PMID- 36199491 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231106 IS - 2150-0878 (Print) IS - 2150-0886 (Electronic) IS - 2150-0878 (Linking) VI - 13 IP - 7 DP - 2022 Sep TI - 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. PG - 664-672 LID - 10.6004/jadpro.2022.13.7.2 [doi] AB - 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. CI - (c) 2022 Harborside. FAU - Barber, Fedricker D AU - Barber FD AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Campbell, Erick AU - Campbell E AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Yamamura, Yuko AU - Yamamura Y AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Patterson, Clover J AU - Patterson CJ AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Hartnett, Audrey C AU - Hartnett AC AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Kinahan, Holly AU - Kinahan H AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Miller, Victoria A AU - Miller VA AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Brink, Amanda L AU - Brink AL AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Poullard, Anna AU - Poullard A AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Urschel, Gabriele E AU - Urschel GE AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Brantley, Andre AU - Brantley A AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Cepeda, Isabel G AU - Cepeda IG AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Goswami, Poonam AU - Goswami P AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Charles, Sheena AU - Charles S AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Philip, Shincy AU - Philip S AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Bresser, Sara AU - Bresser S AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Musekiwa-Adjei, Sandra AU - Musekiwa-Adjei S AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Perez, Nageli AU - Perez N AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Le, Hung AU - Le H AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Phillips, Penny AU - Phillips P AD - Clinical Center for Targeted Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Subbiah, Vivek AU - Subbiah V AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Meric-Bernstam, Funda AU - Meric-Bernstam F AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. AD - Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas. AD - Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. FAU - Dumbrava, Ecaterina E AU - Dumbrava EE AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. LA - eng GR - K12 CA088084/CA/NCI NIH HHS/United States GR - P30 CA016672/CA/NCI NIH HHS/United States PT - Journal Article DEP - 20221012 PL - United States TA - J Adv Pract Oncol JT - Journal of the advanced practitioner in oncology JID - 101550346 PMC - PMC9514129 COIS- The authors have no potential conflicts of interest to disclose. This work was partially supported by the National Institutes of Health through MD Anderson Cancer Center's Support Grant (P30 CA016672) and the NCI K12 Paul Calabresi Award CA088084. EDAT- 2022/10/07 06:00 MHDA- 2022/10/07 06:01 PMCR- 2022/09/01 CRDT- 2022/10/06 02:07 PHST- 2022/10/06 02:07 [entrez] PHST- 2022/10/07 06:00 [pubmed] PHST- 2022/10/07 06:01 [medline] PHST- 2022/09/01 00:00 [pmc-release] AID - 2022.13.7.2 [pii] AID - 10.6004/jadpro.2022.13.7.2 [doi] PST - ppublish SO - J Adv Pract Oncol. 2022 Sep;13(7):664-672. doi: 10.6004/jadpro.2022.13.7.2. Epub 2022 Oct 12.