Improved clinical outcome in a randomized phase II study of anti-PD-1 camrelizumab plus decitabine in relapsed/refractory Hodgkin lymphoma.
Improved clinical outcome in a randomized phase II study of anti-PD-1 camrelizumab plus decitabine in relapsed/refractory Hodgkin lymphoma.
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抗 PD-1 卡瑞利珠单抗联合地西他滨治疗复发/难治性霍奇金淋巴瘤的随机 II 期研究改善了临床结果
DOI：
10.1136/jitc-2021-002347
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发表时间：
2021-04
影响因子：
10.9
通讯作者：
Han W
中科院分区：
文献类型：
--
作者：
Liu Y;Wang C;Li X;Dong L;Yang Q;Chen M;Shi F;Brock M;Liu M;Mei Q;Liu J;Nie J;Han W
程序性死亡-1 （PD-1）阻断单药治疗在复发/难治性经典霍奇金淋巴瘤（cHL）患者亚组中诱导持久缓解。我们询问抗pd -1药物camrelizumab联合DNA去甲基化药物decitabine是否比单用camrelizumab改善复发/难治性cHL患者的无进展生存期（PFS）。这项正在进行的随机II期试验的延长随访分析了2017年1月至2018年7月入组的患者的PFS。61例临床naïve对PD-1阻断且既往接受≥2种治疗的复发/难治性cHL患者按1:2随机分组，每3周接受camrelizumab （200 mg）单药治疗或camrelizumab （200 mg，第8天）联合地西他滨（10 mg/天，第1-5天）。中位随访34.5个月，地西他滨+ camrelizumab组的完全缓解率为79% (95% CI 63% ~ 90%)， camrelizumab组的完全缓解率为32% (95% CI 13% ~ 57%) （p=0.001）。地西他滨+ camrelizumab组的中位反应持续时间未达到，估计有63% （95% CI 46%至75%）的患者在24个月时保持反应。地西他滨+ camrelizumab治疗的中位PFS为35.0个月（95% CI未达到），camrelizumab单药治疗的中位PFS为15.5个月（95% CI 8.4至22.7个月）（HR, 0.46; 95% CI 0.21至1.01;p=0.02）。女性、较低的肿瘤负担和较少的既往治疗是camrelizumab单药治疗持久缓解的有利预后因素。在大多数亚组中观察到地西他滨+ camrelizumab与camrelizumab的PFS益处，特别是在肿瘤负担相对较大的患者和既往治疗≥3次的患者中。在地西他滨+ camrelizumab治疗后，循环外周中枢记忆t细胞的百分比增加与临床反应和PFS的改善相关，这表明地西他滨+ camrelizumab治疗cHL的一个假定的生物标志物。在复发/难治性cHL患者中，地西他滨+ camrelizumab与单独camrelizumab相比可获得更长的PFS。NCT02961101和NCT03250962。
Programmed death-1 (PD-1) blockade monotherapy induced durable remission in a subset of patients with relapsed/refractory classical Hodgkin lymphoma (cHL). We asked whether the anti-PD-1 agent, camrelizumab, combined with the DNA demethylating agent, decitabine, improves progression-free survival (PFS) in patients with relapsed/refractory cHL over camrelizumab alone. This extended follow-up of an ongoing randomized phase II trial analyzed PFS among patients enrolled from January 2017 through July 2018. Sixty-one patients with relapsed/refractory cHL who were clinically naïve to PD-1 blockade and had received ≥2 previous therapies were randomized 1:2 to receive either camrelizumab (200 mg) monotherapy or camrelizumab (200 mg, day 8) combined with decitabine (10 mg/day, days 1–5) every 3 weeks. With a median follow-up of 34.5 months, complete remission was 79% (95% CI 63% to 90%) in the decitabine-plus-camrelizumab group versus 32% (95% CI 13% to 57%) in the camrelizumab group (p=0.001). Median duration of response was not reached in the decitabine-plus-camrelizumab group, with an estimated 63% (95% CI 46% to 75%) of patients maintaining a response at 24 months. Median PFS with decitabine-plus-camrelizumab therapy was 35.0 months (95% CI not reached) and 15.5 months (95% CI 8.4 to 22.7 months) with camrelizumab monotherapy (HR, 0.46; 95% CI 0.21 to 1.01; p=0.02). Female gender, lower tumor burden, and fewer previous therapies were favorable prognostic factors for durable remission with camrelizumab monotherapy. The PFS benefits of decitabine-plus-camrelizumab versus camrelizumab were observed in most subgroups, especially in patients with relative larger tumor burdens and those treated with ≥3 prior therapies. After decitabine-plus-camrelizumab treatment, the percentage increase of circulating peripheral central memory T-cells correlated with both improved clinical response and PFS, suggesting a putative biomarker of decitabine-plus-camrelizumab therapy for cHL. Decitabine-plus-camrelizumab results in longer PFS compared with camrelizumab alone in patients with relapsed/refractory cHL. NCT02961101 and NCT03250962.
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影响因子：
24.7
作者：
Shi, Yuankai;Su, Hang;Liu, Peng
通讯作者：
Liu, Peng
从头表观遗传程序抑制PD-1封锁介导的T细胞再生。
影响因子：
64.5
作者：
Ghoneim HE;Fan Y;Moustaki A;Abdelsamed HA;Dash P;Dogra P;Carter R;Awad W;Neale G;Thomas PG;Youngblood B
通讯作者：
Youngblood B
DOI：
10.3322/caac.21438
发表时间：
2018-03
期刊：
CA: a cancer journal for clinicians
影响因子：
--
作者：
Shanbhag S;Ambinder RF
通讯作者：
Ambinder RF
影响因子：
50.5
作者：
Sureda, A;Constans, A;Conde, E
通讯作者：
Conde, E
影响因子：
64.8
作者：
Jansen, Caroline S.;Prokhnevska, Nataliya;Kissick, Haydn
通讯作者：
Kissick, Haydn