Originally published as JCO Early Release 10.1200/JCO.2005.05.4684 on August 8 2006

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Phase II Trial of CHOP Plus Rituximab in Patients With HIV-Associated Non-Hodgkin's Lymphoma

François Boué, Jean Gabarre, Christian Gisselbrecht, Jacques Reynes, Antoine Cheret, Fabrice Bonnet, Eric Billaud, Martine Raphael, Remi Lancar, Dominique Costagliola

From the Agence Nationale Recherche sur le Sida et les Hépatites Paris; Hôpital Antoine Béclère, Clamart; Université Paris Sud; Hôpital Salpétrière, Paris; Hôpital Saint Louis, Paris; Hòpital Gui de Chauliac, Montpellier; Hôpital Gustave Dron, Tourcoing; Hôpital Saint André, Bordeaux; Hôtel Dieu, Nantes; Hôpital Bicêtre, Le Kremlin Bicêtre; INSERM U720 and Université Pierre et Marie Curie, Paris, France

Address reprint requests to François Boué, Hopital Antoine Beclere, 157 rue de la porte de Trivaux 92140 Clamart, Clamart, France; e-mail: francois.boue{at}abc.aphp.fr

Purpose To evaluate the safety and efficacy of rituximab adjunction to the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed AIDS-related non-Hodgkin's lymphoma.

Patients and Methods HIV-seropositive patients with high-grade lymphoma of B-cell origin were eligible if they had no more than one of the following characteristics: CD4 cell count less than 100/µL, prior AIDS, or performance status less than 2. This multicenter phase II trial evaluated the response rate and disease-free survival after six courses of rituximab plus CHOP.

Results Sixty-one patients were enrolled. All the patients were assessable for safety and 52 were assessable for the tumor response after treatment completion. Characteristics of patients were median age, 41 years; median CD4 cells, 172/µL; histology, diffuse large B-cell lymphoma (n = 42), immunoblastic (n = 2), Burkitt lymphoma (n = 16), and plasmablastic (n = 1); 42 patients with stage III to IV; International Prognostic Index 0 to 1 (n=31), and 2 to 3 (n = 27). Grade 3 or 4 toxicity consisted of febrile neutropenia in nine patients, anemia in 16 patients, and thrombocytopenia in five patients. Complete remission (CR) or unconfirmed CR was achieved in 40 of the 52 assessable patients, partial remission was achieved in five patients, and seven patients experienced progression. Forty-three patients were alive after a median follow-up of 33 months. The estimated 2-year overall survival rate was 75% (95% CI, 64% to 86%). Eighteen patients died: 16 as a result of lymphoma, one as a result of infection, and one as a result of encephalitis.

Conclusion Rituximab adjunction to CHOP produced a CR rate of 77% and a 2-year survival rate of 75% in patients with AIDS-related non-Hodgkin's lymphoma, without increasing the risk of life-threatening infections.

published online ahead of print at www.jco.org on August 7, 2006.

Supported by the French National Agency for AIDS and Viral Hepatitis Research (ANRS).

Presented in part at the 44th Annual Meeting of the American Society of Hematology, Philadelphia, PA, December 4-10, 2002, and at the 10th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 8-14, 2003.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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