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

Transplant Outcomes in Older Patients With Nonalcoholic Steatohepatitis Compared to Alcohol-related Liver Disease and Hepatitis C.

BACKGROUND: Patients with nonalcoholic steatohepatitis (NASH) are waitlisted at older ages than individuals with other liver diseases, but the effect of age on liver transplantation (LT) outcomes in this population and whether it differs from other etiologies is not known. We aimed to evaluate the impact of age on LT outcomes in NASH. METHODS: The United Network for Organ Sharing database was used to identify adults with NASH, hepatitis C virus (HCV) infection, and alcohol-related liver disease (ALD) listed for LT during 2004-2017. Patients were split into age groups (18-49, 50-54, 55-59, 60-64, 65-69, ≥70), and their outcomes were compared. RESULTS: From 2004 to 2017, 14 197 adults with NASH were waitlisted, and the proportion ≥65 increased from 15.8% to 28.9%. NASH patients ages 65-69 had an increased risk of waitlist and posttransplant mortality compared to younger groups, whereas the outcomes in ages 60-64 and 55-59 were similar. The outcomes of individuals with NASH were similar to patients of the same age group with ALD or HCV. Functional status and dialysis were predictors of posttransplant mortality in individuals ≥65 with NASH, and cardiovascular disease was the leading cause of death. CONCLUSIONS: Older NASH patients (≥65) have an increased risk of waitlist and posttransplant mortality compared to younger individuals, although outcomes were similar to patients with ALD or HCV of corresponding age. These individuals should be carefully evaluated prior to LT, considering their functional status, renal function, and cardiovascular risk. Further studies are needed to optimize outcomes in this growing population of transplant candidates.
Authors
Henson, JB; Wilder, JM; Kappus, MR; Barbas, AS; Moylan, CA; Niedzwiecki, D; Muir, AJ; Berg, CL; Patel, YA
MLA Citation
Henson, Jacqueline B., et al. “Transplant Outcomes in Older Patients With Nonalcoholic Steatohepatitis Compared to Alcohol-related Liver Disease and Hepatitis C.Transplantation, vol. 104, no. 6, June 2020, pp. e164–73. Pubmed, doi:10.1097/TP.0000000000003219.
URI
https://scholars.duke.edu/individual/pub1434746
PMID
32150036
Source
pubmed
Published In
Transplantation
Volume
104
Published Date
Start Page
e164
End Page
e173
DOI
10.1097/TP.0000000000003219

Development and Implementation of an Educational Simulation Workshop in Fiberoptic Laryngoscopy for Radiation Oncology Residents.

PURPOSE: Fiberoptic laryngoscopy (FOL) is a critical tool for the diagnosis, staging, assessment of treatment response, and detection of recurrence for head and neck (H&N) malignancies. No standardized recommendations exist for procedural FOL education in radiation oncology. We therefore implemented a pilot simulation workshop to train radiation oncology residents in pertinent H&N anatomy and FOL technique. METHODS AND MATERIALS: A 2-phase workshop and simulation session was designed. Residents initially received a lecture on H&N anatomy and the logistics of the FOL examination. Subsequently, residents had a practical session in which they performed FOL in 2 simulated environments: a computerized FOL program and mannequin-based practice. Site-specific attending physicians were present to provide real-time guidance and education. Pre- and postworkshop surveys were administered to the participants to determine the impact of the workshop. Subsequently, postgraduate year (PGY)-2 residents were required to complete 6 supervised FOL examinations in clinic and were provided immediate feedback. RESULTS: Annual workshops were performed in 2017 to 2019. The survey completion rate was 14 of 18 (78%). Participants ranged from fourth-year medical students to PGY-2 to PGY-5 residents. All PGY-2 residents completed their 6 supervised FOL examinations. On a 5-point Likert scale, mean H&N anatomy knowledge increased from 2.4 to 3.7 (standard deviation = 0.6, P < .0001). Similarly, mean FOL procedural skill confidence increased from 2.2 to 3.3 (standard deviation = 0.7, P < .0001). These effects were limited to novice (fourth-year medical students to PGY-2) participants. All participants found the exercise clinically informative. CONCLUSIONS: A simulation-based workshop for teaching FOL procedural skills increased confidence and procedural expertise of new radiation oncology residents and translated directly to supervised clinical encounters. Adoption of this type of program may help to improve resident training in H&N cancer.
Authors
Price, JG; Spiegel, DY; Yoo, DS; Moravan, MJ; Mowery, YM; Niedzwiecki, D; Brizel, DM; Salama, JK
MLA Citation
Price, Jeremy G., et al. “Development and Implementation of an Educational Simulation Workshop in Fiberoptic Laryngoscopy for Radiation Oncology Residents.Int J Radiat Oncol Biol Phys, May 2020. Pubmed, doi:10.1016/j.ijrobp.2020.05.009.
URI
https://scholars.duke.edu/individual/pub1441495
PMID
32417408
Source
pubmed
Published In
Int J Radiat Oncol Biol Phys
Published Date
DOI
10.1016/j.ijrobp.2020.05.009

A novel interaction of genotype, gender, and adjuvant treatment in survival after resection of stage III colon cancer: Results of CALGB 89803.

<jats:p> 452 </jats:p><jats:p> Background: The p53 tumor suppressor gene is frequently mutated in colorectal cancer, but reports on the effect of p53 mutations on response to adjuvant chemotherapy and survival are inconclusive. This study investigates whether p53 mutational status (wild-type, zinc or non-zinc binding mutations) impacts survival following adjuvant therapy containing fluorouracil/leucovorin with or without irinotecan (5FU/LV or IFL) in women and men with stage III colon cancer. </jats:p><jats:p> Methods: As part of a retrospective analysis of prospectively accrued data, p53 mutational status was determined for 609 patients with stage III colon cancer who were randomized on CALGB 89803, a phase III adjuvant chemotherapy trial. p53 exons 5-8 were analyzed by direct sequencing or sequencing by hybridization. p53 mutations were identified in 276 tumors (45%), of which 134 were in the zinc binding and 142 were in the non-zinc binding regions of the core domain. Cox regression was used to study the impact of p53 mutational status, sex, and adjuvant chemotherapy on disease-free (DFS) and overall survival (OS). </jats:p><jats:p> Results: p53 mutational status did not predict differential survival or response to adjuvant therapy among the 609 patients assessed. However, a significant sex by treatment interaction was observed for both DFS (P<jats:sub>interaction</jats:sub>=0.008) and OS (P<jats:sub>interaction</jats:sub>=0.002). Significant differences in DFS by p53 mutational status were observed among women (logrank P = 0.009). No such differences were observed among men (logrank P = 0.33). Similar results were observed for OS. There was marginal evidence of a treatment-related impact on the interaction between sex and p53 mutational status for both DFS and OS (DFS P<jats:sub>interaction </jats:sub>= 0.07; OS P<jats:sub>interaction</jats:sub> = 0.11). There was a trend toward improved OS when women with zinc binding mutations received IFL versus 5FU/LV (P = 0.08) and toward worse DFS when women with non-zinc binding mutations were treated with IFL versus 5FU/LV (P =0.08). </jats:p><jats:p> Conclusions: This exploratory subset analysis suggests that p53 mutational status may be used to predict prognosis in a sex- and potentially chemotherapeutic regimen-specific manner. </jats:p>
Authors
Atreya, CE; Warren, RS; Niedzwiecki, D; Mayer, RJ; Goldberg, RM; Compton, CC; Zuraek, M; Bergsland, EK; Ye, C; Weinberg, VK; Bertagnolli, MM
MLA Citation
Atreya, Chloe Evelyn, et al. “A novel interaction of genotype, gender, and adjuvant treatment in survival after resection of stage III colon cancer: Results of CALGB 89803.Journal of Clinical Oncology, vol. 30, no. 4_suppl, American Society of Clinical Oncology (ASCO), 2012, pp. 452–452. Crossref, doi:10.1200/jco.2012.30.4_suppl.452.
URI
https://scholars.duke.edu/individual/pub1407167
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
30
Published Date
Start Page
452
End Page
452
DOI
10.1200/jco.2012.30.4_suppl.452

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

The original version of this article unfortunately contained a mistake. The shared first authorship information was missing in the published article. It has been given below. The first authorship is shared between Dr. Shai Posner and Kurren Mehta.
Authors
Posner, S; Mehta, K; Parish, A; Niedzwiecki, D; Gupta, RT; Fisher, DA; Leiman, DA
MLA Citation
Posner, Shai, et al. “Correction to: Esophageal Function Tests are Not Associated with Barium Swallow Findings in Advanced Lung Disease.Dysphagia, May 2020. Pubmed, doi:10.1007/s00455-020-10122-1.
URI
https://scholars.duke.edu/individual/pub1441519
PMID
32388772
Source
pubmed
Published In
Dysphagia
Published Date
DOI
10.1007/s00455-020-10122-1