AEGiS-10CROI: CHOP Chemotherapy Plus Rituximab in HIV Patients with High-grade Lymphoma-Results of an ANRS Trial.

10th Conference on Retroviruses and Opportunistic Infections

Boston, MA USA - February 10 -14, 2003

CHOP Chemotherapy Plus Rituximab in HIV Patients with High-grade Lymphoma-Results of an ANRS Trial.

Conf Retroviruses Opportunistic Infect 2003 Feb 10-14;10th: abstract no. 805
BOUE F, GABARRE J, GISSELBRECHT C, REYNES J, CHERET A, BONNET F, BILLAUD E, RAPHAEL M, LANCAR R, COSTAGLIOLA D; Hosp Antoine Beclere, Clamart, France

BACKGROUND: HIV infection is associated with a high incidence of AIDS-related lymphomas (ARL). Since the use of highly active antiretroviral therapy (HAART), the incidence of AIDS-defining illnesses has decreased, leading to a significant improvement in survival of HIV-infected patients (pts). The incidence of ARL has decreased in a lower degree and lymphoma remains the major cause of death of HIV pts. Most treatment procedures disclose a relatively poor outcome of pts with low response rates, high number of relapses, and AIDS events. Since the majority of HIV-associated NHL are CD20-positive the addition of rituximab to the standard regimen-CHOP could improve the outcome of these pts.

METHODS: We conducted a phase II multicentric trial (ANRS 085) to evaluate the efficacy and safety of 6 cycles of CHOP plus rituximab 375 mg/m2 given on day 1 of each cycle.

RESULTS: Sixty-one (61) pts were enrolled, 60 are evaluable for safety, 50 are evaluable for the primary end-point, which is tumor response at the end of the 6 cycles. Characteristics of pts were: median age: 42 yrs male sex 54/61; histology: DLCL 43 (72%), Burkitt 6 (10%), Burkitt Like 8 (13%), Immunoblastic 2 (3%), unclassified 1 (1.5%); stage: III-IV (66%), 78% were extra nodal, International Prognostic Index: 0-1 (66%), 2 (25%), 3 (7%), median CD4 count: 171/ml, median viral load = 6930 cp /ml. 26/60 (43%) pts had GCSF at first cycle. Grade 3 or 4 toxicity was observed as follows: febrile neutropenia 9 pts, anemia 16pts, Thrombocytopenia 5 pts, bacterial infection 34%, opportunistic infection 3. At the end of the therapeutic procedure pts were evaluated for response: Complete remission CR and CRU was achieved in 40 of the 50 evaluable (80%) pts, partial remission in 4 and 6 pts were in progression. Four (4) pts died during treatment. Among CR and CRU pts, 7 relapsed. After a median follow-up of 18 mos the median overall survival is not reached. At this time, among 18 deaths, 17 are related to lymphoma.

CONCLUSIONS: These findings suggest that the combination of rituximab with CHOP in pts with HIV-associated NHL is safe and feasible and that the addition of the anti-CD20 antibody does not increase the risk for infections. The high complete remission rate also indicates a potential therapeutic benefit and may confirm the advantage of the CHOP-Rituximab regimen as it has been shown in elderly people.

Keywords: AEGIS, Vincristine, Cyclophosphamide, Doxorubicin, Prednisone, Antineoplastic Combined Chemotherapy Protocols, CHOP protocol, Antibodies, Monoclonal, rituximab, Antineoplastic Agents, Antigens, CD20, Antiretroviral Therapy, Highly Active, Prednisolone, Male, Human, drug therapy

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Copyright © 2003 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.