Abstract
Rituximab plus intravenous bolus chemotherapy is a standard treatment for immunocompetent patients with B-cell non-Hodgkin lymphoma (NHL). Some studies have suggested that rituximab is associated with excessive toxicity in HIV-associated NHL, and that infusional chemotherapy may be more effective. We performed a randomized phase 2 trial of rituximab (375 mg/m(2)) given either concurrently before each infusional etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH) chemotherapy cycle or sequentially (weekly for 6 weeks) after completion of all chemotherapy in HIV-associated NHL. EPOCH consisted of a 96-hour intravenous infusion of etoposide, doxorubicin, and vincristine plus oral prednisone followed by intravenous bolus cyclophosphamide given every 21 days for 4 to 6 cycles. In the concurrent arm, 35 of 48 evaluable patients (73%; 95% confidence interval, 58%-85%) had a complete response. In the sequential arm, 29 of 53 evaluable patients (55%; 95% confidence interval, 41%-68%) had a complete response. The primary efficacy endpoint was met for the concurrent arm only. Toxicity was comparable in the 2 arms, although patients with a baseline CD4 count less than 50/microL had a high infectious death rate in the concurrent arm. We conclude that concurrent rituximab plus infusional EPOCH is an effective regimen for HIV-associated lymphoma.
Trial registration:
ClinicalTrials.gov NCT00049036.
Publication types
-
Clinical Trial, Phase II
-
Randomized Controlled Trial
-
Research Support, N.I.H., Extramural
MeSH terms
-
Adult
-
Antibodies, Monoclonal / administration & dosage
-
Antibodies, Monoclonal / adverse effects
-
Antibodies, Monoclonal / therapeutic use*
-
Antibodies, Monoclonal, Murine-Derived
-
Antineoplastic Agents / administration & dosage
-
Antineoplastic Agents / therapeutic use*
-
Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
-
Antineoplastic Combined Chemotherapy Protocols / adverse effects
-
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
-
Cyclophosphamide / administration & dosage
-
Cyclophosphamide / adverse effects
-
Cyclophosphamide / therapeutic use
-
Disease Progression
-
Disease-Free Survival
-
Doxorubicin / administration & dosage
-
Doxorubicin / adverse effects
-
Doxorubicin / therapeutic use
-
Etoposide / administration & dosage
-
Etoposide / adverse effects
-
Etoposide / therapeutic use
-
Female
-
HIV / physiology*
-
Humans
-
Infusions, Intravenous
-
Lymphoma, B-Cell / drug therapy*
-
Lymphoma, B-Cell / pathology
-
Lymphoma, B-Cell / virology*
-
Male
-
Middle Aged
-
Prednisone / administration & dosage
-
Prednisone / adverse effects
-
Prednisone / therapeutic use
-
Rituximab
-
Treatment Outcome
-
Vincristine / administration & dosage
-
Vincristine / adverse effects
-
Vincristine / therapeutic use
Substances
-
Antibodies, Monoclonal
-
Antibodies, Monoclonal, Murine-Derived
-
Antineoplastic Agents
-
Rituximab
-
Vincristine
-
Etoposide
-
Doxorubicin
-
Cyclophosphamide
-
Prednisone
Associated data
-
ClinicalTrials.gov/NCT00049036