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Title: Rituximab Adds Efficacy to Aggressive Chemotherapy Regimen for HIV Patients With Non-Hodgkin's Lymphoma: Presented at NHL

"Rituximab Adds Efficacy to Aggressive Chemotherapy Regimen for HIV Patients With Non-Hodgkin's Lymphoma: Presented at NHL"

By Chris Berrie PRAGUE, CZECH REPUBLIC -- September 14, 2004 -- The combination of rituximab with aggressive chemotherapy regimens can show high response rates in patients with HIV-associated lymphomas without having an impact on the HIV infection, according to a study presented here September 11th at The Role of Immunotherapy in NHL: Optimising Treatment Outcomes, sponsored by Roche. Significant improvements in HIV-related lymphomas first became possible after the introduction of highly active antiretroviral therapy in the treatment of AIDS. This was because the standard dose therapy became feasible and advantageous, resulting in an improved prognosis for these patients. However, Michele Spina, MD, chief, lymphoma unit, and assistant to the director, division of medical oncology A, National Cancer Institute, Aviano, Italy, said that despite improvements through infusional cytotoxic chemotherapy in HIV-associated non-Hodgkin's lymphoma, there remained further room for improvement, as 2-year overall survival (OS) was still below 50%. The researchers therefore started an international phase 2 study aimed at evaluating the feasibility and activity of a combination of rituximab at the standard dose of 375 mg/m[² on day 1 followed by a 4-day continuous infusion of cyclophosphamide 187.5 mg/m²/day, doxorubicin 12.5 mg/m²/day and etoposide 60 mg/m²/day by continuous infusion over 4 days (CDE), Dr. Spina said. All patients also received methotrexate 12 mg IT on day 1.

This trial, which was published in abstract form last year (Spina et al. Blood 2003;102, 123a) involved 74 patients with HIV infection and lymphoma, and resulted in greatly improved prognosis provided for these patients using this rituximab plus CDE protocol (R-CDE), with the 2-year OS at 72%.

Dr. Spina pointed to similar findings in a recent comparison between R-CDE and CDE alone (Kaplan LD et al. Proc Am Soc Clin Oncol. 2003;22 [Abstract 2268]). The R-CDE and CDE patients in HIV-related NHL patients in these 2 trials showed essentially the same staging (III-IV; 70% vs 76%, respectively) and International Prognostic Index (IPI) >2 proportions (57% vs 58%, respectively).

Rates of CR for R-CDE in this comparison were greatly increased compared to CDE alone (70% vs 45%, respectively), and there were similar increases seen in 2-year OS (72% vs 45%, respectively) and 2-year time to treatment failure (64% vs 36%, respectively).

Dr. Spina said that a consideration of these indications and those from 2 further studies that have also demonstrated the benefits of combined immunochemotherapy in patients with HIV-related NHL, do now indicate that a high proportion of patients with HIV-related NHL can be cured with aggressive chemotherapy regimens without having a significant negative impact on the HIV infection.

[Presentation title: Treatment of HIV Lymphomas With Immunochemotherapy. Abstract 443]

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