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Final Results of a Phase I Radioimmunotherapy Trial Using ¹⁸⁶Re-Epratuzumab for the Treatment of Patients with Non-Hodgkin’s Lymphoma¹

Departments of Nuclear Medicine [E. J. P., W. J. G. O., O. C. B., F. H. M. C.] and Hematology [J. M. M. R., C. M. P. W. M.], University Medical Center Nijmegen, 6500 HB Nijmegen, the Netherlands; Garden State Cancer Center, Center for Molecular Medicine and Immunology, Belleville, New Jersey 07109 [D. M. G.]; and Department of Head and Neck Surgery, VU University Medical Center, 1007 MB Amsterdam, the Netherlands [G. A. M. S. v. D.]

Purpose: Radioimmunotherapy (RIT) is an effective, new treatment modality for non-Hodgkin’s lymphoma (NHL). The aim of this study was to determine the maximum tolerated dose and a first impression of the therapeutic potential of ¹⁸⁶Re-epratuzumab in patients with NHL.

Experimental Design: Patients with relapsed or refractory CD22-positive NHL of diverse histopathology and prior treatments received ^99mTc-labeled epratuzumab (anti-CD22 IgG1), followed by RIT with ¹⁸⁶Re-epratuzumab 1 week later. Dose escalation of RIT was started at 0.5 GBq/m². Three patients were entered per dose level. If no dose-limiting toxicity occurred, the dose was increased by 0.5 GBq/m²; otherwise three additional patients were included on that dose level.

Results: A total of 18 patients received a diagnostic dose of ^99mTc-epratuzumab. Fifteen patients were actually treated with ¹⁸⁶Re-epratuzumab at four different dose levels, 0.5, 1.0, 1.5, and 2.0 GBq/m². During or after infusion of ¹⁸⁶Re-epratuzumab, no adverse reactions were seen. In all patients, a transient decrease of leukocyte and platelet levels was observed 1 month after treatment. At the 1.5-GBq/m² dose level, one grade 4 hematological toxicity was observed. At the highest dose level of 2 GBq/m², no grade 4 hematological toxicity was seen, but WBC and platelet counts of two of the three patients did not recover completely. One patient had a complete remission lasting 4 months. Four patients had a partial remission, lasting 3, 3, 6, and 14 months, respectively. Four patients had stable disease for 3, 3, 7, and 9 months, respectively.

Conclusions: ¹⁸⁶Re-epratuzumab at a dose of 2.0 GBq/m² is well tolerated without major toxicity. A single dose of ¹⁸⁶Re-epratuzumab led to objective responses in 5 of 15 treated patients.