非霍奇金淋巴瘤 (NHL) 一线治疗方案
权威癌症研究机构美国国家癌症研究所 (NCI)对非霍奇金淋巴瘤(惰性、复发性成人非霍奇金淋巴瘤 (NHL) )一线治疗方案:奥妥珠单抗。
奥妥珠单抗治疗非霍奇金淋巴瘤 (惰性、复发性成人非霍奇金淋巴瘤(NHL))医学证据
在一项涉及 396 名利妥昔单抗难治性惰性淋巴瘤(主要是滤泡性淋巴瘤)患者的随机前瞻性试验 ( NCT01059630 )[1]中,患者接受了Obinutuzumab(奥妥珠单抗)加苯达莫司汀,随后接受了 2 年的Obinutuzumab(奥妥珠单抗)维持治疗,而不是单独使用苯达莫司汀而不进行维持治疗。 [1,2][证据等级:1iiA ]
1.中位随访时间为 31.8个月,2 年 OS 率有利于Obinutuzumab(奥妥珠单抗)组合(74.5% 对 65.1%)(风险比 [HR],0.67;95% 置信区间 [CI],0.47–0.96;P = .027)。中位 PFS 也有利于Obinutuzumab(奥妥珠单抗)组合(25.8 个月 [95% CI,19.5-41.1 个月] vs. 14.1 个月 [95% CI,12.6-16.0 个月])(HR,0.57;95% CI,0.44-0.73;P < .001).[2][证据级别:1iiA ]
2.在此设计中无法评估维持治疗对结果的贡献。
参考资料:
[1]A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)[NCT01059630].
[2]Sehn LH, Chua N, Mayer J, et al.: Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol 17 (8): 1081-93, 2016.
[3]Cheson BD, Chua N, Mayer J, et al.: Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study. J Clin Oncol 36 (22): 2259-2266, 2018.