Authors: | Sparano, J. A.; Lee, J. Y.; Kaplan, L. D.; Levine, A. M.; Ramos, J. C.; Ambinder, R. F.; Wachsman, W.; Aboulafia, D.; Noy, A.; Henry, D. H.; Von Roenn, J.; Dezube, B. J.; Remick, S. C.; Shah, M. H.; Leichman, L.; Ratner, L.; Cesarman, E.; Chadburn, A.; Mitsuyasu, R. |
Article Title: | Rituximab plus concurrent infusional EPOCH chemotherapy is highly effective in HIV-associated B-cell non-Hodgkin lymphoma |
Abstract: | Rituximab plus intravenous bolus chemotherapy is a standard treatment for immunocompetent patients with B-cell non-Hodgkin lymphoma (NHL). Some studies have suggested that rituximab is associated with excessive toxicity in HIV-associated NHL, and that infusional chemotherapy may be more effective. We performed a randomized phase 2 trial of rituximab (375 mg/m2) given either concurrently before each infusional etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH) chemotherapy cycle or sequentially (weekly for 6 weeks) after completion of all chemotherapy in HIV-associated NHL. EPOCH consisted of a 96-hour intravenous infusion of etoposide, doxorubicin, and vincristine plus oral prednisone followed by intravenous bolus cyclophosphamide given every 21 days for 4 to 6 cycles. In the concurrent arm, 35 of 48 evaluable patients (73%; 95% confidence interval, 58%-85%) had a complete response. In the sequential arm, 29 of 53 evaluable patients (55%; 95% confidence interval, 41%-68%) had a complete response. The primary efficacy endpoint was met for the concurrent arm only. Toxicity was comparable in the 2 arms, although patients with a baseline CD4 count less than 50/μL had a high infectious death rate in the concurrent arm.We conclude that concurrent rituximab plus infusional EPOCH is an effective regimen for HIV-associated lymphoma. This study is registered at http://clinicaltrials.gov as NCT00049036. © 2010 by The American Society of Hematology. |
Keywords: | adult; cancer chemotherapy; treatment outcome; disease-free survival; middle aged; major clinical study; prednisone; clinical trial; constipation; mortality; neutropenia; doxorubicin; drug efficacy; drug withdrawal; side effect; antineoplastic agents; cancer patient; cytarabine; methotrexate; rituximab; human immunodeficiency virus infection; neurotoxicity; controlled clinical trial; infection; multiple cycle treatment; anemia; etoposide; blood toxicity; mucosa inflammation; neuropathy; randomized controlled trial; thrombocytopenia; antineoplastic combined chemotherapy protocols; cyclophosphamide; vincristine; b lymphocyte; drug dose escalation; febrile neutropenia; fever; confidence interval; hypotension; lymphoma, b-cell; antibodies, monoclonal; nonhodgkin lymphoma; disease progression; ciprofloxacin; drug infusion; human immunodeficiency virus; antiretrovirus agent; cd4 lymphocyte count; cd4 antigen; recombinant granulocyte colony stimulating factor; cotrimoxazole; quinoline derived antiinfective agent; infusions, intravenous; bilirubin blood level; recombinant erythropoietin; fluconazole; hiv; creatinine clearance; walking difficulty |
Journal Title: | Blood |
Volume: | 115 |
Issue: | 15 |
ISSN: | 0006-4971 |
Publisher: | American Society of Hematology |
Date Published: | 2010-04-15 |
Start Page: | 3008 |
End Page: | 3016 |
Language: | English |
DOI: | 10.1182/blood-2009-08-231613 |
PUBMED: | 20023215 |
PROVIDER: | scopus |
PMCID: | PMC2858478 |
DOI/URL: | |
Notes: | --- - "Cited By (since 1996): 5" - "Export Date: 20 April 2011" - "CODEN: BLOOA" - "Source: Scopus" |