Greater Transplant-Free Survival in Patients Receiving Obeticholic Acid for Primary Biliary Cholangitis in a Clinical Trial Setting Compared to Real-World External Controls.

Background & Aims: The Primary Biliary Cholangitis (PBC) Obeticholic Acid (OCA) International Study of Efficacy (POISE) randomized, double-blind, placebo-controlled trial demonstrated that OCA reduced biomarkers associated with adverse clinical outcomes (ie, alkaline phosphatase, bilirubin, aspartate aminotransferase, and alanine aminotransferase) in patients with PBC. The objective of this study was to evaluate time to first occurrence of liver transplantation or death in patients with OCA in the POISE trial and open-label extension vs comparable non-OCA-treated external controls.

Methods: Propensity scores were generated for external control patients meeting POISE eligibility criteria from 2 registry studies (Global PBC and UK-PBC) using an index date selected randomly between the first and last date (inclusive) on which eligibility criteria were met.

Early Conduction Disorders After Aortic Valve Replacement With the Sutureless Perceval Prosthesis.

Background: This study was conducted to determine the incidence of postoperative conduction disorders and need for pacemaker (PM) implantation after aortic valve replacement (AVR) with the Perceval prosthesis (Livanova, Saluggia, Italy).

Methods: From January 2007 to December 2017, 908 patients underwent AVR with Perceval S in 5 participating centers. Study end points focused on electrocardiographic changes after AVR and the incidence of new PM implantation in 801 patients after exclusion of patients with previous PM (n = 48) or patients undergoing tricuspid (n = 28) and/or atrial fibrillation ablation (n = 31) surgery.

Progression-Free and Overall Survival for Concurrent Nivolumab With Standard Concurrent Chemoradiotherapy in Locally Advanced Stage IIIA-B NSCLC: Results From the European Thoracic Oncology Platform NICOLAS Phase II Trial (European Thoracic Oncology Platform 6-14).

Introduction: The NICOLAS study is the first completed single-arm phase II trial in stage III NSCLC evaluating hierarchically first the safety and then the efficacy of adding nivolumab concurrently to standard definitive concurrent chemoradiotherapy. The safety end point was reported earlier; here, we present the efficacy results.

Methods: Stage IIIA-B unresectable treatment-naive patients with NSCLC received three cycles of platinum-based chemotherapy and concurrent radiotherapy (66 Gy, 33 fractions), along with nivolumab (360 mg, 3-weekly).

Consensus on molecular imaging and theranostics in prostate cancer.

Rapid developments in imaging and treatment with radiopharmaceuticals targeting prostate cancer pose issues for the development of guidelines for their appropriate use. To tackle this problem, international experts representing medical oncologists, urologists, radiation oncologists, radiologists, and nuclear medicine specialists convened at the European Association of Nuclear Medicine Focus 1 meeting to deliver a balanced perspective on available data and clinical experience of imaging in prostate cancer, which had been supported by a systematic review of the literature and a modified Delphi process. Relevant conclusions included the following: diphosphonate bone scanning and contrast-enhanced CT are mentioned but rarely recommended for most patients in clinical guidelines; MRI (whole-body or multiparametric) and prostate cancer-targeted PET are frequently suggested, but the specific contexts in which these methods affect practice are not established; sodium fluoride-18 for PET-CT bone scanning is not widely advocated, whereas gallium-68 or fluorine-18 prostate-specific membrane antigen gain acceptance; and, palliative treatment with bone targeting radiopharmaceuticals (rhenium-186, samarium-153, or strontium-89) have largely been replaced by radium-223 on the basis of the survival benefit that was reported in prospective trials, and by other systemic therapies with proven survival benefits.

Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial.

Importance: There are no specifically approved targeted therapies for the most common genomically defined subset of non-small cell lung cancer (NSCLC), KRAS-mutant lung cancer.

Objective: To compare efficacy of the mitogen-activated protein kinase kinase (MEK) inhibitor selumetinib + docetaxel with docetaxel alone as a second-line therapy for advanced KRAS-mutant NSCLC.

Design, Setting, And Participants: Multinational, randomized clinical trial conducted at 202 sites across 25 countries from October 2013 through January 2016.

Randomized Phase II Trial of Seribantumab in Combination With Paclitaxel in Patients With Advanced Platinum-Resistant or -Refractory Ovarian Cancer.

Purpose Seribantumab is a fully human immunoglobulin G2 monoclonal antibody that binds to human epidermal growth factor receptor (HER) 3 (ErbB3), blocking heregulin (HRG) -mediated ErbB3 signaling and inducing ErbB3 receptor downregulation. This open-label randomized phase II study evaluated progression-free survival (PFS) with seribantumab in combination with once-per-week paclitaxel compared with paclitaxel alone in patients with platinum-resistant or -refractory ovarian cancer. A key secondary objective was to determine if any of five prespecified biomarkers predicted benefit from seribantumab.

The role of CnTI-SonoVue in the diagnosis of ovarian masses with papillary projections: a preliminary study.

Objectives: To describe sonographically the distribution patterns of a second-generation contrast agent in the microcirculation of unilocular and multilocular ovarian masses with papillary projections, and to investigate whether qualitative evaluation of the passage of the contrast agent can improve the performance of sonography in distinguishing between benign and malignant masses with papillary projections.

Methods: Thirty-three patients with unilocular or multilocular ovarian masses with papillary projections were enrolled into the study in three clinical centers. The contrast-enhanced transvaginal examination was performed using 'Contrast Tuned Imaging' (CnTI) technology and SonoVue ultrasound contrast agent.

Airborne dermatosis.

Dermatologists and occupational physicians are those who have to deal with airborne allergens and irritants most often, and the awareness of these substances has grown over the years. In this report, skin symptoms of airborne dermatosis, the nature of airborne contactans, and the localization of lesions are presented, along with the differential diagnoses. Recognizing the characteristic nature of these reactions can greatly facilitate the diagnosis.

Attributions in chronic fatigue syndrome and fibromyalgia syndrome in tertiary care.

Objective: To evaluate the attributions of patients with chronic fatigue syndrome (CFS) and fibromyalgia (FM) consulting at a university fatigue and pain clinic.

Methods: Consecutive attenders (n = 192) who met the CFS criteria (n = 95) or FM criteria (n = 56) or who had medically unexplained chronic pain and/or fatigue without meeting both criteria (CPF) (n = 41) were evaluated. All subjects completed an extended form of the Cause of Illness Inventory.