AMC 048: modified CODOX-M/IVAC-rituximab is safe and effective for HIV-associated Burkitt lymphoma
Ariela Noy, Jeannette Y Lee, Ethel Cesarman, Richard Ambinder, Robert Baiocchi, Erin Reid, Lee Ratner, Nina Wagner-Johnston, Lawrence Kaplan, AIDS Malignancy Consortium, Joseph Sparano, Bruce Dezube, Yvette Kasamon, Ariela Noy, Robert Baiocchi, David Henry, William Wachsman, Lawrence Kaplan, Ronald Mitsuyasu, Parkash Gill, David Aboulafia, Lee Ratner, Michael Craig, Ariela Noy, Jeannette Y Lee, Ethel Cesarman, Richard Ambinder, Robert Baiocchi, Erin Reid, Lee Ratner, Nina Wagner-Johnston, Lawrence Kaplan, AIDS Malignancy Consortium, Joseph Sparano, Bruce Dezube, Yvette Kasamon, Ariela Noy, Robert Baiocchi, David Henry, William Wachsman, Lawrence Kaplan, Ronald Mitsuyasu, Parkash Gill, David Aboulafia, Lee Ratner, Michael Craig
Abstract
The toxicity of dose-intensive regimens used for Burkitt lymphoma prompted modification of cyclophosphamide, vincristine, doxorubicin, high-dose methotrexate/ifosfamide, etoposide, and high-dose cytarabine (CODOX-M/IVAC) for HIV-positive patients. We added rituximab, reduced and/or rescheduled cyclophosphamide and methotrexate, capped vincristine, and used combination intrathecal chemotherapy. Antibiotic prophylaxis and growth factor support were required; highly active antiretroviral therapy (HAART) was discretionary. Thirteen AIDS Malignancy Consortium centers enrolled 34 patients from 2007 to 2010. Median age was 42 years (range, 19-55 years), 32 of 34 patients were high risk, 74% had stage III to IV BL and CD4 count of 195 cells per μL (range, 0-721 cells per μL), and 5 patients (15%) had CD4 <100 cells per μL. Twenty-six patients were receiving HAART; viral load was <100 copies per mL in 12 patients. Twenty-seven patients had at least one grade 3 to 5 toxicity, including 20 hematologic, 14 infectious, and 6 metabolic. None had grade 3 to 4 mucositis. Five patients did not complete treatments because of adverse events. Eleven patients died, including 1 treatment-related and 8 disease-related deaths. The 1-year progression-free survival was 69% (95% confidence interval [CI], 51%-82%) and overall survival was 72% (95% CI, 53%-84%); 2-year overall survival was 69% (95% CI, 50%-82%). Modifications of the CODOX-M/IVAC regimen resulted in a grade 3 to 4 toxicity rate of 79%, which was lower than that in the parent regimen (100%), without grade 3 to 4 mucositis. Despite a 68% protocol completion rate, the 1-year survival rate compares favorably with 2 studies that excluded HIV-positive patients. This trial was registered at https://ichgcp.net/clinical-trials-registry/NCT00392834" title="See in ClinicalTrials.gov">#NCT00392834.
© 2015 by The American Society of Hematology.
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Source: PubMed