Final Report on the Safety and Efficacy of Retreatment With Rituximab for Patients With Non-Hodgkins Lymphoma

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OncologyONCOLOGY Vol 14 No 3
Volume 14
Issue 3

This phase II trial investigated the safety and efficacy of retreatment with rituximab (Rituxan) in patients with low-grade or follicular non-Hodgkin’s lymphoma who relapsed following a response to rituximab therapy.

This phase II trial investigated the safety and efficacy of retreatment with rituximab (Rituxan) in patients with low-grade or follicular non-Hodgkin’s lymphoma who relapsed following a response to rituximab therapy. A total of 60 patients received 375 mg/m² of rituximab every week × 4 doses (intravenous [IV] infusion). Of the 60 patients, 5% had lymphomas classified as International Working Formulation (IWF) A; 45%, IWF B; 47%, IWF C; and 3%, IWF D. All patients had received at least two prior therapies and at least one prior course of rituximab.

Most adverse experiences were transient and grade 1 or 2. Significant myelosuppression was not observed; hematologic toxicity was generally mild and reversible. All patients remained CD20 positive, and none developed human antichimeric antibody (HACA). The type, frequency, and severity of adverse events were not apparently different from those reported in other rituximab studies.

The overall response rate (ORR) in 57 evaluable patients was 40%. Medians for time to progression (TTP) in responders and duration of response (DR) have not been reached; Kaplan-Meier estimates are 16.7+ months (range, 3.7+ to 25.1 months) and 15.0+ months (range, 5.4 to 26.6 months), respectively, and are longer than the medians achieved in these patients’ prior course of rituximab (TTP and DR of 12.4 and 9.8 months, respectively). Responses are ongoing in 6 of 23 responders.

CONCLUSION: This study shows that patients can be treated safely and effectively with multiple courses of rituximab without induction of human antichimeric antibody (HACA) and without the myelosuppression common after multiple courses of chemotherapy. In this retreated population, safety and efficacy were not apparently different than are seen following initial rituximab exposure.

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

Articles in this issue

Comparative Economic Analysis of the Treatment of Relapsed Low-Grade B-Cell Non-Hodgkin’s Lymphoma (NHL) in France Using CHOP, Fludarabine, or Rituximab
FHIT Gene, Smoking, and Cervical Cancer
Final Report on the Safety and Efficacy of Retreatment With Rituximab for Patients With Non-Hodgkins Lymphoma
Prospective, Randomized, Controlled Study of Zevalin Radioimmunotherapy Compared to Rituximab Immunotherapy for B-Cell, Non-Hodgkins Lymphoma: Interim Results
IOM Medical Error Estimates Questioned, But Legislation Considered
Less Toxic Therapies for Hodgkin’s Disease May Reduce Secondary Cancers
Preserving Fertility in Young Women With Ovarian Cancer Does Not Decrease Survival
Iodine-131 Tositumomab for Patients With Transformed, Low-Grade Non-Hodgkin’s Lymphoma: Overall Clinical Trial Experience
Survival Rates Significantly Worse For African-Americans With Endometrial Cancer
Rituximab Has Significant Activity in Patients With Chronic Lymphocytic Leukemia
Responders to Rituximab Show Continued Tumor Regression Over Time and a Progression-Free Survival That Correlates With Response Classification
PhRMA Criticizes FDA’s Proposed Rule on Antibiotic Approvals
Phase II Study of Rituximab in Combination With CHOP in Patients With Previously Untreated Intermediate- or High-Grade Non-Hodgkin’s Lymphoma
New Antibiotic Effective in Treating Gram-Positive Bacteremia
Reduced-Dose Zevalin Radioimmunotherapy for Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma Patients With Preexisting Thrombocytopenia: Report of Interim Results of a Phase II Trial
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