IDEC-Y2B8 Radioimmunotherapy: Responses in Patients With Splenomegaly

Publication
Article
OncologyONCOLOGY Vol 13 No 3
Volume 13
Issue 3

Splenomegaly has been considered by some to be a contraindication to monoclonal antibody immunotherapy or

Splenomegaly has been considered by some to be a contraindication to monoclonal antibody immunotherapy or radioimmunotherapy because of theoretical concerns about the spleen acting as an “antibody sink” and limiting efficacy. IDEC-Y2B8 is a murine IgG1 kappa monoclonal antibody covalently bound to MX-DTPA (a derivative of diethylenetriamine-pentaacetic acid), which securely chelates the isotope yttrium-90. The antibody targets the CD20 antigen found on more than 90% of B-cell non-Hodgkin’s lymphomas (NHLs).

A phase I/II study treated 58 relapsed or refractory NHL patients (6% small lymphocyte, 65% follicular, 24% diffuse large cell [DLC] or diffuse mixed cell [DMC], 6% mantle cell) with a median age of 60 years, 29% female, and 3.8 years median time since diagnosis. Of the 58 patients, 43% had bone marrow involvement, 37% had bulky (> 7 cm single lesion) disease, 92% had prior anthracycline therapy, and 20% were resistant to all prior chemotherapy.

Adverse events were primarily hematologic, transient, and reversible. Mean serum immunoglobulin remained normal over a 1-year observation period, and only 4% of patients had a 50% decrease in immunoglobulins from baseline. Only three patients (6%) developed infections requiring hospitalization. Only 2% developed human antimurine antibody/human antichimeric antibody (HAMA/HACA) responses.

Overall response rate (ORR) was 67% (25% complete responses [CRs], 41% partial responses [PRs]), with 82% (27% CR, 56% PR) ORR in low-grade NHL patients treated at doses of 0.2, 0.3, or 0.4 mCi/kg and 89% ORR in low-grade NHL patients treated at the standard dose of 0.4 mCi/kg.

Four (50%) of eight patients who were noted to have baseline splenomegaly achieved a CR or PR, as compared with 70% (30/43) of those without splenomegaly. This difference was not statistically significant (P = .416). Six patients had complete resolution of splenomegaly, one had marked regression, and only one had no splenic response.

CONCLUSION: These phase I/II results suggest that IDEC-Y2B8 radioimmunotherapy is a safe and effective alternative for the treatment of relapsed or refractory NHL and can be used in patients with splenomegaly.

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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