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2. A pooled analysis of patients with wound infections in the Phase 3 REVIVE trials: randomized, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin structure infections

Author

Noviello, Stephanie, primary, Corey, G. Ralph, additional, Holland, Thomas L., additional, Lodise, Thomas, additional, O’Riordan, William, additional, Wilcox, Mark H., additional, File, Thomas M., additional, Dryden, Matthew, additional, Balser, Barbara, additional, Scaramucci, Amy, additional, Torres, Antoni, additional, and Huang, David B., additional

Published
2020
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4. Erratum to: Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial

Author

Foss, Francine, Horwitz, Steven, Pro, Barbara, Miles Prince, H., Sokol, Lubomir, Balser, Barbara, Wolfson, Julie, and Coiffier, Bertrand

Subjects
Adult, Male, Cancer Research, Neutropenia, Time Factors, lcsh:RC254-282, Disease-Free Survival, Drug Administration Schedule, Romidepsin, Young Adult, Depsipeptides, Humans, Molecular Biology, Fatigue, Aged, Aged, 80 and over, Antibiotics, Antineoplastic, lcsh:RC633-647.5, Research, Remission Induction, Lymphoma, T-Cell, Peripheral, Nausea, lcsh:Diseases of the blood and blood-forming organs, Hematology, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Histone Deacetylase Inhibitors, Treatment Outcome, Oncology, Drug Resistance, Neoplasm, Stable disease, Disease Progression, Peripheral T cell lymphoma, Female, Erratum, Neoplasm Recurrence, Local
Abstract

Background Achievement of durable responses in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) is challenging with current therapies, and there are few data regarding the potential benefits of continuing treatment in patients with the best response of stable disease (SD). Histone deacetylase inhibitors are a novel class of drugs with activity in T cell malignancies. Romidepsin was approved by the US Food and Drug Administration for the treatment of relapsed/refractory PTCL based on a pivotal trial demonstrating an objective response rate of 25 % (33/130), including 15 % with confirmed/unconfirmed complete response and a median duration of response of 28 months. Our objective was to further study the clinical benefits of romidepsin in patients that had the best response of SD. Methods Patients with PTCL relapsed/refractory to ≥1 prior therapy were treated with the approved dose of 14 mg/m2 romidepsin on days 1, 8, and 15 of six 28-day cycles; patients with SD or response after cycle 6 were allowed to continue on study until progression. By protocol amendment, patients treated for ≥12 cycles could receive maintenance dosing twice per cycle; after cycle 24, dosing could be further reduced to once per cycle in those who had received maintenance dosing for ≥6 months. Results Of the 32 patients (25 %) with the best response of SD, 22 had SD for ≥90 days (SD90; cycle 4 response assessment). The longest SD was >3 years in a patient who received maintenance dosing of 14 mg/m2 on days 1 and 15 beginning in cycle 13. Patients with the best response of SD90 or partial response achieved similar overall and progression-free survival. Prolonged dosing of romidepsin was well tolerated. Conclusions We concluded that patients who achieve SD may consider continuing treatment because the clinical benefits of romidepsin may extend beyond objective responses. Trial registration NCT00426764

Published
2017

5. 1338. A Pooled Analysis of Patients With Wound Infections in the Phase 3 REVIVE Trials: Randomized, Double-blind Studies to EValuate the Safety and Efficacy of Iclaprim Vs. Vancomycin for trEatment of Acute Bacterial Skin and Skin Structure Infections

Author

Huang, David, primary, Corey, G Ralph, additional, Holland, Thomas L, additional, Lodise, Thomas P, additional, O’Rirodan, William, additional, Wilcox, Mark, additional, File, Thomas M, additional, Dryden, Matthew, additional, Torres, Antoni, additional, Balser, Barbara, additional, and Desplats, Eve, additional

Published
2018
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6. Pooled analysis of the phase 3 REVIVE trials: randomised, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin-structure infections

Author

Huang, David B., primary, Corey, G. Ralph, additional, Holland, Thomas L., additional, Lodise, Thomas, additional, O'Riordan, William, additional, Wilcox, Mark H., additional, File, Thomas M., additional, Dryden, Matthew, additional, Balser, Barbara, additional, Desplats, Eve, additional, and Torres, Antoni, additional

Published
2018
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7. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials

Author

Shustov, Andrei, primary, Coiffier, Bertrand, additional, Horwitz, Steven, additional, Sokol, Lubomir, additional, Pro, Barbara, additional, Wolfson, Julie, additional, Balser, Barbara, additional, Eisch, Robin, additional, Popplewell, Leslie, additional, Prince, H. Miles, additional, Allen, Steven L., additional, Piekarz, Richard, additional, and Bates, Susan, additional

Published
2017
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8. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial.

Author

Foss, Francine, Horwitz, Steven, Pro, Barbara, Prince, H Miles, Sokol, Lubomir, Balser, Barbara, Wolfson, Julie, Coiffier, Bertrand, Foss, Francine, Horwitz, Steven, Pro, Barbara, Prince, H Miles, Sokol, Lubomir, Balser, Barbara, Wolfson, Julie, and Coiffier, Bertrand

Abstract

BACKGROUND: Achievement of durable responses in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) is challenging with current therapies, and there are few data regarding the potential benefits of continuing treatment in patients with the best response of stable disease (SD). Histone deacetylase inhibitors are a novel class of drugs with activity in T cell malignancies. Romidepsin was approved by the US Food and Drug Administration for the treatment of relapsed/refractory PTCL based on a pivotal trial demonstrating an objective response rate of 25 % (33/130), including 15 % with confirmed/unconfirmed complete response and a median duration of response of 28 months. Our objective was to further study the clinical benefits of romidepsin in patients that had the best response of SD. METHODS: Patients with PTCL relapsed/refractory to ≥1 prior therapy were treated with the approved dose of 14 mg/m(2) romidepsin on days 1, 8, and 15 of six 28-day cycles; patients with SD or response after cycle 6 were allowed to continue on study until progression. By protocol amendment, patients treated for ≥12 cycles could receive maintenance dosing twice per cycle; after cycle 24, dosing could be further reduced to once per cycle in those who had received maintenance dosing for ≥6 months. RESULTS: Of the 32 patients (25 %) with the best response of SD, 22 had SD for ≥90 days (SD90; cycle 4 response assessment). The longest SD was >3 years in a patient who received maintenance dosing of 14 mg/m(2) on days 1 and 15 beginning in cycle 13. Patients with the best response of SD90 or partial response achieved similar overall and progression-free survival. Prolonged dosing of romidepsin was well tolerated. CONCLUSIONS: We concluded that patients who achieve SD may consider continuing treatment because the clinical benefits of romidepsin may extend beyond objective responses. TRIAL REGISTRATION: NCT00426764.

Published
2016

9. Romidepsin induces durable responses in patients with relapsed or refractory angioimmunoblastic T-cell lymphoma

Author

Pro, Barbara, primary, Horwitz, Steven M., additional, Prince, H. Miles, additional, Foss, Francine M., additional, Sokol, Lubomir, additional, Greenwood, Matthew, additional, Caballero, Dolores, additional, Morschhauser, Franck, additional, Wilhelm, Martin, additional, Iyer, Swaminathan Padmanabhan, additional, Shustov, Andrei R., additional, Wolfson, Julie, additional, Balser, Barbara E., additional, and Coiffier, Bertrand, additional

Published
2016
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13. Romidepsin Induces Durable Responses in Patients with Relapsed or Refractory Angioimmunoblastic T-Cell Lymphoma (AITL)

Author

Pro, Barbara, primary, Horwitz, Steven M., additional, Prince, H. Miles, additional, Foss, Francine M., additional, Sokol, Lubomir, additional, Greenwood, Matthew, additional, Caballero, Dolores, additional, Morschhauser, Franck, additional, Wilhelm, Martin, additional, Pinter-Brown, Lauren, additional, Padmanabhan Iyer, Swaminathan, additional, Shustov, Andrei R., additional, Wolfson, Julie, additional, Balser, Barbara E, additional, and Coiffier, Bertrand, additional

Published
2014
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14. Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma

Author

Foss, Francine, primary, Coiffier, Bertrand, additional, Horwitz, Steven, additional, Pro, Barbara, additional, Prince, H Miles, additional, Sokol, Lubomir, additional, Greenwood, Matthew, additional, Lerner, Adam, additional, Caballero, Dolores, additional, Baran, Eugeniusz, additional, Kim, Ellen, additional, Nichols, Jean, additional, Balser, Barbara, additional, Wolfson, Julie, additional, and Whittaker, Sean, additional

Published
2014
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15. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses

Author

Coiffier, Bertrand, primary, Pro, Barbara, additional, Prince, H Miles, additional, Foss, Francine, additional, Sokol, Lubomir, additional, Greenwood, Matthew, additional, Caballero, Dolores, additional, Morschhauser, Franck, additional, Wilhelm, Martin, additional, Pinter-Brown, Lauren, additional, Padmanabhan Iyer, Swaminathan, additional, Shustov, Andrei, additional, Nielsen, Tina, additional, Nichols, Jean, additional, Wolfson, Julie, additional, Balser, Barbara, additional, and Horwitz, Steven, additional

Published
2014
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16. Romidepsin Is Effective and Well-Tolerated In Patients ≥ 60 Years Old With Relapsed Or Refractory Peripheral T-Cell Lymphoma (PTCL): Analysis From Phase 2 Trials

Author

Shustov, Andrei R., primary, Coiffier, Bertrand, additional, Horwitz, Steven M., additional, Sokol, Lubomir, additional, Pro, Barbara, additional, Nielsen, Tina, additional, Wolfson, Julie, additional, Balser, Barbara E, additional, Eisch, Robin, additional, Popplewell, Leslie, additional, Prince, Miles, additional, Allen, Steven L., additional, Piekarz, Richard, additional, and Bates, Susan E., additional

Published
2013
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17. Romidepsin Induces Durable Responses in Patients with Peripheral T-Cell Lymphoma: GPI-06–0002 Study Update

Author

Coiffier, Bertrand, primary, Pro, Barbara, additional, Prince, Miles, additional, Foss, Francine M., additional, Sokol, Lubomir, additional, Greenwood, Matthew, additional, Caballero, Dolores, additional, Morschhauser, Franck, additional, Wilhelm, Martin, additional, Pinter-Brown, Lauren, additional, Padmanabhan, Swaminathan, additional, Shustov, Andrei R., additional, Nielsen, Tina, additional, Nichols, Jean, additional, Wolfson, Julie, additional, Balser, Barbara E, additional, and Horwitz, Steven M., additional

Published
2012
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18. Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy

Author

Coiffier, Bertrand, primary, Pro, Barbara, additional, Prince, H. Miles, additional, Foss, Francine, additional, Sokol, Lubomir, additional, Greenwood, Matthew, additional, Caballero, Dolores, additional, Borchmann, Peter, additional, Morschhauser, Franck, additional, Wilhelm, Martin, additional, Pinter-Brown, Lauren, additional, Padmanabhan, Swaminathan, additional, Shustov, Andrei, additional, Nichols, Jean, additional, Carroll, Susan, additional, Balser, John, additional, Balser, Barbara, additional, and Horwitz, Steven, additional

Published
2012
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20. Letters.

Author

Davies, Andrew, Dickey, Lawrence W., Spisak, Karl, Coburn, Ann, Lonergan, Mary, Garcia, Dana, Ackerman, Felicia Nimue, Balser, Barbara B., James, Jack, Gasch, Lynn, Degette, Rep. Diana, Milgram, Alvin, and Grantham, Reed

Subjects
LETTERS to the editor, CIVIL rights workers, COLLEGE textbooks
Abstract

Presents letters to the editor of the May 31, 2004 issue of "U.S. News & World Report." Response to an article regarding the search for terrorist leader Osama bin Laden; Discussion of national civil rights organizations in the United States; Article regarding the cost of college textbooks; Others.

Published
2004

21. How Others See Sharon's Vision.

Author

Balser, Barbara B., Foxman, Abraham H., Haque, Izaz, Kaswin, Reuven, and Fendel, Dan

Subjects
*ARAB-Israeli peace process, *LETTERS to the editor
Abstract

Presents letter to the editor on the goal of Prime Minister Ariel Sharon of Israel to achieve peace agreement with the Palestinians.

Published
2003

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