Gary Rosner

Professor

1984 …2020
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Research Output 1984 2020

2020

Individualized treatment effects with censored data via fully nonparametric Bayesian accelerated failure time models

Henderson, N. C., Louis, T. A., Rosner, G. L. & Varadhan, R., Jan 1 2020, In : Biostatistics (Oxford, England). 21, 1, p. 50-68 19 p.

Research output: Contribution to journalArticle

Accelerated Failure Time Model
Censored Data
Treatment Effects
Bayesian Model
Angiotensin
2019
Nonparametric Inference
Causal Inference
Randomized Clinical Trial
Bayesian Nonparametrics
Propensity Score
Homologous Transplantation
Acute Myeloid Leukemia
Prospective Studies
Transplants
Survival

Bayesian Methods in Regulatory Science

Rosner, G. L., Jan 1 2019, (Accepted/In press) In : Statistics in Biopharmaceutical Research.

Research output: Contribution to journalArticle

Open Access
Bayes Theorem
Bayesian Methods
Clinical Trials
Decision Theory
Research

Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology

Hobbs, B. P., Barata, P. C., Kanjanapan, Y., Paller, C., Perlmutter, J., Pond, G. R., Prowell, T. M., Rubin, E. H., Seymour, L. K., Wages, N. A., Yap, T. A., Feltquate, D., Garrett-Mayer, E., Grossman, W., Hong, D. S., Ivy, S. P., Siu, L. L., Reeves, S. A. & Rosner, G., Feb 1 2019, In : Journal of the National Cancer Institute. 111, 2, p. 118-128 11 p.

Research output: Contribution to journalArticle

Open Access
Pharmaceutical Preparations
Investigational Drugs
Drug Approval
National Cancer Institute (U.S.)
Poisons
2018

A Bayesian design for phase I cancer therapeutic vaccine trials

Wang, C., Rosner, G. & Roden, R. S., Jan 1 2018, (Accepted/In press) In : Statistics in Medicine.

Research output: Contribution to journalArticle

Bayesian Design
Cancer Vaccines
Vaccine
Phase I Trial
Cancer

A phase II study evaluating the efficacy of zoledronic acid in prevention of aromatase inhibitor-associated musculoskeletal symptoms: the ZAP trial

Santa-Maria, C., Bardia, A., Blackford, A. L., Snyder, C., Connolly, R., Fetting, J. H., Hayes, D. F., Jeter, S. C., Miller, R. S., Nguyen, A., Quinlan, K., Rosner, G., Slater, S., Storniolo, A. M., Wolff, A. C., Zorzi, J., Henry, N. L. & Stearns, V., May 11 2018, (Accepted/In press) In : Breast Cancer Research and Treatment. p. 1-9 9 p.

Research output: Contribution to journalArticle

zoledronic acid
letrozole
Aromatase Inhibitors
exemestane
Pharmacogenetics

A phase I trial of a guadecitabine (SGI-110) and irinotecan in metastatic colorectal cancer patients previously exposed to irinotecan

Lee, V., Wang, J., Zahurak, M., Gootjes, E., Verheul, H. M., Parkinson, R., Kerner, Z., Sharma, A., Rosner, G., De Jesus-Acosta, A., Laheru, D., Le, D., Oganesian, A., Lilly, E., Brown, T., Jones, P., Baylin, S. B., Ahuja, N. & Azad, N., Dec 15 2018, In : Clinical Cancer Research. 24, 24, p. 6160-6167 8 p.

Research output: Contribution to journalArticle

irinotecan
Colorectal Neoplasms
Intercellular Signaling Peptides and Proteins
Fever
Gastrointestinal Neoplasms
Metformin
Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Drug Therapy

Bayesian approaches to evaluating doses of drugs

Rosner, G., Apr 1 2018, In : Clinical Advances in Hematology and Oncology. 16, 4, p. 258-261 4 p.

Research output: Contribution to journalComment/debate

Bayes Theorem
Pharmaceutical Preparations

Dependent generalized Dirichlet process priors for the analysis of acute lymphoblastic leukemia

Barcella, W., De Iorio, M., Favaro, S. & Rosner, G., Jul 1 2018, In : Biostatistics. 19, 3, p. 342-358 17 p.

Research output: Contribution to journalArticle

Dirichlet Process Prior
Leukemia
Acute
MCMC Algorithm
Bayesian Nonparametrics

Erratum: The oral VEGF receptor tyrosine kinase inhibitor pazopanib in combination with the MEK inhibitor trametinib in advanced cholangiocarcinoma (British journal of cancer (2017) 116 11 (1402-1407))

Shroff, R. T., Yarchoan, M., O'Connor, A., Gallagher, D., Zahurak, M. L., Rosner, G., Ohaji, C., Sartorius-Mergenthaler, S., Parkinson, R., Subbiah, V., Zinner, R. & Azad, N. S., Jan 1 2018, In : British journal of cancer. 118, 2, p. e2

Research output: Contribution to journalComment/debate

Open Access

Final results of a randomized multicenter phase II study of alvocidib, cytarabine, and mitoxantrone versus cytarabine and daunorubicin (7 + 3) in newly diagnosed high-risk acute myeloid leukemia (AML)

Zeidner, J. F., Foster, M. C., Blackford, A. L., Litzow, M. R., Morris, L. E., Strickland, S. A., Lancet, J. E., Bose, P., Levy, M. Y., Tibes, R., Gojo, I., Gocke, C., Rosner, G., Little, R. F., Wright, J. J., Doyle, L. A., Smith, B. D. & Karp, J., Sep 1 2018, In : Leukemia Research. 72, p. 92-95 4 p.

Research output: Contribution to journalLetter

alvocidib
Mitoxantrone
Daunorubicin
Cytarabine
Acute Myeloid Leukemia
Bone Marrow Transplantation
Cyclophosphamide
Tissue Donors
Confidence Intervals
Transplants

Muscadine grape skin extract (MPX) in men with biochemically recurrent prostate cancer: A randomized, multicenter, placebo-controlled clinical trial

Paller, C., Zhou, X. C., Heath, E. I., Taplin, M. E., Mayer, T., Stein, M. N., Bubley, G. J., Pili, R., Hudson, T., Kakarla, R., Abbas, M. M., Anders, N., Dowling, D., King, S., Bruns, A. B., Wagner, W. D., Drake, C. G., Antonarakis, E., Eisenberger, M., Denmeade, S. R. & 3 others, Rudek-Renaut, M., Rosner, G. & Carducci, M. A., Jan 15 2018, In : Clinical Cancer Research. 24, 2, p. 306-315 10 p.

Research output: Contribution to journalArticle

Controlled Clinical Trials
Vitis
Prostatic Neoplasms
Placebos
Skin

Neoadjuvant PD-1 blockade in resectable lung cancer

Forde, P., Chaft, J. E., Smith, K., Anagnostou, V., Cottrell, T. R., Hellmann, M. D., Zahurak, M., Broderick, S., Yang, S. C., Jones, D. R., Battafarano, R. J., Velez, M. J., Rekhtman, N., Olah, Z., Verde, F., Naidoo, J., Marrone, K., Guo, H., Sidhom, J. W., Zhang, J. & 15 others, Caushi, J. X., Chan, H. Y., Scharpf, R. B., White, J., Gabrielson, E., Wang, H., Rosner, G., Rusch, V., Wolchok, J. D., Merghoub, T., Taube, J. M., Velculescu, V. E., Topalian, S., Brahmer, J. & Pardoll, A. M., May 24 2018, In : New England Journal of Medicine. 378, 21, p. 1976-1986 11 p.

Research output: Contribution to journalArticle

Lung Neoplasms
Clone Cells
Neoplasms
Non-Small Cell Lung Carcinoma
T-Lymphocytes

Racial disparities in the rate of cardiotoxicity of HER2-targeted therapies among women with early breast cancer

Litvak, A., Batukbhai, B., Russell, S. D., Tsai, H. L., Rosner, G., Jeter, S. C., Armstrong, D. K., Emens, L. A., Fetting, J. H., Wolff, A. C., Silhy, R., Stearns, V. & Connolly, R., Jan 1 2018, (Accepted/In press) In : Cancer.

Research output: Contribution to journalArticle

Breast Neoplasms
Therapeutics
Confidence Intervals
Stroke Volume
Incidence
Tacrolimus
Graft vs Host Disease
Bone Marrow Transplantation
Transplantation
Arm
2017

A phase I study of topotecan, carboplatin and the PARP inhibitor veliparib in acute leukemias, aggressive myeloproliferative neoplasms, and chronic myelomonocytic leukemia

Pratz, K., Rudek-Renaut, M., Gojo, I., Litzow, M. R., McDevitt, M. A., Ji, J., Karnitz, L. M., Herman, J. G., Kinders, R. J., Smith, B. D., Gore, S. D., Carraway, H. E., Showel, M., Gladstone, D., Levis, M. J., Tsai, H. L., Rosner, G., Chen, A., Kaufmann, S. H. & Karp, J., Feb 15 2017, In : Clinical Cancer Research. 23, 4, p. 899-907 9 p.

Research output: Contribution to journalArticle

Leukemia, Myelomonocytic, Chronic
Topotecan
Carboplatin
Leukemia
Neoplasms

Challenges and opportunities in adapting clinical trial design for immunotherapies

Siu, L. L., Ivy, S. P., Dixon, E. L., Gravell, A. E., Reeves, S. A. & Rosner, G., Sep 1 2017, In : Clinical Cancer Research. 23, 17, p. 4950-4958 9 p.

Research output: Contribution to journalArticle

Immunotherapy
Clinical Trials
Immune System
Neoplasms
Biomarkers
Graft vs Host Disease
Cyclophosphamide
Transplantation
Recurrence
Bone Marrow

From famine to feast: Developing early-phase combination immunotherapy trials wisely

Day, D., Monjazeb, A. M., Sharon, E., Ivy, S. P., Rubin, E. H., Rosner, G. & Butler, M. O., Sep 1 2017, In : Clinical Cancer Research. 23, 17, p. 4980-4991 12 p.

Research output: Contribution to journalArticle

Starvation
Immunotherapy
Safety
Therapeutics
Allergy and Immunology
Graft vs Host Disease
Cyclophosphamide
Disease-Free Survival
Confidence Intervals
Transplants

Individualized Molecular Analyses Guide Efforts (IMAGE): A prospective study of molecular profiling of tissue and blood in metastatic triple-negative breast cancer

Parsons, H. A., Beaver, J., Cimino-Mathews, A. M., Ali, S. M., Axilbund, J., Chu, D., Connolly, R., Cochran, R. L., Croessmann, S., Clark, T. A., Gocke, C., Jeter, S. C., Kennedy, M. R., Lauring, J., Lee, J., Lipson, D., Miller, V. A., Otto, G. A., Rosner, G., Ross, J. S. & 10 others, Slater, S., Stephens, P. J., Vandenberg, D. A., Wolff, A. C., Young, L. E., Zabransky, D. J., Zhang, Z., Zorzi, J., Stearns, V. & Park, B. H., Jan 15 2017, In : Clinical Cancer Research. 23, 2, p. 379-386 8 p.

Research output: Contribution to journalArticle

Triple Negative Breast Neoplasms
Prospective Studies
Biopsy
Neoplasms
Medical Futility

Prospective Study of Hippocampal-Sparing Prophylactic Cranial Irradiation in Limited-Stage Small Cell Lung Cancer

Redmond, K. A., Hales, R., Anderson-Keightly, H., Zhou, X. C., Kummerlowe, M., Sair, H., Duhon, M., Kleinberg, L. R., Rosner, G. & Vannorsdall, T., Jul 1 2017, In : International Journal of Radiation Oncology, Biology, Physics. 98, 3, p. 603-611 9 p.

Research output: Contribution to journalArticle

Cranial Irradiation
Small Cell Lung Carcinoma
lungs
brain
metastasis
Open Access
Cyclophosphamide
Graft vs Host Disease
Unrelated Donors
Transplantation
Bone Marrow

Randomized phase II trial of cytosine arabinoside with and without the CHK1 inhibitor MK-8776 in relapsed and refractory acute myeloid leukemia

Webster, J., Tibes, R., Morris, L., Blackford, A. L., Litzow, M., Patnaik, M., Rosner, G., Gojo, I., Kinders, R., Wang, L., Doyle, L. A., Huntoon, C. J., Karnitz, L. M., Kaufmann, S. H., Karp, J. & Smith, B. D., Oct 1 2017, In : Leukemia Research. 61, p. 108-116 9 p.

Research output: Contribution to journalArticle

Cytarabine
Acute Myeloid Leukemia
DNA Damage
Cell Cycle Checkpoints
MK-8776
Bone Marrow Transplantation
Cyclophosphamide
Young Adult
Pediatrics
Transplants

The oral VEGF receptor tyrosine kinase inhibitor pazopanib in combination with the MEK inhibitor trametinib in advanced cholangiocarcinoma

Shroff, R. T., Yarchoan, M., O'Connor, A., Gallagher, D., Zahurak, M. L., Rosner, G., Ohaji, C., Sartorius-Mergenthaler, S., Subbiah, V., Zinner, R. & Azad, N., May 23 2017, In : British Journal of Cancer. 116, 11, p. 1402-1407 6 p.

Research output: Contribution to journalArticle

Vascular Endothelial Growth Factor Receptor
Cholangiocarcinoma
Mitogen-Activated Protein Kinase Kinases
Protein-Tyrosine Kinases
Disease-Free Survival
2016

Association of acute myeloid leukemia’s most immature phenotype with risk groups and outcomes

Gerber, J. M., Zeidner, J. F., Morse, S., Blackford, A. L., Perkins, B., Yanagisawa, B., Zhang, H., Morsberger, L., Karp, J., Ning, Y., Gocke, C., Rosner, G., Smith, B. D. & Jones, R. J., Apr 30 2016, In : Haematologica. 101, 5, p. 607-616 10 p.

Research output: Contribution to journalArticle

Acute Myeloid Leukemia
Leukemia
Phenotype
Aldehyde Dehydrogenase
Stem Cells

Clinical validity of new genetic biomarkers of irinotecan neutropenia: An independent replication study

Crona, D. J., Ramirez, J., Qiao, W., De Graan, A. J., Ratain, M. J., Van Schaik, R. H. N., Mathijssen, R. H. J., Rosner, G. & Innocenti, F., Feb 1 2016, In : Pharmacogenomics Journal. 16, 1, p. 54-59 6 p.

Research output: Contribution to journalArticle

irinotecan
Neutropenia
Biomarkers
Neutrophils
Pharmacokinetics

Quantifying over-estimation in early stopped clinical trials and the "freezing effect" on subsequent research

Wang, H., Rosner, G. & Goodman, S. N., Dec 1 2016, In : Clinical Trials. 13, 6, p. 621-631 11 p.

Research output: Contribution to journalArticle

Freezing
Randomized Controlled Trials
Clinical Trials
Research
Hospital Distribution Systems

Therapeutic drug monitoring for either oral or intravenous busulfan when combined with pre-and post-transplantation cyclophosphamide

Lombardi, L. R., Kanakry, C. G., Zahurak, M., Durakovic, N., Bolanos Meade, F. J., Kasamon, Y. L., Gladstone, D., Matsui, W., Borrello, I. M., Huff, C. A., Swinnen, L., Brodsky, R. A., Ambinder, R. F., Fuchs, E. J., Rosner, G., Jones, R. J. & Luznik, L., Mar 3 2016, In : Leukemia and Lymphoma. 57, 3, p. 666-675 10 p.

Research output: Contribution to journalArticle

Busulfan
Drug Monitoring
Cyclophosphamide
Transplantation
Pharmacokinetics
2015
Adoptive Transfer
Multiple Myeloma
Immunity
Bone Marrow
Lymphocytes

A phase i study of muscadine grape skin extract in men with biochemically recurrent prostate cancer: Safety, tolerability, and dose determination

Paller, C., Rudek-Renaut, M., Zhou, X. C., Wagner, W. D., Hudson, T. S., Anders, N., Hammers, H. J., Dowling, D., King, S., Antonarakis, E., Drake, C. G., Eisenberger, M., Denmeade, S. R., Rosner, G. & Carducci, M. A., Oct 1 2015, In : Prostate. 75, 14, p. 1518-1525 8 p.

Research output: Contribution to journalArticle

Vitis
Prostatic Neoplasms
Safety
Skin
Eructation

Comment

Ivanova, A., Anderson, K. M., Rosner, G. & Rubin, E., Oct 2 2015, In : Statistics in Biopharmaceutical Research. 7, 4, p. 357-358 2 p.

Research output: Contribution to journalArticle

Non-proportional Hazards
Phase I Trial
Fungi
Interpretability
Progression

Impact of the 2010 Consensus Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee

Seymour, L., Groshen, S., Rosner, G., Sullivan, D. M., Spriggs, D. R., Reeves, S., Gravell, A., Ivy, S. P. & Ratain, M. J., Nov 15 2015, In : Clinical Cancer Research. 21, 22, p. 5057-5063 7 p.

Research output: Contribution to journalArticle

Pharmacy and Therapeutics Committee
Investigational Drugs
Advisory Committees
Clinical Trials
Benchmarking
Cyclophosphamide
Transplantation
Bone Marrow
Graft vs Host Disease
Disease-Free Survival

Patients and physicians can discuss costs of cancer treatment in the clinic

Kelly, R. J., Forde, P., Elnahal, S. M., Forastiere, A. A., Rosner, G. & Smith, T. J., Jul 1 2015, In : Journal of Oncology Practice. 11, 4, p. 308-312 5 p.

Research output: Contribution to journalArticle

Health Care Costs
Physicians
Costs and Cost Analysis
Neoplasms
Emotions
alvocidib
Mitoxantrone
Daunorubicin
Cytarabine
Acute Myeloid Leukemia

Risk-stratified outcomes of nonmyeloablative HLA-haploidentical BMT with high-dose posttransplantation cyclophosphamide

McCurdy, S. R., Kanakry, J. A., Showel, M., Tsai, H. L., Bolanos Meade, F. J., Rosner, G., Kanakry, C. G., Perica, K., Symons, H., Brodsky, R. A., Gladstone, D., Huff, C. A., Pratz, K., Prince, G. T., Dezern, A., Gojo, I., Matsui, W. H., Borrello, I. M., McDevitt, M. A., Swinnen, L. & 7 others, Smith, B. D., Levis, M. J., Ambinder, R. F., Luznik, L., Jones, R. J., Fuchs, E. J. & Kasamon, Y. L., May 7 2015, In : Blood. 125, 19, p. 3024-3031 8 p.

Research output: Contribution to journalArticle

Cyclophosphamide
Blood
Transplantation
Bone Marrow
Disease-Free Survival
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Protein-Tyrosine Kinases
Bone Marrow
Tissue Donors
Lymphocytes
2014

Advances in Statistical Approaches to Oncology Drug Development

Ivanova, A., Rosner, G., Marchenko, O., Parke, T., Perevozskaya, I. & Wang, Y., Jan 2014, In : Therapeutic Innovation and Regulatory Science. 48, 1, p. 81-89 9 p.

Research output: Contribution to journalArticle

Pharmaceutical Preparations
Decision Making
Industry
Costs and Cost Analysis

Bayesian inference for longitudinal data with non-parametric treatment effects

Müller, P., Quintana, F. A., Rosner, G. & Maitland, M. L., Apr 2014, In : Biostatistics. 15, 2, p. 341-352 12 p.

Research output: Contribution to journalArticle

Treatment Effects
Longitudinal Data
Bayesian inference
Bayesian Nonparametrics
Regression

Design of phase I combination trials: Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee

Paller, C., Bradbury, P. A., Ivy, S. P., Seymour, L., LoRusso, P. M., Baker, L., Rubinstein, L., Huang, E., Collyar, D., Groshen, S., Reeves, S., Ellis, L. M., Sargent, D. J., Rosner, G., LeBlanc, M. L. & Ratain, M. J., Aug 15 2014, In : Clinical Cancer Research. 20, 16, p. 4210-4217 8 p.

Research output: Contribution to journalArticle

Pharmacy and Therapeutics Committee
Investigational Drugs
Advisory Committees
Clinical Trials
Pharmacokinetics

Inference of long term effects and overdiagnosis in periodic cancer screening

Wu, D., Kafadar, K. & Rosner, G., Apr 1 2014, In : Statistica Sinica. 24, 2, p. 815-831 17 p.

Research output: Contribution to journalArticle

Screening
Cancer
Term
Credible Interval
Mutually exclusive
Graft vs Host Disease
Grafts
Cyclophosphamide
Transplantation
Bone Marrow
Prostatic Neoplasms
Placebos
Randomized Controlled Trials
Therapeutics
Research Personnel