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154 results on '"Mulkey, Flora A."'

2. Pharmacogenetic and clinical risk factors for bevacizumab-related gastrointestinal hemorrhage in prostate cancer patients treated on CALGB 90401 (Alliance)

Author

Patel, Jai N., Jiang, Chen, Owzar, Kouros, Hertz, Daniel L., Wang, Janey, Mulkey, Flora A., Kelly, William K., Halabi, Susan, Furukawa, Yoichi, Lassiter, Cameron, Dorsey, Susan G., Friedman, Paula N., Small, Eric J., Carducci, Michael A., Kelley, Michael J., Nakamura, Yusuke, Kubo, Michiaki, Ratain, Mark J., Morris, Michael J., and McLeod, Howard L.

Published
2024
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3. Genomewide Meta‐Analysis Validates a Role for S1PR1 in Microtubule Targeting Agent‐Induced Sensory Peripheral Neuropathy

Author

Chua, Katherina C, Xiong, Chenling, Ho, Carol, Mushiroda, Taisei, Jiang, Chen, Mulkey, Flora, Lai, Dongbing, Schneider, Bryan P, Rashkin, Sara R, Witte, John S, Friedman, Paula N, Ratain, Mark J, McLeod, Howard L, Rugo, Hope S, Shulman, Lawrence N, Kubo, Michiaki, Owzar, Kouros, and Kroetz, Deanna L

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Prevention, Human Genome, Peripheral Neuropathy, Cancer, Neurodegenerative, Neurosciences, Genetics, 2.1 Biological and endogenous factors, Aetiology, Good Health and Well Being, Adult, Aged, Cells, Cultured, Female, Genome-Wide Association Study, Humans, Male, Middle Aged, Neurites, Paclitaxel, Peripheral Nervous System Diseases, Pharmacogenetics, Pharmacogenomic Variants, Polymorphism, Single Nucleotide, Randomized Controlled Trials as Topic, Risk Assessment, Risk Factors, Sphingosine-1-Phosphate Receptors, Tubulin Modulators, Young Adult, Pharmacology and Pharmaceutical Sciences, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

Microtubule targeting agents (MTAs) are anticancer therapies commonly prescribed for breast cancer and other solid tumors. Sensory peripheral neuropathy (PN) is the major dose-limiting toxicity for MTAs and can limit clinical efficacy. The current pharmacogenomic study aimed to identify genetic variations that explain patient susceptibility and drive mechanisms underlying development of MTA-induced PN. A meta-analysis of genomewide association studies (GWAS) from two clinical cohorts treated with MTAs (Cancer and Leukemia Group B (CALGB) 40502 and CALGB 40101) was conducted using a Cox regression model with cumulative dose to first instance of grade 2 or higher PN. Summary statistics from a GWAS of European subjects (n = 469) in CALGB 40502 that estimated cause-specific risk of PN were meta-analyzed with those from a previously published GWAS of European ancestry (n = 855) from CALGB 40101 that estimated the risk of PN. Novel single nucleotide polymorphisms in an enhancer region downstream of sphingosine-1-phosphate receptor 1 (S1PR1 encoding S1PR1 ; e.g., rs74497159, βCALGB 40101 per allele log hazard ratio (95% confidence interval (CI)) = 0.591 (0.254-0.928), βCALGB 40502 per allele log hazard ratio (95% CI) = 0.693 (0.334-1.053); PMETA  = 3.62 × 10-7 ) were the most highly ranked associations based on P values with risk of developing grade 2 and higher PN. In silico functional analysis identified multiple regulatory elements and potential enhancer activity for S1PR1 within this genomic region. Inhibition of S1PR1 function in induced pluripotent stem cell-derived human sensory neurons shows partial protection against paclitaxel-induced neurite damage. These pharmacogenetic findings further support ongoing clinical evaluations to target S1PR1 as a therapeutic strategy for prevention and/or treatment of MTA-induced neuropathy.

Published
2020

4. A Pharmacogenetic Prediction Model of Progression‐Free Survival in Breast Cancer using Genome‐Wide Genotyping Data from CALGB 40502 (Alliance)

Author

Rashkin, Sara R, Chua, Katherina C, Ho, Carol, Mulkey, Flora, Jiang, Chen, Mushiroda, Tasei, Kubo, Michiaki, Friedman, Paula N, Rugo, Hope S, McLeod, Howard L, Ratain, Mark J, Castillos, Francisco, Naughton, Michael, Overmoyer, Beth, Toppmeyer, Deborah, Witte, John S, Owzar, Kouros, and Kroetz, Deanna L

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Breast Cancer, Genetics, Human Genome, Cancer, Adult, Aged, Aged, 80 and over, Breast Neoplasms, Female, Follow-Up Studies, Genome-Wide Association Study, Genotype, Humans, Middle Aged, Pharmacogenetics, Pharmacogenomic Testing, Predictive Value of Tests, Progression-Free Survival, Young Adult, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

Genome-wide genotyping data are increasingly available for pharmacogenetic association studies, but application of these data for development of prediction models is limited. Prediction methods, such as elastic net regularization, have recently been applied to genetic studies but only limitedly to pharmacogenetic outcomes. An elastic net was applied to a pharmacogenetic study of progression-free survival (PFS) of 468 patients with advanced breast cancer in a clinical trial of paclitaxel, nab-paclitaxel, and ixabepilone. A final model included 13 single nucleotide polymorphisms (SNPs) in addition to clinical covariates (prior taxane status, hormone receptor status, disease-free interval, and presence of visceral metastases) with an area under the curve (AUC) integrated over time of 0.81, an increase compared to an AUC of 0.64 for a model with clinical covariates alone. This model may be of value in predicting PFS with microtubule targeting agents and may inform reverse translational studies to understand differential response to these drugs.

Published
2019

5. Bevacizumab-induced hypertension and proteinuria: a genome-wide study of more than 1000 patients

Author

Quintanilha, Julia C. F., Wang, Jin, Sibley, Alexander B., Jiang, Chen, Etheridge, Amy S., Shen, Fei, Jiang, Guanglong, Mulkey, Flora, Patel, Jai N., Hertz, Daniel L., Dees, Elizabeth Claire, McLeod, Howard L., Bertagnolli, Monica, Rugo, Hope, Kindler, Hedy L., Kelly, William Kevin, Ratain, Mark J., Kroetz, Deanna L., Owzar, Kouros, Schneider, Bryan P., Lin, Danyu, and Innocenti, Federico

Published
2022
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6. Identification of a Genomic Region between SLC29A1 and HSP90AB1 Associated with Risk of Bevacizumab-Induced Hypertension: CALGB 80405 (Alliance)

Author

Li, Megan, Mulkey, Flora, Jiang, Chen, O’Neil, Bert H, Schneider, Bryan P, Shen, Fei, Friedman, Paula N, Momozawa, Yukihide, Kubo, Michiaki, Niedzwiecki, Donna, Hochster, Howard S, Lenz, Heinz-Josef, Atkins, James N, Rugo, Hope S, Halabi, Susan, Kelly, William Kevin, McLeod, Howard L, Innocenti, Federico, Ratain, Mark J, Venook, Alan P, Owzar, Kouros, and Kroetz, Deanna L

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Human Genome, Genetics, Cancer, Cardiovascular, Clinical Research, Patient Safety, Biotechnology, Hypertension, Aetiology, 2.1 Biological and endogenous factors, Adult, Aged, Aged, 80 and over, Angiogenesis Inhibitors, Bevacizumab, Clinical Trials as Topic, Equilibrative Nucleoside Transporter 1, Female, Genetic Predisposition to Disease, Genome-Wide Association Study, HSP90 Heat-Shock Proteins, Human Umbilical Vein Endothelial Cells, Humans, Male, Middle Aged, Neoplasms, Neovascularization, Pathologic, Vascular Endothelial Growth Factor A, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

Purpose: Bevacizumab is a VEGF-specific angiogenesis inhibitor indicated as an adjunct to chemotherapy for the treatment of multiple cancers. Hypertension is commonly observed during bevacizumab treatment, and high-grade toxicity can limit therapy or lead to cardiovascular complications. The factors that contribute to interindividual variability in blood pressure rise during bevacizumab treatment are not well understood.Experimental Design: To identify genomic regions associated with bevacizumab-induced hypertension risk, sequencing of candidate genes and flanking regulatory regions was performed on 61 patients treated with bevacizumab (19 cases developed early-onset grade 3 hypertension and 42 controls had no reported hypertension in the first six cycles of treatment). SNP-based tests for common variant associations and gene-based tests for rare variant associations were performed in 174 candidate genes.Results: Four common variants in independent linkage disequilibrium blocks between SLC29A1 and HSP90AB1 were among the top associations. Validation in larger bevacizumab-treated cohorts supported association between rs9381299 with early grade 3+ hypertension (P = 0.01; OR, 2.4) and systolic blood pressure >180 mm Hg (P = 0.02; OR, 2.1). rs834576 was associated with early grade 3+ hypertension in CALGB 40502 (P = 0.03; OR, 2.9). These SNP regions are enriched for regulatory elements that may potentially increase gene expression. In vitro overexpression of SLC29A1 in human endothelial cells disrupted adenosine signaling and reduced nitric oxide levels that were further lowered upon bevacizumab exposure.Conclusions: The genomic region between SLC29A1 and HSP90AB1 and its role in regulating adenosine signaling are key targets for further investigation into the pathogenesis of bevacizumab-induced hypertension. Clin Cancer Res; 24(19); 4734-44. ©2018 AACR.

Published
2018

7. Clinical impact of ABL1 kinase domain mutations and IKZF1 deletion in adults under age 60 with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL): molecular analysis of CALGB (Alliance) 10001 and 9665

Author

DeBoer, Rebecca, Koval, Gregory, Mulkey, Flora, Wetzler, Meir, Devine, Steven, Marcucci, Guido, Stone, Richard M, Larson, Richard A, Bloomfield, Clara D, Geyer, Susan, Mullighan, Charles G, and Stock, Wendy

Subjects
Clinical Research, Rare Diseases, Pediatric Cancer, Human Genome, Childhood Leukemia, Hematology, Pediatric, Genetics, Cancer, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, Adult, Biomarkers, Tumor, DNA Mutational Analysis, Female, Fusion Proteins, bcr-abl, Gene Deletion, Humans, Ikaros Transcription Factor, Leukocyte Count, Male, Middle Aged, Mutation, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Prognosis, Protein Interaction Domains and Motifs, Proto-Oncogene Proteins c-abl, Survival Analysis, Young Adult, Drug resistance, lymphoid leukemia, prognostication, transcription factor changes, Clinical Sciences, Immunology
Abstract

Recent studies have identified oncogenic lesions in Philadelphia chromosome-positive (Ph+)  acute lymphoblastic leukemia (ALL) and ABL1 kinase mutations that confer resistance to tyrosine kinase inhibitors. We sought to determine the prevalence and clinical impact of these lesions in patients on CALGB 10001, a previously reported Phase II study of imatinib, chemotherapy, and hematopoietic cell transplant in adult Ph + ALL. Of the 58 enrolled, 22 relapsed. By direct sequencing, an ABL1 kinase mutation known to induce imatinib resistance was present at relapse in 13 of 20. Using quantitative PCR assays, the mutations were detectable at diagnosis or early during treatment in most (62%) relapsed patients. Aberrations in IKZF1, CDKN2A/B, and PAX5 were assessed in 28 samples using SNP arrays and genomic DNA sequencing. Of these, 22 (79%) had IKZF1 deletion. The combination of IKZF1 deletion and p210 BCR-ABL1 (p

Published
2016

8. Pharmacogenetic Discovery in CALGB (Alliance) 90401 and Mechanistic Validation of a VAC14 Polymorphism that Increases Risk of Docetaxel-Induced Neuropathy

Author

Hertz, Daniel L, Owzar, Kouros, Lessans, Sherrie, Wing, Claudia, Jiang, Chen, Kelly, William Kevin, Patel, Jai, Halabi, Susan, Furukawa, Yoichi, Wheeler, Heather E, Sibley, Alexander B, Lassiter, Cameron, Weisman, Lois, Watson, Dorothy, Krens, Stefanie D, Mulkey, Flora, Renn, Cynthia L, Small, Eric J, Febbo, Phillip G, Shterev, Ivo, Kroetz, Deanna L, Friedman, Paula N, Mahoney, John F, Carducci, Michael A, Kelley, Michael J, Nakamura, Yusuke, Kubo, Michiaki, Dorsey, Susan G, Dolan, M Eileen, Morris, Michael J, Ratain, Mark J, and McLeod, Howard L

Subjects
Genetics, Peripheral Neuropathy, Clinical Research, Neurosciences, Neurodegenerative, Chronic Pain, Cancer, Pain Research, Good Health and Well Being, Adult, Aged, Aged, 80 and over, Animals, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Docetaxel, Double-Blind Method, Genetic Predisposition to Disease, Genome-Wide Association Study, Genotype, Humans, Intracellular Signaling Peptides and Proteins, Male, Membrane Proteins, Mice, Mice, Inbred C57BL, Mice, Knockout, Middle Aged, Pharmacogenomic Testing, Polymorphism, Single Nucleotide, Polyneuropathies, Prednisone, Prostatic Neoplasms, Castration-Resistant, Taxoids, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeDiscovery of SNPs that predict a patient's risk of docetaxel-induced neuropathy would enable treatment individualization to maximize efficacy and avoid unnecessary toxicity. The objectives of this analysis were to discover SNPs associated with docetaxel-induced neuropathy and mechanistically validate these associations in preclinical models of drug-induced neuropathy.Experimental designA genome-wide association study was conducted in metastatic castrate-resistant prostate cancer patients treated with docetaxel, prednisone and randomized to bevacizumab or placebo on CALGB 90401. SNPs were genotyped on the Illumina HumanHap610-Quad platform followed by rigorous quality control. The inference was conducted on the cumulative dose at occurrence of grade 3+ sensory neuropathy using a cause-specific hazard model that accounted for early treatment discontinuation. Genes with SNPs significantly associated with neuropathy were knocked down in cellular and mouse models of drug-induced neuropathy.ResultsA total of 498,081 SNPs were analyzed in 623 Caucasian patients, 50 (8%) of whom experienced grade 3+ neuropathy. The 1,000 SNPs most associated with neuropathy clustered in relevant pathways including neuropathic pain and axonal guidance. An SNP in VAC14 (rs875858) surpassed genome-wide significance (P = 2.12 × 10-8, adjusted P = 5.88 × 10-7). siRNA knockdown of VAC14 in stem cell-derived peripheral neuronal cells increased docetaxel sensitivity as measured by decreased neurite processes (P = 0.0015) and branches (P < 0.0001). Prior to docetaxel treatment, VAC14 heterozygous mice had greater nociceptive sensitivity than wild-type litter mate controls (P = 0.001).ConclusionsVAC14 should be prioritized for further validation of its potential role as a predictor of docetaxel-induced neuropathy and biomarker for treatment individualization. Clin Cancer Res; 22(19); 4890-900. ©2016 AACR.

Published
2016

9. Pharmacogenetic study in gastric cancer patients treated with adjuvant fluorouracil/leucovorin or epirubicin/cisplatin/fluorouracil before and after chemoradiation on CALGB 80101 (Alliance)

Author

Patel, Jai N., Jiang, Chen, Owzar, Kouros, Mulkey, Flora, Luzum, Jasmine A., Mamon, Harvey J., Haller, Daniel G., Dragovich, Tomislav, Alberts, Steven R., Bjarnason, Georg, Willet, Christopher G., Niedzwiecki, Donna, Enzinger, Peter, Ratain, Mark J., Fuchs, Charles, and McLeod, Howard L.

Published
2021
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10. Correction: Bevacizumab-induced hypertension and proteinuria: a genome-wide study of more than 1000 patients

Author

Quintanilha, Julia C. F., Wang, Jin, Sibley, Alexander B., Jiang, Chen, Etheridge, Amy S., Shen, Fei, Jiang, Guanglong, Mulkey, Flora, Patel, Jai N., Hertz, Daniel L., Dees, Elizabeth Claire, McLeod, Howard L., Bertagnolli, Monica, Rugo, Hope, Kindler, Hedy L., Kelly, William Kevin, Ratain, Mark J., Kroetz, Deanna L., Owzar, Kouros, Schneider, Bryan P., Lin, Danyu, and Innocenti, Federico

Published
2022
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14. Supplementary Table from Plasma Protein Biomarkers in Advanced or Metastatic Colorectal Cancer Patients Receiving Chemotherapy With Bevacizumab or Cetuximab: Results from CALGB 80405 (Alliance)

Author

Nixon, Andrew B., primary, Sibley, Alexander B., primary, Liu, Yingmiao, primary, Hatch, Ace J., primary, Jiang, Chen, primary, Mulkey, Flora, primary, Starr, Mark D., primary, Brady, John C., primary, Niedzwiecki, Donna, primary, Venook, Alan P., primary, Baez-Diaz, Luis, primary, Lenz, Heinz-Josef, primary, O'Neil, Bert H., primary, Innocenti, Federico, primary, Meyerhardt, Jeffrey A., primary, O'Reilly, Eileen M., primary, Owzar, Kouros, primary, and Hurwitz, Herbert I., primary

Published
2023
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15. Supplementary Table 2 from Pharmacogenetic Discovery in CALGB (Alliance) 90401 and Mechanistic Validation of a VAC14 Polymorphism that Increases Risk of Docetaxel-Induced Neuropathy

Author

Hertz, Daniel L., primary, Owzar, Kouros, primary, Lessans, Sherrie, primary, Wing, Claudia, primary, Jiang, Chen, primary, Kelly, William Kevin, primary, Patel, Jai, primary, Halabi, Susan, primary, Furukawa, Yoichi, primary, Wheeler, Heather E., primary, Sibley, Alexander B., primary, Lassiter, Cameron, primary, Weisman, Lois, primary, Watson, Dorothy, primary, Krens, Stefanie D., primary, Mulkey, Flora, primary, Renn, Cynthia L., primary, Small, Eric J., primary, Febbo, Phillip G., primary, Shterev, Ivo, primary, Kroetz, Deanna L., primary, Friedman, Paula N., primary, Mahoney, John F., primary, Carducci, Michael A., primary, Kelley, Michael J., primary, Nakamura, Yusuke, primary, Kubo, Michiaki, primary, Dorsey, Susan G., primary, Dolan, M. Eileen, primary, Morris, Michael J., primary, Ratain, Mark J., primary, and McLeod, Howard L., primary

Published
2023
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16. Data from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

Author

Singh, Sonia, primary, Jaigirdar, Adnan A., primary, Mulkey, Flora, primary, Cheng, Joyce, primary, Hamed, Salaheldin S., primary, Li, Yangbing, primary, Liu, Jiang, primary, Zhao, Hong, primary, Goheer, Anwar, primary, Helms, Whitney S., primary, Wang, Xing, primary, Agarwal, Rajiv, primary, Pragani, Rajan, primary, Korsah, Kwadwo, primary, Tang, Shenghui, primary, Leighton, John, primary, Rahman, Atiqur, primary, Beaver, Julia A., primary, Pazdur, Richard, primary, Theoret, Marc R., primary, and Singh, Harpreet, primary

Published
2023
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17. Supplementary Tables S1 and S2 from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

Author

Singh, Sonia, primary, Jaigirdar, Adnan A., primary, Mulkey, Flora, primary, Cheng, Joyce, primary, Hamed, Salaheldin S., primary, Li, Yangbing, primary, Liu, Jiang, primary, Zhao, Hong, primary, Goheer, Anwar, primary, Helms, Whitney S., primary, Wang, Xing, primary, Agarwal, Rajiv, primary, Pragani, Rajan, primary, Korsah, Kwadwo, primary, Tang, Shenghui, primary, Leighton, John, primary, Rahman, Atiqur, primary, Beaver, Julia A., primary, Pazdur, Richard, primary, Theoret, Marc R., primary, and Singh, Harpreet, primary

Published
2023
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18. Supplementary Figure from Plasma Protein Biomarkers in Advanced or Metastatic Colorectal Cancer Patients Receiving Chemotherapy With Bevacizumab or Cetuximab: Results from CALGB 80405 (Alliance)

Author

Nixon, Andrew B., primary, Sibley, Alexander B., primary, Liu, Yingmiao, primary, Hatch, Ace J., primary, Jiang, Chen, primary, Mulkey, Flora, primary, Starr, Mark D., primary, Brady, John C., primary, Niedzwiecki, Donna, primary, Venook, Alan P., primary, Baez-Diaz, Luis, primary, Lenz, Heinz-Josef, primary, O'Neil, Bert H., primary, Innocenti, Federico, primary, Meyerhardt, Jeffrey A., primary, O'Reilly, Eileen M., primary, Owzar, Kouros, primary, and Hurwitz, Herbert I., primary

Published
2023
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19. Supplementary Figure 1 from Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Author

Norsworthy, Kelly J., primary, Mulkey, Flora, primary, Scott, Emma C., primary, Ward, Ashley F., primary, Przepiorka, Donna, primary, Charlab, Rosane, primary, Dorff, Sarah E., primary, Deisseroth, Albert, primary, Kazandjian, Dickran, primary, Sridhara, Rajeshwari, primary, Beaver, Julia A., primary, Farrell, Ann T., primary, de Claro, R. Angelo, primary, and Pazdur, Richard, primary

Published
2023
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20. Supplemental Data from Identification of a Genomic Region between SLC29A1 and HSP90AB1 Associated with Risk of Bevacizumab-Induced Hypertension: CALGB 80405 (Alliance)

Author

Li, Megan, primary, Mulkey, Flora, primary, Jiang, Chen, primary, O’Neil, Bert H., primary, Schneider, Bryan P., primary, Shen, Fei, primary, Friedman, Paula N., primary, Momozawa, Yukihide, primary, Kubo, Michiaki, primary, Niedzwiecki, Donna, primary, Hochster, Howard S., primary, Lenz, Heinz-Josef, primary, Atkins, James N., primary, Rugo, Hope S., primary, Halabi, Susan, primary, Kelly, William Kevin, primary, McLeod, Howard L., primary, Innocenti, Federico, primary, Ratain, Mark J., primary, Venook, Alan P., primary, Owzar, Kouros, primary, and Kroetz, Deanna L., primary

Published
2023
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21. Supplementary Figure 3: VAC14 Heterozygous Mice are Sensitive to Nociceptive Stimuli from Pharmacogenetic Discovery in CALGB (Alliance) 90401 and Mechanistic Validation of a VAC14 Polymorphism that Increases Risk of Docetaxel-Induced Neuropathy

Author

Hertz, Daniel L., primary, Owzar, Kouros, primary, Lessans, Sherrie, primary, Wing, Claudia, primary, Jiang, Chen, primary, Kelly, William Kevin, primary, Patel, Jai, primary, Halabi, Susan, primary, Furukawa, Yoichi, primary, Wheeler, Heather E., primary, Sibley, Alexander B., primary, Lassiter, Cameron, primary, Weisman, Lois, primary, Watson, Dorothy, primary, Krens, Stefanie D., primary, Mulkey, Flora, primary, Renn, Cynthia L., primary, Small, Eric J., primary, Febbo, Phillip G., primary, Shterev, Ivo, primary, Kroetz, Deanna L., primary, Friedman, Paula N., primary, Mahoney, John F., primary, Carducci, Michael A., primary, Kelley, Michael J., primary, Nakamura, Yusuke, primary, Kubo, Michiaki, primary, Dorsey, Susan G., primary, Dolan, M. Eileen, primary, Morris, Michael J., primary, Ratain, Mark J., primary, and McLeod, Howard L., primary

Published
2023
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22. Supplementary Tables from Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Author

Norsworthy, Kelly J., primary, Mulkey, Flora, primary, Scott, Emma C., primary, Ward, Ashley F., primary, Przepiorka, Donna, primary, Charlab, Rosane, primary, Dorff, Sarah E., primary, Deisseroth, Albert, primary, Kazandjian, Dickran, primary, Sridhara, Rajeshwari, primary, Beaver, Julia A., primary, Farrell, Ann T., primary, de Claro, R. Angelo, primary, and Pazdur, Richard, primary

Published
2023
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23. Supplementary Figure 2: VAC14 Knockdown and neuronal cell sensitivity to docetaxel or paclitaxel for additional morphological phenotypes from Pharmacogenetic Discovery in CALGB (Alliance) 90401 and Mechanistic Validation of a VAC14 Polymorphism that Increases Risk of Docetaxel-Induced Neuropathy

Author

Hertz, Daniel L., primary, Owzar, Kouros, primary, Lessans, Sherrie, primary, Wing, Claudia, primary, Jiang, Chen, primary, Kelly, William Kevin, primary, Patel, Jai, primary, Halabi, Susan, primary, Furukawa, Yoichi, primary, Wheeler, Heather E., primary, Sibley, Alexander B., primary, Lassiter, Cameron, primary, Weisman, Lois, primary, Watson, Dorothy, primary, Krens, Stefanie D., primary, Mulkey, Flora, primary, Renn, Cynthia L., primary, Small, Eric J., primary, Febbo, Phillip G., primary, Shterev, Ivo, primary, Kroetz, Deanna L., primary, Friedman, Paula N., primary, Mahoney, John F., primary, Carducci, Michael A., primary, Kelley, Michael J., primary, Nakamura, Yusuke, primary, Kubo, Michiaki, primary, Dorsey, Susan G., primary, Dolan, M. Eileen, primary, Morris, Michael J., primary, Ratain, Mark J., primary, and McLeod, Howard L., primary

Published
2023
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24. Supplementary Table 3 from Pharmacogenetic Discovery in CALGB (Alliance) 90401 and Mechanistic Validation of a VAC14 Polymorphism that Increases Risk of Docetaxel-Induced Neuropathy

Author

Hertz, Daniel L., primary, Owzar, Kouros, primary, Lessans, Sherrie, primary, Wing, Claudia, primary, Jiang, Chen, primary, Kelly, William Kevin, primary, Patel, Jai, primary, Halabi, Susan, primary, Furukawa, Yoichi, primary, Wheeler, Heather E., primary, Sibley, Alexander B., primary, Lassiter, Cameron, primary, Weisman, Lois, primary, Watson, Dorothy, primary, Krens, Stefanie D., primary, Mulkey, Flora, primary, Renn, Cynthia L., primary, Small, Eric J., primary, Febbo, Phillip G., primary, Shterev, Ivo, primary, Kroetz, Deanna L., primary, Friedman, Paula N., primary, Mahoney, John F., primary, Carducci, Michael A., primary, Kelley, Michael J., primary, Nakamura, Yusuke, primary, Kubo, Michiaki, primary, Dorsey, Susan G., primary, Dolan, M. Eileen, primary, Morris, Michael J., primary, Ratain, Mark J., primary, and McLeod, Howard L., primary

Published
2023
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25. Supplementary Figure 2 from Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Author

Norsworthy, Kelly J., primary, Mulkey, Flora, primary, Scott, Emma C., primary, Ward, Ashley F., primary, Przepiorka, Donna, primary, Charlab, Rosane, primary, Dorff, Sarah E., primary, Deisseroth, Albert, primary, Kazandjian, Dickran, primary, Sridhara, Rajeshwari, primary, Beaver, Julia A., primary, Farrell, Ann T., primary, de Claro, R. Angelo, primary, and Pazdur, Richard, primary

Published
2023
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26. Supplementary Table 1 from Pharmacogenetic Discovery in CALGB (Alliance) 90401 and Mechanistic Validation of a VAC14 Polymorphism that Increases Risk of Docetaxel-Induced Neuropathy

Author

Hertz, Daniel L., primary, Owzar, Kouros, primary, Lessans, Sherrie, primary, Wing, Claudia, primary, Jiang, Chen, primary, Kelly, William Kevin, primary, Patel, Jai, primary, Halabi, Susan, primary, Furukawa, Yoichi, primary, Wheeler, Heather E., primary, Sibley, Alexander B., primary, Lassiter, Cameron, primary, Weisman, Lois, primary, Watson, Dorothy, primary, Krens, Stefanie D., primary, Mulkey, Flora, primary, Renn, Cynthia L., primary, Small, Eric J., primary, Febbo, Phillip G., primary, Shterev, Ivo, primary, Kroetz, Deanna L., primary, Friedman, Paula N., primary, Mahoney, John F., primary, Carducci, Michael A., primary, Kelley, Michael J., primary, Nakamura, Yusuke, primary, Kubo, Michiaki, primary, Dorsey, Susan G., primary, Dolan, M. Eileen, primary, Morris, Michael J., primary, Ratain, Mark J., primary, and McLeod, Howard L., primary

Published
2023
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27. Data from Plasma Protein Biomarkers in Advanced or Metastatic Colorectal Cancer Patients Receiving Chemotherapy With Bevacizumab or Cetuximab: Results from CALGB 80405 (Alliance)

Author

Nixon, Andrew B., primary, Sibley, Alexander B., primary, Liu, Yingmiao, primary, Hatch, Ace J., primary, Jiang, Chen, primary, Mulkey, Flora, primary, Starr, Mark D., primary, Brady, John C., primary, Niedzwiecki, Donna, primary, Venook, Alan P., primary, Baez-Diaz, Luis, primary, Lenz, Heinz-Josef, primary, O'Neil, Bert H., primary, Innocenti, Federico, primary, Meyerhardt, Jeffrey A., primary, O'Reilly, Eileen M., primary, Owzar, Kouros, primary, and Hurwitz, Herbert I., primary

Published
2023
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28. Supplementary Figure 3 from Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Author

Norsworthy, Kelly J., primary, Mulkey, Flora, primary, Scott, Emma C., primary, Ward, Ashley F., primary, Przepiorka, Donna, primary, Charlab, Rosane, primary, Dorff, Sarah E., primary, Deisseroth, Albert, primary, Kazandjian, Dickran, primary, Sridhara, Rajeshwari, primary, Beaver, Julia A., primary, Farrell, Ann T., primary, de Claro, R. Angelo, primary, and Pazdur, Richard, primary

Published
2023
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29. Supplementary Figure 1: Patient Disposition from Clinical Trial to Pharmacogenetic Analysis from Pharmacogenetic Discovery in CALGB (Alliance) 90401 and Mechanistic Validation of a VAC14 Polymorphism that Increases Risk of Docetaxel-Induced Neuropathy

Author

Hertz, Daniel L., primary, Owzar, Kouros, primary, Lessans, Sherrie, primary, Wing, Claudia, primary, Jiang, Chen, primary, Kelly, William Kevin, primary, Patel, Jai, primary, Halabi, Susan, primary, Furukawa, Yoichi, primary, Wheeler, Heather E., primary, Sibley, Alexander B., primary, Lassiter, Cameron, primary, Weisman, Lois, primary, Watson, Dorothy, primary, Krens, Stefanie D., primary, Mulkey, Flora, primary, Renn, Cynthia L., primary, Small, Eric J., primary, Febbo, Phillip G., primary, Shterev, Ivo, primary, Kroetz, Deanna L., primary, Friedman, Paula N., primary, Mahoney, John F., primary, Carducci, Michael A., primary, Kelley, Michael J., primary, Nakamura, Yusuke, primary, Kubo, Michiaki, primary, Dorsey, Susan G., primary, Dolan, M. Eileen, primary, Morris, Michael J., primary, Ratain, Mark J., primary, and McLeod, Howard L., primary

Published
2023
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31. FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer

Author

Royce, Melanie, primary, Osgood, Christy, additional, Mulkey, Flora, additional, Bloomquist, Erik, additional, Pierce, William F., additional, Roy, Arpita, additional, Kalavar, Shyam, additional, Ghosh, Soma, additional, Philip, Reena, additional, Rizvi, Fatima, additional, Mixter, Bronwyn D., additional, Tang, Shenghui, additional, Pazdur, Richard, additional, Beaver, Julia A., additional, and Amiri-Kordestani, Laleh, additional

Published
2022
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34. Study Methods, Recruitment, Sociodemographic Findings, and Demographic Representativeness in the OPPERA Study

Author

Slade, Gary D., Bair, Eric, By, Kunthel, Mulkey, Flora, Baraian, Cristina, Rothwell, Rebecca, Reynolds, Maria, Miller, Vanessa, Gonzalez, Yoly, Gordon, Sharon, Ribeiro-Dasilva, Margarete, Lim, Pei Feng, Greenspan, Joel D., Dubner, Ron, Fillingim, Roger B., Diatchenko, Luda, Maixner, William, Dampier, Dawn, Knott, Charles, and Ohrbach, Richard

Published
2011
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37. Plasma Protein Biomarkers in Advanced or Metastatic Colorectal Cancer Patients Receiving Chemotherapy With Bevacizumab or Cetuximab: Results from CALGB 80405 (Alliance)

Author

Nixon, Andrew B., primary, Sibley, Alexander B., additional, Liu, Yingmiao, additional, Hatch, Ace J., additional, Jiang, Chen, additional, Mulkey, Flora, additional, Starr, Mark D., additional, Brady, John C., additional, Niedzwiecki, Donna, additional, Venook, Alan P., additional, Baez-Diaz, Luis, additional, Lenz, Heinz-Josef, additional, O'Neil, Bert H., additional, Innocenti, Federico, additional, Meyerhardt, Jeffrey A., additional, O'Reilly, Eileen M., additional, Owzar, Kouros, additional, and Hurwitz, Herbert I., additional

Published
2021
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38. Correction: Bevacizumab-induced hypertension and proteinuria: a genome-wide study of more than 1000 patients

Author

Quintanilha, Julia C. F., primary, Wang, Jin, additional, Sibley, Alexander B., additional, Jiang, Chen, additional, Etheridge, Amy S., additional, Shen, Fei, additional, Jiang, Guanglong, additional, Mulkey, Flora, additional, Patel, Jai N., additional, Hertz, Daniel L., additional, Dees, Elizabeth Claire, additional, McLeod, Howard L., additional, Bertagnolli, Monica, additional, Rugo, Hope, additional, Kindler, Hedy L., additional, Kelly, William Kevin, additional, Ratain, Mark J., additional, Kroetz, Deanna L., additional, Owzar, Kouros, additional, Schneider, Bryan P., additional, Lin, Danyu, additional, and Innocenti, Federico, additional

Published
2021
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40. Bevacizumab-induced hypertension and proteinuria: a genome-wide study of more than 1000 patients

Author

Quintanilha, Julia C. F., primary, Wang, Jin, additional, Sibley, Alexander B., additional, Jiang, Chen, additional, Etheridge, Amy S., additional, Shen, Fei, additional, Jiang, Guanglong, additional, Mulkey, Flora, additional, Patel, Jai N., additional, Hertz, Daniel L., additional, Dees, Elizabeth Claire, additional, McLeod, Howard L., additional, Bertagnolli, Monica, additional, Rugo, Hope, additional, Kindler, Hedy L., additional, Kelly, William Kevin, additional, Ratain, Mark J., additional, Kroetz, Deanna L., additional, Owzar, Kouros, additional, Schneider, Bryan P., additional, Lin, Danyu, additional, and Innocenti, Federico, additional

Published
2021
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41. A phase I/ II study of ixazomib, pomalidomide, and dexamethasone for lenalidomide and proteasome inhibitor refractory multiple myeloma (Alliance A061202 )

Author

Voorhees, Peter M., primary, Suman, Vera J., additional, Tuchman, Sascha A., additional, Laubach, Jacob P., additional, Hassoun, Hani, additional, Efebera, Yvonne A., additional, Mulkey, Flora, additional, Bova‐Solem, Misty, additional, Santo, Katelyn, additional, Carlisle, Destin, additional, McCarthy, Philip L., additional, and Richardson, Paul G., additional

Published
2021
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43. Bevacizumab and the risk of arterial and venous thromboembolism in patients with metastatic, castration-resistant prostate cancer treated on Cancer and Leukemia Group B (CALGB) 90401 (Alliance)

Author

Patel, Jai N., Jiang, Chen, Hertz, Daniel L., Mulkey, Flora A., Owzar, Kouros, Halabi, Susan, Ratain, Mark J., Friedman, Paula N., Small, Eric J., Carducci, Michael A., Mahoney, John F., Kelley, Michael J., Morris, Michael J., Kelly, William K., and McLeod, Howard L.

Published
2015
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45. FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non–small Cell Lung Cancer, A Collaborative Project Orbis Review

Author

Vellanki, Paz J., primary, Mulkey, Flora, additional, Jaigirdar, Adnan A., additional, Rodriguez, Lisa, additional, Wang, Yibo, additional, Xu, Yuan, additional, Zhao, Hong, additional, Liu, Jiang, additional, Howe, Grant, additional, Wang, Jian, additional, Choo, Qiuyi, additional, Golding, Sarah J., additional, Mansell, Victoria, additional, Korsah, Kwadwo, additional, Spillman, Dianne, additional, de Claro, R. Angelo, additional, Pazdur, Richard, additional, Beaver, Julia A., additional, and Singh, Harpreet, additional

Published
2021
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46. FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

Author

Singh, Sonia, primary, Jaigirdar, Adnan A., additional, Mulkey, Flora, additional, Cheng, Joyce, additional, Hamed, Salaheldin S., additional, Li, Yangbing, additional, Liu, Jiang, additional, Zhao, Hong, additional, Goheer, Anwar, additional, Helms, Whitney S., additional, Wang, Xing, additional, Agarwal, Rajiv, additional, Pragani, Rajan, additional, Korsah, Kwadwo, additional, Tang, Shenghui, additional, Leighton, John, additional, Rahman, Atiqur, additional, Beaver, Julia A., additional, Pazdur, Richard, additional, Theoret, Marc R., additional, and Singh, Harpreet, additional

Published
2020
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47. Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Author

Norsworthy, Kelly J., primary, Mulkey, Flora, additional, Scott, Emma C., additional, Ward, Ashley F., additional, Przepiorka, Donna, additional, Charlab, Rosane, additional, Dorff, Sarah E., additional, Deisseroth, Albert, additional, Kazandjian, Dickran, additional, Sridhara, Rajeshwari, additional, Beaver, Julia A., additional, Farrell, Ann T., additional, de Claro, R. Angelo, additional, and Pazdur, Richard, additional

Published
2020
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48. Genome-Wide Meta-Analysis Validates a Role for S1PR1 in Microtubule Targeting Agent-Induced Sensory Peripheral Neuropathy

Author

Chua, Katherina C., primary, Xiong, Chenling, additional, Ho, Carol, additional, Mushiroda, Taisei, additional, Jiang, Chen, additional, Mulkey, Flora, additional, Lai, Dongbing, additional, Schneider, Bryan P., additional, Rashkin, Sara R., additional, Witte, John S., additional, Friedman, Paula N., additional, Ratain, Mark J., additional, McLeod, Howard L., additional, Rugo, Hope S., additional, Shulman, Lawrence N., additional, Kubo, Michiaki, additional, Owzar, Kouros, additional, and Kroetz, Deanna L., additional

Published
2020
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