Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012.
Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012.
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DOI：
10.1038/s41416-018-0131-9
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发表时间：
2018-07
影响因子：
8.8
通讯作者：
Haddad R
中科院分区：
文献类型：
--
作者：
Mehra R;Seiwert TY;Gupta S;Weiss J;Gluck I;Eder JP;Burtness B;Tahara M;Keam B;Kang H;Muro K;Geva R;Chung HC;Lin CC;Aurora-Garg D;Ray A;Pathiraja K;Cheng J;Chow LQM;Haddad R
晚期头颈部鳞状细胞癌（HNSCC）的二线治疗选择有限。Ib期KEYNOTE-012研究在长期随访后评估了帕博利珠单抗治疗HNSCC的安全性和疗效。多中心、非随机试验包括两个HNSCC队列（初始和扩展），其中192例患者符合条件。患者接受帕博利珠单抗10 mg/kg每2周一次（初始队列; N = 60）或200 mg每3周一次（扩展队列; N = 132）。联合主要终点为安全性和总缓解率（ORR; RECIST v1.1;中心影像学供应商审查）。中位随访时间为9个月（范围，0.2 - 32）。123例（64%）和24例（13%）患者分别发生了任何级别和3/4级的治疗相关不良事件（AE）。无死亡归因于治疗相关AE。ORR为18%（34/192; 95% CI，13 - 24%）。未达到中位缓解持续时间（范围：2+至30+个月）; 85%的缓解持续时间≥ 6个月。12个月时的总生存率为38%。一些患者接受了2年的治疗，缓解持续超过30个月;长期随访观察到的持久抗肿瘤活性和可耐受的安全性特征支持使用pembrolizumab治疗复发性/转移性HNSCC。
Second-line treatment options for advanced head and neck squamous cell carcinoma (HNSCC) are limited. The phase Ib KEYNOTE-012 study evaluated the safety and the efficacy of pembrolizumab for the treatment of HNSCC after long-term follow-up. Multi-centre, non-randomised trial included two HNSCC cohorts (initial and expansion) in which 192 patients were eligible. Patients received pembrolizumab 10 mg/kg every 2 weeks (initial cohort; N = 60) or 200 mg every 3 weeks (expansion cohort; N = 132). Co-primary endpoints were safety and overall response rate (ORR; RECIST v1.1; central imaging vendor review). Median follow-up was 9 months (range, 0.2–32). Treatment-related adverse events (AEs) of any grade and grade 3/4 occurred in 123 (64%) and 24 (13%) patients, respectively. No deaths were attributed to treatment-related AEs. ORR was 18% (34/192; 95% CI, 13–24%). Median response duration was not reached (range, 2+ to 30+ months); 85% of responses lasted ≥6 months. Overall survival at 12 months was 38%. Some patients received 2 years of treatment and the responses were ongoing for more than 30 months; the durable anti-tumour activity and tolerable safety profile, observed with long-term follow-up, support the use of pembrolizumab as a treatment for recurrent/metastatic HNSCC.
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DOI：
10.1038/nrc3239
发表时间：
2012-03-22
期刊：
Nature reviews. Cancer
影响因子：
--
作者：
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通讯作者：
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影响因子：
51.1
作者：
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通讯作者：
Stone, Julie A.
影响因子：
51.1
作者：
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