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

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:

Need for Pretransplant Midodrine Does Not Negatively Impact Simultaneous Liver-kidney Transplant Outcomes.

Background: Midodrine is often needed pretransplant to improve hemodynamics in simultaneous liver-kidney transplant candidates. Previous research has shown that patients requiring midodrine before kidney transplant alone have increased posttransplant risk for delayed allograft function, graft failure, and death. However, the impact of pretransplant midodrine use on outcomes after simultaneous liver-kidney transplant is unknown. Methods: We performed a retrospective study of all adult (age ≥18 y) simultaneous liver-kidney transplant recipients from a single academic transplant center from February 1, 2002, to June 30, 2019. Results: Sixty-four simultaneous liver-kidney transplants were performed in our institution during this time period, of which, 43 were not on midodrine before transplant, 17 were on midodrine alone, and 4 were on intravenous (IV) vasopressor therapy. Despite the midodrine group having a higher MELD-Na at listing, higher MELD-Na at transplant, and being older, there were no significant differences in key outcomes including delayed renal allograft function, estimated glomerular filtration rate at transplant discharge, and estimated glomerular filtration rate at 1 y after transplant compared with the nonmidodrine group. There was no significant difference in graft failure or survival at last follow-up. Conclusions: Our study suggests that need for pretransplant midodrine should not be a barrier to simultaneous liver-kidney transplant.
Authors
Barman, PM; King, LY; Berg, CL; Parish, A; Niedzwiecki, D; Barbas, AS; McElroy, L; Patel, YA
MLA Citation
Barman, Pranab M., et al. “Need for Pretransplant Midodrine Does Not Negatively Impact Simultaneous Liver-kidney Transplant Outcomes.Transplant Direct, vol. 7, no. 1, Jan. 2021, p. e640. Pubmed, doi:10.1097/TXD.0000000000001071.
URI
https://scholars.duke.edu/individual/pub1469986
PMID
33344762
Source
pubmed
Published In
Transplantation Direct
Volume
7
Published Date
Start Page
e640
DOI
10.1097/TXD.0000000000001071

Hospital-level compliance with the commission on cancer's quality of care measures and the association with patient survival.

BACKGROUND: Quality measurement has become a priority for national healthcare reform, and valid measures are necessary to discriminate hospital performance and support value-based healthcare delivery. The Commission on Cancer (CoC) is the largest cancer-specific accreditor of hospital quality in the United States and has implemented Quality of Care Measures to evaluate cancer care delivery. However, none has been formally tested as a valid metric for assessing hospital performance based on actual patient outcomes. METHODS: Eligibility and compliance with the Quality of Care Measures are reported within the National Cancer Database, which also captures data for robust patient-level risk adjustment. Hospital-level compliance was calculated for the core measures, and the association with patient survival was tested using Cox regression. RESULTS: Seven hundred sixty-eight thousand nine hundred sixty-nine unique cancer cases were included from 1323 facilities. Increasing hospital-level compliance was associated with improved survival for only two measures, including a 35% reduced risk of mortality for the gastric cancer measure G15RLN (HR 0.65, 95% CI 0.58-0.72) and a 19% reduced risk of mortality for the colon cancer measure 12RLN (HR 0.81, 95% CI 0.77-0.85). For the lung cancer measure LNoSurg, increasing compliance was paradoxically associated with an increased risk of mortality (HR 1.14, 95% CI 1.08-1.20). For the remaining measures, hospital-level compliance demonstrated no consistent association with patient survival. CONCLUSION: Hospital-level compliance with the CoC's Quality of Care Measures is not uniformly aligned with patient survival. In their current form, these measures do not reliably discriminate hospital performance and are limited as a tool for value-based healthcare delivery.
Authors
Nussbaum, DP; Rushing, CN; Sun, Z; Yerokun, BA; Worni, M; Saunders, RS; McClellan, MB; Niedzwiecki, D; Greenup, RA; Blazer, DG
MLA Citation
Nussbaum, Daniel P., et al. “Hospital-level compliance with the commission on cancer's quality of care measures and the association with patient survival.Cancer Med, May 2021. Pubmed, doi:10.1002/cam4.3875.
URI
https://scholars.duke.edu/individual/pub1481917
PMID
33943026
Source
pubmed
Published In
Cancer Medicine
Published Date
DOI
10.1002/cam4.3875

Effect of Celecoxib vs Placebo Added to Standard Adjuvant Therapy on Disease-Free Survival Among Patients With Stage III Colon Cancer: The CALGB/SWOG 80702 (Alliance) Randomized Clinical Trial.

Importance: Aspirin and cyclooxygenase 2 (COX-2) inhibitors have been associated with a reduced risk of colorectal polyps and cancer in observational and randomized studies. The effect of celecoxib, a COX-2 inhibitor, as treatment for nonmetastatic colon cancer is unknown. Objective: To determine if the addition of celecoxib to adjuvant chemotherapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) improves disease-free survival in patients with stage III colon cancer. Design, Setting, and Participants: Cancer and Leukemia Group B (Alliance)/Southwest Oncology Group 80702 was a 2 × 2 factorial design, phase 3 trial conducted at 654 community and academic centers throughout the United States and Canada. A total of 2526 patients with stage III colon cancer were enrolled between June 2010 and November 2015 and were followed up through August 10, 2020. Interventions: Patients were randomized to receive adjuvant FOLFOX (every 2 weeks) for 3 vs 6 months with or without 3 years of celecoxib (400 mg orally daily; n = 1263) vs placebo (n = 1261). This report focuses on the results of the celecoxib randomization. Main Outcomes and Measures: The primary end point was disease-free survival, measured from the time of randomization until documented recurrence or death from any cause. Secondary end points included overall survival, adverse events, and cardiovascular-specific events. Results: Of the 2526 patients who were randomized (mean [SD] age, 61.0 years [11 years]; 1134 women [44.9%]), 2524 were included in the primary analysis. Adherence with protocol treatment, defined as receiving celecoxib or placebo for more than 2.75 years or continuing treatment until recurrence, death, or unacceptable adverse events, was 70.8% for patients treated with celecoxib and 69.9% for patients treated with placebo. A total of 337 patients randomized to celecoxib and 363 to placebo experienced disease recurrence or died, and with 6 years' median follow-up, the 3-year disease-free survival was 76.3% for celecoxib-treated patients vs 73.4% for placebo-treated patients (hazard ratio [HR] for disease recurrence or death, 0.89; 95% CI, 0.76-1.03; P = .12). The effect of celecoxib treatment on disease-free survival did not vary significantly according to assigned duration of adjuvant chemotherapy (P for interaction = .61). Five-year overall survival was 84.3% for celecoxib vs 81.6% for placebo (HR for death, 0.86; 95% CI, 0.72-1.04; P = .13). Hypertension (any grade) occurred while treated with FOLFOX in 14.6% of patients in the celecoxib group vs 10.9% of patients in the placebo group, and a grade 2 or higher increase in creatinine levels occurred after completion of FOLFOX in 1.7% vs 0.5% of patients, respectively. Conclusions and Relevance: Among patients with stage III colon cancer, the addition of celecoxib for 3 years, compared with placebo, to standard adjuvant chemotherapy did not significantly improve disease-free survival. Trial Registration: ClinicalTrials.gov Identifier: NCT01150045.
Authors
Meyerhardt, JA; Shi, Q; Fuchs, CS; Meyer, J; Niedzwiecki, D; Zemla, T; Kumthekar, P; Guthrie, KA; Couture, F; Kuebler, P; Bendell, JC; Kumar, P; Lewis, D; Tan, B; Bertagnolli, M; Grothey, A; Hochster, HS; Goldberg, RM; Venook, A; Blanke, C; O'Reilly, EM; Shields, AF
MLA Citation
URI
https://scholars.duke.edu/individual/pub1478492
PMID
33821899
Source
pubmed
Published In
Jama
Volume
325
Published Date
Start Page
1277
End Page
1286
DOI
10.1001/jama.2021.2454

The Diet of Higher Insulinemic Potential Is Not Associated with Worse Survival in Patients with Stage III Colon Cancer (Alliance).

BACKGROUND: Hyperinsulinemia is considered to be important in the development of colon cancer, but few studies have investigated the associations of hyperinsulinemia with colon cancer survival via dietary scores. METHODS: Empirical dietary index for hyperinsulinemia (EDIH) was derived to assess the insulinemic potential of daily diets reflecting the long-term insulin exposure, with higher (more positive) scores indicating higher insulinemic diets. We prospectively estimated the HRs and 95% confidence intervals (CI) to investigate the association of EDIH with disease-free, recurrence-free, and overall survival among patients with stage III colon cancer (1999-2009) enrolled in a randomized adjuvant chemotherapy trial (CALGB 89803). RESULTS: Of 1,024 patients (median follow-up: 7.3 years), 311 died, 350 had recurrences, and 394 had events for disease-free survival. Compared with patients in the lowest quintile of EDIH, the corresponding HRs of patients in the highest quintile for disease-free survival events, cancer recurrence, and overall mortality were 0.80 (95% CI, 0.56-1.15), 0.76 (95% CI, 0.51-1.11), and 0.77 (95% CI, 0.52-1.14). CONCLUSIONS: Higher EDIH was not associated with the risk of colon cancer recurrence or mortality in this population of patients with stage III colon cancer. IMPACT: EDIH, as a measure of dietary insulinemic potential, may be associated with colon cancer risk but not survival in patients with late-stage colon cancer.
Authors
Cheng, E; Zhang, S; Ou, F-S; Mullen, B; Ng, K; Saltz, LB; Niedzwiecki, D; Mayer, RJ; Mowat, RB; Whittom, R; Hantel, A; Benson, A; Atienza, D; Messino, M; Kindler, H; Giovannucci, EL; Van Blarigan, EL; Meyerhardt, JA; Fuchs, CS
MLA Citation
Cheng, En, et al. “The Diet of Higher Insulinemic Potential Is Not Associated with Worse Survival in Patients with Stage III Colon Cancer (Alliance).Cancer Epidemiol Biomarkers Prev, vol. 29, no. 8, Aug. 2020, pp. 1692–95. Pubmed, doi:10.1158/1055-9965.EPI-19-1454.
URI
https://scholars.duke.edu/individual/pub1446874
PMID
32499312
Source
pubmed
Published In
Cancer Epidemiol Biomarkers Prev
Volume
29
Published Date
Start Page
1692
End Page
1695
DOI
10.1158/1055-9965.EPI-19-1454

Image quality of EOS low-dose radiography in comparison with conventional radiography for assessment of ventriculoperitoneal shunt integrity.

OBJECTIVE: Patients with shunted hydrocephalus often accumulate high levels of radiation over their lifetimes during evaluation of hardware integrity. Current practice involves the use of a series of conventional radiographs for this purpose. Newer low-dose EOS radiography is currently used to evaluate scoliosis but has not been explored to evaluate shunt integrity on a large scale. The goal of this study was to compare the quality of imaging using EOS low-dose radiography to conventional radiography to evaluate shunt tubing. METHODS: A retrospective chart review was performed on 57 patients who previously had both conventional radiographs and low-dose EOS images of their cerebral shunt tubing from 2000 to 2018. Patient demographics (age, sex, type of shunt tubing, primary diagnosis) were collected. Conventional radiographic images and low-dose EOS images were independently analyzed by a neurosurgeon and neuroradiologist in three categories: image quality, delineation of shunt, and distinction of shunt compared to adjacent anatomy. RESULTS: All patients had shunted hydrocephalus due to spina bifida and Chiari type II malformation. Ratings of EOS and conventional radiographic images by both raters did not differ significantly in terms of image quality (rater 1, p = 0.499; rater 2, p = 0.578) or delineation of shunt (p = 0.107 and p = 0.256). Conventional radiographic images received significantly higher ratings than EOS on the ability to distinguish the shunt versus adjacent anatomy by rater 1 (p = 0.039), but not by rater 2 (p = 0.149). The overall score of the three categories combined was not significantly different between EOS and conventional radiography (rater 1, p = 0.818; rater 2, p = 0.186). In terms of cost, an EOS image was less costly than a conventional radiography shunt series ($236-$366 and $1300-$1547, respectively). The radiation dose was also lower for EOS images, with an effective dose of 0.086-0.140 mSv compared to approximately 1.6 mSv for a similar field of view with conventional radiography. CONCLUSIONS: The image quality of low-dose EOS radiography does not significantly differ from conventional radiography for the evaluation of cerebral shunts. In addition, EOS affords a much lower radiation dose and a lower cost.
Authors
Monuszko, K; Malinzak, M; Yang, LZ; Niedzwiecki, D; Fuchs, H; Muh, CR; Gingrich, K; Lark, R; Thompson, EM
MLA Citation
Monuszko, Karen, et al. “Image quality of EOS low-dose radiography in comparison with conventional radiography for assessment of ventriculoperitoneal shunt integrity.J Neurosurg Pediatr, Jan. 2021, pp. 1–7. Pubmed, doi:10.3171/2020.8.PEDS20428.
URI
https://scholars.duke.edu/individual/pub1470934
PMID
33418531
Source
pubmed
Published In
J Neurosurg Pediatr
Published Date
Start Page
1
End Page
7
DOI
10.3171/2020.8.PEDS20428