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 at 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:

MK 3475 - PN811

Administered By
Duke Cancer Institute
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
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
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
Role
Principal Investigator
Start Date
End Date

Key LARGO: PII

Administered By
Duke Cancer Institute
Role
Principal Investigator
Start Date
End Date

Publications:

Safety at the Time of the COVID-19 Pandemic: How to Keep our Oncology Patients and Healthcare Workers Safe.

The novel coronavirus, SARS-CoV-2, was first detected as a respiratory illness in December 2019 in Wuhan City, China. Since then, coronavirus disease 2019 (COVID-19) has impacted every aspect of our lives worldwide. In a time when terms such as social distancing and flattening the curve have become a part of our vernacular, it is essential that we understand what measures can be implemented to protect our patients and healthcare workers. Undoubtedly, healthcare providers have had to rapidly alter care delivery models while simultaneously acknowledging the crucial unknowns of how these changes may affect clinical outcomes. This special feature reviews strategies on how to mitigate transmission of COVID-19 in an effort to reduce morbidity and mortality associated with the disease for patients with cancer without infection, for patients with cancer with COVID-19 infection, and for the healthcare workers caring for them, while continuing to provide the best possible cancer care. [Editor's Note: This article includes the most current information available at time of publication; however, recommendations regarding public safety and practice may change rapidly in this situation. Individuals should get the most up to date information from the CDC website.].
Authors
Cinar, P; Kubal, T; Freifeld, A; Mishra, A; Shulman, L; Bachman, J; Fonseca, R; Uronis, H; Klemanski, D; Slusser, K; Lunning, M; Liu, C
MLA Citation
Cinar, Pelin, et al. “Safety at the Time of the COVID-19 Pandemic: How to Keep our Oncology Patients and Healthcare Workers Safe.Journal of the National Comprehensive Cancer Network : Jnccn, Apr. 2020, pp. 1–6. Epmc, doi:10.6004/jnccn.2020.7572.
URI
https://scholars.duke.edu/individual/pub1438557
PMID
32294617
Source
epmc
Published In
Jnccn Journal of the National Comprehensive Cancer Network
Published Date
Start Page
1
End Page
6
DOI
10.6004/jnccn.2020.7572

A phase Ib study of capecitabine and ziv-aflibercept followed by a phase II single-arm expansion cohort in chemotherapy refractory metastatic colorectal cancer.

BACKGROUND: Patients with chemotherapy refractory metastatic colorectal cancer (CRC) have a poor prognosis and limited therapeutic options. In this phase Ib/II clinical trial, we established the maximum tolerated dose (MTD) and recommended phase II dose (RPTD) for the combination of capecitabine and ziv-aflibercept, and then we evaluated the efficacy of the combination in patients with chemotherapy refractory metastatic CRC. METHODS: All patients were required to have a Karnofsky Performance Status > 70% and adequate organ function. The phase Ib dose escalation cohort included patients with advanced solid tumors who had progressed on all standard therapies. Using a standard 3 + 3 design, we identified the MTD and RPTD for the combination. Fifty patients with metastatic CRC who had progressed on or were intolerant of a fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab were then enrolled in a single-arm phase II expansion cohort, and were treated at the RPTD. Prior EGFR antibody therapy was required for subjects with RAS wildtype tumors. The primary endpoint for the expansion cohort was progression-free survival (PFS) at two months. Secondary endpoints included objective response rate (ORR) and overall survival (OS). RESULTS: A total of 63 patients were enrolled and evaluable for toxicity (13 dose escalation; 50 expansion). The MTD and RPTD were: capecitabine 850 mg/m2, P.O. bid, days 1-14, and ziv-aflibercept 6 mg/kg I.V., day 1, of each 21-day cycle. In the expansion cohort, 72% of patients were progression-free at two months (95% confidence interval [CI], 60-84%). Median PFS and OS were 3.9 months (95% CI, 2.3-4.5) and 7.1 months (95% CI: 5.8-10.0), respectively. Among all patients evaluable for toxicity, the most common treatment related adverse events (all grade [%]; grade ≥ 3 [%]) included palmar-plantar erythrodysesthesia (41%; 6%), hypertension (33%; 22%), and mucositis (19%; 5%). RNA was isolated from archived tumor specimens and gene expression analyses revealed no association between angiogenic biomarkers and clinical outcomes. CONCLUSION: The combination of capecitabine and ziv-aflibercept at the RPTD demonstrated acceptable safety and tolerability. PFS at 2 months in patients with chemotherapy refractory metastatic CRC was significantly greater than that in historical controls, indicating that this combination warrants further study. TRIAL REGISTRATION: This clinical trial was registered in the www.clinicaltrials.gov system as NCT01661972 on July 31, 2012.
Authors
Strickler, JH; Rushing, CN; Niedzwiecki, D; McLeod, A; Altomare, I; Uronis, HE; Hsu, SD; Zafar, SY; Morse, MA; Chang, DZ; Wells, JL; Blackwell, KL; Marcom, PK; Arrowood, C; Bolch, E; Haley, S; Rangwala, FA; Hatch, AJ; Nixon, AB; Hurwitz, HI
MLA Citation
Strickler, John H., et al. “A phase Ib study of capecitabine and ziv-aflibercept followed by a phase II single-arm expansion cohort in chemotherapy refractory metastatic colorectal cancer.Bmc Cancer, vol. 19, no. 1, Nov. 2019, p. 1032. Pubmed, doi:10.1186/s12885-019-6234-8.
URI
https://scholars.duke.edu/individual/pub1417915
PMID
31675952
Source
pubmed
Published In
Bmc Cancer
Volume
19
Published Date
Start Page
1032
DOI
10.1186/s12885-019-6234-8

A phase Ib study of the combination regorafenib with PF-03446962 in patients with refractory metastatic colorectal cancer (REGAL-1 trial).

PURPOSE: This study aimed to evaluate the maximum tolerated dose (MTD) and recommended phase II dose (RPTD), as well as the safety and tolerability of PF-03446962, a monoclonal antibody targeting activin receptor like kinase 1 (ALK-1), in combination with regorafenib in patients with refractory metastatic colorectal cancer. METHODS: The first stage of this study was a standard "3 + 3" open-label dose-escalation scheme. Cohorts of 3-6 subjects were started with 120 mg of regorafenib given PO daily for 3 weeks of a 4 week cycle, plus 4.5 mg/kg of PF-03446962 given IV every 2 weeks. Doses of both drugs were adjusted according to dose-limiting toxicities (DLT). Plasma was collected for multiplexed ELISA analysis of factors related to tumor growth and angiogenesis. RESULTS: Seventeen subjects were enrolled, of whom 11 were deemed evaluable. Seven subjects were enrolled at dose level 1, and four were enrolled at level - 1. Overall, three DLTs were observed during the dose-escalation phase: two in level 1 and one in level - 1. A planned dose-expansion cohort was not started due to early termination of the clinical trial. Common adverse events were infusion-related reaction, fatigue, palmar-plantar erythrodysesthesia syndrome, abdominal pain, dehydration, nausea, back pain, anorexia, and diarrhea. One subject achieved stable disease for 5.5 months, but discontinued treatment due to adverse events. CONCLUSIONS: The regimen of regorafenib and PF-03446962 was associated with unacceptable toxicity and did not demonstrate notable clinical activity in patients with refractory metastatic colorectal cancer.
Authors
Clarke, JM; Blobe, GC; Strickler, JH; Uronis, HE; Zafar, SY; Morse, M; Dropkin, E; Howard, L; O'Neill, M; Rushing, CN; Niedzwiecki, D; Watson, H; Bolch, E; Arrowood, C; Liu, Y; Nixon, AB; Hurwitz, HI
MLA Citation
Clarke, Jeffrey Melson, et al. “A phase Ib study of the combination regorafenib with PF-03446962 in patients with refractory metastatic colorectal cancer (REGAL-1 trial).Cancer Chemother Pharmacol, vol. 84, no. 4, Oct. 2019, pp. 909–17. Pubmed, doi:10.1007/s00280-019-03916-0.
URI
https://scholars.duke.edu/individual/pub1405169
PMID
31444620
Source
pubmed
Published In
Cancer Chemother Pharmacol
Volume
84
Published Date
Start Page
909
End Page
917
DOI
10.1007/s00280-019-03916-0

The Use of Re-irradiation in Locally Recurrent, Non-metastatic Rectal Cancer.

BACKGROUND: The optimal approach to patients with locally recurrent, non-metastatic rectal cancer is unclear. This study evaluates the outcomes and toxicity associated with pelvic re-irradiation. METHODS: Patients undergoing re-irradiation for locally recurrent, non-metastatic, rectal cancer between 2000 and 2014 were identified. Acute and late toxicities were assessed using common terminology criteria for adverse events version 4.0. Disease-related endpoints included palliation of local symptoms, surgical outcomes, and local progression-free survival (PFS), distant PFS and overall survival (OS) using the Kaplan-Meier method. RESULTS: Thirty-three patients met the criteria for inclusion in this study. Two (6 %) experienced early grade 3+ toxicity and seven (21 %) experienced late grade 3+ toxicity. Twenty-three patients presented with symptomatic local recurrence and 18 (78 %) reported symptomatic relief. Median local PFS was 8.7 (95 % CI 3.8-15.2) months, with a 2-year rate of 15.7 % (4.1-34.2), and median time to distant progression was 4.4 (2.2-33.3) months, with a 2-year distant PFS rate of 38.9 % (20.1-57.3). Median OS time for patients was 23.1 (11.1-33.0) months. Of the 14 patients who underwent surgery, median survival was 32.3 (13.8-48.0) months compared with 13.3 (2.2-33.0) months in patients not undergoing surgery (p = 0.10). A margin-negative (R0) resection was achieved in 10 (71 %) of the surgeries. Radiation treatment modality (intensity-modulated radiation therapy, three-dimensional conformal radiotherapy, intraoperative radiation therapy) did not influence local or distant PFS or OS. CONCLUSION: Re-irradiation is a beneficial treatment modality for the management of locally recurrent, non-metastatic rectal cancer. It is associated with symptom improvement, low rates of toxicity, and similar benefits among radiation modalities.
Authors
Susko, M; Lee, J; Salama, J; Thomas, S; Uronis, H; Hsu, D; Migaly, J; Willett, C; Czito, B; Palta, M
MLA Citation
Susko, Matthew, et al. “The Use of Re-irradiation in Locally Recurrent, Non-metastatic Rectal Cancer.Ann Surg Oncol, vol. 23, no. 11, Oct. 2016, pp. 3609–15. Pubmed, doi:10.1245/s10434-016-5250-z.
URI
https://scholars.duke.edu/individual/pub1131953
PMID
27169769
Source
pubmed
Published In
Annals of Surgical Oncology
Volume
23
Published Date
Start Page
3609
End Page
3615
DOI
10.1245/s10434-016-5250-z

Is follow-up CT imaging of the chest and abdomen necessary after preoperative neoadjuvant therapy in rectal cancer patients without evidence of metastatic disease at diagnosis?

AIM: Patients with rectal cancer often undergo multiple CT scans prior to surgical resection. We propose that in patients with locally advanced rectal cancer without evidence of metastatic disease at presentation, CT imaging of the chest and abdomen after preoperative neoadjuvant therapy does not change clinical information or surgical management. METHOD: An institutional review board-approved medical record review identified patients with contrast enhanced CT of the chest, abdomen and pelvis alone or in conjunction with (18)F-fluoro-2-deoxy-d-glucose/positron emission tomography imaging for staging of rectal cancer prior to and after neoadjuvant therapy. Eighty-eight patients were included in the study. Scans were reviewed for the presence of metastatic disease on initial and follow-up imaging prior to surgical resection. RESULTS: Seventy-six (86%) of 88 patients had no evidence of metastasis at presentation. None of these patients developed metastatic disease after neoadjuvant therapy. Twelve (14%) had metastases at presentation. No study patient developed metastatic disease in a new organ. CONCLUSION: Imaging after preoperative neoadjuvant therapy in rectal cancer does not change the designation of metastatic disease. Patients with locally advanced rectal adenocarcinoma without evidence of metastases may not benefit from repeat imaging of the chest and abdomen after neoadjuvant therapy.
Authors
Jaffe, TA; Neville, AM; Bashir, MR; Uronis, HE; Thacker, JM
MLA Citation
Jaffe, T. A., et al. “Is follow-up CT imaging of the chest and abdomen necessary after preoperative neoadjuvant therapy in rectal cancer patients without evidence of metastatic disease at diagnosis?Colorectal Dis, vol. 15, no. 11, Nov. 2013, pp. e654–58. Pubmed, doi:10.1111/codi.12372.
URI
https://scholars.duke.edu/individual/pub960402
PMID
23910050
Source
pubmed
Published In
Colorectal Dis
Volume
15
Published Date
Start Page
e654
End Page
e658
DOI
10.1111/codi.12372

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