Management of Adverse Events in Early Clinical Trials by Advanced Practice Providers in the Outpatient Setting: The University of Texas MD Anderson Cancer Center Experience.

Background: Advanced practice providers (APPs) play important roles in enrolling, educating, and caring for patients in clinical trials. However, much remains unknown about the role of APPs in managing adverse events (AEs) in early (phase I to II) clinical trials. In this study, we assessed the outpatient management of grade 3 to 4 AEs by APPs in early trials and characterized the workflow of our APP Phase I to II Fast Track (FT) Clinic. Patients and Methods: We retrospectively reviewed records of patients with advanced or metastatic solid tumors enrolled in phase I to II clinical trials who were seen by APPs from September 2017 to August 2018 in the APP phase I to II FT clinic in the Department of Investigational Cancer Therapeutics. Results: A total of 808 patients enrolled in 159 clinical trials were seen in 2,697 visits (median 3 visits per patient; range 1-28) by 10 APPs. Treatment was interrupted in 6.9% of visits, and grade 3 to 4 AEs were seen in 5.4% of visits; however, patients from 1.4% of visits were sent to the emergency center (EC) and/or admitted. Patients referred to the EC and/or admitted were more likely to have baseline hypoalbuminemia, high lactate dehydrogenase, and poor Eastern Cooperative Oncology Group performance status (i.e., ECOG > 1; p < .001). There were no associations between EC referral and gender, APP years of experience, or type of treatment. Conclusions: The APP Phase I to II FT Clinic has an important role in the management of AEs by APPs in early clinical trials in the outpatient setting, potentially avoiding EC visits and admissions.

Identification and Management of Posterior Reversible Encephalopathy Syndrome in a Patient Enrolled in an Immunotherapy Combination Phase I Clinical Trial: A Case Study.

Posterior reversible encephalopathy syndrome (PRES) is a rare potential immune-related adverse event (irAE) of checkpoint inhibitors. PRES is a disorder that has a variety of clinical and radiological features, which makes it a challenge for advanced practice registered nurses to diagnose. IrAEs such as PRES require prompt recognition and intervention to optimize clinical outcomes.

Clinical Trial Subinvestigator: An Emerging Role for Oncology Nurse Practitioners.

Phase 1 clinical trials are essential to improving outcomes in cancer care. The investigational agents in these trials may be associated with adverse events that can contribute to symptom burden and declining performance status for trial participants. The emerging role for oncology nurse practitioners (ONPs) as subinvestigators offers a unique practice setting for advanced practice nurses. In this role, ONPs provide expert oncology care, are responsible for swift recognition and management of adverse events, and ensure adherence to the clinical trial protocol.

Hepatic arterial infusion chemotherapy for metastatic colorectal cancer: a concise overview.

Patients with colorectal cancer commonly succumb to the sequelae of hepatic metastases. Response to systemic therapy is inadequate. Hepatic arterial infusion (HAI) exposes liver metastases to high local concentrations of drug. Herein, we review the randomized trials of HAI in colorectal cancer. Data for this review were identified by searches of MEDLINE and references from relevant articles using the search terms "infusion intra-arterial" and "colorectal cancer." Abstracts and reports from meetings were included only when they related directly to previously published work. Only papers published in English between 1966 and 2003 were included. Randomized trials (5-fluorouracil- (5-FU-) or fluordeoxyuridine- (FUDR-) based regimens) often demonstrated superior response rates for HAI as compared to systemic chemotherapy (primary treatment or post-resection). Enhanced survival has, however, shown only when HAI was combined with systemic chemotherapy in the post-resection setting. For 5-FU-based and perhaps other regimens, randomized trials of combined regional and systemic therapy versus systemic treatment alone may be needed in order to determine whether or not there is a survival advantage after HAI in unresectable patients, as has been recently demonstrated in resectable patients. A variety of agents other than 5-FU have also been given by HAI to patients with liver metastases from diverse cancers. Such regional therapy often yields encouraging response rates and impact on survival therefore merits investigation.