F Morschhauser1, P Marlton2, U Vitolo3, O Lindén4, J F Seymour5, M Crump6, B Coiffier7, R Foà8, E Wassner9, H-U Burger9, B Brennan9, M Mendila9. 1. Department of Hematology, Claude Huriez Hospital, Lille, France. Electronic address: franck.morschhauser@chru-lille.fr. 2. Department of Clinical Hematology and Medical Oncology, Princess Alexandra Hospital, Brisbane, Australia. 3. Department of Hematology, San Giovanni Battista Hospital, Turin, Italy. 4. Department of Oncology, Lund University Hospital, Lund, Sweden. 5. Department of Hematology and Medical Oncology, Peter MacCallum Cancer Institute and University of Melbourne, Victoria, Australia. 6. Department of Medical Oncology, Princess Margaret Hospital, Toronto, Canada. 7. Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre Bénite, France. 8. Department of Cellular Biotechnologies and Hematology, 'Sapienza University', Rome, Italy. 9. F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Abstract
BACKGROUND:Ocrelizumab is a humanized anti-CD20 antibody with increased antibody-dependent cellular cytotoxicity compared with rituximab. This phase I/II study evaluated its safety and efficacy in patients with relapsed/refractory follicular lymphoma (FL) after prior rituximab therapy. DESIGN AND METHODS: Forty-seven patients were treated in three dose cohorts and received eight infusions every 3 weeks: cohort A, 200 mg/m(2) (n = 15); cohort B, 375 mg/m(2) (n = 16); cohort C, first dose 375 mg/m(2), seven subsequent doses of 750 mg/m(2) (n = 16). Patients were assessed for safety, efficacy, pharmacodynamics and pharmacokinetics. RESULTS: The median patient age was 58 years, the majority had Ann Arbor stage III/IV disease and had received a median of 2 (range 1-6) prior regimens. Ocrelizumab was well tolerated with grade 3/4 toxicity occurring in 9% of patients. The most common toxicity was infusion-related reactions (74% patients), all grade 1/2 except one grade 3 event. The objective response rate was 38% and was similar in patients with low-affinity and high-affinity variants of the Fcgamma receptor IIIa (FcgammaRIIIa). With follow-up of approximately 28 months, the median progression-free survival was 11.4 months. CONCLUSION:Ocrelizumab demonstrated activity in patients with relapsed/refractory FL following prior rituximab treatment, with safety similar to rituximab although adverse events appeared milder.
RCT Entities:
BACKGROUND:Ocrelizumab is a humanized anti-CD20 antibody with increased antibody-dependent cellular cytotoxicity compared with rituximab. This phase I/II study evaluated its safety and efficacy in patients with relapsed/refractory follicular lymphoma (FL) after prior rituximab therapy. DESIGN AND METHODS: Forty-seven patients were treated in three dose cohorts and received eight infusions every 3 weeks: cohort A, 200 mg/m(2) (n = 15); cohort B, 375 mg/m(2) (n = 16); cohort C, first dose 375 mg/m(2), seven subsequent doses of 750 mg/m(2) (n = 16). Patients were assessed for safety, efficacy, pharmacodynamics and pharmacokinetics. RESULTS: The median patient age was 58 years, the majority had Ann Arbor stage III/IV disease and had received a median of 2 (range 1-6) prior regimens. Ocrelizumab was well tolerated with grade 3/4 toxicity occurring in 9% of patients. The most common toxicity was infusion-related reactions (74% patients), all grade 1/2 except one grade 3 event. The objective response rate was 38% and was similar in patients with low-affinity and high-affinity variants of the Fcgamma receptor IIIa (FcgammaRIIIa). With follow-up of approximately 28 months, the median progression-free survival was 11.4 months. CONCLUSION:Ocrelizumab demonstrated activity in patients with relapsed/refractory FL following prior rituximab treatment, with safety similar to rituximab although adverse events appeared milder.
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