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 & Bioinformatics

Biostatistics & Bioinformatics
School of Medicine

Director, DCI Biostatistics

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, Transplant and Cellular Therapy
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:

Divergent Interpretations of Imaging After Stereotactic Body Radiation Therapy for Lung Cancer.

PURPOSE: Conflicting information from health care providers contributes to anxiety among cancer patients. The purpose of this study was to investigate discordant interpretations of follow-up imaging studies after lung stereotactic body radiation therapy (SBRT) between radiologists and radiation oncologists. METHODS AND MATERIALS: Patients treated with SBRT for stage I non-small cell lung cancer from 2007 to 2018 at Duke University Medical Center were included. Radiology interpretations of follow-up computed tomography (CT) chest or positron emission tomography (PET)/CT scans and the corresponding radiation oncology interpretations in follow-up notes from the medical record were assessed. Based on language used, interpretations were scored as concerning for progression (Progression), neutral differential listed (Neutral Differential), or favor stability/postradiation changes (Stable). Neutral Differential required that malignancy was specifically listed as a possibility in the differential. Encounters were categorized as discordant when either radiology or radiation oncology interpreted the surveillance imaging as Progression when the other interpreted the imaging study as Stable or Neutral Differential. The incidence of discordant interpretations was the primary endpoint of the study. RESULTS: From 2007 to 2018, 139 patients were treated with SBRT and had available follow-up CT or PET-CT imaging for the analysis. Median follow-up was 61 months and the median number of follow-up encounters per patient was 3. Of 534 encounters evaluated, 25 (4.7%) had overtly discordant interpretations of imaging studies. This most commonly arose when radiology felt the imaging study showed Progression but radiation oncology favored Stable or Neutral Differential (24/25, 96%). No patient or treatment variables were found to be significantly associated with discordant interpretations on univariate analysis including type of scan (CT 22/489, 4.5%; PET-CT 3/45, 7%; P = .46). CONCLUSIONS: Surveillance imaging after lung SBRT is often interpreted differently by radiologists and radiation oncologists, but overt discordance was relatively low at our institution. Providers should be aware of differences in interpretation patterns that may contribute to increased patient distress.
Authors
Ackerson, BG; Sperduto, W; D'Anna, R; Niedzwiecki, D; Christensen, J; Patel, P; Mullikin, TC; Kelsey, CR
MLA Citation
Ackerson, Bradley G., et al. “Divergent Interpretations of Imaging After Stereotactic Body Radiation Therapy for Lung Cancer.Pract Radiat Oncol, Nov. 2022. Pubmed, doi:10.1016/j.prro.2022.09.006.
URI
https://scholars.duke.edu/individual/pub1556704
PMID
36375770
Source
pubmed
Published In
Pract Radiat Oncol
Published Date
DOI
10.1016/j.prro.2022.09.006

Impact of Malnutrition on Outcomes in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Insertion.

BACKGROUND: Malnutrition is common in patients with cirrhosis and is associated with poor outcomes after hepatic resection and liver transplantation. Transjugular intrahepatic portosystemic shunt (TIPS) is performed for complications of cirrhosis. AIM: To assess the impact of malnutrition on TIPS outcomes. METHODS: A retrospective analysis was performed using the Healthcare Cost and Utilization Project: National Inpatient Sample database for TIPS procedures from 2005 to 2014. The primary end point was in-hospital mortality. The association of specific malnutrition diagnostic codes and race-ethnicity on mortality was evaluated with survey-weighted logistic regression adjusted for age, gender, admission type, insurance payer, hospital region, comorbidities, and length of stay (LOS). RESULTS: From 2005 to 2014, an estimated 53,207 (95% CI 49,330-57,085) admissions with TIPS occurred. A diagnosis of malnutrition was present in 11%. In-hospital death post-TIPS occurred in 15.0% versus 10.7% (p value < 0.001) of patients with and without malnutrition, respectively. Patients with malnutrition had longer post-procedural LOS (median 6.7 vs. 2.9 days, p value < 0.001) and greater total hospital charges (median $144,752 vs. $79,781, p value < 0.001) and were more likely to be discharged to a skilled nursing facility (21.6% vs. 9.7%) than patients without malnutrition. Patients with malnutrition had increased odds of mortality (OR 1.31, 95% CI 1.07, 1.59) compared to patients with no malnutrition. CONCLUSION: Malnutrition was associated with worse outcomes after TIPS. Further research is needed to understand the mechanism of malnutrition in post-procedure outcomes and the ability of interventions for nutritional optimization to improve outcomes.
Authors
Chiang, RS; Parish, A; Niedzwiecki, D; Kappus, MR; Muir, AJ
MLA Citation
Chiang, Ryan S., et al. “Impact of Malnutrition on Outcomes in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Insertion.Dig Dis Sci, vol. 65, no. 11, Nov. 2020, pp. 3332–40. Pubmed, doi:10.1007/s10620-019-06038-y.
URI
https://scholars.duke.edu/individual/pub1428417
PMID
31965391
Source
pubmed
Published In
Dig Dis Sci
Volume
65
Published Date
Start Page
3332
End Page
3340
DOI
10.1007/s10620-019-06038-y

Race, Income, and Survival in Stage III Colon Cancer: CALGB 89803 (Alliance).

BACKGROUND: Disparities in colon cancer outcomes have been reported across race and socioeconomic status, which may reflect, in part, access to care. We sought to assess the influences of race and median household income (MHI) on outcomes among colon cancer patients with similar access to care. METHODS: We conducted a prospective, observational study of 1206 stage III colon cancer patients enrolled in the CALGB 89803 randomized adjuvant chemotherapy trial. Race was self-reported by 1116 White and 90 Black patients at study enrollment; MHI was determined by matching 973 patients' home zip codes with publicly available US Census 2000 data. Multivariate analyses were adjusted for baseline sociodemographic, clinical, dietary, and lifestyle factors. All statistical tests were 2-sided. RESULTS: Over a median follow-up of 7.7 years, the adjusted hazard ratios for Blacks (compared with Whites) were 0.94 (95% confidence interval [CI] = 0.66 to 1.35, P = .75) for disease-free survival, 0.91 (95% CI = 0.62 to 1.35, P = .65) for recurrence-free survival, and 1.07 (95% CI = 0.73 to 1.57, P = .73) for overall survival. Relative to patients in the highest MHI quartile, the adjusted hazard ratios for patients in the lowest quartile were 0.90 (95% CI = 0.67 to 1.19, P trend = .18) for disease-free survival, 0.89 (95% CI = 0.66 to 1.22, P trend = .14) for recurrence-free survival, and 0.87 (95% CI = 0.63 to 1.19, P trend = .23) for overall survival. CONCLUSIONS: In this study of patients with similar health-care access, no statistically significant differences in outcomes were found by race or MHI. The substantial gaps in outcomes previously observed by race and MHI may not be rooted in differences in tumor biology but rather in access to quality care.
Authors
Lee, S; Zhang, S; Ma, C; Ou, F-S; Wolfe, EG; Ogino, S; Niedzwiecki, D; Saltz, LB; Mayer, RJ; Mowat, RB; Whittom, R; Hantel, A; Benson, A; Atienza, D; Messino, M; Kindler, H; Venook, A; Gross, CP; Irwin, ML; Meyerhardt, JA; Fuchs, CS
MLA Citation
Lee, Seohyuk, et al. “Race, Income, and Survival in Stage III Colon Cancer: CALGB 89803 (Alliance).Jnci Cancer Spectr, vol. 5, no. 3, June 2021. Pubmed, doi:10.1093/jncics/pkab034.
URI
https://scholars.duke.edu/individual/pub1484676
PMID
34104867
Source
pubmed
Published In
Jnci Cancer Spectrum
Volume
5
Published Date
DOI
10.1093/jncics/pkab034

Dietary fat in relation to all-cause mortality and cancer progression and death among people with metastatic colorectal cancer: Data from CALGB 80405 (Alliance)/SWOG 80405.

Data on diet and survival among people with metastatic colorectal cancer are limited. We examined dietary fat in relation to all-cause mortality and cancer progression or death among 1149 people in the Cancer and Leukemia Group B (Alliance)/Southwest Oncology Group (SWOG) 80405 trial who completed a food frequency questionnaire at initiation of treatment for advanced or metastatic colorectal cancer. We examined saturated, monounsaturated, total and specific types (n-3, long-chain n-3 and n-6) of polyunsaturated fat, animal and vegetable fats. We hypothesized higher vegetable fat intake would be associated with lower risk of all-cause mortality and cancer progression. We used Cox proportional hazards regression to estimate adjusted hazard ratios (HR) and 95% confidence intervals (CI). Over median follow-up of 6.1 years (interquartile range [IQR]: 5.3, 7.2 y), we observed 974 deaths and 1077 events of progression or death. Participants had a median age of 59 y; 41% were female and 86% identified as White. Moderate or higher vegetable fat was associated with lower risk of mortality and cancer progression or death (HRs comparing second, third and fourth to first quartile for all-cause mortality: 0.74 [0.62, 0.90]; 0.75 [0.61, 0.91]; 0.79 [0.63, 1.00]; P trend: .12; for cancer progression or death: 0.74 [0.62, 0.89]; 0.78 [0.64, 0.95]; 0.71 [0.57, 0.88]; P trend: .01). No other fat type was associated with all-cause mortality and cancer progression or death. Moderate or higher vegetable fat intake may be associated with lower risk of cancer progression or death among people with metastatic colorectal cancer.
Authors
Van Blarigan, EL; Ma, C; Ou, F-S; Bainter, TM; Venook, AP; Ng, K; Niedzwiecki, D; Giovannucci, E; Lenz, H-J; Polite, BN; Hochster, HS; Goldberg, RM; Mayer, RJ; Blanke, CD; O'Reilly, EM; Ciombor, KK; Meyerhardt, JA
MLA Citation
Van Blarigan, Erin L., et al. “Dietary fat in relation to all-cause mortality and cancer progression and death among people with metastatic colorectal cancer: Data from CALGB 80405 (Alliance)/SWOG 80405.Int J Cancer, vol. 152, no. 2, Jan. 2023, pp. 123–36. Pubmed, doi:10.1002/ijc.34230.
URI
https://scholars.duke.edu/individual/pub1532349
PMID
35904874
Source
pubmed
Published In
Int J Cancer
Volume
152
Published Date
Start Page
123
End Page
136
DOI
10.1002/ijc.34230

Evaluating for disparities in place of death for head and neck cancer patients in the United States utilizing the CDC WONDER database.

OBJECTIVE: Evaluate trends in place of death for patients with head and neck cancers (HNC) in the U.S. from 1999 to 2017 based on the CDC WONDER (Wide-ranging Online Data for Epidemiologic Research) database. MATERIALS/METHODS: Using patient-level data from 2015 and aggregate data from 1999 to 2017, multivariable logistic regression analyses (MLR) were performed to evaluate for disparities in place of death. RESULTS: We obtained aggregate data for 101,963 people who died of HNC between 1999 and 2017 (25.9% oral cavity, 24.6% oropharynx/pharynx, 0.4% nasopharynx, and 49.1% larynx/hypopharynx). Most were Caucasian (92.7%) and male (87.0%). Deaths at home or hospice increased over the study period (R2 = 0.96, p < 0.05) from 29.2% in 1999 to 61.2% in 2017. On MLR of patient-level data from 2015, those who were single (ref), ages 85+ (OR 0.78; 95% CI: 0.68, 0.90), African American (OR 0.73; 95% CI: 0.65, 0.82), or Asian/Pacific Islanders (OR 0.66; 95% CI: 0.54, 0.81) were less likely to die at home or hospice. On MLR of the aggregate data (1999-2017), those who were female (OR 0.87; 95% CI: 0.83, 0.91) or ages 75-84 (OR 0.79; 95% CI: 0.76, 0.82) were also less likely to die at home or hospice. In both analyses, those who died from larynx/hypopharynx cancers were less likely to die at home or hospice. CONCLUSIONS: HNC-related deaths at home or hospice increased between 1999 and 2017. Those who were single, female, African American, Asian/Pacific Islander, older (ages 75+), or those with larynx/hypopharynx cancers were less likely to die at home or hospice.
Authors
Stephens, SJ; Chino, F; Williamson, H; Niedzwiecki, D; Chino, J; Mowery, YM
MLA Citation
Stephens, Sarah J., et al. “Evaluating for disparities in place of death for head and neck cancer patients in the United States utilizing the CDC WONDER database.Oral Oncol, vol. 102, Mar. 2020, p. 104555. Pubmed, doi:10.1016/j.oraloncology.2019.104555.
URI
https://scholars.duke.edu/individual/pub1431519
PMID
32006782
Source
pubmed
Published In
Oral Oncol
Volume
102
Published Date
Start Page
104555
DOI
10.1016/j.oraloncology.2019.104555