Hope Uronis

Positions:

Associate Professor of Medicine

Medicine, Medical Oncology
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

M.D. 2000

State University of New York - Buffalo

Medical Resident, Medicine

Duke University

Fellow in Hematology-Oncology, Medicine

Duke University

Chief Medical Resident -Duke Hospital, Medicine

Duke University

Fellow in Hematology-Oncology, Medicine

Duke University

Grants:

A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo asFirst-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Juncti

Administered By
Duke Cancer Institute
Awarded By
Merck Sharp & Dohme
Role
Principal Investigator
Start Date
End Date

A Randomized multicenter double blind Phase III study of Nivolumab or placebo in subjects with resected esophageal junction cancer.

Administered By
Duke Cancer Institute
Awarded By
Bristol-Myers Squibb Company
Role
Principal Investigator
Start Date
End Date

A Multicenter randomized open label study in patients with esophageal cancer refractory or intorlerant to combination therapy with fluoropyrimidine

Administered By
Duke Cancer Institute
Awarded By
Bristol-Myers Squibb Company
Role
Principal Investigator
Start Date
End Date

A Phase 1b/2 open label dose escalation study of Margetuximab incombination with Pembrolizumab in patients with relapsed refrectory advanced HER2 + Gastroesophageal junction or gastric cancer.

Administered By
Duke Cancer Institute
Awarded By
MacroGenics, Inc.
Role
Principal Investigator
Start Date
End Date

Key-LARGO: A Single Arm, Phase II Study of Pembrolizumab, Oxaliplatin, and Capecitabine in the First Line Treatment of Patients with Gastro-esophageal Cancer,"

Administered By
Duke Cancer Institute
Awarded By
Merck Sharp & Dohme
Role
Principal Investigator
Start Date
End Date

Publications:

Phase Ib/II study of pembrolizumab with lanreotide depot for advanced, progressive gastroenteropancreatic neuroendocrine tumors (PLANET).

<jats:p> 369 </jats:p><jats:p> Background: Pembrolizumab has antitumor activity in a subset of GEP-NETs patients. We hypothesized that the lanreotide, by its antitumor effects and reduction of serotonin, a modulator of immunity, would synergize with pembrolizumab in low/intermediate grade GEPNETs. Methods: GEP-NETs patients who had progressed on a prior somatostatin analogue received lanreotide 90mg sq and pembrolizumab 200mg IV every 3 weeks until progressive disease or intolerable toxicity. The primary endpoint was ORR at any time on study and secondary endpoints were PFS and OS. Results: 22 patients were treated (F/M 10/12; Caucasian/AA/other 10/7/5; GI/pancreatic 14/8; median Ki67 5%, median time since diagnosis 5.3 yrs (IQR 2.3-7.9 yrs)). Prior octreotide LAR/lanreotide/both was administered to 20/1/1. Patients had a median of 2 prior systemic therapies (range 1-9) and six had prior locoregional therapy and 3 external beam radiotherapy. Of the 12 tumors analyzed thus far, 4 had detectable PD-L1 expression and 11 had detectable TILs. A median of 6 pembrolizumab doses (range 2-15) and 7 lanreotide doses (range 2-15) were administered. Six patients experienced treatment related SAEs (abdominal pain, pneumonitis, colitis, and hyperglycemia, all related to the pembrolizumab). Selected treatment related adverse events included: Hypothyroidism 23%, colitis 9%, hyperglycemia 14%, and pneumonitis 5%. Best response by RECIST 1.1 was SD/PD/Not available:39/52/9% and by irRECIST was 43/48/9%. Median PFS was 5.4 months (95% CI 1.7-8.3 mo). The median overall survival at a median follow-up of 15 months was not reached. Peripheral blood immunologic correlates will be reported subsequently. Conclusions: In a population of GEP-NET patients, progressing on a median of 2 prior therapies, including prior somatostatin analogue therapy, a minority of whom had PD-L1 expressing tumors, the combination of lanreotide and pembrolizumab produced stable disease in approximately 40% of patients. No new safety signals were identified. Clinical trial information: NCT03043664. </jats:p>
Authors
Morse, M; Halperin, DM; Uronis, HE; Hsu, DS; Hurwitz, H; Bolch, E; Warren, D; Haley, S; John, L; Moyer, A; Rushing, CN; Niedzwiecki, D
MLA Citation
Morse, Michael, et al. “Phase Ib/II study of pembrolizumab with lanreotide depot for advanced, progressive gastroenteropancreatic neuroendocrine tumors (PLANET).Journal of Clinical Oncology, vol. 39, no. 3_suppl, American Society of Clinical Oncology (ASCO), 2021, pp. 369–369. Crossref, doi:10.1200/jco.2021.39.3_suppl.369.
URI
https://scholars.duke.edu/individual/pub1480555
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
39
Published Date
Start Page
369
End Page
369
DOI
10.1200/jco.2021.39.3_suppl.369

KEYlargo: A phase II study of first-line pembrolizumab (P), capecitabine (C), and oxaliplatin (O) in HER2-negative gastroesophageal (GE) adenocarcinoma.

<jats:p> 228 </jats:p><jats:p> Background: Gastric and esophageal adenocarcinomas are a leading cause of cancer death worldwide. Many of these patients (pts) present with locally advanced unresectable or metastatic disease and are treated with combination cytotoxic chemotherapy. Single agent P is FDA approved for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (GEJ) whose tumors have a combined positive score (CPS) ≥ 1 after disease progression on or after two lines of therapy including fluoropyrimidine and platinum and her2/neu-targeted therapy (if indicated). More effective therapy is needed earlier in the disease trajectory. We conducted a single-arm phase II trial to establish the safety and efficacy of first-line C and O + P. Methods: Pts with previously untreated metastatic GE adenocarcinoma regardless of PDL-1 status received intravenous (IV) P 200mg with IV O 130mg/m<jats:sup>2</jats:sup> every three weeks and oral C 850mg/m<jats:sup>2</jats:sup> twice daily for 14 days on/7 days off. After the 6 patient safety cohort, pts first completed a biomarker cycle that included fresh tumor biopsy before P and one week after P before chemotherapy started. Archived FFPE tumor samples were also obtained from all pts with available tissue. The primary endpoint was progression free survival (PFS); secondary endpoints included response rate (RR) and overall survival (OS). Results: 36 pts were enrolled and 34 pts were evaluable for efficacy (1 pt withdrew for personal reasons before end of cycle 1 and 1 pt had immune-related toxicity during cycle 1 and was taken off study before any efficacy assessment). 9 pts (26%) had an esophageal primary, 18 pts (53%) had a GEJ primary and 7 pts (21%) had a gastric primary. Median PFS was 7.6 months [95% CI: 5.8 to 12.2], RR was 72.7% [95% CI: 57% to 88%], and median OS was 15.8 months [95% CI: 11.6 to NE]. 27 patients (81.8%) had decrease in disease burden (ranging from -19% to -100%). After &gt; 18 months of follow-up, 5 patients remained in durable complete response (CR). Immune-mediated treatment related adverse events (TRAEs) included thyroid disorders (n=5; 14%), colitis (n=4; 11%), adrenal insufficiency (n=2; 5%), and type 1 diabetes (n=1). Sixteen patients (44%) experienced grade 3 or 4 TRAEs. There were no grade 5 TRAEs. Conclusions: The combination of C and O + P had acceptable safety and significant clinical activity. These promising results indicate that C and O + P merits further study as a first line option for patients with unresectable locally advanced or metastatic GE adenocarcinoma. Updated survival and correlative data will be presented. Clinical trial information: NCT03342937. </jats:p>
Authors
Uronis, HE; Rushing, C; Blobe, GC; Hsu, SD; Mettu, NB; Wells, JL; Niedzwiecki, D; Hartman, L; Moyer, A; Hurwitz, HI; Strickler, JH
MLA Citation
Uronis, Hope Elizabeth, et al. “KEYlargo: A phase II study of first-line pembrolizumab (P), capecitabine (C), and oxaliplatin (O) in HER2-negative gastroesophageal (GE) adenocarcinoma.Journal of Clinical Oncology, vol. 39, no. 3_suppl, American Society of Clinical Oncology (ASCO), 2021, pp. 228–228. Crossref, doi:10.1200/jco.2021.39.3_suppl.228.
URI
https://scholars.duke.edu/individual/pub1478769
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
39
Published Date
Start Page
228
End Page
228
DOI
10.1200/jco.2021.39.3_suppl.228

Implementation of a Hepatic Artery Infusion Program: Initial Patient Selection and Perioperative Outcomes of Concurrent Hepatic Artery Infusion and Systemic Chemotherapy for Colorectal Liver Metastases.

BACKGROUND: Hepatic artery infusion (HAI) combined with systemic chemotherapy is a treatment strategy for patients with unresectable liver-only or liver-dominant colorectal liver metastases (CRLM). Although HAI has previously been performed in only a few centers, this study aimed to describe patient selection and initial perioperative outcomes during implementation of a new HAI program. METHODS: The study enrolled patients with CRLM selected for HAI after multi-disciplinary review November 2018-January 2020. Demographics, prior treatment, and perioperative outcomes were assessed. Objective hepatic response was calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. RESULTS: During a 14-month period, 21 patients with CRLM underwent HAI pump placement. Of these 21 patients, 20 (95%) had unresectable disease. Most of the patients had synchronous disease (n = 18, 86%) and had received prior chemotherapy (n = 20, 95%) with extended treatment cycles (median 16; interquartile range, 8-22; range, 0-66). The median number of CRLMs was 7 (range, 2-40). Operations often were performed with combined hepatectomy (n = 4, 19%) and/or colectomy/proctectomy (n = 11, 52%). The study had no 90-day mortality. The overall surgical morbidity was 19%. The HAI-specific complications included pump pocket seroma (n = 2), hematoma (n = 1), surgical-site infection (n = 1), and extrahepatic perfusion (n = 1). HAI was initiated in 20 patients (95%). The hepatic response rates at 3 months included partial response (n = 4, 24%), stable disease (n = 9, 53%), and progression of disease (n = 4, 24%), yielding a 3-month hepatic disease control rate (DCR) of 76%. CONCLUSION: Implementation of a new HAI program is feasible, and HAI can be delivered safely to selected patients with CRLM. The initial response and DCR are promising, even for patients heavily pretreated with chemotherapy.
Authors
Creasy, JM; Napier, KJ; Reed, SA; Zani, S; Wong, TZ; Kim, CY; Wildman-Tobriner, B; Strickler, JH; Hsu, SD; Uronis, HE; Allen, PJ; Lidsky, ME
MLA Citation
URI
https://scholars.duke.edu/individual/pub1454414
PMID
32779054
Source
pubmed
Published In
Annals of Surgical Oncology
Volume
27
Published Date
Start Page
5086
End Page
5095
DOI
10.1245/s10434-020-08972-y

Metastatic Pancreatic Cancer: ASCO Guideline Update.

PURPOSE: The aim of this work was to provide an update to the ASCO guideline on metastatic pancreatic cancer pertaining to recommendations for therapy options after first-line treatment. METHODS: ASCO convened an Expert Panel and conducted a systematic review to update guideline recommendations for second-line therapy for metastatic pancreatic cancer. RESULTS: One randomized controlled trial of olaparib versus placebo, one report on phase I and II studies of larotrectinib, and one report on phase I and II studies of entrectinib met the inclusion criteria and inform the guideline update. RECOMMENDATIONS: New or updated recommendations for germline and somatic testing for microsatellite instability high/mismatch repair deficiency, BRCA mutations, and TRK alterations are provided for all treatment-eligible patients to select patients for recommended therapies, including pembrolizumab, olaparib, larotrectinib, or entrectinib, or potential clinical trials. The Expert Panel continues to endorse the remaining recommendations for second-line chemotherapy, as well as other recommendations related to treatment, follow-up, and palliative care from the 2018 version of this guideline. Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines.
Authors
Sohal, DPS; Kennedy, EB; Cinar, P; Conroy, T; Copur, MS; Crane, CH; Garrido-Laguna, I; Lau, MW; Johnson, T; Krishnamurthi, S; Moravek, C; O'Reilly, EM; Philip, PA; Pant, S; Shah, MA; Sahai, V; Uronis, HE; Zaidi, N; Laheru, D
MLA Citation
Sohal, Davendra P. S., et al. “Metastatic Pancreatic Cancer: ASCO Guideline Update.J Clin Oncol, Aug. 2020, p. JCO2001364. Pubmed, doi:10.1200/JCO.20.01364.
URI
https://scholars.duke.edu/individual/pub1454279
PMID
32755482
Source
pubmed
Published In
Journal of Clinical Oncology
Published Date
Start Page
JCO2001364
DOI
10.1200/JCO.20.01364

Feasibility, engagement, and acceptability of a behavioral pain management intervention for colorectal cancer survivors with pain and psychological distress: data from a pilot randomized controlled trial.

PURPOSE: Colorectal cancer survivors report pain and psychological distress to be burdensome long-term cancer consequences. Quality cancer survivorship care includes interventions for managing these symptoms. Yet, no studies have tested the efficacy of an accessible behavioral intervention for colorectal cancer survivors with pain and comorbid psychological distress. This paper reports on the feasibility (i.e., accrual, attrition, and adherence to study procedures), engagement, acceptability, and descriptive outcomes of a telephone-based coping skills training (CST) intervention. METHODS: This randomized pilot trial assigned colorectal cancer patients (N=31) to 5 sessions of CST or standard care. CST sessions focused on cognitive-behavioral theory-based coping skills tailored to colorectal cancer symptoms of pain and psychological distress. Participants completed assessments of pain severity, self-efficacy for pain management, health-related quality of life, and psychological distress at baseline, post-treatment, and 3-month follow-up. RESULTS: Data indicated strong feasibility, evidenced by high completion rates for intervention sessions and assessments (93% completed all sessions; M=48.7 days; baseline=100%; post-treatment=97%; 3-month follow-up=94%). Participants demonstrated robust engagement with CST (M days per week with reported skills use=3.8) and reported high protocol satisfaction (M=3.6/4.0). Descriptive statistics showed self-efficacy for pain management and health-related quality of life improved for all participants. CONCLUSION: Findings suggest that a telephone-based CST intervention has strong feasibility, evidenced by accrual, low attrition, and adherence to intervention sessions and assessments. Likewise, participant engagement and acceptability with CST were high. These data provide a foundation for larger randomized efficacy trials of the telephone-based CST intervention.
Authors
MLA Citation
Kelleher, Sarah A., et al. “Feasibility, engagement, and acceptability of a behavioral pain management intervention for colorectal cancer survivors with pain and psychological distress: data from a pilot randomized controlled trial.Support Care Cancer, vol. 29, no. 9, Sept. 2021, pp. 5361–69. Pubmed, doi:10.1007/s00520-021-06126-8.
URI
https://scholars.duke.edu/individual/pub1475456
PMID
33686520
Source
pubmed
Published In
Support Care Cancer
Volume
29
Published Date
Start Page
5361
End Page
5369
DOI
10.1007/s00520-021-06126-8

Research Areas:

Adenocarcinoma
Administration, Oral
Adult
Aged
Aged, 80 and over
Ampulla of Vater
Anastomotic Leak
Angiogenesis Inhibitors
Aniline Compounds
Anoxia
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols
Anus Neoplasms
Anxiety
Bevacizumab
Carcinoma, Squamous Cell
Chemoradiotherapy
Chemoradiotherapy, Adjuvant
Colorectal Neoplasms
Combined Modality Therapy
Common Bile Duct Neoplasms
Depression
Esophagectomy
Female
Follow-Up Studies
Gastrointestinal Neoplasms
Humans
Hydroxamic Acids
Hypocalcemia
Hypokalemia
Hypoxia
Immunosuppressive Agents
Injections, Intravenous
Kaplan-Meier Estimate
Language
Leukocytes, Mononuclear
Liver Neoplasms
Lymph Nodes
Lymphatic Irradiation
Male
Middle Aged
Models, Statistical
Neoadjuvant Therapy
Neoplasm Recurrence, Local
Organoplatinum Compounds
Oxaliplatin
Pain Measurement
Palliative Care
Pancreatic Neoplasms
Patient Satisfaction
Photons
Platinum Compounds
Protein Kinase Inhibitors
Psychometrics
Pyrimidines
Quality of Life
Randomized Controlled Trials as Topic
Regression Analysis
Reproducibility of Results
Retrospective Studies
Risk Factors
Sirolimus
Socioeconomic Factors
Sulfonamides
Survival Rate
Thiazoles
Tumor Markers, Biological
Young Adult