Department of Hematology, Claude Huriez Hospital, Lille, France.
Department of Clinical Hematology and Medical Oncology, Princess Alexandra Hospital, Brisbane, Australia.
Ann Oncol. 2010 Sep;21(9):1870-1876. doi: 10.1093/annonc/mdq027. Epub 2010 Feb 15.
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.
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.
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.
Ocrelizumab demonstrated activity in patients with relapsed/refractory FL following prior rituximab treatment, with safety similar to rituximab although adverse events appeared milder.
奥瑞珠单抗是一种人源化抗 CD20 抗体，与利妥昔单抗相比，其抗体依赖的细胞细胞毒性增强。这项 I/II 期研究评估了它在先前接受利妥昔单抗治疗后复发/难治性滤泡性淋巴瘤（FL）患者中的安全性和疗效。
47 名患者分为三个剂量组接受治疗，每 3 周接受 8 次输注：A 组 200mg/m2（n=15）；B 组 375mg/m2（n=16）；C 组首剂量 375mg/m2，后续 7 个剂量为 750mg/m2（n=16）。评估患者的安全性、疗效、药效学和药代动力学。
患者的中位年龄为 58 岁，大多数患者处于 III/IV 期疾病，接受过中位数为 2（范围 1-6）种的先前治疗方案。奥瑞珠单抗具有良好的耐受性，毒性发生率为 3/4 级的占 9%。最常见的毒性是输注相关反应（74%的患者），除了 1 例 3 级事件外，所有毒性均为 1/2 级。客观缓解率为 38%，在低亲和力和高亲和力 Fcγ 受体 IIIa（FcγRIIIa）变异体患者中相似。大约随访 28 个月后，中位无进展生存期为 11.4 个月。
奥瑞珠单抗在先前接受利妥昔单抗治疗后复发/难治性 FL 患者中表现出活性，安全性与利妥昔单抗相似，尽管不良事件似乎更轻微。
