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Clinical Cancer Research Vol. 11, 7146s-7150s, October 1, 2005
© 2005 American Association for Cancer Research


Clinical Studies

Full-Dose 90Y Ibritumomab Tiuxetan Therapy Is Safe in Patients with Prior Myeloablative Chemotherapy

Samuel A. Jacobs1, Nicholas Vidnovic1, Judith Joyce2, Barry McCook2, Frank Torok2 and Norbert Avril2

Authors' Affiliations: 1 University of Pittsburgh Cancer Institute and 2 Department of Radiology, Nuclear Medicine Division, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Requests for reprints: Samuel A. Jacobs, University of Pittsburgh Medical Center, Cancer Pavilion, Suite 510, 5150 Center Avenue, Pittsburgh, PA 15232. Phone: 412-235-1278; Fax: 412-623-4655.

Purpose: Targeted radioimmunotherapy with yttrium-90 (90Y)–labeled ibritumomab tiuxetan (Zevalin, IDEC-Biogen, San Diego, CA) has shown significant activity in the treatment of relapsed or refractory CD20+ non–Hodgkin's lymphoma. Eligibility criteria used in phase I trials, and adopted in phase II and III trials, excluded patients with prior myeloablative therapy. We treated eight patients with 90Y ibritumomab tiuxetan who had prior autologous stem cell transplant, but met all other treatment criteria.

Experimental Design: Eight patients with CD20+ non–Hodgkin's lymphoma had extensive prior therapy including myeloablative chemotherapy but did not receive total body irradiation. Each had bone marrow cellularity of >15%, platelet count of >100,000/mm3, and one had documented lymphomatous bone marrow involvement of <25%. The standard course of 0.3 to 0.4 mCi/kg of 90Y ibritumomab tiuxetan was administered to patients at full dose. 18-Flouro-deoxyglucose positron emission tomography/computed tomography scans were done at pretreatment and ~12 weeks after treatment to assess patient response. Maximum toxicities were monitored and classified according to the Common Terminology Criteria for Adverse Events (ver. 3.0).

Results: Toxicities observed included grade 4 thrombocytopenia in three of eight evaluable patients and grade 4 neutropenia in one of eight evaluable patients. One patient had a neutropenic fever; all patients were off blood product support 12 weeks post-zevalin. Complete response by 18-flouro-deoxyglucose positron emission tomography/computed tomography imaging occurred in one of seven evaluable patients and one patient treated as consolidation had no evidence of disease.

Conclusion: Our experience suggests that 90Y ibritumomab tiuxetan treatment is safe for use in patients with prior myeloablative therapy when the general inclusion criteria are fulfilled. In this small series, the response rates, however, are limited. Nevertheless, 90Y ibritumomab tiuxetan treatment may provide clinical benefit in carefully selected extensively pretreated patients.




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Copyright © 2005 by the American Association for Cancer Research.