Susan Halabi

Overview:

Design and analysis of clinical trials, statistical analysis of biomarker and high dimensional data, development and validation of prognostic and predictive models.

Positions:

Professor of Biostatistics and Bioinformatics

Biostatistics & Bioinformatics
School of Medicine

Chief, Division of Biostatistics

Biostatistics & Bioinformatics
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

Ph.D. 1994

University of Texas Health Sciences Center at Houston

Grants:

PCRP Clinical Consortium: Duke University Clinical Research Site

Administered By
Medicine, Medical Oncology
Awarded By
Department of Defense
Role
Co Investigator
Start Date
End Date

Plasma Angiome and Serum Androgens as Predictors of Overall Survival in Metastatic Prostate Cancer

Administered By
Biostatistics & Bioinformatics
Awarded By
Department of Defense
Role
Principal Investigator
Start Date
End Date

Prognostic Models of Clinical Outcomes In Men With Castration Resistant Prostate Cancer

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

Role of oncogenic phosphorylated MED1 in aggressive prostate cancer

Administered By
Pathology
Awarded By
National Institutes of Health
Role
Co Investigator
Start Date
End Date

Surrogate Endpoints of Overall Survival in Men with Metastatic Hormone Sensitive Prostate Cancer

Administered By
Biostatistics & Bioinformatics
Role
Principal Investigator
Start Date
End Date

Publications:

Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice.
Authors
Balogh, EP; Bindman, AB; Eckhardt, SG; Halabi, S; Harvey, RD; Jaiyesimi, I; Miksad, R; Moses, HL; Nass, SJ; Schilsky, RL; Sun, S; Torrente, JM; Warren, KE
MLA Citation
Balogh, Erin P., et al. “Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.Oncologist, vol. 25, no. 3, Mar. 2020, pp. e405–11. Pubmed, doi:10.1634/theoncologist.2019-0698.
URI
https://scholars.duke.edu/individual/pub1435230
PMID
32162805
Source
pubmed
Published In
Oncologist
Volume
25
Published Date
Start Page
e405
End Page
e411
DOI
10.1634/theoncologist.2019-0698

Androgens and Overall Survival in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Docetaxel.

BACKGROUND: Pre-treatment androgen levels are associated with overall survival (OS) in patients with metastatic castration-resistant prostate cancer (CRPC) treated with androgen synthesis inhibitors. The current study sought to determine whether pre-treatment serum androgens predict clinical outcome among patients with metastatic CRPC treated with docetaxel chemotherapy. MATERIALS AND METHODS: Data were obtained from 1050 men who were chemotherapy-naive prior to treatment with docetaxel, prednisone, and either bevacizumab or placebo (CALGB 90401). Pretreatment serum assays for testosterone, androstenedione, and dehydroepiandrosterone (DHEA) were performed with tandem liquid chromatography-mass spectrometry. RESULTS: Median values for testosterone, androstenedione, and DHEA were 1.00, 13.50, and 8.12 ng/dL, respectively. The median was used to define the midpoint between low and high values. In univariate analysis, median OS for low versus high levels was 21.4 and 24.2 months for testosterone, 23.8 and 21.9 months for androstenedione, and 20.2 and 25.2 months for DHEA (P = NS). In multivariable analysis of all androgens, baseline DHEA was prognostic of ≥ 50% PSA decline from baseline (P = .008). In multivariable analysis adjusting for 10 known prognostic values and prior ketoconazole use for metastatic CRPC, a 10-unit increase in baseline testosterone increased risk of death (hazard ratio, 1.11; 95% confidence interval, 1.01-1.23; P = .039), whereas a 10-unit increase in androstenedione lowered risk of death (hazard ratio, 0.92; 95% confidence interval, 0.88-0.97; P = .001). CONCLUSION: Consistent with prior studies, higher androstenedione levels in patients with metastatic CRPC treated with docetaxel are associated with improved survival. However pretreatment levels of other androgen levels are associated with varied effects on clinical outcome in chemotherapy-treated patients.
Authors
Ryan, CJ; Dutta, S; Kelly, WK; Middleberg, R; Russell, C; Morris, MJ; Taplin, M-E; Halabi, S; Alliance for Clinical Trials in Oncology Genitourinary Committee,
MLA Citation
Ryan, Charles J., et al. “Androgens and Overall Survival in Patients With Metastatic Castration-resistant Prostate Cancer Treated With Docetaxel.Clin Genitourin Cancer, Oct. 2019. Pubmed, doi:10.1016/j.clgc.2019.10.002.
URI
https://scholars.duke.edu/individual/pub1437043
PMID
32273234
Source
pubmed
Published In
Clin Genitourin Cancer
Published Date
DOI
10.1016/j.clgc.2019.10.002

Clinical Outcomes in Men of Diverse Ethnic Backgrounds with Metastatic Castration Resistant Prostate Cancer.

BACKGROUND: We have shown previously in multivariable analysis that black men had 19% lower risk of death than white men with metastatic castration resistant prostate cancer (mCRPC) treated with a docetaxel (D) and prednisone (P)-based regimen. The primary goal of this analysis was to compare progression-free survival (PFS), biochemical PFS, ≥50% decline in PSA from baseline and objective response rate (ORR) in white, black and Asian men with mCRPC treated with a DP-based regimen. PATIENTS AND METHODS: Individual patient data from 8,820 mCRPC men randomized on nine phase III trials to DP-containing regimen were combined. Race used in the analysis was based on self-report. Endpoints were PFS, biochemical PSA, ≥50% decline in PSA from baseline and ORR. The proportional hazards and the logistic regression models were employed to assess the prognostic importance of race in predicting outcomes adjusting for established prognostic factors. RESULTS: Of 8,820 patients, 7,528 (85%) were white, 500 (6%) were black, 424 were Asian (5%) and 368 (4%) had race unspecified. Median PFS were in months 8.3 (95% CI 8.1-8.5), 8.2 (95% CI 7.4-8.8), and 8.3 (95% CI 7.6-8.8) in white, black and Asian men, respectively. Median PSA PFS were 9.7 months (95% CI 9.4-10), 8.5 months (95% CI 7.6-10) and 10.0 (95% CI 9.5-11.8) in white, black and Asian men, respectively. CONCLUSIONS: We observed no differences in clinical outcomes by race and ethnic groups in men with mCRPC enrolled on these phase III clinical trials with DP.
Authors
Halabi, S; Dutta, S; Tangen, CM; Rosenthal, M; Petrylak, DP; Thompson, IM; Chi, KN; De Bono, JS; Araujo, JC; Logothetis, C; Eisenberger, MA; Quinn, DI; Fizazi, K; Morris, MJ; Higano, CS; Tannock, IF; Small, EJ; Kelly, WK
MLA Citation
Halabi, S., et al. “Clinical Outcomes in Men of Diverse Ethnic Backgrounds with Metastatic Castration Resistant Prostate Cancer.Ann Oncol, Apr. 2020. Pubmed, doi:10.1016/j.annonc.2020.03.309.
URI
https://scholars.duke.edu/individual/pub1438183
PMID
32289380
Source
pubmed
Published In
Ann Oncol
Published Date
DOI
10.1016/j.annonc.2020.03.309

Metastasis free survival (MFS) is a surrogate for overall survival (OS) in localized prostate cancer (CaP)

Authors
Xie, W; Sweeney, C; Regan, M; Nakabayashi, M; Buyse, M; Clarke, N; Collette, L; Dignam, J; Fizazi, K; Habibian, M; Halabi, S; Kantoff, P; Parulekar, W; Sandler, HM; Sartor, O; Soule, H; Sydes, M; Tombal, B; Williams, S
MLA Citation
Xie, W., et al. “Metastasis free survival (MFS) is a surrogate for overall survival (OS) in localized prostate cancer (CaP).” Annals of Oncology, vol. 27, Oct. 2016, p. vi243. Scopus, doi:10.1093/annonc/mdw372.01.
URI
https://scholars.duke.edu/individual/pub1435009
Source
scopus
Published In
Annals of Oncology
Volume
27
Published Date
Start Page
vi243
DOI
10.1093/annonc/mdw372.01

Improved Reporting in Abstracts When Uncertainty Is Inevitable.

Authors
Halabi, S; Day, S
MLA Citation
Halabi, Susan, and Simon Day. “Improved Reporting in Abstracts When Uncertainty Is Inevitable.Jama Netw Open, vol. 2, no. 12, Dec. 2019, p. e1917543. Pubmed, doi:10.1001/jamanetworkopen.2019.17543.
URI
https://scholars.duke.edu/individual/pub1423441
PMID
31834388
Source
pubmed
Published In
Jama Network Open
Volume
2
Published Date
Start Page
e1917543
DOI
10.1001/jamanetworkopen.2019.17543

Research Areas:

Adenocarcinoma
Adenocarcinoma, Clear Cell
African Americans
Age Factors
Aged, 80 and over
Alkaline Phosphatase
Alleles
Arab countries
Area Under Curve
Biological Markers
Biomarkers, Pharmacological
Breast Neoplasms
Cancer Vaccines
Carcinoma
Carcinoma, Renal Cell
Case-Control Studies
Chemoprevention
Chemotherapy
Chi-Square Distribution
Clinical Trials, Phase II as Topic
Clinical trials
Cohort Studies
Computer Simulation
Confidence Intervals
Construction Materials
Contraceptives, Oral
DNA Damage
DNA Primers
DNA Repair
DNA, Neoplasm
Data Interpretation, Statistical
Decision Making
Decision Support Techniques
Diagnostic Imaging
Disease Progression
Disease-Free Survival
Drug Design
Dust
Efficiency, Organizational
Endpoint Determination
Equipment Design
Factor Analysis, Statistical
Family relationships
Gels
Gene Expression
Genes, Immunoglobulin
Genetic Predisposition to Disease
Genetics, Medical
Genotype
Germany
Graft vs Host Disease
HIV Infections
Hispanic Americans
Individualized Medicine
Kaplan-Meier Estimate
Ketoconazole
Lasso
Logistic Models
Lymphokines
Mining
Models, Biological
Models, Statistical
Models, Theoretical
Molecular Sequence Data
Multiprotein Complexes
Multivariate Analysis
Mutation
Neoplasms, Hormone-Dependent
Nomograms
Odds Ratio
Outcome Assessment (Health Care)
Ovarian Neoplasms
Personalized medicine
Population
Population Surveillance
Precision Medicine
Predictive Value of Tests
Pregnancy
Probability
Prognosis
Proportional Hazards Models
Prospective Studies
ROC Curve
Randomized Controlled Trials as Topic
Receptors, Progesterone
Registries
Reproducibility of Results
Research Design
Residence Characteristics
Retrospective Studies
Ribosomal Protein S6 Kinases
Risk
Risk Assessment
Risk Factors
Sample Size
Selective Estrogen Receptor Modulators
Sensitivity and Specificity
Statistics as Topic
Survival
Survival Analysis
Survival Rate
Tamoxifen
Translocation, Genetic
Treatment Failure
Treatment Outcome
Tumor Markers, Biological
United States
Urologic Neoplasms
Validation Studies as Topic
Vascular Endothelial Growth Factors