Rituximab: Phase II Retreatment Study in Patients With Low-Grade or Follicular Non-Hodgkin’s Lymphoma

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Article
OncologyONCOLOGY Vol 13 No 3
Volume 13
Issue 3

A 60-patient phase II study was conducted to determine the safety and efficacy of retreatment with the anti-CD20 monoclonal antibody (MoAb) rituximab (Rituxan) in patients with low-grade or follicular non-Hodgkin’s lymphoma (NHL). Patients were relapsed or refractory to prior chemotherapy but had previously responded to rituximab. Upon progression of disease, patients received IV infusions of rituximab at 375 mg/m² weekly × 4. Patient characteristics were 55% males with medians of: age, 56 years; three prior therapies; 14.2 months since last treatment; and 4.7 years since diagnosis.

A 60-patient phase II study was conducted to determine the safety and efficacy of retreatment with the anti-CD20 monoclonal antibody (MoAb) rituximab (Rituxan) in patients with low-grade or follicular non-Hodgkin’s lymphoma (NHL). Patients were relapsed or refractory to prior chemotherapy but had previously responded to rituximab. Upon progression of disease, patients received IV infusions of rituximab at 375 mg/m² weekly × 4. Patient characteristics were 55% males with medians of: age, 56 years; three prior therapies; 14.2 months since last treatment; and 4.7 years since diagnosis.

The safety profile was similar to that reported for initial treatment with rituximab, consisting primarily of infusion-related events usually occurring within the first few hours of the first infusion. The most common infusion-related events included fever, asthenia, chills, pruritus, and throat irritation. Less frequent events included leukopenia, nausea, transient bronchospasm, and mild hypotension. No human antichimeric antibody (HACA) reactions were reported.

Of the 60 patients, 57 were evaluable for efficacy. The overall response rate (ORR) was 40%, with 6 (12.5%) complete responses (CRs) and 17 (28.6%) partial responses (PRs). Medians for time to progression (responders) and duration of response have not been reached after 16.7+ months and 15.0+ months of observation, respectively.

CONCLUSION: Patients with relapsed or refractory low-grade or follicular NHL are considered incurable, with a median survival of about 4 years from the first relapse. Their history is characterized by repeated courses of chemotherapy followed by relapses (with progressively lower ORRs and shorter durations), development of chemoresistance, and impaired marrow reserves. This study shows that such patients can be safely and effectively treated with multiple courses of rituximab without significant myelosuppression or induction of HACA. Experience to date suggests that rituximab does not induce resistance to subsequent chemotherapy or reduce its efficacy. The benefits of multiple courses of rituximab include deferring toxic alternative treatments and preserving marrow function.

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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