Donna Niedzwiecki

Overview:

Primary interests include clinical trials design and the design and analysis of biomarker and imaging studies especially in the areas of GI cancer, lymphoma, melanoma, transplant and cancer immunotherapy.

Positions:

Professor of Biostatistics and Bioinformatics

Biostatistics & Bioinformatics
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

Ph.D. 1984

Yale University

Grants:

Planning a Duke Academic Public Private Partnership Program (AP4) Center

Administered By
Duke Cancer Institute
Awarded By
National Cancer Institute
Role
Biostatistician
Start Date
End Date

Role for TbetaRIII Shedding in the Tumor Microenvironment

Administered By
Medicine, Medical Oncology
Awarded By
National Institutes of Health
Role
Collaborator
Start Date
End Date

Graft Engineering and Immunotherapy After Unrelated Cord Blood Transplantation

Administered By
Pediatrics, Blood and Marrow Transplantation
Awarded By
National Institutes of Health
Role
Co Investigator
Start Date
End Date

Dexasome Based Immunotherapy of Lung Cancer

Administered By
Medicine, Medical Oncology
Awarded By
National Institutes of Health
Role
Statistician
Start Date
End Date

The Impact of Race, Ethnicity, and Socioeconomic Status on Listing for Liver Transplant after Referral

Administered By
Medicine, Gastroenterology
Awarded By
American Association for the Study of Liver Diseases
Role
Statistician
Start Date
End Date

Publications:

Diabetes and clinical outcome in patients with metastatic colorectal cancer: CALGB 80405 (Alliance)

© The Author(s) 2020. Published by Oxford University Press. Background: Diabetes is a prognostic factor for some malignancies, but its association with outcome in patients with advanced or metastatic colorectal cancer (CRC) is less clear. Methods: This cohort study was nested within a randomized trial of first-line chemotherapy and bevacizumab and/or cetuxi-mab for advanced or metastatic CRC. Patients were enrolled at 508 community and academic centers throughout the National Clinical Trials Network. The primary exposure was physician-documented diabetes at the time of enrollment. The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS) and adverse events. Tests of statistical significance were two-sided. Results: Among 2326 patients, 378 (16.3%) had diabetes. The median follow-up time was 6.0years. We observed 1973 OS events and 2173 PFS events. The median time to an OS event was 22.7 months among those with diabetes and 27.1 months among those without diabetes (HR = 1.27, 95% CI = 1.13 to 1.44; P <.001). The median time to a PFS event was 9.7 months among those with diabetes and 10.8 months among those without diabetes (HR = 1.16, 95% CI = 1.03 to 1.30; P =.02). Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%; P =.054) but were not more likely to experience other adverse events, including neuropathy. Conclusions: Diabetes is associated with an increased risk of mortality and tumor progression in patients with advanced or metastatic CRC. Patients with diabetes tolerate first-line treatment with chemotherapy and monoclonal antibodies similarly to patients without diabetes.
Authors
Brown, JC; Zhang, S; Ou, FS; Venook, AP; Niedzwiecki, D; Lenz, HJ; Innocenti, F; O'Neil, BH; Shaw, JE; Polite, BN; Denlinger, CS; Atkins, JN; Goldberg, RM; Ng, K; Mayer, RJ; Blanke, CD; O'Reilly, EM; Fuchs, CS; Meyerhardt, JA
MLA Citation
Brown, J. C., et al. “Diabetes and clinical outcome in patients with metastatic colorectal cancer: CALGB 80405 (Alliance).” Jnci Cancer Spectrum, vol. 4, no. 1, Feb. 2020. Scopus, doi:10.1093/jncics/pkz078.
URI
https://scholars.duke.edu/individual/pub1450665
Source
scopus
Published In
Jnci Cancer Spectrum
Volume
4
Published Date
DOI
10.1093/jncics/pkz078

Topical sildenafil in the treatment of hand-foot syndrome and hand-foot skin reaction: A retrospective study.

Authors
Arrowood, C; Rushing, CN; Niedzwiecki, D; Howard, L; Honeycutt, W; Hurwitz, H; Cardones, A
MLA Citation
Arrowood, Christy, et al. “Topical sildenafil in the treatment of hand-foot syndrome and hand-foot skin reaction: A retrospective study.Journal of Clinical Oncology, vol. 36, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2018, pp. e22095–e22095. Crossref, doi:10.1200/jco.2018.36.15_suppl.e22095.
URI
https://scholars.duke.edu/individual/pub1437250
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
36
Published Date
Start Page
e22095
End Page
e22095
DOI
10.1200/jco.2018.36.15_suppl.e22095

A LARGE PROPORTION OF NAFLD PATIENTS WITH ADVANCED FIBROSIS REMAIN CLINICALLY UNIDENTIFIED: AN ANALYSIS OF PCORNET DATA

Authors
Patel, Y; Parish, A; Niedzwiecki, D; Muir, AJ; Fisher, D
MLA Citation
URI
https://scholars.duke.edu/individual/pub1417377
Source
wos
Published In
Hepatology (Baltimore, Md.)
Volume
70
Published Date
Start Page
375A
End Page
376A

Utility of a Near-Infrared Light Device (NIRD) in Detecting Subdural (SDH) and Epidural (EDH) Hematomas: An Effectiveness Trial Toward Using a NIRD for Neurosurgical Triaging in Low and Middle-Income Countries (LMICs)

Authors
Gramer, RM; Fuller, A; Yang, L; Niedzwiecki, D; Graffagnino, C; Perry, B; Haglund, M
URI
https://scholars.duke.edu/individual/pub1402835
Source
wos
Published In
Journal of Neurosurgery
Volume
131
Published Date

Causal modeling of CALGB 80405 (Alliance) to identify network drivers of metastatic colorectal cancer (CRC).

Authors
Das, RK; Furchtgott, L; Meyerhardt, JA; Nixon, AB; Innocenti, F; Cunha, D; Rich, K; Lenz, H-J; Niedzwiecki, D; O'Reilly, EM; Ou, F-S; Latourelle, J; Wuest, D; Hayete, B; Khalil, I; Venook, AP
MLA Citation
Das, Rahul K., et al. “Causal modeling of CALGB 80405 (Alliance) to identify network drivers of metastatic colorectal cancer (CRC).Journal of Clinical Oncology, vol. 36, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2018, pp. 3570–3570. Crossref, doi:10.1200/jco.2018.36.15_suppl.3570.
URI
https://scholars.duke.edu/individual/pub1438785
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
36
Published Date
Start Page
3570
End Page
3570
DOI
10.1200/jco.2018.36.15_suppl.3570