Obinutuzumab as consolidation after chemo-immunotherapy: Results of the UK National Cancer Research Institute phase II/III GALACTIC trial.
Obinutuzumab as consolidation after chemo-immunotherapy: Results of the UK National Cancer Research Institute phase II/III GALACTIC trial.
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DOI：
10.1111/bjh.18427
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发表时间：
2022-12
影响因子：
6.5
通讯作者：
中科院分区：
文献类型：
--
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GA101(Obinutuzumab)单抗作为巩固疗法治疗慢性淋巴细胞白血病(CLL)(银河)是一项无缝的II/III期试验，旨在测试与obinutuzumab巩固治疗是否安全并根除微小残留病(MRD)，以及这是否会延长最近对化学免疫治疗有反应的CLL患者的无进展生存期(PFS)。对化疗后3-24个月有反应的患者进行 评估。MRD阳性患者被随机分成两组，分别接受联合治疗和不联合治疗。由于招募缓慢，审判在第二阶段结束后结束。总共有48名患者入选，其中19名MRD阴性并接受了监测。在29名MRD阳性患者中，14名随机接受巩固治疗，15名不接受巩固治疗。随机化6个月后，骨髓和外周血中分别有10例和13例患者的骨髓和外周血经流式细胞术(敏感性为10 -4)检测为−阴性。合并患者的PFS明显好于非合并患者(p=0.001)。合并后10例MRD阴性患者与19例MRD阴性患者比较，PFS、总生存期和MRD阴性期无明显差异。巩固组常见的不良反应是血小板减少、感染和咳嗽。只有1%的事件是与输液相关的反应。这一观察提供了进一步的证据，表明巩固以实现MRD阴性可以改善慢性淋巴细胞性白血病的预后，并且在疾病水平较低的患者中，obinutuzumab具有良好的耐受性。
The GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In chronic lymphocytic leukaemia (CLL) (GALACTIC) was a seamless phase II/III trial designed to test whether consolidation with obinutuzumab is safe and eradicates minimal residual disease (MRD) and, subsequently, whether this leads to prolonged progression‐free survival (PFS) in patients with CLL who have recently responded to chemo‐immunotherapy. Patients with a response 3–24 months after chemotherapy were assessed for MRD. MRD‐positive patients were randomised to receive consolidation therapy with obinutuzumab or no consolidation. The trial closed after the phase II part due to slow recruitment. In all, 48 patients enrolled of whom 19 were MRD negative and were monitored. Of the 29 MRD‐positive patients, 14 were randomised to receive consolidation and 15 to no consolidation. At 6 months after randomisation, 10 and 13 consolidated patients achieved MRD negativity by flow cytometry (sensitivity 10−4) in bone marrow and peripheral blood respectively. PFS was significantly better in consolidated patients compared to non‐consolidated patients (p = 0.001). No difference was observed in PFS, overall survival or duration of MRD negativity when comparing the 10 MRD‐negative patients after consolidation with the 19 MRD‐negative patients in the monitoring group. Common adverse events in the consolidation arm were thrombocytopenia, infection, and cough. Only 1% of events were infusion‐related reactions. This observation provides further evidence that consolidation to achieve MRD negativity improves outcomes in CLL and that obinutuzumab is well tolerated in patients with low levels of disease.
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影响因子：
11.4
作者：
Howard, D. R.;Munir, T.;Hillmen, P.
通讯作者：
Hillmen, P.
影响因子：
11.4
作者：
Munir, T.;Howard, D. R.;Hillmen, P.
通讯作者：
Hillmen, P.
DOI：
10.1016/j.jclinepi.2010.03.004
发表时间：
2010-01-01
期刊：
Open medicine : a peer-reviewed, independent, open-access journal
影响因子：
--
作者：
Schulz, Kenneth F;Altman, Douglas G;Moher, David
通讯作者：
Moher, David
影响因子：
10.1
作者：
Cartron, Guillaume;Hourcade-Potelleret, Florence;Carlile, David J.
通讯作者：
Carlile, David J.
影响因子：
20.3
作者：
Fischer, Kirsten;Bahlo, Jasmin;Hallek, Michael
通讯作者：
Hallek, Michael