Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma

An Eastern Cooperative Oncology Group study (E1405)

Julie E. Chang, Hailun Li, Mitchell R. Smith, Randy D. Gascoyne, Elisabeth M. Paietta, David T. Yang, Ranjana H. Advani, Sandra J. Horning, Brad S. Kahl

Research output: Contribution to journalArticle

46 Citations (Scopus)

Abstract

Rituximab, bortezomib, modified hyper-cyclophosphamide, doxorubicin, vincristine, dexamethasone (VcR-CVAD) induction chemoimmunotherapy and maintenance rituximab (MR) were evaluated for efficacy and safety in Eastern Cooperative Oncology Group protocol E1405. Patients with previously untreated mantle cell lymphoma received VcR-CVAD chemotherapy every 21 days for 6 cycles, followed by MR for 2 years. Transplant-eligible patients had the option of autologous stem cell transplantation (ASCT) consolidation instead of MR. The primary end point was the complete response (CR) rate to VcR-CVAD. The secondary end points were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and toxicities. Seventy-five eligible patients with a median age of 62 (range 40-76) were enrolled. The ORR was 95% and a CR was achieved in 68% of patients. After a median follow-up of 4.5 years, 3-year PFS and OS were 72% and 88%, respectively. No substantial difference in PFS or OS was observed between patients treated with MR (n = 44) vs ASCT (n = 22). There were no unexpected toxicities. VcR-CVAD produced highORRand CRrates in mantle cell lymphoma. MR after VcR-CVAD induction performed similarly to ASCT and may improve response duration. Randomized clinical trials comparing MR against ASCT should be considered and randomized clinical trials evaluating bortezomib's contribution to conventional therapy are under way. This study was registered at www.clinicaltrials.gov as #NCT00433537.

Original languageEnglish (US)
Pages (from-to)1665-1673
Number of pages9
JournalBlood
Volume123
Issue number11
DOIs
StatePublished - Mar 13 2014

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Mantle-Cell Lymphoma
Oncology
Maintenance
Stem Cell Transplantation
Stem cells
Disease-Free Survival
Survival
Toxicity
Randomized Controlled Trials
Transplants
Chemotherapy
Vincristine
Rituximab
Consolidation
Doxorubicin
Cyclophosphamide
Dexamethasone
Safety
Drug Therapy

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

Cite this

Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma : An Eastern Cooperative Oncology Group study (E1405). / Chang, Julie E.; Li, Hailun; Smith, Mitchell R.; Gascoyne, Randy D.; Paietta, Elisabeth M.; Yang, David T.; Advani, Ranjana H.; Horning, Sandra J.; Kahl, Brad S.

In: Blood, Vol. 123, No. 11, 13.03.2014, p. 1665-1673.

Research output: Contribution to journalArticle

Chang, Julie E. ; Li, Hailun ; Smith, Mitchell R. ; Gascoyne, Randy D. ; Paietta, Elisabeth M. ; Yang, David T. ; Advani, Ranjana H. ; Horning, Sandra J. ; Kahl, Brad S. / Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma : An Eastern Cooperative Oncology Group study (E1405). In: Blood. 2014 ; Vol. 123, No. 11. pp. 1665-1673.
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abstract = "Rituximab, bortezomib, modified hyper-cyclophosphamide, doxorubicin, vincristine, dexamethasone (VcR-CVAD) induction chemoimmunotherapy and maintenance rituximab (MR) were evaluated for efficacy and safety in Eastern Cooperative Oncology Group protocol E1405. Patients with previously untreated mantle cell lymphoma received VcR-CVAD chemotherapy every 21 days for 6 cycles, followed by MR for 2 years. Transplant-eligible patients had the option of autologous stem cell transplantation (ASCT) consolidation instead of MR. The primary end point was the complete response (CR) rate to VcR-CVAD. The secondary end points were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and toxicities. Seventy-five eligible patients with a median age of 62 (range 40-76) were enrolled. The ORR was 95{\%} and a CR was achieved in 68{\%} of patients. After a median follow-up of 4.5 years, 3-year PFS and OS were 72{\%} and 88{\%}, respectively. No substantial difference in PFS or OS was observed between patients treated with MR (n = 44) vs ASCT (n = 22). There were no unexpected toxicities. VcR-CVAD produced highORRand CRrates in mantle cell lymphoma. MR after VcR-CVAD induction performed similarly to ASCT and may improve response duration. Randomized clinical trials comparing MR against ASCT should be considered and randomized clinical trials evaluating bortezomib's contribution to conventional therapy are under way. This study was registered at www.clinicaltrials.gov as #NCT00433537.",
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T2 - An Eastern Cooperative Oncology Group study (E1405)

AU - Chang, Julie E.

AU - Li, Hailun

AU - Smith, Mitchell R.

AU - Gascoyne, Randy D.

AU - Paietta, Elisabeth M.

AU - Yang, David T.

AU - Advani, Ranjana H.

AU - Horning, Sandra J.

AU - Kahl, Brad S.

PY - 2014/3/13

Y1 - 2014/3/13

N2 - Rituximab, bortezomib, modified hyper-cyclophosphamide, doxorubicin, vincristine, dexamethasone (VcR-CVAD) induction chemoimmunotherapy and maintenance rituximab (MR) were evaluated for efficacy and safety in Eastern Cooperative Oncology Group protocol E1405. Patients with previously untreated mantle cell lymphoma received VcR-CVAD chemotherapy every 21 days for 6 cycles, followed by MR for 2 years. Transplant-eligible patients had the option of autologous stem cell transplantation (ASCT) consolidation instead of MR. The primary end point was the complete response (CR) rate to VcR-CVAD. The secondary end points were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and toxicities. Seventy-five eligible patients with a median age of 62 (range 40-76) were enrolled. The ORR was 95% and a CR was achieved in 68% of patients. After a median follow-up of 4.5 years, 3-year PFS and OS were 72% and 88%, respectively. No substantial difference in PFS or OS was observed between patients treated with MR (n = 44) vs ASCT (n = 22). There were no unexpected toxicities. VcR-CVAD produced highORRand CRrates in mantle cell lymphoma. MR after VcR-CVAD induction performed similarly to ASCT and may improve response duration. Randomized clinical trials comparing MR against ASCT should be considered and randomized clinical trials evaluating bortezomib's contribution to conventional therapy are under way. This study was registered at www.clinicaltrials.gov as #NCT00433537.

AB - Rituximab, bortezomib, modified hyper-cyclophosphamide, doxorubicin, vincristine, dexamethasone (VcR-CVAD) induction chemoimmunotherapy and maintenance rituximab (MR) were evaluated for efficacy and safety in Eastern Cooperative Oncology Group protocol E1405. Patients with previously untreated mantle cell lymphoma received VcR-CVAD chemotherapy every 21 days for 6 cycles, followed by MR for 2 years. Transplant-eligible patients had the option of autologous stem cell transplantation (ASCT) consolidation instead of MR. The primary end point was the complete response (CR) rate to VcR-CVAD. The secondary end points were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and toxicities. Seventy-five eligible patients with a median age of 62 (range 40-76) were enrolled. The ORR was 95% and a CR was achieved in 68% of patients. After a median follow-up of 4.5 years, 3-year PFS and OS were 72% and 88%, respectively. No substantial difference in PFS or OS was observed between patients treated with MR (n = 44) vs ASCT (n = 22). There were no unexpected toxicities. VcR-CVAD produced highORRand CRrates in mantle cell lymphoma. MR after VcR-CVAD induction performed similarly to ASCT and may improve response duration. Randomized clinical trials comparing MR against ASCT should be considered and randomized clinical trials evaluating bortezomib's contribution to conventional therapy are under way. This study was registered at www.clinicaltrials.gov as #NCT00433537.

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