AMC 048: modified CODOX-M/IVAC-rituximab is safe and effective for HIV-associated Burkitt lymphoma.

TitleAMC 048: modified CODOX-M/IVAC-rituximab is safe and effective for HIV-associated Burkitt lymphoma.
Publication TypeJournal Article
Year of Publication2015
AuthorsNoy A, Lee JY, Cesarman E, Ambinder R, Baiocchi R, Reid E, Ratner L, Wagner-Johnston N, Kaplan L
Corporate AuthorsAIDS Malignancy Consortium
JournalBlood
Volume126
Issue2
Pagination160-6
Date Published2015 Jul 09
ISSN1528-0020
KeywordsAdult, Antibodies, Monoclonal, Murine-Derived, Antineoplastic Combined Chemotherapy Protocols, Antiretroviral Therapy, Highly Active, Burkitt Lymphoma, Cyclophosphamide, Cytarabine, Doxorubicin, Etoposide, Female, HIV Infections, HIV-1, Humans, Ifosfamide, Male, Methotrexate, Middle Aged, Rituximab, Treatment Outcome, Vincristine, Young Adult
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 http://clinicaltrials.gov as #NCT00392834.

DOI10.1182/blood-2015-01-623900
Alternate JournalBlood
PubMed ID25957391
PubMed Central IDPMC4497960
Grant ListP30 CA008748 / CA / NCI NIH HHS / United States
U01 CA121947 / CA / NCI NIH HHS / United States
UM1 CA121947 / CA / NCI NIH HHS / United States
U01CA121947 / CA / NCI NIH HHS / United States
Related Faculty: 
Ethel Cesarman, M.D., Ph.D.

Pathology & Laboratory Medicine 1300 York Avenue New York, NY 10065 Phone: (212) 746-6464
Surgical Pathology: (212) 746-2700