Pralatrexate in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results From the Pivotal PROPEL Study
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Published:2011-03-20
Issue:9
Volume:29
Page:1182-1189
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ISSN:0732-183X
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Container-title:Journal of Clinical Oncology
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language:en
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Short-container-title:JCO
Author:
O'Connor Owen A.1, Pro Barbara1, Pinter-Brown Lauren1, Bartlett Nancy1, Popplewell Leslie1, Coiffier Bertrand1, Jo Lechowicz Mary1, Savage Kerry J.1, Shustov Andrei R.1, Gisselbrecht Christian1, Jacobsen Eric1, Zinzani Pier Luigi1, Furman Richard1, Goy Andre1, Haioun Corinne1, Crump Michael1, Zain Jasmine M.1, Hsi Eric1, Boyd Adam1, Horwitz Steven1
Affiliation:
1. From the New York University (NYU) Cancer Institute, NYU Langone Medical Center; New York Weill Cornell Medical Center; Memorial Sloan-Kettering Cancer Center, New York, NY; University of Texas MD Anderson Cancer Center, Houston, TX; University of California at Los Angeles, Los Angeles; City of Hope, Duarte, CA; Washington University, Siteman Cancer Center, St Louis, MO; Centre Hospitalier Lyon-Sud, Pierre-Benite, France; Emory University, Atlanta, GA; British Columbia Cancer Agency, Vancouver, British...
Abstract
Purpose Peripheral T-cell lymphoma (PTCL) is a poor prognosis subtype of non-Hodgkin's lymphoma with no accepted standard of care. This study evaluated the efficacy and tolerability of pralatrexate, a novel antifolate with promising activity. Patients and Methods Patients with independently confirmed PTCL who progressed following ≥ 1 line of prior therapy received pralatrexate intravenously at 30 mg/m2/wk for 6 weeks in 7-week cycles. Primary assessment of response was made by independent central review using the International Workshop Criteria. The primary end point was overall response rate. Secondary end points included duration of response, progression-free survival (PFS), and overall survival (OS). Results Of 115 patients enrolled, 111 were treated with pralatrexate. The median number of prior systemic therapies was three (range, 1 to 12). The response rate in 109 evaluable patients was 29% (32 of 109), including 12 complete responses (11%) and 20 partial responses (18%), with a median DoR of 10.1 months. Median PFS and OS were 3.5 and 14.5 months, respectively. The most common grade 3/4 adverse events were thrombocytopenia (32%), mucositis (22%), neutropenia (22%), and anemia (18%). Conclusion To our knowledge, PROPEL (Pralatrexate in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma) is the largest prospective study conducted in patients with relapsed or refractory PTCL. Pralatrexate induced durable responses in relapsed or refractory PTCL irrespective of age, histologic subtypes, amount of prior therapy, prior methotrexate, and prior autologous stem-cell transplant. These data formed the basis for the US Food and Drug Administration approval of pralatrexate, the first drug approved for this disease.
Publisher
American Society of Clinical Oncology (ASCO)
Subject
Cancer Research,Oncology
Cited by
516 articles.
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