Rituximab: First Report of a Phase II Trial in NHL Patients With Bulky Disease

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Article
OncologyONCOLOGY Vol 13 No 3
Volume 13
Issue 3

Rituximab (Rituxan) is the first monoclonal antibody (MoAb) approved for the treatment of non-Hodgkin’s lymphoma (NHL). This anti-CD20 MoAb is effective in inducing apoptosis, complement-dependent cytotoxicity (CDC), and antibody-dependent cellular cytotoxicity (ADCC). In single-agent studies in relapsed or refractory low-grade or follicular NHL (International Working Formula [IWF] types A-D), an overall response rate (ORR) of 48% has been reported.

Rituximab (Rituxan) is the first monoclonal antibody (MoAb) approved for the treatment of non-Hodgkin’s lymphoma (NHL). This anti-CD20 MoAb is effective in inducing apoptosis, complement-dependent cytotoxicity (CDC), and antibody-dependent cellular cytotoxicity (ADCC). In single-agent studies in relapsed or refractory low-grade or follicular NHL (International Working Formula [IWF] types A-D), an overall response rate (ORR) of 48% has been reported.

In this phase II trial, 31 patients (requiring treatment for progressive disease) with bulky low-grade or follicular NHL (³ 1 lesion ³ 10 cm) received rituximab at 375 mg/m² weekly × 4 infusions. Patient characteristics included: 52% male; median age, 55 years; median 4 years from diagnosis; and median three prior therapies.

Most related adverse events were mild to moderate (usually first infusion–related): fever (61%), chills (36%), leukopenia (23%), nausea (19%), dizziness (19%), and throat irritation (19% of patients). Tumor lysis syndrome was not reported. Four patients had grade 3 or 4 nonhematologic adverse events: pulmonary (two patients), chills (one patient), and hypotension (one patient). One patient died with bronchiolitis obliterans 10 months posttreatment. Seven patients had a transient grade 3 or 4 hematologic adverse event: hemoglobin (three patients), absolute neutrophil count (ANC; six patients), and ANC + platelets (one patient). No patient developed a human antichimeric antibody (HACA) reaction. There were no grade 3 or 4 infections.

In evaluable patients, the ORR was 43% (12/28) with 1 complete response (CR) and 11 partial responses (PRs). The median time to progression (responders) was 8.1 months, with a median duration of response of 5.9 months. Of 12 responses, 3 are ongoing, with a maximum time to progression of 24.6+ months. B-symptoms resolved in 8/10 patients.

Exploratory analysis of prognostic factors revealed: 55% ORR in patients with IWF types B, C, D (12/22); higher MoAb levels in responders; and no correlation with number of relapses, number of prior chemotherapies, or chemoresistance.

CONCLUSION: Bulky disease is associated with poor prognosis in patients treated with chemotherapy (poor response, treatment-related mortality, short survival). Outpatient therapy (four infusions in 22 days) with rituximab is safe and effective in bulky low-grade or follicular NHL and does not limit subsequent treatment options.

Click here for Dr. Bruce Cheson’s commentary on this abstract.

Articles in this issue

WHO Declares Lymphatic Mapping to Be the Standard of Care for Melanoma
Rituximab: Phase II Retreatment Study in Patients With Low-Grade or Follicular Non-Hodgkin’s Lymphoma
Response Criteria for NHL: Importance of “Normal” Lymph Node Size and Correlations With Response
Chemotherapy Plus Radiation Improves Survival in Patients With Cervical Cancer
A Randomized Trial of Fludarabine, Mitoxantrone (FM) Versus Doxorubicin, Cyclophosphamide, Vindesine, Prednisone (CHEP) as First Line Treatment in Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma: A Multicenter Study by GOELAMS Group
Navelbine Increased Elderly Lung Cancer Patients’ Survival
Fludarabine Versus Conventional CVP Chemotherapy in Newly C Diagnosed Patients With Stages III and IV Low-Grade Malignant Non-Hodgkin’s Lymphoma: Preliminary Results From a Prospective, Randomized Phase III Clinical Trial in 381 Patients
Multicenter, Phase III Study of Iodine-131 Tositumomab (Anti-B1 Antibody) for Chemotherapy-Refractory Low-Grade or Transformed Low-Grade Non-Hodgkin’s Lymphoma
T-Cell–Depleted Allogeneic Bone Marrow Transplant From HLA-Matched Sibling Donors for Non-Hodgkin’s Lymphoma
Consensus Statement on Prevention and Early Diagnosis of Lung Cancer
In Vivo Purging and Adjuvant Immunotherapy With Rituximab During PBSC Transplant For NHL
Fludarabine and Cyclophosphamide: A Highly Active and Well-Tolerated Regimen for Patients With Previously Untreated Indolent Lymphomas
Campath-1H Monoclonal Antibody in Therapy for Advanced Low-Grade Non-Hodgkin’s Lymphomas: A Phase II Study
AIDS Drugs Effective Against Most Common HIV Strain
Rituximab Therapy in Previously Treated Waldenström’s Macroglobulinemia: Preliminary Evidence of Activity
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