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

• Published in: British journal of haematology Vol. 172; no. 4; pp. 535 - 544
• Main Authors: 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, Pinter‐Brown, Lauren C., Smith, Sonali M., Shustov, Andrei R., Savage, Kerry J., M. Vose, Julie
• Format: Journal Article
• Language: English
• Published: England 01.02.2016
• Subjects: Adult; Aged; Aged, 80 and over; Aminopterin - administration & dosage; Aminopterin - adverse effects; Aminopterin - analogs & derivatives; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; clinical trials; Cyclophosphamide - administration & dosage; Cyclophosphamide - adverse effects; Disease Progression; Disease-Free Survival; Epirubicin - administration & dosage; Epirubicin - adverse effects; Female; Humans; Kaplan-Meier Estimate; Lymphoma, T-Cell, Peripheral - drug therapy; Male; Middle Aged; Prednisone - administration & dosage; Prednisone - adverse effects; therapy; Treatment Outcome; T‐cell lymphoma; Vincristine - administration & dosage; Vincristine - adverse effects; therapy; clinical trials; T-cell lymphoma
• ISSN: 0007-1048; 1365-2141
• DOI: 10.1111/bjh.13855

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.