6533b855fe1ef96bd12b1346

RESEARCH PRODUCT

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.

Harald SteinNoel MilpiedDamien HugloTimothy M IllidgeGiovanni PaganelliGiovanni MartinelliSimon RuleGeorg HessAnna Marina LiberatiRobert MarcusJoachim KalmusFranck MorschhauserPier Luigi Zinzani

subject

Malemedicine.medical_specialtyLymphoma B-Cellmedicine.medical_treatmentImmunologyIbritumomab tiuxetanSalvage therapyAuthor Keywords:RadioimmunotherapyBiochemistryGastroenterologyAntibodies Monoclonal Murine-DerivedTRIAL Author InformationAutologous stem-cell transplantationRecurrenceInternal medicineAntineoplastic Combined Chemotherapy ProtocolsmedicineRefractory Diffuse Large B-Cell LymphomaHumansYttrium RadioisotopesY-90-ibritumomab tiuxetanHematologic toxicity KeyWords Plus:B-CELL LYMPHOMAAuthor Keywords:Radioimmunotherapy; Y-90-ibritumomab tiuxetan; Hematologic toxicity KeyWords Plus:B-CELL LYMPHOMA; LOW-GRADE; RADIOIMMUNOTHERAPY; INDOLENT; TRIAL Author InformationAgedCerebral HemorrhageAged 80 and overSalvage TherapyChemotherapybusiness.industryRemission InductionAntibodies MonoclonalCell BiologyHematologyRADIOIMMUNOTHERAPYINDOLENTmedicine.diseaseSurvival AnalysisLOW-GRADESurgeryTransplantationRituximabFemaleLymphoma Large B-Cell DiffusebusinessRituximabDiffuse large B-cell lymphomamedicine.drug

description

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 transplantation. 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 complete response (CR; stratum AII, n = 43). The overall response rate (ORR) was 52% and 53% in strata AI and AII, respectively, 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, respectively, 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, respectively. 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 diffuse large B-cell lymphoma (DLBCL) and its further evaluation in phase 3 studies is ongoing.

10.1182/blood-2007-01-068056http://hdl.handle.net/11391/152250