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659 results on '"Freedman, Laurence"'

4. Celiac plexus radiosurgery for pain management in advanced cancer: a multicentre, single-arm, phase 2 trial

Author

Lawrence, Yaacov R, Miszczyk, Marcin, Dawson, Laura A, Diaz Pardo, Dayssy Alexandra, Aguiar, Artur, Limon, Dror, Pfeffer, Raphael M, Buckstein, Michael, Barry, Aisling S, Meron, Tikva, Dicker, Adam P, Wydmański, Jerzy, Zimmermann, Camilla, Margalit, Ofer, Hausner, David, Morag, Ofir, Golan, Talia, Jacobson, Galia, Dubinski, Sergey, Stanescu, Teo, Fluss, Ronen, Freedman, Laurence S, Ben-Ayun, Maoz, and Symon, Zvi

Published
2024
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11. Safety and efficacy of VB-111, an anticancer gene therapy, in patients with recurrent glioblastoma: results of a phase I/II study

Author

Brenner, Andrew J, Peters, Katherine B, Vredenburgh, James, Bokstein, Felix, Blumenthal, Deborah T, Yust-Katz, Shlomit, Peretz, Idit, Oberman, Bernice, Freedman, Laurence S, Ellingson, Benjamin M, Cloughesy, Timothy F, Sher, Naamit, Cohen, Yael C, Lowenton-Spier, Noa, Minei, Tamar Rachmilewitz, Yakov, Niva, Mendel, Itzhak, Breitbart, Eyal, and Wen, Patrick Y

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Brain Disorders, Orphan Drug, Cancer, Rare Diseases, Clinical Research, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Brain Neoplasms, Genetic Therapy, Glioblastoma, Humans, Progression-Free Survival, anti-angiogenesis, gene therapy, glioblastoma, VB-111, viral immuno-oncology, VB-111, glioblastoma, Neurosciences, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundVB-111 is a non-replicating adenovirus carrying a Fas-chimera transgene, leading to targeted apoptosis of tumor vascular endothelium and induction of a tumor-specific immune response. This phase I/II study evaluated the safety, tolerability, and efficacy of VB-111 with and without bevacizumab in recurrent glioblastoma (rGBM).MethodsPatients with rGBM (n = 72) received VB-111 in 4 treatment groups: subtherapeutic (VB-111 dose escalation), limited exposure (LE; VB-111 monotherapy until progression), primed combination (VB-111 monotherapy continued upon progression with combination of bevacizumab), and unprimed combination (upfront combination of VB-111 and bevacizumab). The primary endpoint was median overall survival (OS). Secondary endpoints were safety, overall response rate, and progression-free survival (PFS).ResultsVB-111 was well tolerated. The most common adverse event was transient mild-moderate fever. Median OS time was significantly longer in the primed combination group compared with both LE (414 vs 223 days; hazard ratio [HR], 0.48; P = 0.043) and unprimed combination (414 vs 141.5 days; HR, 0.24; P = 0.0056). Patients in the combination phase of the primed combination group had a median PFS time of 90 days compared with 60 in the LE group (HR, 0.36; P = 0.032), and 63 in the unprimed combination group (P = 0.72). Radiographic responders to VB-111 exhibited characteristic, expansive areas of necrosis in the areas of initial enhancing disease.ConclusionsPatients with rGBM who were primed with VB-111 monotherapy that continued after progression with the addition of bevacizumab showed significant survival and PFS advantage, as well as specific imaging characteristics related to VB-111 mechanism of action. These results warrant further assessment in a randomized controlled study.

Published
2020

12. A randomized controlled phase III study of VB-111 combined with bevacizumab vs bevacizumab monotherapy in patients with recurrent glioblastoma (GLOBE)

Author

Cloughesy, Timothy F, Brenner, Andrew, de Groot, John F, Butowski, Nicholas A, Zach, Leor, Campian, Jian L, Ellingson, Benjamin M, Freedman, Laurence S, Cohen, Yael C, Lowenton-Spier, Noa, Minei, Tamar Rachmilewitz, Shmueli, Shifra Fain, Avgeropoulos, Nicholas, Beck, Joseph, Benkers, Tara, Bokstein, Felix, Burton, Eric, Butowski, Nicholas, Campian, Jian, Carrillo, Jose, Cloughesy, Timothy, de Groot, John, De Robles, Paula, Drappatz, Jan, Dunbar, Irine, Fink, Karen, Groves, Morris, Han, Xiaosi, Adila, Hormigo, Jensen, Randy, Kowalska, Agnieszka, Kumthekar, Pyriya, Lee, Mijung, Lesser, Glenn, Lossos, Alexander, Lukas, Rimas, Macdonald, David, Mammoser, Aaron, Mechtler, Laszlo, Mohile, Nimish, Nagpal, Seema, Nicholas, Garth, Kreisl, Teri, Pan, Edward, Peak, Scott, Pearlman, Michael, Perry, James, Peterson, Richard, Piccioni, David, Robins, Henry, Ronan, Lara, Salacz, Michael, Schiff, David, Tran, David, Tzuk-Shina, Tzahala, Walbert, Tobias, Wen, Patrick, Youst, Shlomit, and Y, Wen Patrick

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Brain Disorders, Neurosciences, Brain Cancer, Cancer, Rare Diseases, Clinical Research, Clinical Trials and Supportive Activities, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Angiogenesis Inhibitors, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Brain Neoplasms, Glioblastoma, Humans, Progression-Free Survival, Treatment Outcome, anti-angiogenesis, gene therapy, glioblastoma VB-111, viral immuno-oncology, GLOBE Study Investigators, VB-111, glioblastoma, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundOfranergene obadenovec (VB-111) is an anticancer viral therapy that demonstrated in a phase II study a survival benefit for patients with recurrent glioblastoma (rGBM) who were primed with VB-111 monotherapy that was continued after progression with concomitant bevacizumab.MethodsThis pivotal phase III randomized, controlled trial compared the efficacy and safety of upfront combination of VB-111 and bevacizumab versus bevacizumab monotherapy. Patients were randomized 1:1 to receive VB-111 1013 viral particles every 8 weeks in combination with bevacizumab 10 mg/kg every 2 weeks (combination arm) or bevacizumab monotherapy (control arm). The primary endpoint was overall survival (OS), and secondary endpoints were objective response rate (ORR) by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS).ResultsEnrolled were 256 patients at 57 sites. Median exposure to VB-111 was 4 months. The study did not meet its primary or secondary goals. Median OS was 6.8 versus 7.9 months in the combination versus control arm (hazard ratio, 1.20; 95% CI: 0.91-1.59; P = 0.19) and ORR was 27.3% versus 21.9% (P = 0.26). A higher rate of grades 3-5 adverse events was reported in the combination arm (67% vs 40%), mainly attributed to a higher rate of CNS and flu-like/fever events. Trends for improved survival with combination treatment were seen in the subgroup of patients with smaller tumors and in patients who had a posttreatment febrile reaction.ConclusionsIn this study, upfront concomitant administration of VB-111 and bevacizumab failed to improve outcomes in rGBM. Change of treatment regimen, with the lack of VB-111 monotherapy priming, may explain the differences from the favorable phase II results.Clinical trials registrationNCT02511405.

Published
2020

13. Safety and efficacy of VB-111, an anti-cancer gene-therapy, in patients with recurrent glioblastoma: results of a phase I/II study

Author

Brenner, Andrew J, Peters, Katherine B, Vredenburgh, James, Bokstein, Felix, Blumenthal, Deborah T, Yust-Katz, Shlomit, Peretz, Idit, Oberman, Bernice, Freedman, Laurence S, Ellingson, Benjamin M, Cloughesy, Timothy F, Sher, Naamit, Cohen, Yael C, Lowenton-Spier, Noa, Minei, Tamar Rachmilewitz, Yakov, Niva, Mendel, Itzhak, Breitbart, Eyal, and Wen, Patrick Y

Subjects
Cancer, Clinical Research, Rare Diseases, Orphan Drug, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Brain Neoplasms, Genetic Therapy, Glioblastoma, Humans, Progression-Free Survival, anti-angiogenesis, gene therapy, glioblastoma, VB-111, viral immuno-oncology, VB-111, glioblastoma, Neurosciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundVB-111 is a non-replicating adenovirus carrying a Fas-chimera transgene, leading to targeted apoptosis of tumor vascular endothelium and induction of a tumor-specific immune response. This phase I/II study evaluated the safety, tolerability, and efficacy of VB-111 with and without bevacizumab in recurrent glioblastoma (rGBM).MethodsPatients with rGBM (n = 72) received VB-111 in 4 treatment groups: subtherapeutic (VB-111 dose escalation), limited exposure (LE; VB-111 monotherapy until progression), primed combination (VB-111 monotherapy continued upon progression with combination of bevacizumab), and unprimed combination (upfront combination of VB-111 and bevacizumab). The primary endpoint was median overall survival (OS). Secondary endpoints were safety, overall response rate, and progression-free survival (PFS).ResultsVB-111 was well tolerated. The most common adverse event was transient mild-moderate fever. Median OS time was significantly longer in the primed combination group compared with both LE (414 vs 223 days; hazard ratio [HR], 0.48; P = 0.043) and unprimed combination (414 vs 141.5 days; HR, 0.24; P = 0.0056). Patients in the combination phase of the primed combination group had a median PFS time of 90 days compared with 60 in the LE group (HR, 0.36; P = 0.032), and 63 in the unprimed combination group (P = 0.72). Radiographic responders to VB-111 exhibited characteristic, expansive areas of necrosis in the areas of initial enhancing disease.ConclusionsPatients with rGBM who were primed with VB-111 monotherapy that continued after progression with the addition of bevacizumab showed significant survival and PFS advantage, as well as specific imaging characteristics related to VB-111 mechanism of action. These results warrant further assessment in a randomized controlled study.

Published
2020

21. Utilizing an interim futility analysis of the OVAL study (VB-111-701/GOG 3018) for potential reduction of risk: A phase III, double blind, randomized controlled trial of ofranergene obadenovec (VB-111) and weekly paclitaxel in patients with platinum resistant ovarian cancer

Author

Arend, Rebecca C., Monk, Bradley J., Herzog, Thomas J., Moore, Kathleen N., Shapira-Frommer, Ronnie, Ledermann, Jonathan A., Tewari, Krishnansu S., Secord, Angeles Alvarez, Rachmilewitz Minei, Tamar, Freedman, Laurence S., Miller, Austin, Shmueli, Shifra Fain, Lavi, Michal, and Penson, Richard T.

Published
2021
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22. Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation

Author

Oved, Kfir, Olmer, Liraz, Shemer-Avni, Yonat, Wolf, Tamar, Supino-Rosin, Lia, Prajgrod, George, Shenhar, Yotam, Payorsky, Irina, Cohen, Yuval, Kohn, Yishai, Indenbaum, Victoria, Lazar, Rachel, Geylis, Valeria, Oikawa, Michal Tepperberg, Shinar, Eilat, Stoyanov, Evgeniy, Keinan-Boker, Lital, Bassal, Ravit, Reicher, Shay, Yishai, Ruti, Bar-Chaim, Adina, Doolman, Ram, Reiter, Yoram, Mendelson, Ella, Livneh, Zvi, Freedman, Laurence S., and Lustig, Yaniv

Published
2020
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26. Cohort-Controlled Comparison of Umbilical Cord Blood Transplantation Using Carlecortemcel-L, a Single Progenitor–Enriched Cord Blood, to Double Cord Blood Unit Transplantation

Author

Stiff, Patrick J., Montesinos, Pau, Peled, Tony, Landau, Efrat, Goudsmid, Noga Rosenheimer, Mandel, Julie, Hasson, Nira, Olesinski, Esti, Glukhman, Ela, Snyder, David A., Cohen, Einat Galamidi, Kidron, Orna Srur, Bracha, Dalia, Harati, Dorit, Ben-Abu, Keren, Freind, Etty, Freedman, Laurence S., Cohen, Yael C., Olmer, Liraz, Barishev, Raya, Rocha, Vanderson, Gluckman, Eliane, Horowitz, Mary M., Eapen, Mary, Nagler, Arnon, and Sanz, Guillermo

Published
2018
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28. Report of the Editors: 2005

Author

Freedman, Laurence, Kenward, Mike, Lin, Xihong, Wang, Naisyin, and Davidian, Marie

Published
2006

34. Rituximab maintenance improves overall survival of patients with follicular lymphoma—Individual patient data meta-analysis

Author

Vidal, Liat, Gafter-Gvili, Anat, Salles, Gilles, Bousseta, Sami, Oberman, Bernice, Rubin, Carmit, van Oers, Marinus H.J., Fortpied, Catherine, Ghielmini, Michele, Pettengell, Ruth, Witzens-Harig, Mathias, Dreger, Peter, Vitolo, Umberto, Gomes da Silva, Maria, Evangelista, Andrea, Li, Hailun, Freedman, Laurence, Habermann, Thomas M., and Shpilberg, Ofer

Published
2017
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36. Three phases of increasing complexity in estimating vaccine protection.

Author

Amir, Ofra, Goldberg, Yair, Mandel, Micha, Bar-On, Yinon M, Freedman, Laurence S, Bodenheimer, Omri, Huppert, Amit, and Milo, Ron

Subjects
MEDICAL personnel, BOOSTER vaccines, VACCINE effectiveness, VACCINES, VACCINATION coverage
Abstract

COVID-19 vaccine coverage in health-care workers in England and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN): a prospective, multicentre, cohort study. One of the key questions in the Covid-19 pandemic is estimating the real-world protection conferred by vaccines. [Extracted from the article]

Published
2023
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43. Longitudinal bidirectional link between socioeconomic position and health: a national panel survey analysis.

Author

Benderly, Michal, Fluss, Ronen, Murad, Havi, Averbuch, Emma, Freedman, Laurence S., and Kalter-Leibovici, Ofra

Subjects
HEALTH services accessibility, CONFIDENCE intervals, MINORITIES, COMMUNICATIVE competence, HEALTH status indicators, SOCIOECONOMIC factors, SURVEYS, DESCRIPTIVE statistics, RESEARCH funding, HEALTH equity, ODDS ratio, LONGITUDINAL method
Published
2023
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44. Issues in Implementing Regression Calibration Analyses.

Author

Boe, Lillian A, Shaw, Pamela A, Midthune, Douglas, Gustafson, Paul, Kipnis, Victor, Park, Eunyoung, Sotres-Alvarez, Daniela, Freedman, Laurence, and Initiative, on behalf of the Measurement Error and Misclassification Topic Group (TG4) of the STRATOS

Subjects
EVALUATION of medical care, CALIBRATION, REGRESSION analysis, SIMULATION methods in education, MATHEMATICS, RESEARCH funding, STATISTICAL models, RESEARCH bias
Abstract

Regression calibration is a popular approach for correcting biases in estimated regression parameters when exposure variables are measured with error. This approach involves building a calibration equation to estimate the value of the unknown true exposure given the error-prone measurement and other covariates. The estimated, or calibrated, exposure is then substituted for the unknown true exposure in the health outcome regression model. When used properly, regression calibration can greatly reduce the bias induced by exposure measurement error. Here, we first provide an overview of the statistical framework for regression calibration, specifically discussing how a special type of error, called Berkson error, arises in the estimated exposure. We then present practical issues to consider when applying regression calibration, including: 1) how to develop the calibration equation and which covariates to include; 2) valid ways to calculate standard errors of estimated regression coefficients; and 3) problems arising if one of the covariates in the calibration model is a mediator of the relationship between the exposure and outcome. Throughout, we provide illustrative examples using data from the Hispanic Community Health Study/Study of Latinos (United States, 2008–2011) and simulations. We conclude with recommendations for how to perform regression calibration. [ABSTRACT FROM AUTHOR]

Published
2023
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47. Cancer Registration in the Middle East

Author

Freedman, Laurence S., Al-Kayed, Samir, Qasem, M. Bassam, Barchana, Micha, Boyiadzis, Michael, El-Najjar, Khamis, Ibrahim, Amal Samy, Salhab, Abdel Razzaq, Young, John L., Roffers, Steven, Kahan, Ernesto, Harford, Joe, and Silbermann, Michael

Published
2001

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