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A phase II study of cyclophosphamide, etoposide, vincristine and prednisone ( CEOP ) Alternating with Pralatrexate (P) as front line therapy for patients with peripheral T‐cell lymphoma ( PTCL ): final results from the T‐ cell consortium trial
Author(s) -
Advani Ranjana H.,
Ansell Stephen M.,
Lechowicz Mary J.,
Beaven Anne W.,
Loberiza Fausto,
Carson Kenneth R.,
Evens Andrew M.,
Foss Francine,
Horwitz Steven,
Pro Barbara,
PinterBrown Lauren C.,
Smith Sonali M.,
Shustov Andrei R.,
Savage Kerry J.,
M. Vose Julie
Publication year - 2016
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.13855
Subject(s) - medicine , vincristine , international prognostic index , gastroenterology , chop , mucositis , prednisone , peripheral t cell lymphoma , febrile neutropenia , surgery , etoposide , cyclophosphamide , neutropenia , lymphoma , chemotherapy , immunology , immune system , t cell
Summary Peripheral T‐cell lymphomas ( PTCL ) have suboptimal outcomes using conventional CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy. The anti‐folate pralatrexate, the first drug approved for patients with relapsed/refractory PTCL , provided a rationale to incorporate it into the front‐line setting. This phase 2 study evaluated a novel front‐line combination whereby cyclophosphamide, etoposide, vincristine and prednisone ( CEOP ) alternated with pralatrexate ( CEOP ‐P) in PTCL . Patients achieving a complete or partial remission ( CR / PR ) were eligible for consolidative stem cell transplantation ( SCT ) after 4 cycles. Thirty‐three stage II ‐ IV PTCL patients were treated: 21 PTCL ‐not otherwise specified (64%), 8 angioimmunoblastic T cell lymphoma (24%) and 4 anaplastic large cell lymphoma (12%). The majority (61%) had stage IV disease and 46% were International Prognostic Index high/intermediate or high risk. Grade 3–4 toxicities included anaemia (27%), thrombocytopenia (12%), febrile neutropenia (18%), mucositis (18%), sepsis (15%), increased creatinine (12%) and liver transaminases (12%). Seventeen patients (52%) achieved a CR . The 2‐year progression‐free survival and overall survial, were 39% (95% confidence interval 21–57) and 60% (95% confidence interval 39–76), respectively. Fifteen patients (45%) (12 CR ) received SCT and all remained in CR at a median follow‐up of 21·5 months. CEOP ‐P did not improve outcomes compared to historical data using CHOP . Defining optimal front line therapy in PTCL continues to be a challenge and an unmet need.