Xiaofei Wang

Overview:

Design and Analysis of Clinical Trials
Nonparametric and Semiparametric Methods
Survival Analysis
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
Integrative Genomics
Awarded By
University of North Carolina - Chapel Hill
Role
Principal Investigator
Start Date
End Date

Publications:

Multi-institutional prospective validation of prognostic mRNA signatures in early stage squamous lung cancer (Alliance).

INTRODUCTION: Surgical resection is curative for some patients with early lung squamous cell carcinoma. Staging and clinical factors do not adequately predict recurrence risk. We sought to validate discriminative performance of proposed prognostic gene expression signatures at a level of rigor sufficient to support clinical use. METHODS: Two-stage validation used independent core laboratories, objective quality control standards, locked test parameters, and large multi-institutional specimen/data sets. First stage validation confirmed a signature's ability to stratify patient survival. Second stage validation determined which signature(s) optimally improved risk discrimination when added to baseline clinical predictors. Participants were prospectively enrolled on institutional (Cohort I) or cooperative group (Cohort II) biospecimen/data collection protocols. All cases underwent central review of clinical, pathologic and biospecimen parameters using objective criteria to determine final inclusion (Cohort I: n=249; Cohort II: n=234). Primary selection required that a signature significantly predict 3-years survival after surgery in Cohort I. Signatures meeting this criterion were further tested in Cohort II, comparing risk prediction using baseline risk factors alone versus in combination with the signature. RESULTS: Male sex, advanced age, and higher stage were associated with shorter survival in Cohort I and established a baseline clinical model. Of three signatures validated in Cohort I, one signature was validated in Cohort II and statistically significantly enhanced prognosis relative to the baseline model (C-index difference 0.122; p<0.05). CONCLUSIONS: and relevance: These results represent the first rigorous validation of a test appropriate to direct adjuvant treatment or clinical trials for patients with lung squamous cell carcinoma.
Authors
Bueno, R; Richards, WG; Harpole, DH; Ballman, KV; Tsao, M-S; Chen, Z; Wang, X; Chen, G; Chirieac, LR; Chui, MH; Franklin, WA; Giordano, TJ; Govindan, R; Joshi, M-B; Merrick, DT; Rivard, CJ; Sporn, T; van Bokhoven, A; Yu, H; Shepherd, FA; Watson, MA; Beer, DG; Hirsch, FR
MLA Citation
Bueno, Raphael, et al. “Multi-institutional prospective validation of prognostic mRNA signatures in early stage squamous lung cancer (Alliance).J Thorac Oncol, July 2020. Pubmed, doi:10.1016/j.jtho.2020.07.005.
URI
https://scholars.duke.edu/individual/pub1453144
PMID
32717408
Source
pubmed
Published In
J Thorac Oncol
Published Date
DOI
10.1016/j.jtho.2020.07.005

Randomized Study of Maintenance Pemetrexed Versus Observation for Treatment of Malignant Pleural Mesothelioma: CALGB 30901.

BACKGROUND: The role of maintenance therapy for malignant pleural mesothelioma (MPM) is unknown. We performed a randomized phase II trial to determine if continuation of pemetrexed after first-line pemetrexed and platinum would improve progression-free survival (PFS). PATIENTS AND METHODS: Eligible patients with unresectable MPM, without disease progression following 4 to 6 cycles of pemetrexed and platinum were randomized 1:1 to observation or continuation of pemetrexed until progression, stratified by number of cycles (< 6 or 6), cis- or carboplatin containing regimen, and histology. Study size was calculated based on the assumption that observation would produce a median PFS of 3 months and pemetrexed would yield median PFS of 6 months. RESULTS: A total of 72 patients were registered from December 2010 to June 2016. The study closed early after 53 patients were randomized; 49 eligible (22 on the observation arm and 27 on the pemetrexed arm) were included in the analysis. The median PFS was 3 months (95% confidence interval [CI], 2.6-11.9 months) on observation and 3.4 months (95% CI, 2.8-9.8 months) on pemetrexed (hazard ratio [HR], 0.99; 95% CI, 0.51-1.90; P = .9733). The median overall survival (OS) was 11.8 months (95% CI, 9.3-28.7 months) for observation, and 16.3 months (95% CI, 10.5-26.0 months) for pemetrexed (HR, 0.86; 95% CI, 0.44-1.71; P = .6737). Grade 3 or 4 toxicities on the pemetrexed arm included anemia (8%), lymphopenia (8%), neutropenia (4%), and fatigue (4%). A higher baseline level of soluble mesothelin-related peptide was associated with worse PFS (HR, 1.86; 95% CI, 1.00-3.46; P = .049). CONCLUSION: Maintenance pemetrexed following initial pemetrexed and platinum chemotherapy does not improve PFS in patients with MPM.
Authors
Dudek, AZ; Wang, X; Gu, L; Duong, S; Stinchcombe, TE; Kratzke, R; Borghaei, H; Vokes, EE; Kindler, HL
MLA Citation
Dudek, Arkadiusz Z., et al. “Randomized Study of Maintenance Pemetrexed Versus Observation for Treatment of Malignant Pleural Mesothelioma: CALGB 30901.Clin Lung Cancer, July 2020. Pubmed, doi:10.1016/j.cllc.2020.06.025.
URI
https://scholars.duke.edu/individual/pub1453923
PMID
32727707
Source
pubmed
Published In
Clin Lung Cancer
Published Date
DOI
10.1016/j.cllc.2020.06.025

The importance of body composition and physical function on overall survival (OS) in non-small cell lung cancer (NSCLC) patients receiving platinum based chemotherapy (PBCT).

Authors
Kinsey, E; Ajazi, E; Wang, XF; Johnston, MA; Crawford, J
MLA Citation
Kinsey, Emily, et al. “The importance of body composition and physical function on overall survival (OS) in non-small cell lung cancer (NSCLC) patients receiving platinum based chemotherapy (PBCT).Journal of Clinical Oncology, vol. 36, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2018, pp. e21088–e21088. Crossref, doi:10.1200/jco.2018.36.15_suppl.e21088.
URI
https://scholars.duke.edu/individual/pub1441475
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
36
Published Date
Start Page
e21088
End Page
e21088
DOI
10.1200/jco.2018.36.15_suppl.e21088

Predictive accuracy of markers or risk scores for interval censored survival data.

Methods for the evaluation of the predictive accuracy of biomarkers with respect to survival outcomes subject to right censoring have been discussed extensively in the literature. In cancer and other diseases, survival outcomes are commonly subject to interval censoring by design or due to the follow up schema. In this article, we present an estimator for the area under the time-dependent receiver operating characteristic (ROC) curve for interval censored data based on a nonparametric sieve maximum likelihood approach. We establish the asymptotic properties of the proposed estimator and illustrate its finite-sample properties using a simulation study. The application of our method is illustrated using data from a cancer clinical study. An open-source R package to implement the proposed method is available on Comprehensive R Archive Network.
MLA Citation
Wu, Yuan, et al. “Predictive accuracy of markers or risk scores for interval censored survival data.Stat Med, vol. 39, no. 18, Aug. 2020, pp. 2437–46. Pubmed, doi:10.1002/sim.8547.
URI
https://scholars.duke.edu/individual/pub1437823
PMID
32293745
Source
pubmed
Published In
Stat Med
Volume
39
Published Date
Start Page
2437
End Page
2446
DOI
10.1002/sim.8547

Endpoint surrogacy in oncology Phase 3 randomised controlled trials.

Endpoint surrogacy is an important concept in oncology trials. Using a surrogate endpoint like progression-free survival as the primary endpoint-instead of overall survival-would lead to a potential faster drug approval and therefore more cancer patients with an earlier opportunity to receive the newly approved drugs.
Authors
Zhang, J; Pilar, MR; Wang, X; Liu, J; Pang, H; Brownson, RC; Colditz, GA; Liang, W; He, J
MLA Citation
Zhang, Jianrong, et al. “Endpoint surrogacy in oncology Phase 3 randomised controlled trials.Br J Cancer, vol. 123, no. 3, Aug. 2020, pp. 333–34. Pubmed, doi:10.1038/s41416-020-0896-5.
URI
https://scholars.duke.edu/individual/pub1442163
PMID
32451466
Source
pubmed
Published In
Br J Cancer
Volume
123
Published Date
Start Page
333
End Page
334
DOI
10.1038/s41416-020-0896-5