Zevalin (IDEC-Y2B8) Radioimmunotherapy of Rituximab-Refractory Follicular Non-Hodgkin’s Lymphoma (NHL): Interim Results

OncologyONCOLOGY Vol 14 No 3
Volume 14
Issue 3

Ibritumomab tiuxetan (Zevalin) is an anti-CD20 murine immunoglobulin G1 (IgG1) kappa monoclonal antibody conjugated to tiuxetan that forms a strong chelate with the pure beta-emitting isotope yttrium-90 (90Y). Mechanisms of action include

Ibritumomab tiuxetan (Zevalin) is an anti-CD20 murine immunoglobulin G1 (IgG1) kappa monoclonal antibody conjugated to tiuxetan that forms a strong chelate with the pure beta-emitting isotope yttrium-90 (90Y). Mechanisms of action include direct induction of apoptosis (Blood 88[10; suppl 1]:637a, 1996) and radiolysis.

Based on the phase I/II experience, we are conducting a nonrandomized, phase III, open-label clinical trial to evaluate the efficacy and safety of tiuxetan in follicular NHL patients refractory to rituximab (ie, those who did not achieve a response or had a TTP of < 6 months with the most recent course of rituximab, 375 mg/m² weekly × 4). Efficacy end points include overall response rate, duration of response, TTP, and comparison of overall response rate and duration to those achieved with prior therapy. Patients were excluded if they had more than 25% bone marrow involvement with NHL, > 5,000 circulating lymphocytes, or had received prior radioimmunotherapy.

An interim analysis was performed on the first 26 patients. Patient characteristics included: median age of 56 years, follicular histology (92% of patients), prior therapies (median, 3), bone marrow involvement (27% of patients), splenomegaly (12% of patients), bulky disease > 7 cm (46% of patients), and prior radiotherapy (31% of patients). All patients who underwent dosimetry (N = 23 in this interim analysis group) had acceptable biodistribution and estimated absorbed radiation doses to normal organs.

Toxicity was primarily hematologic, transient, and reversible. Median hematologic nadirs were a granulocyte count of 900 cells/mm³ platelets of 34,000 cells/mm³, and hemoglobin of 10.6 g/dL. Transient grade 4 thrombocytopenia and neutropenia occurred in 8% and 23% of patients, respectively. In these patients, median recovery of platelet and neutrophil counts occurred in 15 and 14 days, respectively.

Response classification was assigned by a LEXCOR (Lymphoma Expert Confirmation of Response) panel that was blinded to investigator designation of response. The overall response rate was 46% in the 24 follicular NHL patients for whom response data were available. Three patients were considered nonresponders, as their response had not been confirmed at ³ 28 days at the time of the interim analysis.

CONCLUSION: This interim analysis suggests that tiuxetan radioimmunotherapy is safe and effective in the treatment of patients with rituximab-refractory follicular NHL. Final conclusions await complete analysis.

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&#146;s Lymphoma Patients With Preexisting Thrombocytopenia: Report of Interim Results of a Phase II Trial
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