Effect of the need for preoperative dialysis on perioperative outcomes on patients undergoing laparoscopic nephrectomy: an analysis of the National Surgical Quality Improvement Program database

Objective: To investigate whether patients requiring dialysis are a higher risk surgical population and would experience more perioperative adverse events even when undergoing a perceived less invasive operation as a laparoscopic radical nephrectomy (LRN). LRN is generally a well-tolerated surgical procedure with minimal morbidity and mortality. Prior to transplantation, dialysis patients will often have to undergo a LRN to remove a native kidney with a suspicious mass. Materials and Methods: Patients in the American College of Surgeons National Surgical Quality Improvement Program who underwent a LRN between 2011 and 2016 were included. Patients were stratified by the need for preoperative dialysis 2 weeks prior to surgery, and perioperative outcomes were compared. A multivariable logistic regression analysis was performed to test the association between the need for preoperative dialysis and perioperative risk. Results: There were 8315 patients included in this analysis of which 445 (5.4%) patients required preoperative dialysis. Patients who required preoperative dialysis had more minor (

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART SWOG 1609) in Patients with Nonpancreatic Neuroendocrine Tumors.

PurposeImmune checkpoint blockade has improved outcomes across tumor types; little is known about the efficacy of these agents in rare tumors. We report the results of the (nonpancreatic) neuroendocrine neoplasm cohort of SWOG S1609 dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART).Patients and methodsWe performed a prospective, open-label, multicenter phase II clinical trial of ipilimumab plus nivolumab across multiple rare tumor cohorts, with the (nonpancreatic) neuroendocrine cohort reported here. Response assessment by grade was not prespecified. The primary endpoint was overall response rate [ORR; RECIST v1.1; complete response (CR) and partial response (PR)]; secondary endpoints included progression-free survival (PFS), overall survival (OS), stable disease >6 months, and toxicity.ResultsThirty-two eligible patients received therapy; 18 (56%) had high-grade disease. Most common primary sites were gastrointestinal (47%; N = 15) and lung (19%; N = 6). The overall ORR was 25% [95% confidence interval (CI) 13-64%; CR, 3%, N = 1; PR, 22%, N = 7]. Patients with high-grade neuroendocrine carcinoma had an ORR of 44% (8/18 patients) versus 0% in low/intermediate grade tumors (0/14 patients; P = 0.004). The 6-month PFS was 31% (95% CI, 19%-52%); median OS was 11 months (95% CI, 6-∞). The most common toxicities were hypothyroidism (31%), fatigue (28%), and nausea (28%), with alanine aminotransferase elevation (9%) as the most common grade 3/4 immune-related adverse event, and no grade 5 events.ConclusionsIpilimumab plus nivolumab demonstrated a 44% ORR in patients with nonpancreatic high-grade neuroendocrine carcinoma, with 0% ORR in low/intermediate grade disease

CO hydrogenation catalyzed by alumina-supported osmium: Particle size effects

Alumina-supported catalysts were prepared by conventional aqueous impregnation with [H2OsCl6] and by reaction of organoosmium clusters {[Os3(CO)12], [H4Os4(CO)12], and [Os6(CO)18]} with the support. The catalysts were tested for CO hydrogenation at 250-325 [deg]C and 10 atm, the products being Schulz-Flory distributions of hydrocarbons with small yields of dimethyl ether. The fresh and used catalysts were characterized by infrared spectroscopy and high-resolution transmission electron microscopy. The catalyst prepared from [H2OsCl6] had larger particles of Os (~70 A). The cluster-derived catalysts initially consisted of molecular clusters on the support; the used catalysts contained small Os aggregates (typically 10-20 A in diameter). The catalytic activity for hydrocarbon formation increased with increasing Os aggregate size, but the activity for dimethyl ether formation was almost independent of aggregate size. The hydrocarbon synthesis was evidently catalyzed by the Os aggregates, and the ether synthesis was perhaps catalyzed by mononuclear Os Complexes.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/25555/1/0000097.pd

nab-Paclitaxel–Based Therapy in Underserved Patient Populations: The ABOUND.PS2 Study in Patients With NSCLC and a Performance Status of 2

IntroductionThe phase II ABOUND.PS2 study (NCT02289456) assessed safety/tolerability of a first-line modified nab-paclitaxel/carboplatin regimen for patients with advanced non-small cell lung cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2.MethodsChemotherapy-naive patients with stage IIIB/IV NSCLC and ECOG PS 2 received four cycles of nab-paclitaxel 100 mg/m2 days 1 and 8 plus carboplatin area under the curve 5 day 1 q3w (induction). Patients without progression received nab-paclitaxel monotherapy (100 mg/m2 days 1 and 8 q3w) until progression/unacceptable toxicity. Primary endpoint: percentage of patients discontinuing induction due to treatment-emergent adverse events (TEAEs).Results11/40 treated patients (27.5%; 95% CI, 14.60–43.89) discontinued chemotherapy induction due to TEAEs; 16/40 (40.0%) continued nab-paclitaxel monotherapy. Median progression-free and overall survival were 4.4 (95% CI, 2.99–7.00) and 7.7 (95% CI, 4.93–13.17) months. Grade 3/4 TEAEs during induction included neutropenia (22.5%), anemia (17.5%), thrombocytopenia (5.0%), and peripheral neuropathy (2.5%).ConclusionThis nab-paclitaxel–based regimen was tolerable in patients with advanced NSCLC and ECOG PS 2, with efficacy comparable to historical chemotherapy data

Metastatic prostate cancer 35 years after sex reassignment surgery

The exact number of male to female transsexuals is not known; however, sex reassignment has become a headline news topic.Individuals who have undergone sex reassignment via hormonal and/or surgical means must undergo appropriate cancer screening.Prostate cancer is the most common noncutaneous malignancy in men, however, its appropriate screening guidelines have become controversial.As the potential for an increased number of male to female transsexuals develops, so should guidelines for individuals who have had sex reassignment. (C) 2016 Elsevier Inc. All rights reserved

Precision medicine and the institutional review board: ethics and the genome

Background: Clinical research studies often integrate precision medicine technologies and techniques, offering novel treatment opportunities for patients but also posing significant challenges for regulatory authorities and local institutional review boards (IRBs) as they attempt to protect patient safety and privacy.Methods: We review the basics of precision medicine and discuss how IRBs are addressing new challenges associated with the era of precision medicine.Results: Precision medicine trials rely on genomic testing for inclusion criteria and investigational drug therapy choices. The vast amounts of complex information that can be obtained from basic genetic sequencing tests must be stored, analyzed, and interpreted, creating challenges for clinicians, researchers, and regulatory staff who are concerned with complex ethical, security, and legal issues surrounding patients'personal genetic data in the digital age. All members of the IRB face a rapidly changing environment. The traditional areas of primary concern, such as patient privacy, terminology, and financial benefits, have been joined by issues associated with precision medicine, such as accelerated US Food and Drug Administration drug approval, multiple informed consent form modifications, increasing length and complexity of informed consent forms, and participant genetic privacy. The challenge to the IRB is to remain focused on the prior areas of significance while also adapting the evaluation process to the novel science of precision medicine.Conclusion: In this era of exponentially increasing big data and easy-to-access genetic sequencing data, IRBs will be tasked with adapting their processes and adjusting to the new technology and its corresponding complexities. Such adaptation has always been required of IRBs, but now it will need to occur rapidly as technology and data analysis capabilities accelerate