A Randomized, Double-Blind, Placebo-Controlled, Phase III Noninferiority Study of the Long-Term Safety and Efficacy of Darbepoetin Alfa for Chemotherapy-Induced Anemia in Patients With Advanced NSCLC.

Introduction: This study evaluated noninferiority of darbepoetin alfa versus placebo for overall survival (OS) and progression-free survival (PFS) in anemic patients with NSCLC treated to a 12.0-g/dL hemoglobin (Hb) ceiling.

Methods: Adults with stage IV NSCLC expected to receive two or more cycles of myelosuppressive chemotherapy and Hb less than or equal to 11.

Analysis of non-obstetric vaginal and vulvar trauma: risk factors for operative intervention.

Vaginal and vulvar trauma may occur accidentally or because of an act of violence. Due to its rarity, little is known about risk factors effecting need for operative intervention. We sought to perform a large descriptive analysis of adult non-obstetric vulvovaginal trauma (VVT) and elucidate risk factors for requiring operative intervention.

Marijuana use and outcomes in adult and pediatric trauma patients after legalization in California.

Background: Marijuana has become legal in eight states since 2012. We hypothesized the incidence of marijuana-positive trauma patients and rate of mortality has increased post-legalization.

Methods: A single level-I trauma center was used to identify patients screening positive for marijuana on urine-toxicology.

Association of Mutations and Visceral Metastasis in Patients with Estrogen Receptor-Positive Advanced Breast Cancer from Brazil.

Mutations in the gene () are important mechanisms of resistance to endocrine therapy in estrogen receptor-positive advanced breast cancer and have been recognized as a prognostic and predictive biomarker as well as a potential therapeutic target. However, the prevalence of in real-world patients has not been adequately described. Therefore, we sought to evaluate the prevalence of in metastatic samples from Brazilian patients with estrogen receptor-positive (ER+) advanced breast cancer previously treated with endocrine therapy.

The impact of associated tenotomies on the outcome of incomplete phalangeal osteotomies for lesser toe deformities.

Background: Partial or incomplete osteotomy (IO) of the phalanx is recently described in the literature. However, the clinical outcome and the rate of complications when applied to lesser toe deformities (LTD) have been never addressed. This study aims to find out if the association of tenotomies to incomplete or partial phalanx osteotomies has a significant impact on the clinical outcomes, the occurrence of complications, and the recovery time after surgery.

Ground-Level Falls at Skilled Nursing Facilities Are Associated With More Serious Lower Extremity Injuries Compared With Home.

Ground-level falls (GLFs) are the number one cause of injury and death in the older adult population. We compared injury profiles of GLFs at SNFs to those at homes, hypothesizing that GLFs at SNFs would lead to higher risks for serious (AIS ≥ 3) traumatic brain injury (TBI) and lower extremity (LE) injuries compared to GLFs at home. The 2015-2016 Trauma Quality Improvement Program was used to compare patients sustaining GLFs at home and SNFs.

Atherosclerosis in Chronic Kidney Disease: More, Less, or Just Different?

Patients with chronic kidney disease (CKD) are at an increased risk of premature mortality, mainly from cardiovascular causes. The association between CKD on hemodialysis and accelerated atherosclerosis was described >40 years ago. However, more recently, it has been suggested that the increase in atherosclerosis risk is actually observed in early CKD stages, remaining stable thereafter.

Increased risk of head injury in pediatric patients with attention deficit hyperactivity disorder.

Objective: The prevalence of attention deficit hyperactivity disorder (ADHD) in the general pediatric population is 7%, whereas the prevalence in trauma is unknown. We hypothesized pediatric patients with ADHD would have a higher risk of involvement in a mechanism of injury (MOI) requiring constant attention to surroundings, such as a bicycle collision.

Methods: The Pediatric Trauma Quality Improvement Program (2014-2016) was queried for patients with ADHD.

Trastuzumab emtansine with or without pertuzumab versus trastuzumab with taxane for human epidermal growth factor receptor 2-positive advanced breast cancer: Final results from MARIANNE.

Background: In the phase 3 MARIANNE trial, trastuzumab emtansine (T-DM1) with or without pertuzumab showed noninferior progression-free survival and better tolerability than trastuzumab plus a taxane (HT) for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer. This article reports the final descriptive overall survival (OS) analysis, updated safety data, and additional patient-reported outcomes and biomarker analyses.

Methods: OS was assessed in 1095 patients with HER2-positive breast cancer and no prior therapy for advanced disease who had been randomized to HT, T-DM1 plus a placebo (hereafter T-DM1), or T-DM1 plus pertuzumab (T-DM1+pertuzumab).

A meta-analysis of bone morphogenetic protein-2 versus iliac crest bone graft for the posterolateral fusion of the lumbar spine.

The impact of autologous iliac crest bone graft versus BMP-2 to improve fusion rates for posterolateral fusion (PLF) of the lumbar spine remains unanswered. Single-institution-centered data dominate the literature, providing results that may be contradictory or inconclusive. The aim of this paper is to analyze data pooled from multiple well-controlled studies that examined both ICBG and BMP-2 for use in PLF.

Design of a Three-Dimensional-Printed Surgical Glove for Minimal-Incision Podiatric Surgery.

Background: Precision in minimal-incision surgery allows surgeons to achieve accurate osteotomies and patients to avoid risks. Herein, a surgical guide for the foot is designed and validated in vitro using resin foot models for hallux abducto valgus surgery.

Methods: Three individuals with different experience levels (an undergraduate student, a master's student, and an experienced podiatric physician) performed an Akin osteotomy, a Reverdin osteotomy, and a basal osteotomy of the first metatarsal.

Correction to: Relationship between tumor biomarkers and efficacy in MARIANNE, a phase III study of trastuzumab emtansine ± pertuzumab versus trastuzumab plus taxane in HER2-positive advanced breast cancer.

Following publication of the original article [1], the authors reported the following errors in the article.

Adiposity-Age Distribution and Nutritional Status in Girls With Adolescent Idiopathic Scoliosis.

Study Design: Cross-sectional comparative study.

Objectives: To assess the adiposity-age distribution in girls with adolescent idiopathic scoliosis (AIS) and to define the prevalence of underweight, overweight, and obesity in these patients as compared with healthy controls.

Summary Of Background Data: The current literature focusing the nutritional status of individuals with AIS does not provide data on the prevalence of overweight in these patients.

Relationship between tumor biomarkers and efficacy in MARIANNE, a phase III study of trastuzumab emtansine ± pertuzumab versus trastuzumab plus taxane in HER2-positive advanced breast cancer.

Background: The phase III EMILIA and TH3RESA trials demonstrated clinical benefits of trastuzumab emtansine (T-DM1) therapy in patients with previously treated HER2-positive metastatic breast cancer (MBC). Data from these and other trials showed that T-DM1-associated survival benefits were observed across biomarker subgroups tested in these trials. Prespecified, exploratory analyses of the phase III MARIANNE study examined the effects of HER2-related biomarkers on PFS in patients administered T-DM1 in the first-line MBC setting.

The LACOG-0415 phase II trial: abiraterone acetate and ADT versus apalutamide versus abiraterone acetate and apalutamide in patients with advanced prostate cancer with non-castration testosterone levels.

Background: Testosterone suppression is the standard treatment for advanced prostate cancer, and it is associated with side-effects that impair patients' quality of life, like sexual dysfunction, osteoporosis, weight gain, and increased cardiovascular risk. We hypothesized that abiraterone acetate with prednisone (AAP) and apalutamide, alone or in combination, can be an effective hormonal therapy also possibly decreasing castration-associated side effects.

Methods: Phase II, open-label, randomized, efficacy trial of abiraterone acetate plus prednisone (AAP) and Androgen Deprivation Therapy (ADT) versus apalutamide versus the combination of AAP (without ADT) and apalutamide.

Smoking is associated with an improved short-term outcome in patients with rib fractures.

Background: Smokers with cardiovascular disease have been reported to have decreased mortality compared to non-smokers. Rib fractures are associated with significant underlying injuries such as lung contusions, lacerations, and/or pneumothoraces. We hypothesized that blunt trauma patients with rib fractures who are smokers have decreased ventilator days and risk of in-hospital mortality compared to non-smokers.

A study of reproducibility of kinesiology tape applications: review, reliability and validity.

Background: Literature addressing the mechanical properties of kinesiology tape is quite scarce. There are no studies which focus on the mechanical characteristics of kinesiology tape, its mechanical properties, nor its adherence following the ISO international standard test methods for tape elongation.

Methods: This study quantified the mechanical characteristics of 380 samples of kinesiology tape from 19 different brands and in 4 different colors using a dynamometer.

Contribution of Surface Energy to pH-Dependent Underwater Adhesion of an Acrylic Pressure-Sensitive Adhesive.

Maintaining the underwater adhesive performance over a broad range of solution pH is challenging but necessary for many biomedical applications. Therefore, understanding how environmental conditions influence the mechanisms of bonding and debonding of pressure-sensitive adhesives (PSAs) can provide guidelines for materials design. We investigate how the presence of acrylic acid as a co-monomer impacts the adhesion of a model PSA in aqueous environments of varying pH.

Determining the incidence of distraction among trauma patients in all modes of transportation.

Background: The use of distracting technology is an increasing source of risk for injury among trauma patients. Both drivers and pedestrians show increased unsafe behavior. The data for prevalence and risk for distraction in trauma has varied widely.

PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial.

Background: Neratinib is an irreversible pan-HER tyrosine kinase inhibitor that inhibits PI3K/Akt and MAPK signaling pathways after HER2 receptor activation. The ExteNET study showed that neratinib significantly improved 5-year invasive disease-free survival (iDFS) in women who completed trastuzumab-based adjuvant therapy for early breast cancer (EBC). We assessed the prognostic and predictive significance of PIK3CA alterations in patients in ExteNET.