期刊
ANNALS OF ONCOLOGY
卷 21, 期 9, 页码 1870-1876出版社
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mdq027
关键词
ADCC; anti-CD20 antibody; CDC; follicular lymphoma; ocrelizumab
类别
资金
- F. Hoffmann-La Roche Ltd.
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 Fc gamma receptor IIIa (Fc gamma RIIIa). With follow-up of similar to 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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