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:

Effective Pain Control With Very Low Dose Palliative Radiation Therapy for Patients With Multiple Myeloma With Uncomplicated Osseous Lesions.

BACKGROUND: Osteolytic lesions are present in 75% of patients with multiple myeloma (MM) and frequently require palliation with radiation therapy (RT). Prior case series of patients with MM with bone pain undergoing palliative RT suggests doses ≥12 Gy (equivalent dose in 2Gy fractions, EQD2) provide excellent bone pain relief. However, recent advances in care and novel biologic agents have significantly improved overall survival and quality of life for patients with MM. We hypothesized that lower-dose RT (LDRT, EQD2 <12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 ≥12 Gy) for palliation of painful, uncomplicated MM bone lesions. METHODS: We retrospectively identified patients with MM treated with RT for uncomplicated, painful bone lesions and stratified by EQD2 ≥/< 12 Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. RESULTS: Thirty-five patients with 70 treated lesions were included: 24 patients (48 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow-up was 14 and 16.89 months for HDRT and LDRT, respectively. The median dose of HDRT treatment was 20 Gy versus 4 Gy in the LDRT group. The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any-grade acute toxicity between the HDRT and LDRT cohorts (24.5% vs 9.1%, Χ2 P = .20). Pain recurred in 10% of lesions (12% HDRT vs 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (P = .91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort, and 3 (6.3%) in the HDRT cohort. CONCLUSION: In this study, LDRT effectively palliated painful, uncomplicated MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful, uncomplicated MM bony lesions.
Authors
Price, JG; Niedzwiecki, D; Oyekunle, T; Arcasoy, MO; Champ, CE; Kelsey, CR; Salama, JK; Moravan, MJ
MLA Citation
Price, Jeremy G., et al. “Effective Pain Control With Very Low Dose Palliative Radiation Therapy for Patients With Multiple Myeloma With Uncomplicated Osseous Lesions.Adv Radiat Oncol, vol. 6, no. 4, July 2021, p. 100729. Pubmed, doi:10.1016/j.adro.2021.100729.
URI
https://scholars.duke.edu/individual/pub1488947
PMID
34258474
Source
pubmed
Published In
Advances in Radiation Oncology
Volume
6
Published Date
Start Page
100729
DOI
10.1016/j.adro.2021.100729

Pharmacogenetic study in gastric cancer patients treated with adjuvant fluorouracil/leucovorin or epirubicin/cisplatin/fluorouracil before and after chemoradiation on CALGB 80101 (Alliance).

There is a lack of pharmacogenetic predictors of outcome in gastric cancer patients. The aim of this study was to assess previously identified candidate genes associated with 5-fluorouracil (5-FU), cisplatin, or epirubicin toxicity or response in a cohort of resected gastric cancer patients treated on CALGB (Alliance) 80101. Gastric or gastroesophageal cancer patients randomized to adjuvant 5-FU/leucovorin or epirubicin/cisplatin/5-FU before and after 5-FU chemoradiation were genotyped for single nucleotide polymorphisms (SNPs) in GSTP1 (rs1695), ERCC1 (rs11615 and rs3212986), XRCC1 (rs25487), UGT2B7 (rs7439366) and the 28 base-pair tandem repeats in TYMS (rs34743033). Logistic regression and log rank tests were used to assess the association between each SNP and incidence of grade 3/4 neutropenia and leukopenia, overall (OS) and progression-free survival (PFS), respectively. Toxicity endpoint analyses were adjusted for the treatment arm, while OS and PFS were also adjusted for performance status, sex, age, lymph node involvement, and primary tumor site and size. Of 281 subjects with successful genotyping results and available clinical (toxicity and efficacy) data, 166 self-reported non-Hispanic White patients were included in the final analysis. There was a lack of evidence of an association among any SNPs tested with grade 3/4 neutropenia and leukopenia or OS and PFS. Age, lymph node involvement, and primary tumor size were significantly associated with OS and PFS. This study failed to confirm results of previous gastric cancer pharmacogenetic studies.
Authors
Patel, JN; Jiang, C; Owzar, K; Mulkey, F; Luzum, JA; Mamon, HJ; Haller, DG; Dragovich, T; Alberts, SR; Bjarnason, G; Willet, CG; Niedzwiecki, D; Enzinger, P; Ratain, MJ; Fuchs, C; McLeod, HL
MLA Citation
Patel, Jai N., et al. “Pharmacogenetic study in gastric cancer patients treated with adjuvant fluorouracil/leucovorin or epirubicin/cisplatin/fluorouracil before and after chemoradiation on CALGB 80101 (Alliance).Pharmacogenet Genomics, vol. 31, no. 9, Dec. 2021, pp. 215–20. Pubmed, doi:10.1097/FPC.0000000000000442.
URI
https://scholars.duke.edu/individual/pub1486059
PMID
34149004
Source
pubmed
Published In
Pharmacogenet Genomics
Volume
31
Published Date
Start Page
215
End Page
220
DOI
10.1097/FPC.0000000000000442

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP).

PURPOSE: Cancer survivors are often sedentary. Self-monitoring may promote physical activity through self-activation. We conducted a pilot trial to evaluate whether wearable activity tracker with personalized text message feedback would increase physical activity. METHODS: We enrolled 30 patients with solid tumor cancers into a non-randomized prospective intervention trial (NCT02627079): 15 had completed treatment in the past year and 15 under active treatment. Each participant received an activity tracker and daily text messages personalized to their activity level. We assessed patient-reported outcomes and 6-min walk (6 MW) at baseline and 3 months. RESULTS: Twenty-six participants completed the study. There was substantial variation in baseline activity. Overall, 39% of participants increased their steps taken by at least 20%, and 23% increased their 6 MW distance by 20% or more. More participants who had completed treatment strongly agreed (73%) that the intervention increased their exercise levels than those receiving active treatment (47%). At 3 months, there was a significant improvement in median Beck Depression Inventory-II and Godin Leisure Index composite scores. At 6 months, 72% still wore their activity tracker at least 4 days per week. CONCLUSION: We found that the intervention was well-accepted with a high completion rate at 3 months and continued self-use at 6 months. In this pilot study of combined activity tracker and motivational messaging, we found a signal for increased physical activity over a 3-month period. Future research is needed to study this technique for its impact on activity and other physical and psychological measures of well-being. IMPLICATION FOR CANCER SURVIVORS: Activity tracker with personalized motivational messaging may be useful in promoting physical activity in cancer survivors.
Authors
Koontz, BF; Levine, E; McSherry, F; Niedzwiecki, D; Sutton, L; Dale, T; Streicher, M; Rushing, C; Owen, L; Kraus, WE; Bennett, G; Pollak, KI
MLA Citation
Koontz, Bridget F., et al. “Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP).Support Care Cancer, vol. 29, no. 12, Dec. 2021, pp. 7339–49. Pubmed, doi:10.1007/s00520-021-06281-y.
URI
https://scholars.duke.edu/individual/pub1484312
PMID
34050402
Source
pubmed
Published In
Support Care Cancer
Volume
29
Published Date
Start Page
7339
End Page
7349
DOI
10.1007/s00520-021-06281-y

Establishing ADC-Based Histogram and Texture Features for Early Treatment-Induced Changes in Head and Neck Squamous Cell Carcinoma.

The purpose of this study was to assess baseline variability in histogram and texture features derived from apparent diffusion coefficient (ADC) maps from diffusion-weighted MRI (DW-MRI) examinations and to identify early treatment-induced changes to these features in patients with head and neck squamous cell carcinoma (HNSCC) undergoing definitive chemoradiation. Patients with American Joint Committee on Cancer Stage III-IV (7th edition) HNSCC were prospectively enrolled on an IRB-approved study to undergo two pre-treatment baseline DW-MRI examinations, performed 1 week apart, and a third early intra-treatment DW-MRI examination during the second week of chemoradiation. Forty texture and six histogram features were derived from ADC maps. Repeatability of the features from the baseline ADC maps was assessed with the intra-class correlation coefficient (ICC). A Wilcoxon signed-rank test compared average baseline and early treatment feature changes. Data from nine patients were used for this study. Comparison of the two baseline ADC maps yielded 11 features with an ICC ≥ 0.80, indicating that these features had excellent repeatability: Run Gray-Level Non-Uniformity, Coarseness, Long Zone High Gray-Level, Variance (Histogram Feature), Cluster Shade, Long Zone, Variance (Texture Feature), Run Length Non-Uniformity, Correlation, Cluster Tendency, and ADC Median. The Wilcoxon signed-rank test resulted in four features with significantly different early treatment-induced changes compared to the baseline values: Run Gray-Level Non-Uniformity (p = 0.005), Run Length Non-Uniformity (p = 0.005), Coarseness (p = 0.006), and Variance (Histogram) (p = 0.006). The feasibility of histogram and texture analysis as a potential biomarker is dependent on the baseline variability of each metric, which disqualifies many features.
Authors
Rodrigues, A; Loman, K; Nawrocki, J; Hoang, JK; Chang, Z; Mowery, YM; Oyekunle, T; Niedzwiecki, D; Brizel, DM; Craciunescu, O
MLA Citation
Rodrigues, Anna, et al. “Establishing ADC-Based Histogram and Texture Features for Early Treatment-Induced Changes in Head and Neck Squamous Cell Carcinoma.Front Oncol, vol. 11, 2021, p. 708398. Pubmed, doi:10.3389/fonc.2021.708398.
URI
https://scholars.duke.edu/individual/pub1497057
PMID
34540674
Source
pubmed
Published In
Frontiers in Oncology
Volume
11
Published Date
Start Page
708398
DOI
10.3389/fonc.2021.708398

Classification of older adults who underwent lumbar-related surgery using pre-operative biopsychosocial predictors and relationships with surgical recovery: An observational study conducted in the United States.

Lumbar surgery is a commonly prescribed intervention for low back pain but poses higher risks and worse outcomes for older adults. Identifying clinical phenotypes based on biopsychosocial factors may help identify older adults who are at greatest risk for poor postoperative recovery. This study aimed to (a) classify older adults who underwent lumbar surgery based on preoperative biopsychosocial factors, and (b) quantify the association between preoperative biopsychosocial classifications and 3 and 12 months postoperative improvement outcomes. Latent class analysis was used to identify biopsychosocial classifications in 10,283 individuals aged ≥60 from the Quality Outcomes Database (the United States, 2021-2018). Logistic regression models measured the association between biopsychosocial classifications and 3 and 12 months postoperative outcomes (back/leg pain intensity, disability and quality of life), adjusting for covariates. Three classes were identified based on 19 a priori biopsychosocial factors and were characterised as 'high-risk' (15%), 'physical-/social health-risk' (44%) and 'low-risk' (41%). The high-risk class demonstrated increased odds of failing to recover post-operatively compared to the other classes. Similarly, the physical-/social-risk class demonstrated increased odds of failing to recover in all outcomes and time points compared to the low-risk class. Biopsychosocial factors with higher prevalence in the high versus low-risk class were depression (92.5% vs. 10.6%), multiple morbidities (55.3% vs. 25.7%) and obesity (59.5% vs. 37.2%). This study introduces novel non-recovery phenotypes for older adults undergoing lumbar surgery and may lead to the development of tailored interventions to improve clinical care and outcomes for this population.
Authors
Garcia, AN; Simon, CB; Yang, ZL; Niedzwiecki, D; Cook, CE; Gottfried, O
URI
https://scholars.duke.edu/individual/pub1498046
PMID
34587349
Source
pubmed
Published In
Health Soc Care Community
Published Date
DOI
10.1111/hsc.13584