Phase II Intergroup Trial of Alisertib in Relapsed and Refractory Peripheral T-Cell Lymphoma and Transformed Mycosis Fungoides: SWOG 1108

作者: Paul M. Barr , Hongli Li , Catherine Spier , Daruka Mahadevan , Michael LeBlanc

DOI: 10.1200/JCO.2014.60.6327

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摘要: Purpose Aurora A kinase (AAK) is upregulated in highly proliferative lymphomas, suggesting its potential as a therapeutic target. Alisertib novel oral AAK inhibitor without adverse safety signals early-phase studies that demonstrated preliminary activity T-cell lymphoma. This phase II study was conducted to further investigate the efficacy of alisertib relapsed or refractory peripheral non-Hodgkin lymphoma (PTCL). Patients and Methods Eligible patients with histologically confirmed relapsed/refractory PTCL transformed Mycosis fungoides (tMF) received 50 mg twice day for 7 days on 21-day cycles. Results Of 37 eligible patients, histologic subtypes enrolled included not otherwise specified (n = 13), angioimmunoblastic 9), tMF 7), adult lymphoma/leukemia 4), anaplastic large-cell 2), extranodal natural killer/T-cell 2). Grade 3 4 events ≥ 5% neutropenia (32%),...

参考文章(29)
Anna Sureda, Cesar O. Freytes, Richard Thomas Maziarz, David J. Inwards, Robert Peter Gale, Thomas G. Gross, Mitchell S. Cairo, Luciano J. Costa, Hillard M. Lazarus, Peter H. Wiernik, Dipnarine Maharaj, Ginna G. Laport, Silvia Montoto, Parameswaran N. Hari, Sonali M. Smith, Linda J. Burns, Koen van Besien, Jennifer LeRademacher, Wensheng He, Timothy S. Fenske, Ritsuro Suzuki, Jack W. Hsu, Harry C. Schouten, Gregory A. Hale, Leona A. Holmberg, Hematopoietic Cell Transplantation for Systemic Mature T-Cell Non-Hodgkin Lymphoma Journal of Clinical Oncology. ,vol. 31, pp. 3100- 3109 ,(2013) , 10.1200/JCO.2012.46.0188
Barbara Pro, Ranjana Advani, Pauline Brice, Nancy L. Bartlett, Joseph D. Rosenblatt, Tim Illidge, Jeffrey Matous, Radhakrishnan Ramchandren, Michelle Fanale, Joseph M. Connors, Yin Yang, Eric L. Sievers, Dana A. Kennedy, Andrei Shustov, Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma: Results of a Phase II Study Journal of Clinical Oncology. ,vol. 30, pp. 2190- 2196 ,(2012) , 10.1200/JCO.2011.38.0402
Owen A. O'Connor, Barbara Pro, Lauren Pinter-Brown, Nancy Bartlett, Leslie Popplewell, Bertrand Coiffier, Mary Jo Lechowicz, Kerry J. Savage, Andrei R. Shustov, Christian Gisselbrecht, Eric Jacobsen, Pier Luigi Zinzani, Richard Furman, Andre Goy, Corinne Haioun, Michael Crump, Jasmine M. Zain, Eric Hsi, Adam Boyd, Steven Horwitz, Pralatrexate in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results From the Pivotal PROPEL Study Journal of Clinical Oncology. ,vol. 29, pp. 1182- 1189 ,(2011) , 10.1200/JCO.2010.29.9024
Mark G. Manfredi, Jeffrey A. Ecsedy, Arijit Chakravarty, Lee Silverman, Mengkun Zhang, Kara M. Hoar, Stephen G. Stroud, Wei Chen, Vaishali Shinde, Jessica J. Huck, Deborah R. Wysong, David A. Janowick, Marc L. Hyer, Patrick J. LeRoy, Rachel E. Gershman, Matthew D. Silva, Melissa S. Germanos, Joseph B. Bolen, Christopher F. Claiborne, Todd B. Sells, Characterization of Alisertib (MLN8237), An Investigational Small Molecule Inhibitor of Aurora A Kinase Using Novel In Vivo Pharmacodynamic Assays Clinical Cancer Research. ,vol. 17, pp. 7614- 7624 ,(2011) , 10.1158/1078-0432.CCR-11-1536
Leo Kretzner, Anna Scuto, Pamela M. Dino, Claudia M. Kowolik, Jun Wu, Patrick Ventura, Richard Jove, Stephen J. Forman, Yun Yen, Mark H. Kirschbaum, Combining Histone Deacetylase Inhibitor Vorinostat with Aurora Kinase Inhibitors Enhances Lymphoma Cell Killing with Repression of c-Myc, hTERT, and microRNA Levels Cancer Research. ,vol. 71, pp. 3912- 3920 ,(2011) , 10.1158/0008-5472.CAN-10-2259
Jonathan W. Friedberg, Daruka Mahadevan, Erin Cebula, Daniel Persky, Izidore Lossos, Amit B. Agarwal, JungAh Jung, Richard Burack, Xiaofei Zhou, E. Jane Leonard, Howard Fingert, Hadi Danaee, Steven H. Bernstein, Phase II Study of Alisertib, a Selective Aurora A Kinase Inhibitor, in Relapsed and Refractory Aggressive B- and T-Cell Non-Hodgkin Lymphomas Journal of Clinical Oncology. ,vol. 32, pp. 44- 50 ,(2014) , 10.1200/JCO.2012.46.8793
Vivien Mak, Jeremey Hamm, Mukesh Chhanabhai, Tamara Shenkier, Richard Klasa, Laurie H. Sehn, Diego Villa, Randy D. Gascoyne, Joseph M. Connors, Kerry J. Savage, Survival of Patients With Peripheral T-Cell Lymphoma After First Relapse or Progression: Spectrum of Disease and Rare Long-Term Survivors Journal of Clinical Oncology. ,vol. 31, pp. 1970- 1976 ,(2013) , 10.1200/JCO.2012.44.7524
Andres Cervantes, Elena Elez, Desamparados Roda, Jeffrey Ecsedy, Teresa Macarulla, Karthik Venkatakrishnan, Susana Roselló, Jordi Andreu, JungAh Jung, Juan Manuel Sanchis-Garcia, Adelaida Piera, Inma Blasco, Laura Maños, José-Alejandro Pérez-Fidalgo, Howard Fingert, Jose Baselga, Josep Tabernero, None, Phase I Pharmacokinetic/Pharmacodynamic Study of MLN8237, an Investigational, Oral, Selective Aurora A Kinase Inhibitor, in Patients with Advanced Solid Tumors Clinical Cancer Research. ,vol. 18, pp. 4764- 4774 ,(2012) , 10.1158/1078-0432.CCR-12-0571
Owen A. O'Connor, Tamás Masszi, Kerry J. Savage, Lauren C. Pinter-Brown, Francine M. Foss, Leslie Popplewell, Amanda F. Cashen, Jeanette Doorduijn, Shanta Chawla, Poul Knoblauch, Pier Luigi Zinzani, Peter Brown, Georg Hess, Achiel Van Hoof, Steven M. Horwitz, Andrei R. Shustov, Belinostat, a novel pan-histone deacetylase inhibitor (HDACi), in relapsed or refractory peripheral T-cell lymphoma (R/R PTCL): Results from the BELIEF trial. Journal of Clinical Oncology. ,vol. 31, pp. 8507- 8507 ,(2013) , 10.1200/JCO.2013.31.15_SUPPL.8507
Daruka Mahadevan, Carla Morales, Bryan D. Huber, Mansoor Ul Haq, Catherine M. Spier, Laurence S. Cooke, Wenqing Qi, Novel Targeted Combination Therapies for Peripheral T-Cell Lymphoma Blood. ,vol. 124, pp. 4494- 4494 ,(2014) , 10.1182/BLOOD.V124.21.4494.4494