 2014 Wiley Periodicals, Inc.
Angiographic characteristics of definite stent thrombosis: Role of thrombus grade, collaterals, epicardial coronary flow, and myocardial perfusion
Authors: Reeves Ryan R. , Patel Mitul , Armstrong Ehrin J. , Sab Shiv , Waldo Stephen W. , Yeo Khung‐Keong , Shunk Kendrick A. , Low Reginald I. , Rogers Jason H. , Mahmud Ehtisham 
Published: April 2014

ObjectivesTo characterize the prevalence of thrombus burden, collateral vessels to the infarct‐related artery, epicardial coronary artery flow, and myocardial perfusion in patients with angiographically confirmed definite stent thrombosis (ST), and to define their relationship with associated treatments and outcomes.BackgroundAngiographic characteristics of ST are not well defined.MethodsAll cases of angiographically determined ST at five academic hospitals from 2005 to 2012 were reviewed. Demographic, procedural, and angiographic characteristics were recorded. In‐hospital and 1‐year follow‐up data were obtained.ResultsAmong 205 cases of angiographic definite ST (60 ± 8 years; 87% male), the majority presented with late/very late ST (69%) and STEMI (66%). High‐risk angiographic findings at presentation included thrombus grade 4–5 (87%), absence of collateral vessels (76%), and reduced initial TIMI 3 flow (90%). Final TIMI 3 flow was achieved in 90% of patients and was associated with greater use of aspiration thrombectomy (60% vs. 25%; P = 0.003), glycoprotein IIb/IIIa inhibitors (80% vs. 30%, P < 0.001), and repeat stenting (67% vs. 10%, P < 0.001). A final myocardial perfusion grade of 2–3 was achieved in 79% of patients and was associated with greater use of aspiration thrombectomy (61% vs. 36%, P = 0.003). After multivariable logistic regression, aspiration thrombectomy (AOR 2.6, 95% CI 1.3–5.2) and implantation of a new stent (AOR 2.1, 95% CI 1.1–4.3) were associated with optimal combined epicardial flow and myocardial perfusion. At 1‐year follow‐up, significantly lower risk of repeat ST (HR 0.1; 95% CI 0.1,0.2; P < 0.001) among patients with initial TIMI 3 flow at index ST was observed.ConclusionsThe majority of ST patients present with late/very late ST with high thrombus burden and STEMI. Presence of collateral vessels and low thrombus burden is cardioprotective, while reduced initial TIMI flow is associated with larger infarct size and recurrent ST. Aspiration thrombectomy and repeat stenting are associated with improved epicardial coronary artery flow and myocardial perfusion among patients treated for ST. © 2014 Wiley Periodicals, Inc.
Shorter (≤6 months) versus longer (≥12 months) duration dual antiplatelet therapy after drug eluting stents: A meta‐analysis of randomized clinical trials
Authors: Pandit Anil , Giri Smith , Hakim Fayaz Ahmad , Fortuin F. David 
Published: April 2014

ObjectiveOptimal duration of dual antiplatelet therapy (DAPT), defined as use of both aspirin and a P2Y12 receptor inhibitor, after implantation of drug eluting stents (DES) is still subject of ongoing debate. We systematically review efficacy and safety of ≤6 months versus ≥12 months DAPT after implantation of DES.MethodsPubMed, Scopus, Cochrane, and clinicaltrials.gov databases were searched for studies published until 30th November 2013. The studies were limited to randomized clinical trials. Independent observers abstracted the data on outcomes, characteristics, and qualities of studies included. Random effect model was employed for meta‐analysis. Heterogeneity of studies included was analyzed using I2 statistics.ResultsIn four randomized clinical trials published involving 8,163 patients with DES, 4,081 patients were randomized to shorter and 4,082 patients to longer duration DAPT. The P2Y12 receptor inhibitor used in all four studies was clopidogrel. Longer duration of DAPT did not reduce risk of all cause mortality (pooled OR 0.89, 95% CI 0.67–1.17, P = 0.4, I2 = 0%), myocardial infarction (pooled OR 1.16, 95% CI 0.85–1.57, P = 0.35, I2 = 0%) cardiac death (pooled OR 0.88, 95% CI 0.61–1.25, P = 0.47, I2 = 0%), stent thrombosis (pooled OR 1.29, 95% CI 0.76–2.21, P = 0.35, I2 = 0%) or cerebrovascular accidents (pooled OR 0.73, 95% CI 0.41–1.27, P = 0.26, I2 = 0%). Longer duration of DAPT was associated with increased risk of TIMI major bleeding (pooled OR 0.51, 95% CI 0.29–0.89, P = 0.02, I2 = 0%).ConclusionThere was no difference in efficacy outcomes between ≤6 months of DAPT and ≥12 months of DAPT in patients with coronary artery disease and DES implantation. Moreover, longer duration of DAPT is associated with increased risk of bleeding complications. © 2014 Wiley Periodicals, Inc.
A phase 2 cooperative group adjuvant trial using a biomarker‐based decision algorithm in patients with stage I non‐small cell lung cancer (SWOG‐0720, NCT00792701)
Authors: Bepler Gerold , Zinner Ralph G. , Moon James , Calhoun Royce , Kernstine Kemp , Williams Charles C. , Mack Philip C. , Oliveira Vasco , Zheng Zhong , Stella Philip J. , Redman Mary W. , Gandara David R. 
Published: April 2014

BACKGROUNDThis cooperative group adjuvant phase 2 trial in patients with completely resected stage I non‐small cell lung cancer with tumor diameters measuring ≥ 2 cm was designed to assess the feasibility and preliminary efficacy of assigning patients to therapy or observation using a molecularly based decision algorithm.METHODSAt least a lobectomy and sampling of recommended mediastinal lymph node stations, good Zubrod performance status, adequate organ function, and a formalin‐fixed and paraffin‐embedded tumor specimen were required. Excision repair cross‐complementing group 1 (ERCC1) and ribonucleotide reductase M1 (RRM1) were analyzed using immunofluorescence‐based in situ automated quantitative image analysis and categorized as high or low using prespecified cutoff values. Patients with high ERCC1 and RRM1 were assigned to observation and all others to 4 cycles of cisplatin and gemcitabine. Feasibility was defined as treatment assignment within 84 days from surgery in > 85% of patients. Secondary objectives were to estimate the 2‐year survival.RESULTSTreatment assignment met the feasibility criteria in 88% of eligible patients (71 of 81 patients). The collective 2‐year disease‐free and overall survival rates were 80% and 96%, respectively. Protein levels for RRM1 fell within the previously established range, ERCC1 levels were slightly lower than expected, and they were significantly correlated (correlation coefficient, 0.4). The rates of assignment of patients to observation (22%) and chemotherapy (78%) were as expected.CONCLUSIONSGene expression analysis for treatment assignment is feasible. Survival results are encouraging and require future validation. Real‐time performance of quantitative in situ ERCC1 and RRM1 analysis requires further development. Cancer 2014;120:2343–2351. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.
Early retirement in cancer patients with or without comorbid mental health conditions: A prospective cohort study
Authors: Singer Susanne , Meyer Alexandra , Wienholz Sabine , Briest Susanne , Brown Anna , Dietz Andreas , Binder Harald , Jonas Sven , Papsdorf Kirsten , Stolzenburg Jens‐Uwe , Köhler Uwe , Raßler Jörg , Zwerenz Rüdiger , Schröter Katharina , Mehnert Anja , Löbner Margrit , König Hans‐Helmut , Riedel‐Heller Steffi G. 
Published: April 2014

BACKGROUNDThe authors investigated whether cancer patients who have comorbid mental health disorders (MD) are at greater risk of early retirement compared with those who do not have MD.METHODSIndividuals ages 18 to 55 years from a consecutive sample of patients who were admitted for inpatient oncologic treatment were interviewed using structured clinical interviews to ascertain MD. The patients were followed for 15 months, and the date of early retirement was documented. Rates of early retirement per 100 person‐years (py) in patients with and without MD were compared using multivariate Poisson regression models.RESULTSAt baseline, 491 patients were interviewed, and 150 of those patients (30.6%) were diagnosed with MD. Forty‐one patients began full early retirement during follow‐up. In patients with MD, the incidence of early retirement was 9.3 per 100 py compared with 6.1 per 100 py in mentally healthy patients. The crude rate ratio (RR) was 1.5 (95% confidence interval [CI], 0.8‐2.8). The effect of MD on early retirement was modified in part by income: in patients with low income, the adjusted RR was 11.7, whereas no effect was observed in higher income groups. Patients with depression were at greater risk of retirement when they had higher income (RR, 3.4; P = .05). The effects of anxiety (RR, 2.4; P = .05), adjustment disorders (RR, 1.7; P = .21), and alcohol dependence (RR, 1.8; P = .40) on early retirement were equal across income groups.CONCLUSIONSMental health conditions are risk factors for early retirement in cancer patients, although this effect differs according to the type of disorder and the patient's income level. Cancer 2014;120:2199–2206. © 2014 American Cancer Society.
Everolimus in combination with octreotide long‐acting repeatable in a first‐line setting for patients with neuroendocrine tumors: An ITMO group study
Authors: Bajetta Emilio , Catena Laura , Fazio Nicola , Pusceddu Sara , Biondani Pamela , Blanco Giusi , Ricci Sergio , Aieta Michele , Pucci Francesca , Valente Monica , Bianco Nadia , Mauri Chiara Maria , Spada Francesca 
Published: April 2014

BACKGROUNDPreclinical and clinical studies suggest synergistic activity between somatostatin analogues and mammalian target of rapamycin inhibitors. The activity and safety of everolimus was assessed in combination with octreotide long‐acting repeatable (LAR) in patients with neuroendocrine tumors (NETs) of gastroenteropancreatic and lung origin.METHODSThis was a phase 2, multicenter trial using a Simon's 2‐stage minimax design. Treatment‐naive patients with advanced well‐differentiated NETs of gastroenteropancreatic tract and lung origin received everolimus 10 mg daily, in combination with octreotide LAR 30 mg every 28 days. The primary endpoint was objective response rate (ORR).RESULTSA total of 50 patients (median age, 60.5 years) were enrolled. Primary tumor sites were: pancreas (14 patients), lung (11 patients), ileum (9 patients), jejunum and duodenum (2 patients), and unknown (14 patients). Thirteen patients (26%) had carcinoid syndrome. Treatment‐related adverse events (AEs) were mostly grade 1 or 2; the only grade 4 AE was mucositis in 1 patient, whereas grade 3 AEs included skin rash in 1 case (2%), stomatitis in 4 cases (8%), and diarrhea in 11 cases (22%). The ORR was 18%; 2% of patients had a complete response (CR), 16% a partial response (PR) and 74% achieved stable disease (SD). All CRs and all PRs as well as 92% of SDs had a duration ≥6 months. The clinical benefit (CR+PR+SD) was 92%. At a median follow‐up of 277 days, median time to progression and overall survival were not reached.CONCLUSIONSThe everolimus‐octreotide LAR combination was active and well tolerated in these previously treated patients with advanced NETs, suggesting a possible role as first‐line treatment in patients with NET. Cancer 2014;120:2457–2463. © 2014 American Cancer Society.
Contemporary cost‐effectiveness analysis comparing sequential bacillus Calmette‐Guerin and electromotive mitomycin versus bacillus Calmette‐Guerin alone for patients with high‐risk non–muscle‐invasive bladder cancer
Authors: Bachir Bassel G. , Dragomir Alice , Aprikian Armen G. , Tanguay Simon , Fairey Adrian , Kulkarni Girish S. , Breau Rodney H. , Black Peter C. , Kassouf Wassim 
Published: April 2014

BACKGROUNDSequential bacillus Calmette‐Guerin (BCG) and electromotive mitomycin (sequential therapy) have been shown in a randomized prospective trial to be superior to therapy with BCG alone in patients with high‐risk non–muscle‐invasive bladder cancer. The objective of the current study was to compare the costs and benefits of these 2 treatment strategies by performing a 5‐year and 10‐year cost‐effectiveness study.METHODSA Markov model was developed to estimate the incremental cost‐effectiveness ratio over a 5‐year and 10‐year period. Estimates of disease progression, death, and treatment efficacy were obtained from what to the authors' knowledge is the only randomized trial comparing the 2 therapies. Costs included: 1) medical costs (physician fees); 2) drug costs (preparation and instillation); and 3) hospital costs (procedure fees, admission fees, and tests and procedures done during surveillance). Patients were allowed a second course of induction therapy.RESULTSSequential therapy was found to be associated with a higher initial material cost for induction and maintenance. The average effectiveness for the patients treated with therapy with BCG alone was 4.39 years with a mean cost of $9236 (95% confidence interval, $9118‐$9345) per patient. The sequential group resulted in an average effectiveness of 4.65 years, with a mean cost of $16,468 (95% confidence interval, $16,371‐$16,527). The 5‐year incremental cost‐effectiveness ratio of sequential versus BCG‐alone therapy was $27,815 per life‐year gained. The corresponding figure over a 10‐year period was $8618 per life‐year gained.CONCLUSIONSThe results of the current study suggest that sequential therapy is a cost‐effective treatment for patients with high‐risk non–muscle‐invasive bladder cancer.Cancer2014;120:2424–2431.©2014 American Cancer Society.
Long‐term cause‐specific mortality in survivors of adolescent and young adult bone and soft tissue sarcoma: A population‐based study of 28,844 patients
Authors: Youn Paul , Milano Michael T. , Constine Louis S. , Travis Lois B. 
Published: April 2014

BACKGROUNDDespite improved cure rates for bone and soft tissue sarcomas, to the authors' knowledge, no large population‐based study to date has evaluated long‐term cause‐specific mortality in patients diagnosed in the adolescent and young adult (AYA) age range (15 years‐39 years).METHODSA total of 28,844 survivors of AYA bone and soft tissue sarcoma, who accrued 113,206 person‐years of follow‐up, were identified in the population‐based Surveillance, Epidemiology, and End Results program. Standardized mortality ratios (SMR) and absolute excess risks (AER) (per 10,000 person‐years) were calculated to evaluate associations with histology (chemotherapy‐sensitive subtypes: Ewing sarcoma, osteosarcoma, and rhabdomyosarcoma vs all other subtypes), age, and initial therapy.RESULTSAll‐cause mortality in survivors of AYA sarcoma was found to be significantly increased compared with that of the general population (SMR, 1.76; 95% confidence interval [95% CI], 1.60‐1.92 [AER of 19]), and persisted for > 20 years (SMR, 1.39; 95% CI, 1.04‐1.82 [AER of 20]). Significant excess mortality was observed for both second malignant neoplasms (SMR, 2.05; 95% CI, 1.71‐2.43 [AER of 7]) and noncancer causes (SMR, 1.66; 95% CI, 1.49‐1.85 [AER of 19]). Significant excess deaths occurred among patients with chemotherapy‐sensitive (SMR, 2.76; 95% CI, 2.20‐3.41 [AER of 32]) and nonchemosensitive (SMR, 1.63; 95% CI, 1.47‐1.80 [AER of 17]) subtypes. Significantly elevated noncancer mortality in the former group included cardiovascular disease (SMR, 2.33) and infections (SMR, 15.6), whereas significant excess deaths in the latter group included diabetes (SMR, 2.40) and infections (SMR, 2.77).CONCLUSIONSSurvivors of AYA bone and soft tissue sarcoma experience significant long‐term mortality due to second malignant neoplasms and noncancer causes. Further research is needed to develop preventive and surveillance guidelines in this understudied population to prevent and reduce long‐term excess mortality. Cancer 2014;120:2334–2342. © 2014 American Cancer Society.
Risk stratification in follicular neoplasm: A cytological assessment using the modified bethesda classification
Authors: Ustun Berrin , Chhieng David , Van Dyke Alison , Carling Tobias , Holt Elizabeth , Udelsman Robert , Adeniran Adebowale J. 
Published: April 2014

BACKGROUNDThe 2007 Bethesda classification for thyroid cytology defines follicular neoplasm as a category of cases with cellular specimens demonstrating abundant follicular cells arranged in a microfollicular pattern with little or no colloid. The current recommendation for the management of these cases is diagnostic lobectomy. There has been great difficulty and variability in triaging and reporting follicular neoplasm. To increase diagnostic accuracy, at the study institution, this category is subclassified further into 3 categories: 1) microfollicular‐patterned neoplasm (MN); 2) Hürthle cell neoplasm (HN); and 3) follicular lesion with some features suggestive of but not diagnostic of the follicular variant of papillary thyroid carcinoma (FL). The authors reviewed the cases of follicular neoplasm observed over a period of 5 years to document the follow‐up trend using this modified classification.METHODSA search of the cytology records was performed for the period between January 2008 and December 2012. All thyroid fine‐needle aspiration cases were reviewed and those with a diagnosis of follicular neoplasm (including Hürthle cell neoplasm) were identified. Correlating follow‐up surgical pathology reports were reviewed.RESULTSA total of 399 cases of follicular neoplasm with surgical follow‐up were identified. Malignancy was identified in 32% of all cases of follicular neoplasm and was found to be disproportionately higher in the FL category (73%). A cytological diagnosis of FL is more likely to be called malignant (73%) than benign neoplastic (9%) or benign nonneoplastic (18%). A cytological diagnosis of MN or HN is more likely to be benign neoplastic (46% and 46%, respectively) than malignant (29% and 26%, respectively) or benign nonneoplastic (25% and 28%, respectively). Of the cytological features examined, 2 (nuclear enlargement and nuclear grooves) were significantly associated with the follicular variant of papillary thyroid carcinoma.CONCLUSIONSThe results of the current study clearly indicate that follicular lesions with even subtle nuclear atypia have a high positive predictive value for malignancy and therefore should be distinguished from other follicular lesions because these cases require more aggressive surgical management. The current study also raises an important issue concerning the current thyroid classification based on the 2007 Bethesda classification for thyroid cytology. Future thyroid fine‐needle aspiration classification schemes should consider subclassifying follicular neoplasms for the purpose of risk stratification. Cancer (Cancer Cytopathol) 2014;122:536–545. © 2014 American Cancer Society.
Evaluation of intraoperative cytological assessment of bone resection margins in patients with oral squamous cell carcinoma
Authors: Nieberler Markus , Häusler Patrick , Drecoll Enken , Stoeckelhuber Mechthild , Deppe Herbert , Hölzle Frank , Kolk Andreas , Wolff Klaus‐Dietrich , Kesting Marco Rainer , Weirich Gregor 
Published: April 2014

BACKGROUNDFrozen sections are routinely applied to control for adequate resection margins. In cases in which carcinoma infiltrates bone, the intraoperative microscopic assessment of bone margins remains challenging due to technical difficulties to section native bone. The objective of the current study was to evaluate an intraoperative cytological approach to control bone resection margins in patients with bone‐infiltrating oral squamous cell carcinomas.METHODSA total of 174 cytological preparations obtained from bone margins of bone‐infiltrating oral squamous cell carcinomas (28 patients) were assessed intraoperatively and compared with the corresponding histological findings. In a validation cohort (45 patients) the intraoperative cytological assessment of bone resection margins (ICAB) (104 margins) was evaluated as a diagnostic tool for routine clinical application.RESULTSIn the first patient cohort, the ICAB revealed 95.3% sensitivity and 96% specificity. The results provided an accuracy of 95.7% with a significant correlation noted between cytological and histological results (κ, 0.91; P < .001), and a positive predictive value and negative predictive value of 93.8% and 96.9%, respectively. In the validation cohort, ICAB revealed 80% sensitivity and 98.9% specificity with 98% accuracy. There was a significant correlation found between cytological and histological results (κ, 0.91; P < .001), providing a positive predictive value and negative predictive value of 80% and 98%, respectively. ICAB could predict final resection status at bone margins with 80% sensitivity and 97.5% specificity. A significant correlation was found between the cytological and histological resection status at bone margins (κ, 0,75; P < .001).CONCLUSIONSICAB could supplement intraoperative frozen sections of soft tissue margins as a standard procedure to control for adequate resection at bone margins. Cancer (Cancer Cytopathol) 2014;122:646–656. © 2014 American Cancer Society.