Xiaofei Wang

Overview:

Design and Analysis of Clinical Trials
Nonparametric and Semiparametric Methods
Survival Analysis
Causal Inference
Statistical Methods for Diagnostic and Predictive Medicine
Biomarker Discovery and Validation
Health Outcomes Research

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. 2003

University of North Carolina - Chapel Hill

Graduate Research Assistant, Computer Sciences

University of North Carolina - Chapel Hill

Graduate Research Assistant, Biostatistics

University of North Carolina - Chapel Hill

Grants:

Translational meta-analysis for elderly lung cancer patients

Administered By
Biostatistics & Bioinformatics
Awarded By
National Institutes of Health
Role
Principal Investigator
Start Date
End Date

National Clinical Trials Network - Network Group Statistics and DMCs

Administered By
Duke Cancer Institute
Awarded By
Mayo Clinic
Role
Statistician
Start Date
End Date

Cancer and Leukemia Group B Statistical Center

Administered By
Duke Cancer Institute
Awarded By
National Institutes of Health
Role
Statistician
Start Date
End Date

Semiparametric ROC Curve Regression for Cancer Screening Studies

Administered By
Biostatistics & Bioinformatics
Awarded By
National Institutes of Health
Role
Principal Investigator
Start Date
End Date

Innovative Biomarker-Integrated Clinical Trial Design and Analysis

Administered By
Biostatistics & Bioinformatics
Awarded By
University of North Carolina - Chapel Hill
Role
Principal Investigator
Start Date
End Date

Publications:

Short Communication: Interim toxicity analysis for patients with limited stage small cell lung cancer (LSCLC) treated on CALGB 30610 (Alliance) / RTOG 0538.

INTRODUCTION: The CALGB 30610/RTOG 0538 randomized trial was designed to test whether high-dose thoracic radiotherapy (TRT) would improve survival compared with 45 Gy twice-daily (BID) TRT in limited stage small cell lung cancer (LSCLC). Two piloted experimental TRT regimens were of interest to study, 70 Gy daily (QD) and 61.2 Gy concomitant boost (CB). Driven by concerns about adequate patient accrual, a study design was employed that eliminated one experimental TRT arm based on early interim toxicity and tolerability, with the study then continuing as a traditional 2-arm phase III study. METHODS: Patients with LSCLC were assigned to receive four cycles of cisplatin and etoposide chemotherapy with one of 3 TRT regimens starting with either the first or second cycle of chemotherapy. The interim endpoint was the cumulative highest toxicity calculated from a scoring system based on treatment-related grade 3 and higher toxicity and the ability to complete therapy in the experimental arms. RESULTS: The final interim analysis was performed after 70 patients accrued to each experimental cohort, and a difference in treatment related toxicity scoring was not found (p = 0.739). Severe esophageal toxicity was comparable in both cohorts. Pulmonary toxicity was low overall, though 4 patients (5.7 %) on the 61.2 Gy arm developed grade 4 dyspnea, which was not observed in the 70 Gy arm. A protocol mandated decision was made to discontinue the 61.2 Gy arm following review of toxicity with the Data and Safety Monitoring Board. CONCLUSION: A randomized trial design using a planned early interim toxicity analysis to discriminate between experimental treatment arms is feasible in a phase III setting. Refinement of the design could increase the likelihood of detecting clinically meaningful differences in toxicity in future studies.
Authors
Bogart, JA; Wang, X; Masters, GA; Gao, J; Komaki, R; Gaspar, LE; Heymach, JV; Dobelbower, MC; Kuzma, C; Stinchcombe, TE; Vokes, EE
MLA Citation
Bogart, Jeffrey A., et al. “Short Communication: Interim toxicity analysis for patients with limited stage small cell lung cancer (LSCLC) treated on CALGB 30610 (Alliance) / RTOG 0538.Lung Cancer, vol. 156, Apr. 2021, pp. 68–71. Pubmed, doi:10.1016/j.lungcan.2021.04.016.
URI
https://scholars.duke.edu/individual/pub1480574
PMID
33894496
Source
pubmed
Published In
Lung Cancer
Volume
156
Published Date
Start Page
68
End Page
71
DOI
10.1016/j.lungcan.2021.04.016

Time-To-Event Data: An Overview and Analysis Considerations.

In oncology, overall survival and progression-free survival are common time-to-event end points used to measure treatment efficacy. Analyses of this type of data rely on a complex statistical framework and the analysis results are only valid when the data meet certain assumptions. This article provides an overview of time-to-event data, the basic mechanics of common analysis methods, and issues often encountered when analyzing such data. Our goal is to provide clinicians and other lung cancer researchers with the knowledge to choose the appropriate time-to-event analysis methods and to interpret the outcomes of such analyses appropriately. We strongly encourage investigators to seek out statisticians with expertise in survival analysis when embarking on studies that include time-to-event data to ensure that their data are collected and analyzed using the appropriate methods.
Authors
Le-Rademacher, J; Wang, X
MLA Citation
Le-Rademacher, Jennifer, and Xiaofei Wang. “Time-To-Event Data: An Overview and Analysis Considerations.J Thorac Oncol, Apr. 2021. Pubmed, doi:10.1016/j.jtho.2021.04.004.
URI
https://scholars.duke.edu/individual/pub1480576
PMID
33887465
Source
pubmed
Published In
J Thorac Oncol
Published Date
DOI
10.1016/j.jtho.2021.04.004

Interim results from the OPTIMAL trial: A phase II clinical trial of combination nivolumab, ipilimumab, and taxane in patients with untreated metastatic non-small cell lung cancer (NSCLC).

URI
https://scholars.duke.edu/individual/pub1475549
Source
wos-lite
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
38
Published Date

Expanding Beyond Maximum Grade: Chemotherapy Toxicity over Time by Age and Performance Status in Advanced Non-Small Cell Lung Cancer in CALGB 9730 (Alliance A151729).

BACKGROUND: Prior comparisons of chemotherapy adverse events (AEs) by age and performance status (PS) are limited by the traditional maximum grade approach, which ignores low-grade AEs and longitudinal changes. MATERIALS AND METHODS: To compare fatigue and neuropathy longitudinally by age (<65, ≥65 years) and PS (0-1, 2), we analyzed data from a large phase III trial of carboplatin and paclitaxel versus paclitaxel for advanced non-small cell lung cancer (CALGB 9730, n = 529). We performed multivariable (a) linear mixed models to estimate mean AE grade over time, (b) linear regression to estimate area under the curve (AUC), and (c) proportional hazards models to estimate the hazard ratio of developing grade ≥2 AE, as well as traditional maximum grade analyses. RESULTS: Older patients had on average a 0.17-point (95% confidence interval [CI], 0.00-0.34; p = .049) higher mean fatigue grade longitudinally compared with younger patients. PS 2 was associated with earlier development of grade ≥2 fatigue (hazard ratio [HR], 1.56; 95% CI, 1.07-2.27; p = .02). For neuropathy, older age was associated with earlier development of grade ≥2 neuropathy (HR, 1.41; 95% CI, 1.00-1.97; p = .049). Patients with PS 2 had a 1.30 point lower neuropathy AUC (95% CI, -2.36 to -0.25; p = .02) compared with PS 0-1. In contrast, maximum grade analyses only detected a higher percentage of older adults with grade ≥3 fatigue and neuropathy at some point during treatment. CONCLUSION: Our comparison of complementary but distinct aspects of chemotherapy toxicity identified important longitudinal differences in fatigue and neuropathy by age and PS that are missed by the traditional maximum grade approach. Clinical trial identification number: NCT00003117 (CALGB 9730) IMPLICATIONS FOR PRACTICE: The traditional maximum grade approach ignores persistent low-grade adverse events (AEs) and changes over time. This toxicity over time analysis of fatigue and neuropathy during chemotherapy for advanced non-small cell lung cancer demonstrates how to use longitudinal methods to comprehensively characterize AEs over time by age and performance status (PS). We identified important longitudinal differences in fatigue and neuropathy that are missed by the maximum grade approach. This new information about how older adults and patients with PS 2 experience these toxicities longitudinally may be used clinically to improve discussions about treatment options and what to expect to inform shared decision making and symptom management.
Authors
Wong, ML; Gao, J; Thanarajasingam, G; Sloan, JA; Dueck, AC; Novotny, PJ; Jatoi, A; Hurria, A; Walter, LC; Miaskowski, C; Cohen, HJ; Wood, WA; Feliciano, JL; Stinchcombe, TE; Wang, X
MLA Citation
Wong, Melisa L., et al. “Expanding Beyond Maximum Grade: Chemotherapy Toxicity over Time by Age and Performance Status in Advanced Non-Small Cell Lung Cancer in CALGB 9730 (Alliance A151729).Oncologist, vol. 26, no. 3, Mar. 2021, pp. e435–44. Pubmed, doi:10.1002/onco.13527.
URI
https://scholars.duke.edu/individual/pub1461250
PMID
32951293
Source
pubmed
Published In
Oncologist
Volume
26
Published Date
Start Page
e435
End Page
e444
DOI
10.1002/onco.13527

Statistical Considerations for Subgroup Analyses.

Authors
Wang, X; Piantadosi, S; Le-Rademacher, J; Mandrekar, SJ
MLA Citation
Wang, Xiaofei, et al. “Statistical Considerations for Subgroup Analyses.J Thorac Oncol, vol. 16, no. 3, Mar. 2021, pp. 375–80. Pubmed, doi:10.1016/j.jtho.2020.12.008.
URI
https://scholars.duke.edu/individual/pub1470032
PMID
33373692
Source
pubmed
Published In
J Thorac Oncol
Volume
16
Published Date
Start Page
375
End Page
380
DOI
10.1016/j.jtho.2020.12.008