Low-Dose Chemotherapy With Central Nervous System Prophylaxis and Zidovudine Maintenance in AIDS-Related Lymphoma: A Prospective Multi-Institutional Trial

Alexandra M. Levine, James C. Wernz, Lawrence Kaplan, Nat Rodman, Philip Cohen, Craig Metroka, John M. Bennett, Mark U. Rarick, Christine Walsh, James Kahn, Steven Miles, W. Christopher Ehmann, Judith Feinberg, Bharat Nathwani, Parkash S. Gill, Ron Mitsuyasu

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Abstract

Objective.—To ascertain if low-dose multiagent chemotherapy, with central nervous system prophylaxis and antiretroviral therapy, might be associated with increased efficacy and decreased risk of intercurrent infection in patients with malignant lymphoma related to the acquired immunodeficiency syndrome (AIDS). Design.—A phase II prospective clinical trial, with median follow-up of 33 months. Setting.—Eight university hospitals, within the context of the AIDS Clinical Trials Units, sponsored by the National Institute of Allergy and Infectious Diseases. Patients.—Forty-two patients with AIDS-related malignant lymphoma. All were evaluable for toxicity assessment, and 35 for response. Intervention.—A low-dose modification of the M-BACOD regimen (day 1): cyclophosphamide, 300 mg/m2 intravenously (IV); doxorubicin, 25 mg/m2 IV; vincristine sulfate, 1.4 mg/m2 IV; bleomycin, 4 mg/m2 IV; dexamethasone, 3 mg/m2 orally on days 1 through 5; methotrexate, 500 mg/m2 IV on day 15, with leucovorin rescue. Intrathecal cytosine arabinoside (50 mg) to all on days 1, 8, 21, and 28, with radiation therapy to a helmet field to those with central nervous system involvement. Zidovudine for 12 months after completion of four to six cycles of chemotherapy. Main Outcome Measures.—Response rate and number of opportunistic infections. Results.—Response rate was 51% with a complete response of 46%. Of 16 complete responses, relapse occurred in four, none isolated to the central nervous system. Opportunistic infections occurred in 21% of those receiving treatment. Median duration of survival among all 42 patients is 5.6 months, 6.5 months in 35 patients evaluable for response, and 15 months in patients with complete response. Lower concentration of CD4 cells, history of prior AIDS, bone marrow involvement, and stage IV disease were independently associated with decreased survival. Conclusions.—Low-dose chemotherapy with central nervous system prophylaxis and zidovudine maintenance may be associated with durable remissions in AIDS-related lymphoma with fewer opportunistic infections than noted in prior reports.

Original languageEnglish (US)
Pages (from-to)84-88
Number of pages5
JournalJAMA: The Journal of the American Medical Association
Volume266
Issue number1
DOIs
StatePublished - Jul 3 1991

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Zidovudine
Lymphoma
Acquired Immunodeficiency Syndrome
Central Nervous System
Maintenance
Drug Therapy
Opportunistic Infections
National Institute of Allergy and Infectious Diseases (U.S.)
Head Protective Devices
Phase II Clinical Trials
Survival
Leucovorin
Cytarabine
Bleomycin
Vincristine
Methotrexate
Doxorubicin
Cyclophosphamide
Dexamethasone
Radiotherapy

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Levine, Alexandra M. ; Wernz, James C. ; Kaplan, Lawrence ; Rodman, Nat ; Cohen, Philip ; Metroka, Craig ; Bennett, John M. ; Rarick, Mark U. ; Walsh, Christine ; Kahn, James ; Miles, Steven ; Ehmann, W. Christopher ; Feinberg, Judith ; Nathwani, Bharat ; Gill, Parkash S. ; Mitsuyasu, Ron. / Low-Dose Chemotherapy With Central Nervous System Prophylaxis and Zidovudine Maintenance in AIDS-Related Lymphoma : A Prospective Multi-Institutional Trial. In: JAMA: The Journal of the American Medical Association. 1991 ; Vol. 266, No. 1. pp. 84-88.
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title = "Low-Dose Chemotherapy With Central Nervous System Prophylaxis and Zidovudine Maintenance in AIDS-Related Lymphoma: A Prospective Multi-Institutional Trial",
abstract = "Objective.—To ascertain if low-dose multiagent chemotherapy, with central nervous system prophylaxis and antiretroviral therapy, might be associated with increased efficacy and decreased risk of intercurrent infection in patients with malignant lymphoma related to the acquired immunodeficiency syndrome (AIDS). Design.—A phase II prospective clinical trial, with median follow-up of 33 months. Setting.—Eight university hospitals, within the context of the AIDS Clinical Trials Units, sponsored by the National Institute of Allergy and Infectious Diseases. Patients.—Forty-two patients with AIDS-related malignant lymphoma. All were evaluable for toxicity assessment, and 35 for response. Intervention.—A low-dose modification of the M-BACOD regimen (day 1): cyclophosphamide, 300 mg/m2 intravenously (IV); doxorubicin, 25 mg/m2 IV; vincristine sulfate, 1.4 mg/m2 IV; bleomycin, 4 mg/m2 IV; dexamethasone, 3 mg/m2 orally on days 1 through 5; methotrexate, 500 mg/m2 IV on day 15, with leucovorin rescue. Intrathecal cytosine arabinoside (50 mg) to all on days 1, 8, 21, and 28, with radiation therapy to a helmet field to those with central nervous system involvement. Zidovudine for 12 months after completion of four to six cycles of chemotherapy. Main Outcome Measures.—Response rate and number of opportunistic infections. Results.—Response rate was 51{\%} with a complete response of 46{\%}. Of 16 complete responses, relapse occurred in four, none isolated to the central nervous system. Opportunistic infections occurred in 21{\%} of those receiving treatment. Median duration of survival among all 42 patients is 5.6 months, 6.5 months in 35 patients evaluable for response, and 15 months in patients with complete response. Lower concentration of CD4 cells, history of prior AIDS, bone marrow involvement, and stage IV disease were independently associated with decreased survival. Conclusions.—Low-dose chemotherapy with central nervous system prophylaxis and zidovudine maintenance may be associated with durable remissions in AIDS-related lymphoma with fewer opportunistic infections than noted in prior reports.",
author = "Levine, {Alexandra M.} and Wernz, {James C.} and Lawrence Kaplan and Nat Rodman and Philip Cohen and Craig Metroka and Bennett, {John M.} and Rarick, {Mark U.} and Christine Walsh and James Kahn and Steven Miles and Ehmann, {W. Christopher} and Judith Feinberg and Bharat Nathwani and Gill, {Parkash S.} and Ron Mitsuyasu",
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Levine, AM, Wernz, JC, Kaplan, L, Rodman, N, Cohen, P, Metroka, C, Bennett, JM, Rarick, MU, Walsh, C, Kahn, J, Miles, S, Ehmann, WC, Feinberg, J, Nathwani, B, Gill, PS & Mitsuyasu, R 1991, 'Low-Dose Chemotherapy With Central Nervous System Prophylaxis and Zidovudine Maintenance in AIDS-Related Lymphoma: A Prospective Multi-Institutional Trial', JAMA: The Journal of the American Medical Association, vol. 266, no. 1, pp. 84-88. https://doi.org/10.1001/jama.1991.03470010088036

Low-Dose Chemotherapy With Central Nervous System Prophylaxis and Zidovudine Maintenance in AIDS-Related Lymphoma : A Prospective Multi-Institutional Trial. / Levine, Alexandra M.; Wernz, James C.; Kaplan, Lawrence; Rodman, Nat; Cohen, Philip; Metroka, Craig; Bennett, John M.; Rarick, Mark U.; Walsh, Christine; Kahn, James; Miles, Steven; Ehmann, W. Christopher; Feinberg, Judith; Nathwani, Bharat; Gill, Parkash S.; Mitsuyasu, Ron.

In: JAMA: The Journal of the American Medical Association, Vol. 266, No. 1, 03.07.1991, p. 84-88.

Research output: Contribution to journalArticle

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T1 - Low-Dose Chemotherapy With Central Nervous System Prophylaxis and Zidovudine Maintenance in AIDS-Related Lymphoma

T2 - A Prospective Multi-Institutional Trial

AU - Levine, Alexandra M.

AU - Wernz, James C.

AU - Kaplan, Lawrence

AU - Rodman, Nat

AU - Cohen, Philip

AU - Metroka, Craig

AU - Bennett, John M.

AU - Rarick, Mark U.

AU - Walsh, Christine

AU - Kahn, James

AU - Miles, Steven

AU - Ehmann, W. Christopher

AU - Feinberg, Judith

AU - Nathwani, Bharat

AU - Gill, Parkash S.

AU - Mitsuyasu, Ron

PY - 1991/7/3

Y1 - 1991/7/3

N2 - Objective.—To ascertain if low-dose multiagent chemotherapy, with central nervous system prophylaxis and antiretroviral therapy, might be associated with increased efficacy and decreased risk of intercurrent infection in patients with malignant lymphoma related to the acquired immunodeficiency syndrome (AIDS). Design.—A phase II prospective clinical trial, with median follow-up of 33 months. Setting.—Eight university hospitals, within the context of the AIDS Clinical Trials Units, sponsored by the National Institute of Allergy and Infectious Diseases. Patients.—Forty-two patients with AIDS-related malignant lymphoma. All were evaluable for toxicity assessment, and 35 for response. Intervention.—A low-dose modification of the M-BACOD regimen (day 1): cyclophosphamide, 300 mg/m2 intravenously (IV); doxorubicin, 25 mg/m2 IV; vincristine sulfate, 1.4 mg/m2 IV; bleomycin, 4 mg/m2 IV; dexamethasone, 3 mg/m2 orally on days 1 through 5; methotrexate, 500 mg/m2 IV on day 15, with leucovorin rescue. Intrathecal cytosine arabinoside (50 mg) to all on days 1, 8, 21, and 28, with radiation therapy to a helmet field to those with central nervous system involvement. Zidovudine for 12 months after completion of four to six cycles of chemotherapy. Main Outcome Measures.—Response rate and number of opportunistic infections. Results.—Response rate was 51% with a complete response of 46%. Of 16 complete responses, relapse occurred in four, none isolated to the central nervous system. Opportunistic infections occurred in 21% of those receiving treatment. Median duration of survival among all 42 patients is 5.6 months, 6.5 months in 35 patients evaluable for response, and 15 months in patients with complete response. Lower concentration of CD4 cells, history of prior AIDS, bone marrow involvement, and stage IV disease were independently associated with decreased survival. Conclusions.—Low-dose chemotherapy with central nervous system prophylaxis and zidovudine maintenance may be associated with durable remissions in AIDS-related lymphoma with fewer opportunistic infections than noted in prior reports.

AB - Objective.—To ascertain if low-dose multiagent chemotherapy, with central nervous system prophylaxis and antiretroviral therapy, might be associated with increased efficacy and decreased risk of intercurrent infection in patients with malignant lymphoma related to the acquired immunodeficiency syndrome (AIDS). Design.—A phase II prospective clinical trial, with median follow-up of 33 months. Setting.—Eight university hospitals, within the context of the AIDS Clinical Trials Units, sponsored by the National Institute of Allergy and Infectious Diseases. Patients.—Forty-two patients with AIDS-related malignant lymphoma. All were evaluable for toxicity assessment, and 35 for response. Intervention.—A low-dose modification of the M-BACOD regimen (day 1): cyclophosphamide, 300 mg/m2 intravenously (IV); doxorubicin, 25 mg/m2 IV; vincristine sulfate, 1.4 mg/m2 IV; bleomycin, 4 mg/m2 IV; dexamethasone, 3 mg/m2 orally on days 1 through 5; methotrexate, 500 mg/m2 IV on day 15, with leucovorin rescue. Intrathecal cytosine arabinoside (50 mg) to all on days 1, 8, 21, and 28, with radiation therapy to a helmet field to those with central nervous system involvement. Zidovudine for 12 months after completion of four to six cycles of chemotherapy. Main Outcome Measures.—Response rate and number of opportunistic infections. Results.—Response rate was 51% with a complete response of 46%. Of 16 complete responses, relapse occurred in four, none isolated to the central nervous system. Opportunistic infections occurred in 21% of those receiving treatment. Median duration of survival among all 42 patients is 5.6 months, 6.5 months in 35 patients evaluable for response, and 15 months in patients with complete response. Lower concentration of CD4 cells, history of prior AIDS, bone marrow involvement, and stage IV disease were independently associated with decreased survival. Conclusions.—Low-dose chemotherapy with central nervous system prophylaxis and zidovudine maintenance may be associated with durable remissions in AIDS-related lymphoma with fewer opportunistic infections than noted in prior reports.

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