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

Ranjana H. Advani, Stephen Maxted Ansell, Mary J. Lechowicz, Anne W. Beaven, Fausto Loberiza, Kenneth R. Carson, Andrew M. Evens, Francine Foss, Steven Horwitz, Barbara Pro, Lauren C. Pinter-Brown, Sonali M. Smith, Andrei R. Shustov, Kerry J. Savage, Julie M. Vose

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38 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)535-544
Number of pages10
JournalBritish Journal of Haematology
Volume172
Issue number4
DOIs
StatePublished - Feb 1 2016

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Keywords

  • Clinical trials
  • T-cell lymphoma
  • Therapy

ASJC Scopus subject areas

  • Hematology

Cite this

Advani, R. H., Ansell, S. M., Lechowicz, M. J., Beaven, A. W., Loberiza, F., Carson, K. R., Evens, A. M., Foss, F., Horwitz, S., Pro, B., Pinter-Brown, L. C., Smith, S. M., Shustov, A. R., Savage, K. J., & Vose, J. M. (2016). 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. British Journal of Haematology, 172(4), 535-544. https://doi.org/10.1111/bjh.13855