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

Research output: Contribution to journalArticle

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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

Fingerprint

Peripheral T-Cell Lymphoma
Vincristine
Etoposide
Prednisone
Cyclophosphamide
T-Lymphocytes
Stem Cell Transplantation
Therapeutics
Confidence Intervals
Anaplastic Large-Cell Lymphoma
Febrile Neutropenia
Mucositis
T-Cell Lymphoma
Transaminases
Folic Acid
Thrombocytopenia
Doxorubicin
Disease-Free Survival
10-propargyl-10-deazaaminopterin
Anemia

All Science Journal Classification (ASJC) codes

  • Hematology

Keywords

  • Clinical trials
  • T-cell lymphoma
  • Therapy

Cite this

Advani, Ranjana H. ; Ansell, Stephen M. ; Lechowicz, Mary J. ; Beaven, Anne W. ; Loberiza, Fausto ; Carson, Kenneth R. ; Evens, Andrew ; Foss, Francine ; Horwitz, Steven ; Pro, Barbara ; Pinter-Brown, Lauren C. ; Smith, Sonali M. ; Shustov, Andrei R. ; Savage, Kerry J. ; Vose, Julie M. / 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. In: British Journal of Haematology. 2016 ; Vol. 172, No. 4. pp. 535-544.
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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.",
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Advani, RH, Ansell, SM, Lechowicz, MJ, Beaven, AW, Loberiza, F, Carson, KR, Evens, A, Foss, F, Horwitz, S, Pro, B, Pinter-Brown, LC, Smith, SM, Shustov, AR, Savage, KJ & Vose, JM 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, vol. 172, no. 4, pp. 535-544. https://doi.org/10.1111/bjh.13855

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

In: British Journal of Haematology, Vol. 172, No. 4, 01.02.2016, p. 535-544.

Research output: Contribution to journalArticle

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T1 - 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)

T2 - Final results from the T- cell consortium trial

AU - Advani, Ranjana H.

AU - Ansell, Stephen M.

AU - Lechowicz, Mary J.

AU - Beaven, Anne W.

AU - Loberiza, Fausto

AU - Carson, Kenneth R.

AU - Evens, Andrew

AU - Foss, Francine

AU - Horwitz, Steven

AU - Pro, Barbara

AU - Pinter-Brown, Lauren C.

AU - Smith, Sonali M.

AU - Shustov, Andrei R.

AU - Savage, Kerry J.

AU - Vose, Julie M.

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N2 - 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.

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