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首页> 外文期刊>Journal of Clinical Oncology >Disabling Immune Tolerance by Programmed Death-1 Blockade With Pidilizumab After Autologous Hematopoietic Stem-Cell Transplantation for Diffuse Large B-Cell Lymphoma: Results of an International Phase II Trial
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Disabling Immune Tolerance by Programmed Death-1 Blockade With Pidilizumab After Autologous Hematopoietic Stem-Cell Transplantation for Diffuse Large B-Cell Lymphoma: Results of an International Phase II Trial

机译：弥漫性大型B细胞淋巴瘤自体造血干细胞移植后通过用Pidilizumab编程性死亡1阻断来禁用免疫耐受：国际II期试验的结果

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Purpose The Programmed Death-1 (PD-1) immune checkpoint pathway may be usurped by tumors, including diffuse large B-cell lymphoma (DLBCL), to evade immune surveillance. The reconstituting immune landscape after autologous hematopoietic stem-cell transplantation (AHSCT) may be particularly favorable for breaking immune tolerance through PD-1 blockade. Patients and Methods We conducted an international phase II study of pidilizumab, an anti-PD-1 monoclonal antibody, in patients with DLBCL undergoing AHSCT, with correlative studies of lymphocyte subsets. Patients received three doses of pidilizumab beginning 1 to 3 months after AHSCT. Results Sixty-six eligible patients were treated. Toxicity was mild. At 16 months after the first treatment, progression-free survival (PFS) was 0.72 (90% Cl, 0.60 to 0.82), meeting the primary end point. Among the 24 high-risk patients who remained positive on positron emission tomography after salvage chemotherapy, the 16-month PFS was 0.70 (90% Cl, 0.51 to 0.82). Among the 35 patients with measurable disease after AHSCT, the overall response rate after pidilizumab treatment was 51%. Treatment was associated with increases in circulating lymphocyte subsets including PD-L1E-bearing lymphocytes, suggesting an on-target in vivo effect of pidilizumab. Conclusion This is the first demonstration of clinical activity of PD-1 blockade in DLBCL. Given these results, PD-1 blockade after AHSCT using pidilizumab may represent a promising therapeutic strategy in this disease.
机译：目的程序性死亡1（PD-1）免疫检查点途径可能被肿瘤（包括弥漫性大B细胞淋巴瘤（DLBCL））篡改，以逃避免疫监视。自体造血干细胞移植（AHSCT）后重建的免疫格局可能特别有利于通过PD-1阻断来打破免疫耐受性。患者和方法我们对接受AHSCT的DLBCL患者进行了抗PD-1单克隆抗体pidilizumab的国际II期研究，并对淋巴细胞亚群进行了相关研究。患者在AHSCT后1至3个月开始接受三剂pidilizumab。结果共收治了66例患者。毒性轻微。首次治疗后16个月，无进展生存期（PFS）为0.72（90％Cl，0.60至0.82），达到了主要终点。在挽救性化疗后正电子发射断层扫描仍保持阳性的24位高危患者中，16个月PFS为0.70（90％Cl，0.51至0.82）。在35例AHSCT后可测量的疾病中，使用pidilizumab治疗后的总缓解率为51％。治疗与循环淋巴细胞亚群（包括带有PD-L1E的淋巴细胞）的增加有关，这表明吡吡珠单抗具有体内靶向作用。结论这是对DLBCL PD-1阻断剂临床活性的首次证明。鉴于这些结果，在AHSCT后使用pidilizumab阻断PD-1可能代表了该疾病的一种有前途的治疗策略。

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