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

Esophageal Function Tests are Not Associated with Barium Swallow Findings in Advanced Lung Disease.

Gastroesophageal reflux disease and esophageal dysmotility are common in patients with advanced lung disease (ALD) and are associated with worse outcomes. Assessing esophageal function in these patients is relevant for determining pulmonary transplant eligibility and prognosticating post-transplant outcomes. Barium Swallow (BaS) is a non-invasive testing modality often performed as a complement to formal esophageal function tests (EFTs), but its role and clinical utility in this context is unknown. Therefore, we aimed to determine the relationship between BaS and EFTs with high-resolution manometry (HRM) and 24-h ambulatory pH-metry in patients with ALD. We performed a retrospective study of 226 consecutive patients undergoing evaluation for lung transplantation at a single center. All patients underwent EFTs and BaS independent of clinical history or symptoms per institutional protocol. Appropriate statistical tests were performed to evaluate the relationship between EFTs and BaS. Mucosal, reflux and motility findings were categorized. Abnormal motility was reported in 133 (59%) patients by BaS and 99 (44%) by HRM, with a significant difference in the proportions of patients with abnormal studies (p < 0.01). There were 7 (26%) patients with abnormal barium tablet passage who had normal HRM. The sensitivity (35%) and specificity (77%) for detecting pathologic reflux with BaS was poor. Inducibility of reflux and barium column height were not associated with pH-metry results. No clinically significant luminal irregularities were identified. In conclusion, while BaS can non-invasively assess esophageal mucosa, its findings are not associated with EFTs in patients with ALD.
Authors
Posner, S; Mehta, K; Parish, A; Niedzwiecki, D; Gupta, RT; Fisher, DA; Leiman, DA
MLA Citation
Posner, Shai, et al. “Esophageal Function Tests are Not Associated with Barium Swallow Findings in Advanced Lung Disease.Dysphagia, Apr. 2020. Pubmed, doi:10.1007/s00455-020-10113-2.
URI
https://scholars.duke.edu/individual/pub1436979
PMID
32277290
Source
pubmed
Published In
Dysphagia
Published Date
DOI
10.1007/s00455-020-10113-2

1089 Hypophosphatemia in Patients With Alcoholic Hepatitis

Authors
Chiang, RS; Farooq, A; Parish, A; Niedzwiecki, D; Kappus, MR; Patel, Y; Liddle, RA; Muir, AJ
MLA Citation
Chiang, Ryan S., et al. “1089 Hypophosphatemia in Patients With Alcoholic Hepatitis.” American Journal of Gastroenterology, vol. 114, no. 1, Ovid Technologies (Wolters Kluwer Health), 2019, pp. S615–16. Crossref, doi:10.14309/01.ajg.0000593888.05451.17.
URI
https://scholars.duke.edu/individual/pub1433427
Source
crossref
Published In
American Journal of Gastroenterology
Volume
114
Published Date
Start Page
S615
End Page
S616
DOI
10.14309/01.ajg.0000593888.05451.17

Deletions in HSP110 T17 and patient prognosis in stage III microsatellite instable (MSI) colon cancers: Findings from CALGB 89803 and NCCTG N0147.

Authors
Wu, CS-Y; Shi, Q; Tomsic, J; Meyers, JP; Frankel, WL; Timmers, CD; Saltz, L; Alberts, SR; Niedzwiecki, D; Sargent, DJ; Hampel, H; De La Chapelle, A; Goldberg, RM
MLA Citation
Wu, Christina Sing-Ying, et al. “Deletions in HSP110 T17 and patient prognosis in stage III microsatellite instable (MSI) colon cancers: Findings from CALGB 89803 and NCCTG N0147.Journal of Clinical Oncology, vol. 34, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2016, pp. e15148–e15148. Crossref, doi:10.1200/jco.2016.34.15_suppl.e15148.
URI
https://scholars.duke.edu/individual/pub1396467
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
34
Published Date
Start Page
e15148
End Page
e15148
DOI
10.1200/jco.2016.34.15_suppl.e15148

Impact of primary (1º) tumor location on overall survival (OS) and progression-free survival (PFS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB/SWOG 80405 (Alliance).

Authors
Venook, AP; Niedzwiecki, D; Innocenti, F; Fruth, B; Greene, C; O'Neil, BH; Shaw, JE; Atkins, JN; Horvath, LE; Polite, BN; Meyerhardt, JA; O'Reilly, EM; Goldberg, RM; Hochster, HS; Blanke, CD; Schilsky, RL; Mayer, RJ; Bertagnolli, MM; Lenz, H-J
MLA Citation
Venook, Alan P., et al. “Impact of primary (1º) tumor location on overall survival (OS) and progression-free survival (PFS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB/SWOG 80405 (Alliance).Journal of Clinical Oncology, vol. 34, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2016, pp. 3504–3504. Crossref, doi:10.1200/jco.2016.34.15_suppl.3504.
URI
https://scholars.duke.edu/individual/pub1396468
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
34
Published Date
Start Page
3504
End Page
3504
DOI
10.1200/jco.2016.34.15_suppl.3504