Modified FOLFOX versus modified FOLFOX plus nivolumab and ipilimumab in patients with previously untreated advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction: Moonlight, a randomized phase 2 trial of the German Gastric Group of the AIO.

TPS4144 Background: The majority of patients (pts) with gastroesophageal cancer present with inoperable or metastatic disease and there is a strong need for efficient and tolerable first-line (1L) treatment. Oxaliplatin-based regimens like FOLFOX have become one standard of care. However, median survival is still below 12 months. Results from trials using nivolumab plus ipilimumab treatment of subjects with advanced/metastatic GC and GEJ cancers demonstrated clinical activity, in pts whose tumors did or did not express PD-L1; in addition, nivolumab alone and in combination with ipilimumab demonstrated clinical benefits in various other tumor types. Based on this clinical experience, the AIO-STO-0417 trial (Moonlight) has been designed to evaluate the combination of chemotherapy with two checkpoint inhibitors in first-line therapy of pts with gastroesophageal adenocarcinoma. Methods: This is a prospective, multicenter, randomized, investigator-initiated phase II trial. Pts with Her2-negative, inoperable, advanced or metastatic gastric or esophagogastric junction cancer will be randomized 1:1 to 1L treatment with FOLFOX (Oxaliplatin 85 mg/m²; Leucovorin 400 mg/m²; 5FU 400 mg/m² on d1 of each treatment cycle and 5FU 1200 mg/m² continuous infusion over 24 hrs d1 and d2) every 2 weeks plus Nivolumab 240 mg every 2 weeks and Ipilimumab 1mg/kg every 6 weeks (Arm A) or FOLFOX alone (Arm B). Primary endpoint of the trial is progression-free survival based on the ITT population. Main secondary endpoints are overall survival, objective response rate, Safety and Quality of life (EORTC QLQ-C30). 118 pts (59 per arm) will be enrolled to provide 80% power for detecting an average HR of 0.68 using the log rank test at a one-sided type I error of 10%. At the date of submission, (Feb 2019), 28 of planned 118 pts are randomized. Clinical trial information: NCT03647969. </jats:p

Conservation of Aquatic Biodiversity in the Context of Multiple-Use Management on National Forest System Lands

The U.S. Department of Agriculture Forest Service (USFS) manages 193 million acres of public lands across 43 states and Puerto Rico. The original intent behind reserving lands managed by the USFS was to improve and protect forests, secure favorable conditions for water flows, and furnish a continuous supply of timber for the nation. Through time national forests have evolved, so they are managed for a broad array of uses. Differing expectations have led to conflicts between aquatic conservation and other aspects of the USFS’ mandate. In the 1990s, these conflicting goals came to a head with the listing of the northern spotted owl Strix occidentalis caurina and the need to better protect streams that fostered populations of anadromous salmonids. To better balance these conflicting uses, the agency placed additional emphasis on conserving and restoring aquatic systems by integrating conservation concepts into the forest planning process. If the USFS is to succeed in protecting and restoring aquatic biodiversity, it must continue to address traditional challenges such as minimizing the effects of timber harvest, roads, grazing, and mining on aquatic systems while improving policies and practices regarding contemporary challenges such as climate change and invasive species

Is the risk of hypertension an indication for prophylactic nephrectomy in patients with unilateral multicystic dysplastic kidney?

We report 41 cases treated between 1980 and 2001.In conclusion it is reasonable to conservatively manage patients with UMCDK by means ultrasound examinations and blood pressurew control