Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study

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 with independently confirmed PTCL who progressed fo...

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Vydáno v:Journal of clinical oncology Ročník 29; číslo 9; s. 1182
Hlavní autoři: O'Connor, Owen A, Pro, Barbara, Pinter-Brown, Lauren, Bartlett, Nancy, Popplewell, Leslie, Coiffier, Bertrand, Lechowicz, Mary Jo, Savage, Kerry J, Shustov, Andrei R, Gisselbrecht, Christian, Jacobsen, Eric, Zinzani, Pier Luigi, Furman, Richard, Goy, Andre, Haioun, Corinne, Crump, Michael, Zain, Jasmine M, Hsi, Eric, Boyd, Adam, Horwitz, Steven
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 20.03.2011
Témata:
Adult
Aged
Aged, 80 and over
Aminopterin - analogs & derivatives
Aminopterin - therapeutic use
Drug Resistance, Neoplasm - drug effects
Female
Folic Acid Antagonists - therapeutic use
Humans
International Agencies
Lymphoma, T-Cell, Peripheral - drug therapy
Lymphoma, T-Cell, Peripheral - pathology
Male
Middle Aged
Neoplasm Recurrence, Local - drug therapy
Neoplasm Recurrence, Local - pathology
Prospective Studies
Remission Induction
Salvage Therapy
Standard of Care
Survival Rate
Treatment Outcome
Young Adult
ISSN:1527-7755, 1527-7755
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Shrnutí: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 with independently confirmed PTCL who progressed following ≥ 1 line of prior therapy received pralatrexate intravenously at 30 mg/m(2)/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). 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%). 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.
Bibliografie:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
content type line 23
ISSN:1527-7755
1527-7755
DOI:10.1200/JCO.2010.29.9024