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Journal of Clinical Oncology, Vol 17, Issue 12 (December), 1999: 3793-3803
© 1999 American Society for Clinical Oncology

Phase I/II Trial of IDEC-Y2B8 Radioimmunotherapy for Treatment of Relapsed or Refractory CD20+ B-Cell Non-Hodgkin's Lymphoma

Thomas E. Witzig, Christine A. White, Gregory A. Wiseman, Leo I. Gordon, Christos Emmanouilides, Andrew Raubitschek, Nalini Janakiraman, John Gutheil, Russell J. Schilder, Stewart Spies, Daniel H.S. Silverman, Elizabeth Parker, Antonio J. Grillo-López

From the Divisions of Hematology and Nuclear Medicine, Department of Internal Medicine, Mayo Clinic and Mayo Foundation, Rochester, MN; IDEC Pharmaceuticals Corporation, San Diego, CA; Division of Hematology/Oncology, Department of Medicine, and Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; University of California—Los Angeles, Los Angeles, CA; City of Hope, Duarte, CA; Henry Ford Hospital, Detroit, MI; Sidney Kimmel Cancer Center, San Diego, CA; and Fox Chase Cancer Center, Philadelphia, PA.

Address reprint requests to Thomas E. Witzig, MD, 920 E Hilton Building, Mayo Clinic, Rochester, MN 55905; email witzig{at}mayo.edu

PURPOSE: Yttrium-90 ibritumomab tiuxetan (IDEC-Y2B8) is a murine immunoglobulin G1 kappa monoclonal antibody that covalently binds MX-DTPA (tiuxetan), which chelates the radioisotope yttrium-90. The antibody targets CD20, a B-lymphocyte antigen. A multicenter phase I/II trial was conducted to compare two doses of unlabeled rituximab given before radiolabeled antibody, to determine the maximum-tolerated single dose of IDEC-Y2B8 that could be administered without stem-cell support, and to evaluate safety and efficacy.

PATIENTS AND METHODS: Eligible patients had relapsed or refractory (two prior regimens or anthracycline if low-grade disease) CD20+ B-cell low-grade, intermediate-grade, or mantle-cell non-Hodgkin's lymphoma (NHL). There was no limit on bulky disease, and 59% had at least one mass >= 5 cm.

RESULTS: The maximum-tolerated dose was 0.4 mCi/kg IDEC-Y2B8 (0.3 mCi/kg for patients with baseline platelet counts 100 to 149,000/µL). The overall response rate for the intent-to-treat population (n = 51) was 67% (26% complete response [CR]; 41% partial response [PR]); for low-grade disease (n = 34), 82% (26% CR; 56% PR); for intermediate-grade disease (n = 14), 43%; and for mantle-cell disease (n = 3), 0%. Responses occurred in patients with bulky disease (>= 7 cm; 41%) and splenomegaly (50%). Kaplan-Meier estimate of time to disease progression in responders and duration of response is 12.9+ months and 11.7+ months, respectively. Adverse events were primarily hematologic and correlated with baseline extent of marrow involvement with NHL and baseline platelet count. One patient (2%) developed an anti-antibody response (human antichimeric antibody/human antimouse antibody).

CONCLUSION: These phase I/II data demonstrate that IDEC-Y2B8 radioimmunotherapy is a safe and effective alternative for outpatient therapy of patients with relapsed or refractory NHL. A phase III study is ongoing.




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