Search Results - "Mulkey, Flora"

Evaluation of Overall Response Rate and Progression-Free Survival as Potential Surrogate Endpoints for Overall Survival in Immunotherapy Trials by Mushti, Sirisha L, Mulkey, Flora, Sridhara, Rajeshwari

“…With the approval of immunotherapies for a variety of indications, methods to assess treatment benefit addressing the response patterns observed are important…”
Get full text

FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer by Singh, Sonia, Jaigirdar, Adnan A, Mulkey, Flora, Cheng, Joyce, Hamed, Salaheldin S, Li, Yangbing, Liu, Jiang, Zhao, Hong, Goheer, Anwar, Helms, Whitney S, Wang, Xing, Agarwal, Rajiv, Pragani, Rajan, Korsah, Kwadwo, Tang, Shenghui, Leighton, John, Rahman, Atiqur, Beaver, Julia A, Pazdur, Richard, Theoret, Marc R, Singh, Harpreet

“…On June 15, 2020, the FDA granted accelerated approval to lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with…”
Get full text

Comparison of iRECIST versus RECIST V.1.1 in patients treated with an anti-PD-1 or PD-L1 antibody: pooled FDA analysis by Mulkey, Flora, Theoret, Marc R, Keegan, Patricia, Pazdur, Richard, Sridhara, Rajeshwari

“…BackgroundResponse criteria developed when cytotoxic chemotherapy was the predominant therapeutic modality to treat patients with cancer, do not capture the…”
Get full text

Clinical findings and pain symptoms as potential risk factors for chronic TMD: descriptive data and empirically identified domains from the OPPERA case-control study by Ohrbach, Richard, Fillingim, Roger B, Mulkey, Flora, Gonzalez, Yoly, Gordon, Sharon, Gremillion, Henry, Lim, Pei-Feng, Ribeiro-Dasilva, Margarete, Greenspan, Joel D, Knott, Charles, Maixner, William, Slade, Gary

“…Clinical characteristics might be associated with temporomandibular disorders (TMD) because they are antecedent risk factors that increase the likelihood of a…”
Get more information

Pain sensitivity risk factors for chronic TMD: descriptive data and empirically identified domains from the OPPERA case control study by Greenspan, Joel D, Slade, Gary D, Bair, Eric, Dubner, Ronald, Fillingim, Roger B, Ohrbach, Richard, Knott, Charlie, Mulkey, Flora, Rothwell, Rebecca, Maixner, William

“…Many studies report that people with temporomandibular disorders (TMD) are more sensitive to experimental pain stimuli than TMD-free controls. Such differences…”
Get more information

Bevacizumab-induced hypertension and proteinuria: a genome-wide study of more than 1000 patients by 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, Innocenti, Federico

“…Background Hypertension and proteinuria are common bevacizumab-induced toxicities. No validated biomarkers are available for identifying patients at risk of…”
Get full text

Autologous transplantation for Philadelphia chromosome-positive acute lymphoblastic leukemia achieves outcomes similar to allogeneic transplantation: results of CALGB Study 10001 (Alliance) by Wetzler, Meir, Watson, Dorothy, Stock, Wendy, Koval, Gregory, Mulkey, Flora A, Hoke, Eva E, McCarty, John M, Blum, William G, Powell, Bayard L, Marcucci, Guido, Bloomfield, Clara D, Linker, Charles A, Larson, Richard A

“…Allogeneic stem cell transplantation is the standard approach to Philadelphia chromosome positive acute lymphoblastic leukemia. We hypothesized that imatinib…”
Get full text

Pharmacogenetic and clinical risk factors for bevacizumab-related gastrointestinal hemorrhage in prostate cancer patients treated on CALGB 90401 (Alliance) by 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., McLeod, Howard L.

“…The objective of this study was to discover clinical and pharmacogenetic factors associated with bevacizumab-related gastrointestinal hemorrhage in Cancer and…”
Get full text

Study methods, recruitment, sociodemographic findings, and demographic representativeness in the OPPERA study by 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, Ohrbach, Richard

“…This paper describes methods used in the project "Orofacial Pain Prospective Evaluation and Risk Assessment" (OPPERA) and evaluates sociodemographic…”
Get more information

Potential autonomic risk factors for chronic TMD: descriptive data and empirically identified domains from the OPPERA case-control study by Maixner, William, Greenspan, Joel D, Dubner, Ronald, Bair, Eric, Mulkey, Flora, Miller, Vanessa, Knott, Charles, Slade, Gary D, Ohrbach, Richard, Diatchenko, Luda, Fillingim, Roger B

“…Several case-control studies have been conducted that examine the association between autonomic variables and persistent pain conditions; however, there is a…”
Get more information

Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy by Mushti, Sirisha L., Mulkey, Flora, Tang, Shenghui, Singh, Harpreet, Lemery, Steven J., Goldberg, Kirsten B., Sridhara, Rajeshwari, Keegan, Patricia, Kluetz, Paul G., Pazdur, Richard, Theoret, Marc R., Beaver, Julia A.

“…Purpose of Review This review provides a comprehensive assessment of recent literature reports describing atypical response patterns observed with immune…”
Get full text

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) by 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., McLeod, Howard L.

“…BACKGROUND Bevacizumab is associated with an increased risk of arterial thromboembolism (ATE); however, its effect on venous thromboembolism (VTE) remains…”
Get full text

FDA analysis of pembrolizumab trials in multiple myeloma: Immune related adverse events (irAEs) and response by Krauss, Aviva C, Mulkey, Flora, Shen, Yuan-Li, Rosenberg, Amy, Miller, Barry, Carioti, Theresa, Scott, Kimberly, Gormley, Nicole, Theoret, Marc Robert, Sridhara, Rajeshwari, Farrell, Ann T., Pazdur, Richard

“…Abstract only…”
Get full text

The vitamin D receptor gene as a determinant of survival in pancreatic cancer patients: Genomic analysis and experimental validation by Innocenti, Federico, Owzar, Kouros, Jiang, Chen, Etheridge, Amy S, Gordân, Raluca, Sibley, Alexander B, Mulkey, Flora, Niedzwiecki, Donna, Glubb, Dylan, Neel, Nicole, Talamonti, Mark S, Bentrem, David J, Seiser, Eric, Yeh, Jen Jen, Van Loon, Katherine, McLeod, Howard, Ratain, Mark J, Kindler, Hedy L, Venook, Alan P, Nakamura, Yusuke, Kubo, Michiaki, Petersen, Gloria M, Bamlet, William R, McWilliams, Robert R

“…Advanced pancreatic cancer is a highly refractory disease almost always associated with survival of little more than a year. New interventions based on novel…”
Get full text

Abstract 2037: A discovery study to identify clinical and genetic risk factors for bevacizumab (BEV)-related gastrointestinal (GI) hemorrhage (HEM) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) treated on CALGB 90401 (Alliance) by Patel, Jai N., Jiang, Chen, Owzar, Kouros, Hertz, Daniel L., Mulkey, Flora A., Kelly, William K., Halabi, Susan, Furukawa, Yoichi, Lassiter, Cameron, Dorsey, Susan G., Friedman, Paula N., Small, Eric J., Carducci, Michael A., Mahoney, John F., Kelley, Michael J., Nakamura, Yusuke, Kubo, Michiaki, Ratain, Mark J., Morris, Michael J., McLeod, Howard L.

“…Abstract Background: Treatment-related GI HEM is a major health concern with few known predictive risk factors. The objective of this analysis was to discover…”
Get full text

US Food and Drug Administration Expanded Adjuvant Indication of Abemaciclib in High-Risk Early Breast Cancer by Royce, Melanie, Mulkey, Flora, Osgood, Christy, Bloomquist, Erik, Amiri-Kordestani, Laleh

Get full text

FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer by Royce, Melanie, Osgood, Christy, Mulkey, Flora, Bloomquist, Erik, Pierce, William F, Roy, Arpita, Kalavar, Shyam, Ghosh, Soma, Philip, Reena, Rizvi, Fatima, Mixter, Bronwyn D, Tang, Shenghui, Pazdur, Richard, Beaver, Julia A, Amiri-Kordestani, Laleh

“…The US Food and Drug Administration approved abemaciclib in combination with endocrine therapy (ET) for the adjuvant treatment of adult patients with hormone…”
Get full text

Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis by Beaver, Julia A, Hazarika, Maitreyee, Mulkey, Flora, Mushti, Sirisha, Chen, Huanyu, He, Kun, Sridhara, Rajeshwari, Goldberg, Kirsten B, Chuk, Meredith K, Chi, Dow-Chung, Chang, Jennie, Barone, Amy, Balasubramaniam, Sanjeeve, Blumenthal, Gideon M, Keegan, Patricia, Pazdur, Richard, Theoret, Marc R

“…Patients who receive immunotherapeutic drugs might develop an atypical response pattern, wherein they initially meet conventional response criteria for…”
Get full text

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

“…Differentiation syndrome (DS) is a serious adverse reaction of isocitrate dehydrogenase (IDH) inhibitors ivosidenib and enasidenib in patients with and…”
Get full text

FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis Review by Vellanki, Paz J, Mulkey, Flora, Jaigirdar, Adnan A, Rodriguez, Lisa, Wang, Yibo, Xu, Yuan, Zhao, Hong, Liu, Jiang, Howe, Grant, Wang, Jian, Choo, Qiuyi, Golding, Sarah J, Mansell, Victoria, Korsah, Kwadwo, Spillman, Dianne, de Claro, R Angelo, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet

“…On May 26, 2020, the FDA approved nivolumab with ipilimumab and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with…”
Get full text