ABSTRACT
There is a critical need for effective treatments for leptomeningeal disease (LMD). Here, we report the interim analysis results of an ongoing single-arm, first-in-human phase 1/1b study of concurrent intrathecal (IT) and intravenous (IV) nivolumab in patients with melanoma and LMD. The primary endpoints are determination of safety and the recommended IT nivolumab dose. The secondary endpoint is overall survival (OS). Patients are treated with IT nivolumab alone in cycle 1 and IV nivolumab is included in subsequent cycles. We treated 25 patients with metastatic melanoma using 5, 10, 20 and 50 mg of IT nivolumab. There were no dose-limiting toxicities at any dose level. The recommended IT dose of nivolumab is 50 mg (with IV nivolumab 240 mg) every 2 weeks. Median OS was 4.9 months, with 44% and 26% OS rates at 26 and 52 weeks, respectively. These initial results suggest that concurrent IT and IV nivolumab is safe and feasible with potential efficacy in patients with melanoma LMD, including in patients who had previously received anti-PD1 therapy. Accrual to the study continues, including in patients with lung cancer. ClinicalTrials.gov registration: NCT03025256 .
Subject(s)
Lung Neoplasms , Melanoma , Humans , Nivolumab , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Melanoma/pathology , Lung Neoplasms/drug therapy , Treatment Outcome , IpilimumabABSTRACT
In critically ill trauma patients, adequate nutrition is essential for the body's healing process. Currently, there is no clinical standard for initiating feeds after percutaneous endoscopic gastrostomy (PEG) tube placement. We aimed to demonstrate that early enteral nutrition (EN) is as safe as delayed EN in patients who have undergone PEG tube insertion. We conducted a multi-center, retrospective cohort study of 384 patients from the Prisma Health Trauma Registries who received PEGs. Feeding intolerance was defined as high gastric residuals, nausea, emesis, sustained diarrhea, or ileus. The probability that a patient would experience intolerance was 11.7% in those fed within 6 hours, 5.1% among patients fed between 6 and 12 hours, 6.0% among patients fed between 12 and 24 hours, and 7.6% among patients fed after 24 hours, for which no statistically significant difference was detected. These findings support that early EN after PEG placement is safe in critically ill, trauma patients.
