Pembrolizumab 派姆单抗(Keytruda健痊得, 默沙东)
The NCCN Panel recommends pembrolizumab (category 1) as subsequent therapy for patients with metastatic non-squamous or squamous NSCLC and PD-L1 expression. NCCN小组推荐派姆单抗(1类)作为转移性非鳞或鳞型NSCLC并且表达PD-L1患者的后续治疗。
如果病人身体非常差常病不起情况的不建议用药PD1或者必须遵医嘱进行用药。
由于PD1抗体起效时间和观察和评估效果时间所以已经告知寿命短于3个月病人慎用
肝功能不健全或严重受损的病人要遵医嘱
本身有自身免疫疾病的人群慎用。比如:红斑狼疮。
之前接受过器官移植手术的病人一定要遵医嘱用药。
要严重肺炎病人也是不建议用药
瑞斯国际hpv2030希望对每个癌症病人及家属提供香港PD1抑制剂会诊订购便利,为晚期癌症病人延长寿命做出快而有效的服务。PD1抑制剂用药一般是2-3周用药一次每次用药建议60分钟以上一般是三个月为一个观察期。
For the 2016 update (Version 4), the NCCN Panel revised the recommendation for pembrolizumab to category 1 (from category 2A) as subsequent therapy based on the randomized phase 2/3 trial (KEYNOTE-010).
基于随机2/3期试验(KEYNOTE-010),2016第4版更新,NCCN小组将派姆单抗作为后续治疗推荐从2A类修改为1类。
Previously (Version 1), the NCCN Panel had a category 2A recommendation for pembrolizumab based on the phase 1 KEYNOTE-001 trial and FDA approval.
基于1期KEYNOTE-001试验和FDA的批准,之前的第1版,NCCN小组将派姆单抗列为2A类推荐。
In addition, the NCCN Panel recommends immune checkpoint inhibitors, such as pembrolizumab and nivolumab, as preferred agents for subsequent therapy.
此外,NCCN专家组推荐免疫检查点抑制剂,如派姆单抗和尼鲁单抗作为后续治疗的首选药物。
As previously mentioned, human immune-checkpoint--inhibitor antibodies inhibit the programmed death (PD-1) receptor, which improves antitumor immunity; PD-1 receptors are expressed on activated cytotoxic T-cells.
如前所述,人类免疫检查点抑制剂抗体抑制程序性死亡(PD-1)受体,从而改善抗肿瘤免疫;在活化的细胞毒性T细胞上表达PD-1受体。
A recent randomized phase 2/3 trial (KEYNOTE-010) assessed pembrolizumab in patients with previously treated advanced non-squamous and squamous NSCLC who were PD-L1 positive (≥ 1%); most were current or former smokers.
最近一项随机2/3试验(KEYNOTE-010)评估了派姆单抗治疗既往治疗过的、PD-L1阳性的晚期非鳞和鳞型NSCLC患者(≥1%);大部分都是当前或既往吸烟者。
There were 3 arms in this trial: pembrolizumab at 2 mg/kg, pembrolizumab at 10 mg/kg, and docetaxel at 75 mg/m2 every 3 weeks.
在这项试验中有3组:派姆单抗2mg/kg、派姆单抗10mg/kg、多西他赛75mg/㎡每3周1次。
The median overall survival was 10.4 months for the lower dose of pembrolizumab, 12.7 months for the higher dose, and 8.5 months for docetaxel.
中位总生存期:派姆单抗较低剂量组为10.4个月、高剂量组为12.7 个月,而多西他赛组为8.5个月。
Overall survival was significantly longer for both doses of pembrolizumab when compared with docetaxel (pembrolizumab 2 mg/kg: HR 0.71; 95% CI, 0.58–0.88; P=.0008) (pembrolizumab 10 mg/kg: (HR 0.61; CI, 0.49–0.75; P<.0001).
与多西他赛相比,两个剂量的派姆单抗组总生存期显著更长(派姆单抗2mg/kg:HR 0.71;95% CI,0.58–0.88;P = 0.0008)(派姆单抗10mg/kg:HR 0.61;CI,0.49–0.75;P<0.0001) 。
For those patients with at least 50% PD-L1 expression in tumor cells, overall survival was also significantly longer at either dose of pembrolizumab when compared with docetaxel (pembrolizumab 2 mg/kg: 14.9 vs. 8.2 months; HR 0.54; 95% CI, 0.38–0.77; P=.0002) (pembrolizumab 10 mg/kg: 17.3 vs. 8.2 months; HR 0.50; CI, 0.36–0.70; P<.0001).
对于那些至少50%的肿瘤细胞表达PD-L1的患者,与多西他赛相比,派姆单抗两个剂量中的任一剂量总生存期也显著更长(派姆单抗2mg/kg:14.9对8.2个月;HR 0.54;95 %CI,0.38-0.77;P =0.0002) (派姆单抗10mg/kg:17.3对8.2个月;HR 0.50;CI,0.36-0.70;P<0.0001)。< span="">
When compared with docetaxel, there were fewer grade 3 to 5 treatment-related adverse events at either dose of pembrolizumab (pembrolizumab 2 mg/kg: 13% [43/339] of patients, pembrolizumab 10 mg/kg: 16% [55/343], and docetaxel: 35% [109/309]).
与多西他赛相比,任一剂量的派姆单抗3-5度治疗相关不良事件较少(派姆单抗2mg/kg:13% [43/339]、派姆单抗10mg/kg:16% [55/343],而多西他赛:35% [109/309])。