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Background: Phase 1 clinical trials introduce new therapies to humans with the goal of establishing their safety. A prior Children's Oncology Group (COG) study analyzed the proportional enrollment of patients by race, ethnicity, sex, and age for all trial phases. The current study evaluated the representation of patients by race, ethnicity, sex, and age in phase 1 clinical trials.Methods: This study evaluated 1348 children with 128 diagnoses enrolled in COG and Pediatric Brain Tumor Consortium phase 1 clinical trials in the United States from February 28, 2000 to December 29, 2008. Observed and expected proportions were calculated according to an established methodology with a representative population from Surveillance, Epidemiology, and End Results data, which included 27,766 children with the same International Classification of Diseases for Oncology (third edition) diagnostic codes.Results: Underrepresentation in phase 1 trials was seen for lymphohematopoietic (LH) tumors (9.3% observed vs 37% expected) versus solid tumors (90.6% observed vs 63% expected). Although representation was fairly proportional, Hispanics (12.6% observed vs 27% expected), particularly Hispanic females (6% observed vs 18% expected), were significantly underrepresented. The 0- to 4-year age group was underrepresented (11.7% observed vs 36.5% expected). By tumor type, the most significantly underrepresented groups were 0- to 4-year-old children and Hispanics for both solid cancers (11% observed vs 34.4% expected for 0- to 4-year-old children and 12% observed vs 24% expected for Hispanics) and LH cancers (16% observed vs 40% expected for 0- to 4-year-old children and 19.4% observed vs 33% expected for Hispanics).Conclusions: Although sex and racial/ethnic groups are mostly proportionally represented in phase 1 trials, some specific subgroups such as Hispanic children are underrepresented and may benefit from focused accrual. Cancer 2016;122:3207-14. © 2016 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background: The last 3 decades have witnessed limited therapeutic advances in small cell lung cancer (SCLC) management. This study evaluated real-world trends in the use of systemic therapies and the impact on patient outcomes in the United States.Methods: The Surveillance, Epidemiology, and End Results-Medicare database was used to find patients diagnosed with SCLC between 1985 and 2005. The 1985-1990 period served as the baseline for a temporal analysis conducted at 5-year intervals (1985-1990, 1991-1995, 1996-2000, and 2001-2005). Cox proportional models were used to estimate the effect of chemotherapy on survival. Results were validated with a propensity-matched analysis.Results: There were 47,351 eligible patients: 52% were male; the median age was 71 years; and 87% were white, 7% were black, and 1.4% were Asian. The proportion of patients treated with chemotherapy was low but increased over time (38%, 55%, 50%, and 53%; P < .001). Race, diagnosis period, age, stage, and location of residence significantly predicted chemotherapy use. Females (51%), Asians (53%), and rural residents (60%) were more likely to receive chemotherapy. The median overall survival with and without chemotherapy was 9.6 and 3.6 months, respectively. Linear trend analyses showed a modest reduction in the impact of chemotherapy on survival for patients treated with chemotherapy versus untreated patients (hazard ratios [HRs], 0.59, 0.61, 0.64, and 0.62; P < .001) but an overall trend of improved survival for treated (HRs, 1.0, 1.03, 1.00, and 0.96; P = .005) and untreated patients (HRs, 1.0, 0.99, 0.94, and 0.92; P < .001). There was no survival difference between patients treated with carboplatin and patients treated with cisplatin (HR, 0.99; confidence interval [CI], 0.81-1.19; P = .875). Additional therapy beyond platinum-based chemotherapy was associated with a survival benefit (HR, 0.78; CI, 0.75-0.81; P < .001).Conclusions: Chemotherapy use was associated with a survival benefit in Medicare patients with SCLC treated in a real-world setting. [ABSTRACT FROM AUTHOR]

The author reflects on the Crizotinib therapy associated with the hypogonadism. He informs that the Crizotinib is a small molecule of tyrosine kinase inhibitor and recently approved by the U.S. Food and Drug Administration for the treatment of patients who are suffering from advanced nonsmall cell lung cancer (NSCLC). He also opines that the Crizotinib therapy is one of the effective and safe treatments for patients suffering from lung cancer.

Objective(s): To characterize procedural trends in facial plastic and reconstructive surgery procedures in relation to the United States economy., Methods: Retrospective cohort study examining annual procedure rates were determined from the American Society of Plastic Surgeons (ASPS) National Clearinghouse of Plastic Surgery Procedural Statistics from January 1 2007 to December 30, 2017. Procedures were compared to economic activity of the United States as measured by gross domestic product (GDP) were compared using Kolmogorov-Smirnov goodness of fit testing and piecewise multivariate regression modeling., Results: Annual trends in procedural rates showed an overall decrease in the rates of rhinoplasty (284,960 to 218,924), blepharoplasty (240,660 to 209,571), and otoplasty (28,571 to 23,433) from 2007 to 2017. Total cosmetic surgery remained fairly stable, while minimally invasive cosmetic surgery increased in frequency over the study period. On piecewise regression analysis, rhinoplasty (P = .02), rhytidectomy (P = .007), invasive cosmetic surgery (P < .001) were significantly associated with GDP, whereas otoplasty (P = .98) and reconstructive surgery (P = .11) were not associated with GDP., Conclusion: Cosmetic plastic surgery procedures show a greater correlation to GDP than reconstructive procedures. Trends in plastic surgery cases over the last decade show a decreasing number of rhinoplasty, otoplasty, and blepharoplasty, with stabilization in the last few years. An increasing number of reconstructive cases are found., Level of Evidence: 4 Laryngoscope, 130:632-636, 2020., (© 2019 The American Laryngological, Rhinological and Otological Society, Inc.)

Background: Although animal studies have documented metformin's cardioprotective effects, the impact in humans remains elusive. The study objective was to explore the association between metformin and myocardial infarct size in patients with diabetes presenting with ST-segment elevation myocardial infarction., Methods and Results: Data extraction used the National Cardiovascular Data CathPCI Registry in all patients with diabetes aged >18 years presenting with ST-segment elevation myocardial infarction at 2 academic medical centers from January 2010 to December 2013. The exposure of interest was ongoing metformin use before the event. Propensity score matching was used for the metformin and nonmetformin groups on key prognostic variables. All matched pairs had acceptable D scores of <10%, confirming an efficient matching procedure. The primary outcome was myocardial infarct size, reflected by peak serum creatine kinase-myocardial band, troponin T, and hospital discharge left ventricular ejection fraction. Of all 1726 ST-segment elevation myocardial infarction cases reviewed, 493 patients had diabetes (28.5%), with 208 metformin users (42.1%) and 285 nonusers. Matched pairs analysis yielded 137 cases per group. The difference between metformin and nonmetformin groups was -18.1 ng/mL (95% CI -55.0 to 18.8; P=0.56) for total peak serum creatine kinase-myocardial band and -1.1 ng/mL (95% CI -2.8 to 0.5; P=0.41) for troponin T. Median discharge left ventricular ejection fraction in both groups was 45, and the difference between metformin and nonmetformin users was 0.7% (95% CI -2.2 to 3.6; P=0.99)., Conclusions: No statistically significant association of cardioprotection was found between metformin and myocardial infarct size in patients with diabetes and acute ST-segment elevation myocardial infarction., (© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

The last decade has seen increased use of aggressive, catheter-based methods of treating deep vein thrombosis (DVT). In this article, we outline the risks, benefits, and uncertainties surrounding endovascular DVT therapies, describe clinical situations in which endovascular treatment options should reasonably be considered, and update the reader on new outcome data that pertains to catheter-based DVT interventions. Endovascular thrombolytic therapy is reasonable to perform for selected patients with DVT causing acute limb-threatening circulatory compromise, acute inferior vena cava occlusion, or acute iliofemoral DVT for the purposes of limb salvage and relief of presenting DVT symptoms, and appears likely to prevent post-thrombotic syndrome (PTS) in patients with proximal DVT. A multicenter randomized trial, the ATTRACT Study, is currently underway in the United States to determine whether pharmacomechanical catheter-directed thrombolysis (PCDT) is sufficiently safe and effective to be recommended for routine use in proximal DVT patients. Selected patients with established moderate-to-severe PTS in association with an occluded iliac vein or a refluxing saphenous vein may also be amenable to endovascular intervention to reduce venous hypertension, alleviate symptoms, and improve limb function and quality of life. Pending the results of further studies, an individualized approach to patient selection for interventional DVT therapies is recommended., (Copyright © 2012 Wiley Periodicals, Inc.)

Objectives: To determine the prevalence of mitral regurgitation (MR) in the U.S. adult population by classifying its mechanisms according to Carpentier's functional class., Background: MR is the most common clinically recognizable valvular heart condition in the U.S. affecting 2 to 2.5 million people in 2000. A true estimate of the prevalence of MR in accordance to the functional class and etiology is unavailable., Methods: We conducted a Medline search regarding prevalence and etiologies of MR. Etiologies were grouped by Carpentier's functional classification, and estimated prevalence numbers were projected to U.S. adult population of 200 million. Moderate-to-severe grades of MR were included., Results: Carpentier type I, including congenital MR and endocarditis, has a prevalence of less than 20 per million. Myxomatous infiltration leading to mitral valve prolapse is the largest group associated with a type II mechanism with 15,000 per million prevalence. Type IIIa includes rheumatic heart disease, systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS), and rare infiltrative and tropical disorders. SLE and APS have a mean prevalence of 10,520 per million. Carpentier IIIb is the largest group leading to MR, which is mostly functional, and includes ischemic cardiomyopathy, left ventricular (LV) dysfunction, and dilated cardiomyopathies. The estimated prevalence of MR in ischemic cardiomyopathy is 7500 to 9000 per million, and in LV dysfunction, 16,250 per million., Conclusions: The largest number of people with MR is in type IIIb. Certain etiologies show overlap within functional classes due to multiple mechanisms of MR. We attempted to classify etiologies of MR by a functional class to determine the disease burden., (© 2011 Wiley Periodicals, Inc.)