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758 results on '"Freedman, Laurence S"'

3. 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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7. 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

8. 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

9. 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

12. Epidemiologic analyses with error-prone exposures: Review of current practice and recommendations

Author

Shaw, Pamela A., Deffner, Veronika, Keogh, Ruth H., Tooze, Janet A., Dodd, Kevin W., Küchenhoff, Helmut, Kipnis, Victor, and Freedman, Laurence S.

Subjects
Statistics - Applications
Abstract

Background: Variables in epidemiological observational studies are commonly subject to measurement error and misclassification, but the impact of such errors is frequently not appreciated or ignored. As part of the STRengthening Analytical Thinking for Observational Studies (STRATOS) Initiative, a Task Group on measurement error and misclassification (TG4) seeks to describe the scope of this problem and the analysis methods currently in use to address measurement error. Methods: TG4 conducted a literature survey of four types of research studies that are typically impacted by exposure measurement error: 1) dietary intake cohort studies, 2) dietary intake population surveys, 3) physical activity cohort studies, and 4) air pollution cohort studies. The survey was conducted to understand current practice for acknowledging and addressing measurement error. Results: The survey revealed that while researchers were generally aware that measurement error affected their studies, very few adjusted their analysis for the error. Most articles provided incomplete discussion of the potential effects of measurement error on their results. Regression calibration was the most widely used method of adjustment. Conclusions: Even in areas of epidemiology where measurement error is a known problem, the dominant current practice is to ignore errors in analyses. Methods to correct for measurement error are available but require additional data to inform the error structure. There is a great need to incorporate such data collection within study designs and improve the analytical approach. Increased efforts by investigators, editors and reviewers are also needed to improve presentation of research when data are subject to error., Comment: 41 pages, including 4 tables and supplementary material

Published
2018
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15. A historical cohort study with 27,754 individuals on the association between meat consumption and gastrointestinal tract and colorectal cancer incidence.

Author

Dankner, Rachel, Chetrit, Angela, Avraham, Sivan Ben, Agay, Nirit, Kalter‐Leibovici, Ofra, Goldbourt, Uri, Saliba, Walid, Keinan‐Boker, Lital, Shahar, Danit, and Freedman, Laurence S.

Subjects
GASTROINTESTINAL cancer, PROPORTIONAL hazards models, BEEF industry, POULTRY as food, COLORECTAL cancer
Abstract

In order to explore the association between meat consumption and gastrointestinal/colorectal cancer (CRC) risk and to estimate the Israeli population attributable fraction (PAF), we conducted a collaborative historical cohort study using the individual participant data of seven nutritional studies from the past 6 decades. We included healthy adult men and women who underwent a nutritional interview. Dietary assessment data, using food‐frequency or 24‐h recall questionnaires, were harmonized. The study file was linked to the National Cancer and death registries. Among 27,754 participants, 1216 (4.4%) were diagnosed with gastrointestinal cancers and 839 (3.0%) with CRC by the end of 2016. Using meta‐analysis methods applied to Cox proportional hazard models (adjusted for daily energy intake, sex, age, ethnic origin, education and smoking),100 g/day increments in beef, red meat and poultry consumption, and 50 g/day increment in processed meat consumption were associated with hazard ratios (HRs) and 95% confidence intervals of 1.46 (1.06–2.02), 1.15 (0.87–1.52), 1.06 (0.89–1.26), and 0.93 (0.76–1.12), respectively, for CRC. Similar results were obtained for gastrointestinal cancer, although red meat consumption reached statistical significance (HR = 1.27; 95%CI: 1.02–1.58). The PAFs associated with a reduction to a maximum of 50 g/day in the consumption of red meat were 2.7% (95%CI: −1.9 to 12.0) and 5.2% (0.3–13.9) for CRC and gastrointestinal cancers, respectively. Reduction of beef consumption to a maximum of 50 g/day will result in a CRC PAF reduction of 7.5% (0.7%–24.3%). While beef consumption was associated with gastrointestinal/CRC excess risk, poultry consumption was not. A substantial part of processed meat consumption in Israel is processed poultry, perhaps explaining the lack of association with CRC. [ABSTRACT FROM AUTHOR]

Published
2024
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17. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study

Author

Horwitz, Mitchell E., Stiff, Patrick J., Cutler, Corey, Brunstein, Claudio, Hanna, Rabi, Maziarz, Richard T., Rezvani, Andrew R., Karris, Nicole A., McGuirk, Joseph, Valcarcel, David, Schiller, Gary J., Lindemans, Caroline A., Hwang, William Y.K., Koh, Liang Piu, Keating, Amy, Khaled, Yasser, Hamerschlak, Nelson, Frankfurt, Olga, Peled, Tony, Segalovich, Irit, Blackwell, Beth, Wease, Stephen, Freedman, Laurence S., Galamidi-Cohen, Einat, and Sanz, Guillermo

Published
2021
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19. 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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20. 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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25. 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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30. CHAPTER 4. Information bias: misclassification and mismeasurement of exposure and outcome.

Author

Stayner, Leslie, Pearce, Neil, Nøhr, Ellen Aagaard, Freeman, Laura Beane, Deffner, Veronika, Ferrari, Pietro, Freedman, Laurence S., Kogevinas, Manolis, Kromhout, Hans, Lewis, Sarah, MacLehose, Richard, Parent, Marie-Elise, Richiardi, Lorenzo, Shaw, Pamela, and Wedekind, Roland

Subjects
HEALTH, EARLY detection of cancer, DOSIMETERS, INFORMATION resources, MEASUREMENT errors, CARCINOGENS, TUMORS, EPIDEMIOLOGISTS, SENSITIVITY & specificity (Statistics)
Abstract

The article discusses misclassification and mismeasurement of exposure and outcome in epidemiological studies of carcinogenic hazards, resulting to information bias. Topics discussed include qualitative evaluation of the direction of bias due to errors in exposure, tools for quantifying bias due to errors in exposure, and non-differential and differential outcome misclassification.

Published
2024

39. Celiac plexus radiosurgery for pain management in advanced cancer: An international phase II trial, health-related quality of life (HRQOL) outcomes.

Author

Lawrence, Yaacov Richard, primary, Miszczyk, Marcin, additional, Barry, Aisling S, additional, Diaz Pardo, Dayssy Alexandra, additional, Aguiar, Artur, additional, Limon, Dror, additional, Pfeffer, Raphael M., additional, Buckstein, Michael, additional, Margalit, Ofer, additional, Fluss, Ronen, additional, Meron, Tikva, additional, Dicker, Adam P., additional, Zimmermann, Camilla, additional, Hausner, David, additional, Morag, Ofir, additional, Golan, Talia, additional, Freedman, Laurence S, additional, Ben-Ayun, Maoz, additional, Symon, Zvi, additional, and Dawson, Laura A., additional

Published
2023
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42. Six-Month Follow-up after a Fourth BNT162b2 Vaccine Dose

Author

Canetti, Michal, primary, Barda, Noam, additional, Gilboa, Mayan, additional, Indenbaum, Victoria, additional, Asraf, Keren, additional, Gonen, Tal, additional, Weiss-Ottolenghi, Yael, additional, Amit, Sharon, additional, Doolman, Ram, additional, Mendelson, Ella, additional, Freedman, Laurence S., additional, Kreiss, Yitshak, additional, Lustig, Yaniv, additional, and Regev-Yochay, Gili, additional

Published
2022
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43. The Association Between Prebooster Vaccination Antibody Levels and the Risk of Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Author

Barda, Noam, primary, Canetti, Michal, additional, Gilboa, Mayan, additional, Asraf, Keren, additional, Indenboim, Victoria, additional, Weiss-Ottolenghi, Yael, additional, Amit, Sharon, additional, Zubli, Daniel, additional, Doolman, Ram, additional, Mendelson, Ella, additional, Freedman, Laurence S, additional, Kreiss, Yitshak, additional, Lustig, Yaniv, additional, and Regev-Yochay, Gili, additional

Published
2022
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44. Evaluating a Model of Added Sugar Intake Based on Amino Acid Carbon Isotope Ratios in a Controlled Feeding Study of U.S. Adults

Author

Johnson, Jessica J., primary, Sági-Kiss, Virág, additional, Palma-Duran, Susana A., additional, Commins, John, additional, Chaloux, Matthew, additional, Barrett, Brian, additional, Midthune, Douglas, additional, Kipnis, Victor, additional, Freedman, Laurence S., additional, Tasevska, Natasha, additional, and O’Brien, Diane M., additional

Published
2022
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49. 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

50. 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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