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Volume 336:1641-1648 June 5, 1997 Number 23
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Low-Dose Compared with Standard-Dose m-BACOD Chemotherapy for Non-Hodgkin's Lymphoma Associated with Human Immunodeficiency Virus Infection
Lawrence D. Kaplan, M.D., David J. Straus, M.D., Marcia A. Testa, M.P.H., Ph.D., Jamie Von Roenn, M.D., Bruce J. Dezube, M.D., Timothy P. Cooley, M.D., Brian Herndier, M.D., Ph.D., Donald W. Northfelt, M.D., Jenny Huang, M.S., Anil Tulpule, M.D., Alexandra M. Levine, M.D., for The National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group

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ABSTRACT

Background Reduced doses of cytotoxic chemotherapy or standard-dose therapy plus a myeloid colony-stimulating factor decreases hematologic toxicity and its complications in patients with non-Hodgkin's lymphoma associated with infection with the human immunodeficiency virus (HIV). However, the effect of reducing the doses of cytotoxic chemotherapeutic agents on clinical outcome is not known.

Methods We randomly assigned 198 HIV-seropositive patients with previously untreated, aggressive non-Hodgkin's lymphoma to receive standard-dose therapy with methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone (m-BACOD) along with granulocyte–macrophage colony-stimulating factor (GM-CSF; n = 94) or reduced-dose m-BACOD with GM-CSF administered only as indicated (n = 98).

Results A complete response was achieved in 39 of the 94 assessable patients assigned to low-dose therapy (41 percent) and in 42 of the 81 assessable patients assigned to standard-dose therapy (52 percent, P = 0.56). There were no significant differences in overall or disease-free survival; median survival times were 35 weeks for patients receiving low-dose therapy and 31 weeks for those receiving standard-dose therapy (risk ratio for death in the standard-dose group, 1.17; 95 percent confidence interval, 0.84 to 1.63; P =0.25). Toxic effects of chemotherapy rated grade 3 or higher occurred in 66 of 94 patients assigned to standard-dose therapy (70 percent) and 50 of 98 patients assigned to low-dose treatment (51 percent, P = 0.008). Hematologic toxicity accounted for the difference.

Conclusions As compared with treatment with standard doses of cytotoxic chemotherapy (m-BACOD), reduced doses caused significantly fewer hematologic toxic effects yet had similar efficacy in patients with HIV-related lymphoma. Dose-modified chemotherapy should be considered for most HIV-infected patients with lymphoma.


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From the Departments of Medicine (L.D.K.) and Pathology (B.H.), San Francisco General Hospital, and the Department of Medicine, University of California, San Francisco (L.D.K., D.W.N.) — both in San Francisco; Memorial Sloan-Kettering Cancer Center and Cornell University Medical College, New York (D.J.S.); the Statistics and Data Analysis Center, Harvard School of Public Health, Boston (M.A.T., J.H.); the Department of Hematology–Oncology, Northwestern University, Chicago (J.V.R.); Beth Israel Deaconess Medical Center, Boston (B.J.D.); the Sections of Hematology and Oncology, Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston (T.P.C.); and the University of Southern California – Norris Cancer Hospital, University of Southern California School of Medicine, Los Angeles (A.T., A.M.L.).

Address reprint requests to Dr. Kaplan at the University of California, San Francisco – San Francisco General Hospital AIDS Program, Oncology Division, Ward 84, 995 Potrero Ave., San Francisco, CA 94110.

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Related Letters:

Chemotherapy for AIDS-Related Lymphomas
Wilson W. H., Sparano J., Kaplan L. D., Straus D. J., Testa M. A.
Extract | Full Text  
N Engl J Med 1997; 337:1172-1174, Oct 16, 1997. Correspondence

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