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Article
July 3, 1991

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

Author Affiliations

From the University of Southern California School of Medicine and the Los Angeles County-USC Medical Center, Los Angeles (Drs Levine, Rarick, Nathwani, and Gill); New York (NY) University (Drs Wernz and Walsh); University of California at San Francisco and the San Francisco General Hospital (Drs Kaplan and Kahn); Research Triangle Institute, Research Triangle Park, NC (Mr Rodman); George Washington University, Washington, DC (Dr Cohen); Saint Lukes-Roosevelt Medical Center, New York, NY (Dr Metroka); University of Rochester (NY) Cancer Center (Dr Bennett); Pennsylvania State College of Medicine, Hershey (Dr Ehmann); University of California, Los Angeles (Drs Miles and Mitsuyasu); and the Division of AIDS (AIDS Clinical Trials Units) of the National Institute of Allergy and Infectious Disease, Bethesda, Md (Dr Feinberg).

From the University of Southern California School of Medicine and the Los Angeles County-USC Medical Center, Los Angeles (Drs Levine, Rarick, Nathwani, and Gill); New York (NY) University (Drs Wernz and Walsh); University of California at San Francisco and the San Francisco General Hospital (Drs Kaplan and Kahn); Research Triangle Institute, Research Triangle Park, NC (Mr Rodman); George Washington University, Washington, DC (Dr Cohen); Saint Lukes-Roosevelt Medical Center, New York, NY (Dr Metroka); University of Rochester (NY) Cancer Center (Dr Bennett); Pennsylvania State College of Medicine, Hershey (Dr Ehmann); University of California, Los Angeles (Drs Miles and Mitsuyasu); and the Division of AIDS (AIDS Clinical Trials Units) of the National Institute of Allergy and Infectious Disease, Bethesda, Md (Dr Feinberg).

JAMA. 1991;266(1):84-88. doi:10.1001/jama.1991.03470010088036
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.(JAMA. 1991;266:84-88)

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