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Blood, 1 July 2007, Vol. 110, No. 1, pp. 54-58.
Prepublished online as a Blood First Edition Paper on March 26, 2007; DOI 10.1182/blood-2007-01-068056.
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Submitted January 19, 2007
Accepted March 8, 2007
Efficacy and safety of yttrium 90 ibritumomab tiuxetan in patients with relapsed or refractory diffuse large B-cell lymphoma not appropriate for autologous stem cell transplantation
Franck Morschhauser, Timothy Illidge, Damien Huglo, Giovanni Martinelli, Giovanni Paganelli, Pier Luigi Zinzani, Simon Rule, Anna Marina Liberati, Noel Milpied, Georg Hess, Harald Stein, Joachim Kalmus, and Robert E Marcus*
Dept of Hematology, Centre Hospitalier Universitaire (CHU) Lille, Lille, France
Dept of Oncology, Christie Hospital, Manchester University, Manchester, United Kingdom
Nuclear Medicine Division, European Institute of Oncology, Milan, Italy
Institute of Hematology "Seragnoli", University of Bologna, Bologna, Italy
Dept of Haematology, Derriford Hospital, Plymouth, United Kingdom
Dept of Hematology, Policlinico Monteluce, Perugia, Italy
Dept of Hematology, University Hospital of Bordeaux, Bordeaux, France
Dept of Nuclear Medicine, Johannes Gutenberg University, Mainz, Germany
Dept of Pathology, University Hospital Charite, Berlin, Germany
Dept of Oncology, Bayer Schering Pharma, Berlin, Germany
Dept of Haematology, Addenbrooke's Hospital, Cambridge, United Kingdom
* Corresponding author; email: robert.marcus{at}addenbrookes.nhs.uk.
A prospective, multicenter, nonrandomized phase 2 trial was conducted to evaluate the efficacy and safety of a single dose of yttrium 90 (90Y) ibritumomab tiuxetan in elderly patients in first relapsed or primary refractory diffuse large B-cell lymphoma (DLBCL) ineligible for stem cell transplant. Patients had been previously treated with chemotherapy (group A, n = 76) or chemotherapy plus rituximab (group B, n = 28). Patients in group A were further divided into patients in whom induction therapy had failed (stratum AI, n = 33) and patients who had relapsed after achieving CR (stratum AII, n = 43). The ORR was 52% and 53% in strata AI and AII and 19% in group B, with CR/CRu rates of 24%, 39.5%, and 12%, respectively. Median progression-free survival was 5.9 months and 3.5 months in strata AI and AII, and 1.6 months in group B. Median overall survival was 21.4, 22.4, and 4.6 months in stratum AI, stratum AII, and group B. Two patients died from thrombocytopenic cerebral bleeding following administration of therapy. Nonhematologic adverse events were mild to moderate. 90Y-ibritumomab is active in patients with relapsed and refractory DLBCL and its further evaluation in phase III studies is ongoing.

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