Rituximab does not improve clinical outcome in a randomized phase 3 trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin lymphoma

AIDS-Malignancies Consortium Trial 010

Lawrence D. Kaplan, Jeannette Y. Lee, Richard F. Ambinder, Joseph A. Sparano, Ethel Cesarman, Amy Chadburn, Alexandra M. Levine, David T. Scadden

Research output: Contribution to journalArticle

302 Citations (Scopus)

Abstract

The addition of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy results in significant improvement in clinical outcome for individuals with non-HIV-associated aggressive B-cell lymphoma. To assess the potential risks and benefits of the addition of rituximab to CHOP for HIV-associated non-Hodgkin lymphoma (HIV-NHL) 150 patients receiving CHOP for HIV-NHL were randomized (2:1) to receive 375 mg/m 2 rituximab with each chemotherapy cycle (n = 99) or no immunotherapy (n = 50) in a multicenter phase 3 trial. The complete response rate (CR + CRu) was 57.6% for R-CHOP and 47% for CHOP (P = .147). With a median follow-up of 137 weeks, time to progression, progression-free survival, and overall survival times were 125, 45, and 139 weeks, respectively, for R-CHOP and 85, 38, and 110 weeks, respectively, for CHOP (P = not significant, all comparisons). Treatment-related infectious deaths occurred in 14% of patients receiving R-CHOP compared with 2% in the chemotherapy-alone group (P = .035). Of these deaths, 60% occurred in patients with CD4 counts less than 50/mm3. Progression-free survival was significantly influenced by CD4+ count (P < .001) and International Prognostic Index score (P = .022), but not bcl-2 status. The addition of rituximab to CHOP in patients with HIV-NHL may be associated with improved tumor responses. However, these benefits may be offset by an increase in infectious deaths, particularly in those individuals with CD4+ lymphocyte counts less than 50/mm3.

Original languageEnglish (US)
Pages (from-to)1538-1543
Number of pages6
JournalBlood
Volume106
Issue number5
DOIs
StatePublished - Sep 1 2005
Externally publishedYes

Fingerprint

Non-Hodgkin's Lymphoma
Chemotherapy
Acquired Immunodeficiency Syndrome
CD4 Lymphocyte Count
HIV
Drug Therapy
Disease-Free Survival
Neoplasms
Lymphocytes
Vincristine
B-Cell Lymphoma
Prednisone
Immunotherapy
Doxorubicin
Cyclophosphamide
Tumors
Cells
Survival
Rituximab
Therapeutics

ASJC Scopus subject areas

  • Hematology

Cite this

Rituximab does not improve clinical outcome in a randomized phase 3 trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin lymphoma : AIDS-Malignancies Consortium Trial 010. / Kaplan, Lawrence D.; Lee, Jeannette Y.; Ambinder, Richard F.; Sparano, Joseph A.; Cesarman, Ethel; Chadburn, Amy; Levine, Alexandra M.; Scadden, David T.

In: Blood, Vol. 106, No. 5, 01.09.2005, p. 1538-1543.

Research output: Contribution to journalArticle

Kaplan, Lawrence D. ; Lee, Jeannette Y. ; Ambinder, Richard F. ; Sparano, Joseph A. ; Cesarman, Ethel ; Chadburn, Amy ; Levine, Alexandra M. ; Scadden, David T. / Rituximab does not improve clinical outcome in a randomized phase 3 trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin lymphoma : AIDS-Malignancies Consortium Trial 010. In: Blood. 2005 ; Vol. 106, No. 5. pp. 1538-1543.
@article{89bd28325c2843cd92f7cb2524a6ad94,
title = "Rituximab does not improve clinical outcome in a randomized phase 3 trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin lymphoma: AIDS-Malignancies Consortium Trial 010",
abstract = "The addition of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy results in significant improvement in clinical outcome for individuals with non-HIV-associated aggressive B-cell lymphoma. To assess the potential risks and benefits of the addition of rituximab to CHOP for HIV-associated non-Hodgkin lymphoma (HIV-NHL) 150 patients receiving CHOP for HIV-NHL were randomized (2:1) to receive 375 mg/m 2 rituximab with each chemotherapy cycle (n = 99) or no immunotherapy (n = 50) in a multicenter phase 3 trial. The complete response rate (CR + CRu) was 57.6{\%} for R-CHOP and 47{\%} for CHOP (P = .147). With a median follow-up of 137 weeks, time to progression, progression-free survival, and overall survival times were 125, 45, and 139 weeks, respectively, for R-CHOP and 85, 38, and 110 weeks, respectively, for CHOP (P = not significant, all comparisons). Treatment-related infectious deaths occurred in 14{\%} of patients receiving R-CHOP compared with 2{\%} in the chemotherapy-alone group (P = .035). Of these deaths, 60{\%} occurred in patients with CD4 counts less than 50/mm3. Progression-free survival was significantly influenced by CD4+ count (P < .001) and International Prognostic Index score (P = .022), but not bcl-2 status. The addition of rituximab to CHOP in patients with HIV-NHL may be associated with improved tumor responses. However, these benefits may be offset by an increase in infectious deaths, particularly in those individuals with CD4+ lymphocyte counts less than 50/mm3.",
author = "Kaplan, {Lawrence D.} and Lee, {Jeannette Y.} and Ambinder, {Richard F.} and Sparano, {Joseph A.} and Ethel Cesarman and Amy Chadburn and Levine, {Alexandra M.} and Scadden, {David T.}",
year = "2005",
month = "9",
day = "1",
doi = "10.1182/blood-2005-04-1437",
language = "English (US)",
volume = "106",
pages = "1538--1543",
journal = "Blood",
issn = "0006-4971",
publisher = "American Society of Hematology",
number = "5",

}

TY - JOUR

T1 - Rituximab does not improve clinical outcome in a randomized phase 3 trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin lymphoma

T2 - AIDS-Malignancies Consortium Trial 010

AU - Kaplan, Lawrence D.

AU - Lee, Jeannette Y.

AU - Ambinder, Richard F.

AU - Sparano, Joseph A.

AU - Cesarman, Ethel

AU - Chadburn, Amy

AU - Levine, Alexandra M.

AU - Scadden, David T.

PY - 2005/9/1

Y1 - 2005/9/1

N2 - The addition of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy results in significant improvement in clinical outcome for individuals with non-HIV-associated aggressive B-cell lymphoma. To assess the potential risks and benefits of the addition of rituximab to CHOP for HIV-associated non-Hodgkin lymphoma (HIV-NHL) 150 patients receiving CHOP for HIV-NHL were randomized (2:1) to receive 375 mg/m 2 rituximab with each chemotherapy cycle (n = 99) or no immunotherapy (n = 50) in a multicenter phase 3 trial. The complete response rate (CR + CRu) was 57.6% for R-CHOP and 47% for CHOP (P = .147). With a median follow-up of 137 weeks, time to progression, progression-free survival, and overall survival times were 125, 45, and 139 weeks, respectively, for R-CHOP and 85, 38, and 110 weeks, respectively, for CHOP (P = not significant, all comparisons). Treatment-related infectious deaths occurred in 14% of patients receiving R-CHOP compared with 2% in the chemotherapy-alone group (P = .035). Of these deaths, 60% occurred in patients with CD4 counts less than 50/mm3. Progression-free survival was significantly influenced by CD4+ count (P < .001) and International Prognostic Index score (P = .022), but not bcl-2 status. The addition of rituximab to CHOP in patients with HIV-NHL may be associated with improved tumor responses. However, these benefits may be offset by an increase in infectious deaths, particularly in those individuals with CD4+ lymphocyte counts less than 50/mm3.

AB - The addition of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy results in significant improvement in clinical outcome for individuals with non-HIV-associated aggressive B-cell lymphoma. To assess the potential risks and benefits of the addition of rituximab to CHOP for HIV-associated non-Hodgkin lymphoma (HIV-NHL) 150 patients receiving CHOP for HIV-NHL were randomized (2:1) to receive 375 mg/m 2 rituximab with each chemotherapy cycle (n = 99) or no immunotherapy (n = 50) in a multicenter phase 3 trial. The complete response rate (CR + CRu) was 57.6% for R-CHOP and 47% for CHOP (P = .147). With a median follow-up of 137 weeks, time to progression, progression-free survival, and overall survival times were 125, 45, and 139 weeks, respectively, for R-CHOP and 85, 38, and 110 weeks, respectively, for CHOP (P = not significant, all comparisons). Treatment-related infectious deaths occurred in 14% of patients receiving R-CHOP compared with 2% in the chemotherapy-alone group (P = .035). Of these deaths, 60% occurred in patients with CD4 counts less than 50/mm3. Progression-free survival was significantly influenced by CD4+ count (P < .001) and International Prognostic Index score (P = .022), but not bcl-2 status. The addition of rituximab to CHOP in patients with HIV-NHL may be associated with improved tumor responses. However, these benefits may be offset by an increase in infectious deaths, particularly in those individuals with CD4+ lymphocyte counts less than 50/mm3.

UR - http://www.scopus.com/inward/record.url?scp=23944508056&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=23944508056&partnerID=8YFLogxK

U2 - 10.1182/blood-2005-04-1437

DO - 10.1182/blood-2005-04-1437

M3 - Article

VL - 106

SP - 1538

EP - 1543

JO - Blood

JF - Blood

SN - 0006-4971

IS - 5

ER -