Rituximab and infusional cyclophosphamide, doxorubicin and etoposide (CDE) in combination with HAART: A safe and highly active regimen in HIV-related non-Hodgkin's lymphomas.
Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. ThOrB1404)
Simonelli C, Spina M, Vaccher E, Rossi G, Jaeger U, Sparano J, Tirelli U National Cancer Center, Aviano (PN), Italy
Recent data suggest that the combination of rituximab plus chemotherapy (CT) is more effective than CT alone in the treatment of high grade NHL. With the aim to evaluate the efficacy and activity of combining infusional CDE plus rituximab, in June 1998 we started a phase II study using infusional CDE (cyclophosphamide 187.5 mg/m2/day, doxorubicin 12.5 mg/m[2]/day and etoposide 60 mg/m[2]/day) administered by continuous intravenous infusion for 4 days every 4 weeks for up to 6 cycles and rituximab 375 mg/m[2] i.v. on day 1 prior to each CDE. HAART was given concomitantly with CT, irrespectively of CD4+ cell count and HIV viral load. Up to June 2002, 53 patients have been enrolled. Forty-four patients (83%) were males and median age was 38 years (range 29-65). The median CD4+ cell count was 161 (range 3-691) and the median PS was 1. Sixty-eight percent of patients had advanced stage (III-IV) disease and 51% had B symptoms and all were high grade NHL. Forty-one out of 53 patients (77%) achieved a complete remission (CR), 3/53 (6%) had a partial remission and 9 patients progressed. Only 4 patients out of 41 (10%) CRs have relap sed and 40/53 patients are alive. The major cause of death was NHL (10/13 patients). Grade 3-4 neutropenia, anemia and thrombocytopenia were observed in 75%, 28% and 26% of patients respectively. Twenty-six percent of patients developed bacterial infections during neutropenia. Only one toxic death was observed. With a median follow-up of 14 months, the actuarial overall survival and time to treatment failure (TTF) at 2 yrs were 71% and 73%, respectively. The combination of rituximab and infusional CDE in patients with HIV-associated NHL treated concomitantly with HAART is safe, feasible and active, even if there is a small increase in bacterial infections. CR rate (77%) and TTF at 2 yrs (73%) are comparable to those observed in high grade NHL of the general population. Supported by ISS and AIRC grants.
Keywords: AEGIS, Cyclophosphamide, Etoposide, Doxorubicin, Lymphoma, Non-Hodgkin, HIV, Acquired Immunodeficiency Syndrome, HIV Seropositivity, Antineoplastic Combined Chemotherapy Protocols, Antiretroviral Therapy, Highly Active, Antibodies, Monoclonal, CD4 Lymphocyte Count, Antineoplastic Agents, Antibiotics, Antineoplastic, HIV Infections, Anti-HIV Agents, ACE protocol 1, M-2 protocol, rituximab, Humans, Male, immunology
