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:

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

Administered By
Biostatistics & Bioinformatics
Awarded By
Department of Defense
Role
Partnering PI
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

Health Disparity in African Americans: A Meta-analysis of Six Phase III Trials in Metastatic Castration-Resistant Prosta

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

Precision Medicine in Platinum-treated Lethal Bladder Cancer

Administered By
Biostatistics & Bioinformatics
Awarded By
Memorial Sloan Kettering Cancer Center
Role
Principal Investigator
Start Date
End Date

Serum Androgens and Survival in CRPC

Administered By
Duke Cancer Institute
Awarded By
University of California, San Francisco
Role
Principal Investigator
Start Date
End Date

Publications:

Phase 1b trial of docetaxel, prednisone, and pazopanib in men with metastatic castration-resistant prostate cancer.

BACKGROUND: Docetaxel prednisone is a standard of care for men with metastatic castration-resistant prostate cancer (mCRPC), and plasma vascular endothelial growth factor (VEGF) levels are a poor prognostic factor in this population; therefore, we evaluated the combination of docetaxel prednisone with pazopanib, an oral VEGF receptor inhibitor, for safety and preliminary efficacy. METHODS: This is a two-site phase 1b Department of Defense Prostate Cancer Clinical Trials Consortium trial of docetaxel, prednisone, and pazopanib once daily and ongoing androgen deprivation therapy and prophylactic pegfilgrastim in men with mCRPC. The primary endpoint was safety and the determination of a maximum tolerated dose (MTD) through a dose-escalation and expansion design; secondary endpoints included progression-free and overall survival (OS), prostate specific antigen (PSA) declines, radiographic responses, and pharmacokinetic and plasma angiokine biomarker analyses. RESULTS: Twenty-five men were treated over six dose levels. Pegfilgrastim was added to the regimen after myelosuppression limited dose escalation. With pegfilgrastim, our target MTD of docetaxel 75 mg/m2 q3 weeks; prednisone 10 mg daily; and pazopanib 800 mg daily was reached. Eleven additional patients were accrued at this dose level for a total of 36 patients. Dose-limiting toxicities included neutropenia, syncope, and hypertension. Three deaths attributed to study treatment occurred. The objective response rate was 31%; median PFS was 14.1 months (95% confidence interval [CI]: 7.1 and 22.2); and OS was 18.6 months (95% CI: 11.8 and 22.2). CONCLUSIONS: The combination of docetaxel, prednisone, and pazopanib (with pegfilgrastim) was tolerable at full doses and demonstrated promising efficacy in a relatively poor risk patients with mCRPC. Further development of predictive biomarkers may enrich for patients who receive clinical benefit from this regimen.
Authors
George, DJ; Halabi, S; Healy, P; Barak, I; Winters, C; Anand, M; Wilder, R; Klein, M; Martinez, E; Nixon, AB; Harrison, MR; Szmulewitz, R; Armstrong, AJ
MLA Citation
George, Daniel J., et al. “Phase 1b trial of docetaxel, prednisone, and pazopanib in men with metastatic castration-resistant prostate cancer..” Prostate, Sept. 2019. Pubmed, doi:10.1002/pros.23899.
URI
https://scholars.duke.edu/individual/pub1409756
PMID
31497882
Source
pubmed
Published In
Prostate
Published Date
DOI
10.1002/pros.23899

Exploring the role of RB and AR in a phase II randomized multicenter trial of abiraterone acetate with or without cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC).

Authors
Slovin, SF; Knudsen, KE; Carbone, E; Showunmi, A; Hullings, M; Morris, MJ; Autio, KA; Kampel, LJ; Molina, AM; Chen, Y; Arauz, G; Curley, T; Tse, K; Halabi, S; Scher, HI; Kelly, WK
MLA Citation
Slovin, Susan F., et al. “Exploring the role of RB and AR in a phase II randomized multicenter trial of abiraterone acetate with or without cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC)..” Journal of Clinical Oncology, vol. 34, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2016, pp. TPS5093–TPS5093. Crossref, doi:10.1200/jco.2016.34.15_suppl.tps5093.
URI
https://scholars.duke.edu/individual/pub1406790
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
34
Published Date
Start Page
TPS5093
End Page
TPS5093
DOI
10.1200/jco.2016.34.15_suppl.tps5093

Disease-free survival (DFS) as a surrogate for overall survival (OS) in localized prostate cancer (CaP).

Authors
Sweeney, C; Xie, W; Regan, MM; Nakabayashi, M; Buyse, ME; Clarke, NW; Collette, L; Dignam, JJ; Fizazi, K; Habibian, M; Halabi, S; Kantoff, PW; Parulekar, WR; Sandler, HM; Sartor, O; Soule, HR; Sydes, MR; Tombal, BF; Williams, SG
MLA Citation
Sweeney, Christopher, et al. “Disease-free survival (DFS) as a surrogate for overall survival (OS) in localized prostate cancer (CaP)..” Journal of Clinical Oncology, vol. 34, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2016, pp. 5023–5023. Crossref, doi:10.1200/jco.2016.34.15_suppl.5023.
URI
https://scholars.duke.edu/individual/pub1407077
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
34
Published Date
Start Page
5023
End Page
5023
DOI
10.1200/jco.2016.34.15_suppl.5023

Serum androgens and survival in metastatic castration resistant prostate cancer (mCRPC) patients treated with docetaxel and prednisone: Results from CALGB 90401 (Alliance).

Authors
Ryan, CJ; Dutta, S; Kelly, WK; Middleberg, R; Russell, C; Small, EJ; Morris, MJ; Taplin, M-E; Halabi, S
MLA Citation
Ryan, Charles J., et al. “Serum androgens and survival in metastatic castration resistant prostate cancer (mCRPC) patients treated with docetaxel and prednisone: Results from CALGB 90401 (Alliance)..” Journal of Clinical Oncology, vol. 35, no. 15_suppl, American Society of Clinical Oncology (ASCO), 2017, pp. 5067–5067. Crossref, doi:10.1200/jco.2017.35.15_suppl.5067.
URI
https://scholars.duke.edu/individual/pub1396305
Source
crossref
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
35
Published Date
Start Page
5067
End Page
5067
DOI
10.1200/jco.2017.35.15_suppl.5067

Reply to L. Dirix, B. De Laere et al, and A. Sharp et al.

Authors
Armstrong, AJ; Halabi, S; Luo, J; Nanus, DM; Scher, HI; Antonarakis, ES; George, DJ
MLA Citation
Armstrong, Andrew J., et al. “Reply to L. Dirix, B. De Laere et al, and A. Sharp et al..” J Clin Oncol, vol. 37, no. 24, Aug. 2019, pp. 2184–86. Pubmed, doi:10.1200/JCO.19.01230.
URI
https://scholars.duke.edu/individual/pub1396157
PMID
31265357
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
37
Published Date
Start Page
2184
End Page
2186
DOI
10.1200/JCO.19.01230

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