Phase II Trial of 131-Iodine Tositumomab with High-Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed Diffuse Large B Cell Lymphoma

Julie Marie Vose, Philip Jay Bierman, Fausto R. Loberiza, Charles Arthur Enke, Jordan Hankins, Robert G Bociek, Wing C. Chan, Dennis D. Weisenburger, James Olen Armitage

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Abstract

The purpose of this study was to evaluate the standard outpatient dose of 131-Iodine tositumomab (75 cGy) combined with high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM) followed by autologous stem cell rescue for the treatment of chemotherapy-sensitive relapsed or refractory, or high-risk first complete remission (CR) patients with diffuse large B cell non-Hodgkin's lymphoma (DLBCL). Forty patients with chemotherapy-sensitive persistent or relapsed or high/intermediate or high international prognostic index DLCBL were treated in a phase II trial combining 75 cGy 131-Iodine tositumomab with high-dose BEAM followed by autologous stem cell transplantation. The CR rate after transplantation was 78%, and the overall response rate was 80%. Short-term and long-term toxicities were similar to historical control patients treated with BEAM alone. With a median follow-up of 6 years (range, 3-10 years), the 5-year overall survival (OS) was 72% (95% confidence interval [CI], 55%-83%), and the 5-year progression-free survival (PFS) rate was 70% (95% CI, 53%-82%). The PFS and OS were encouraging in this group of chemotherapy-sensitive persistent, relapsed, or high-risk patients with DLBCL. A follow-up phase III trial with 131-Iodine tositumomab/BEAM vs rituximab/BEAM was planned based on this information.

Original languageEnglish (US)
Pages (from-to)123-128
Number of pages6
JournalBiology of Blood and Marrow Transplantation
Volume19
Issue number1
DOIs
StatePublished - Jan 1 2013

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Lymphoma, Large B-Cell, Diffuse
Stem Cell Transplantation
Drug Therapy
B-Cell Lymphoma
Non-Hodgkin's Lymphoma
Disease-Free Survival
Confidence Intervals
Carmustine
Melphalan
Survival
Cytarabine
Etoposide
Outpatients
Stem Cells
Survival Rate
Transplantation
iodine-131 anti-B1 antibody
Therapeutics

Keywords

  • 131-Iodine tositumomab
  • Autologous stem cell transplantation
  • Diffuse large B cell lymphoma
  • Radioimmunotherapy

ASJC Scopus subject areas

  • Hematology
  • Transplantation

Cite this

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title = "Phase II Trial of 131-Iodine Tositumomab with High-Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed Diffuse Large B Cell Lymphoma",
abstract = "The purpose of this study was to evaluate the standard outpatient dose of 131-Iodine tositumomab (75 cGy) combined with high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM) followed by autologous stem cell rescue for the treatment of chemotherapy-sensitive relapsed or refractory, or high-risk first complete remission (CR) patients with diffuse large B cell non-Hodgkin's lymphoma (DLBCL). Forty patients with chemotherapy-sensitive persistent or relapsed or high/intermediate or high international prognostic index DLCBL were treated in a phase II trial combining 75 cGy 131-Iodine tositumomab with high-dose BEAM followed by autologous stem cell transplantation. The CR rate after transplantation was 78{\%}, and the overall response rate was 80{\%}. Short-term and long-term toxicities were similar to historical control patients treated with BEAM alone. With a median follow-up of 6 years (range, 3-10 years), the 5-year overall survival (OS) was 72{\%} (95{\%} confidence interval [CI], 55{\%}-83{\%}), and the 5-year progression-free survival (PFS) rate was 70{\%} (95{\%} CI, 53{\%}-82{\%}). The PFS and OS were encouraging in this group of chemotherapy-sensitive persistent, relapsed, or high-risk patients with DLBCL. A follow-up phase III trial with 131-Iodine tositumomab/BEAM vs rituximab/BEAM was planned based on this information.",
keywords = "131-Iodine tositumomab, Autologous stem cell transplantation, Diffuse large B cell lymphoma, Radioimmunotherapy",
author = "Vose, {Julie Marie} and Bierman, {Philip Jay} and Loberiza, {Fausto R.} and Enke, {Charles Arthur} and Jordan Hankins and Bociek, {Robert G} and Chan, {Wing C.} and Weisenburger, {Dennis D.} and Armitage, {James Olen}",
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doi = "10.1016/j.bbmt.2012.08.013",
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T1 - Phase II Trial of 131-Iodine Tositumomab with High-Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed Diffuse Large B Cell Lymphoma

AU - Vose, Julie Marie

AU - Bierman, Philip Jay

AU - Loberiza, Fausto R.

AU - Enke, Charles Arthur

AU - Hankins, Jordan

AU - Bociek, Robert G

AU - Chan, Wing C.

AU - Weisenburger, Dennis D.

AU - Armitage, James Olen

PY - 2013/1/1

Y1 - 2013/1/1

N2 - The purpose of this study was to evaluate the standard outpatient dose of 131-Iodine tositumomab (75 cGy) combined with high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM) followed by autologous stem cell rescue for the treatment of chemotherapy-sensitive relapsed or refractory, or high-risk first complete remission (CR) patients with diffuse large B cell non-Hodgkin's lymphoma (DLBCL). Forty patients with chemotherapy-sensitive persistent or relapsed or high/intermediate or high international prognostic index DLCBL were treated in a phase II trial combining 75 cGy 131-Iodine tositumomab with high-dose BEAM followed by autologous stem cell transplantation. The CR rate after transplantation was 78%, and the overall response rate was 80%. Short-term and long-term toxicities were similar to historical control patients treated with BEAM alone. With a median follow-up of 6 years (range, 3-10 years), the 5-year overall survival (OS) was 72% (95% confidence interval [CI], 55%-83%), and the 5-year progression-free survival (PFS) rate was 70% (95% CI, 53%-82%). The PFS and OS were encouraging in this group of chemotherapy-sensitive persistent, relapsed, or high-risk patients with DLBCL. A follow-up phase III trial with 131-Iodine tositumomab/BEAM vs rituximab/BEAM was planned based on this information.

AB - The purpose of this study was to evaluate the standard outpatient dose of 131-Iodine tositumomab (75 cGy) combined with high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM) followed by autologous stem cell rescue for the treatment of chemotherapy-sensitive relapsed or refractory, or high-risk first complete remission (CR) patients with diffuse large B cell non-Hodgkin's lymphoma (DLBCL). Forty patients with chemotherapy-sensitive persistent or relapsed or high/intermediate or high international prognostic index DLCBL were treated in a phase II trial combining 75 cGy 131-Iodine tositumomab with high-dose BEAM followed by autologous stem cell transplantation. The CR rate after transplantation was 78%, and the overall response rate was 80%. Short-term and long-term toxicities were similar to historical control patients treated with BEAM alone. With a median follow-up of 6 years (range, 3-10 years), the 5-year overall survival (OS) was 72% (95% confidence interval [CI], 55%-83%), and the 5-year progression-free survival (PFS) rate was 70% (95% CI, 53%-82%). The PFS and OS were encouraging in this group of chemotherapy-sensitive persistent, relapsed, or high-risk patients with DLBCL. A follow-up phase III trial with 131-Iodine tositumomab/BEAM vs rituximab/BEAM was planned based on this information.

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