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张品良 副主任医师 山东省肿瘤医院 呼吸肿瘤内科

NSCLC靶向治疗NCCN指南:尼鲁单抗Opdivo

张品良 副主任医师 山东省肿瘤医院 呼吸肿瘤内科
发表于2016-09-18
人已读

Non-Small Cell Lung Cancer非小细胞肺癌

NCCN Guidelines Version 4.2016 NCCN指南2016第4版

Discussion 讨论

Treatment Approaches 治疗手段

Targeted Therapies 靶向治疗山东省肿瘤医院呼吸肿瘤内科张品良

Nivolumab尼鲁单抗(Opdivo,百时美施贵宝)

The NCCN Panel recommends nivolumab (category 1) as subsequent therapy for patients with metastatic non-squamous NSCLC who have progressed on or after first-line chemotherapy based on data from a phase 3 randomized trial (CheckMate-057) and recent FDA approval. 基于一项3期随机试验(CheckMate-057)的数据和最近FDA的批准,NCCN小组推荐尼鲁单抗(1类)作为转移性非鳞NSCLC患者在一线化疗时或一线化疗后进展者的后续治疗。

For the 2016 update (Version 1), the NCCN Panel recommends immune checkpoint inhibitors as preferred agents for subsequent therapy based on improved overall survival rates, longer duration of response, and fewer adverse events when compared with cytotoxic chemotherapy.
基于与细胞毒性化疗相比,总生存率改善、应答持续时间更长且不良事件更少,2016第1版更新,NCCN小组推荐免疫检查点抑制剂作为后续治疗的首选药物。

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.
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。

Immune checkpoint inhibitors are associated with a delay in benefit when compared with targeted therapy or cytotoxic chemotherapy.
与靶向治疗或细胞毒性化疗相比,免疫检查点抑制剂获益延迟。

Pseudoprogression has been reported; therefore, traditional RECIST criteria may not be applicable.
已报道假性进展;因此,传统的RECIST标准可能不适用。

For the 2016 update (Version 1), the NCCN Panel revised the recommendation for nivolumab to category 1 (from category 2A) based on the published data from CheckMate-057 and the recent FDA approval of nivolumab for patients with metastatic non-squamous NSCLC.
根据CheckMate-057公布的数据和近期美国FDA对尼鲁单抗的批准,对于转移性非鳞NSCLC患者,2016第1版更新,NCCN小组修订了尼鲁单抗为1类推荐(从2A类)。

For patients receiving nivolumab, median overall survival was 12.2 months compared with 9.4 months for docetaxel (HR, 0.73; 95% CI, 0.59–0.89; P = .002).
对于接受尼鲁单抗治疗的患者,中位总生存期为12.2个月,而多西他赛为9.4个月(HR,0.73;95% CI,0.59-0.89;P= 0.002)。

The median duration of response was 17.2 months with nivolumab compared with 5.6 months for docetaxel.
中位疗效持续时间尼鲁单抗是17.2个月,而多西他赛是5.6个月。

At 18 months, the overall survival rate was 39% (95% CI, 34%–45%) with nivolumab compared with 23% (95% CI, 19%–28%) with docetaxel.
在18个月时,总生存率尼鲁单抗是39%(95% CI,34%–45%),而多西他赛是23%(95% CI,19%–28%)。

Fewer grade 3 to 5 adverse events were reported for nivolumab (10%) when compared with docetaxel (54%) in the CheckMate-057 trial.
在CheckMate-057试验中报道的3至5度不良事件,尼鲁单抗(10 %)比多西他赛(54%)更少。

Although many patients with metastatic non-squamous NSCLC benefit from nivolumab, those whose tumors have PD-L1 staining of 1% to 10% or more have overall survival of 17 to 19 months compared with 8 to 9 months for docetaxel.
虽然许多转移性非鳞NSCLC患者从尼鲁单抗治疗中获益,但是那些肿瘤PD-L1染色1%-10%或更高的患者总生存期17-19个月,而多西他赛为8-9个月。

However, the NCCN Panel does not recommend testing for PD-L1, because many patients with metastatic NSCLC benefit from nivolumab.
然而,NCCN小组不推荐检测PD-L1,因为许多转移性NSCLC患者从尼鲁单抗中获益。

For patients who did not have PD-L1 expression, there was no difference in overall survival for nivolumab versus docetaxel; however, nivolumab was associated with a longer duration of response and fewer side effects.
对于那些无PD-L1表达的患者,与多西他赛相比,尼鲁单抗总生存无差异;然而,尼鲁单抗具有更长的应答持续时间和更少的副作用。

To help clinicians determine which patients with non-squamous NSCLC may benefit most from treatment with nivolumab, the FDA has approved a complementary diagnostic biomarker test to assess for PD-L1 protein expression.
为了帮助临床医生确定哪些非鳞NSCLC患者可能从尼鲁单抗治疗中获益最多,FDA已经批准了一项评估PD-L1蛋白表达的辅助诊断性生物标志物检测。

Testing for PD-L1 is not required for prescribing nivolumab but may provide useful information.
对于处方尼鲁单抗,PD-L1的检测不是必需的,但可能提供有用的信息。

Current or former smoking status correlated with the response rate to immune checkpoint inhibitors.
目前或以前的吸烟情况与对免疫检查点抑制剂的应答率有关。

Recent data suggest that mismatch repair deficiency is associated with response to immune checkpoint inhibitors.
最新数据表明,错配修复缺陷与对免疫检查点抑制剂的应答有关。

The NCCN Panel also recommends (category 1) nivolumab as subsequent therapy for patients with metastatic squamous cell NSCLC who have progressed on or after first-line chemotherapy based on data from a phase 3 randomized trial (CheckMate-017), the recent FDA approval, and results of a phase 2 trial.
基于一项3期随机试验(CheckMate-017)的数据、最近FDA的批准以及一项2期试验结果,对于在一线化疗时或一线化疗后进展的转移性鳞型NSCLC患者,NCCN小组也建议(1类)尼鲁单抗作为后续治疗。

In the CheckMate-017 trial, the median overall survival was 9.2 months with nivolumab compared with 6.0 months for docetaxel.
在CheckMate-017试验中,尼鲁单抗中位总生存期是9.2个月,而多西他赛是6.0个月。

Patients had a response rate of 20% with nivolumab compared with 9% for docetaxel (P = .008).
与多西他赛的9%相比,尼鲁单抗患者的有效率为20%(P = 0.008)。

PD-L1 expression was not associated with response to nivolumab in patients with squamous cell NSCLC.
PD-L1表达与鳞状细胞NSCLC患者对尼鲁单抗的应答无关。

There were fewer grade 3 to 4 adverse events with nivolumab (7%) when compared with docetaxel (55%).
与多西他赛(55%)相比,尼鲁单抗具有较少的3-4度不良事件(7%)。

No patients died in the nivolumab arm versus 3 deaths in the docetaxel arm.
尼鲁单抗组没有患者死亡而多西他赛组3人死亡。

Immune-related adverse events, such as pneumonitis, may occur with nivolumab.
尼鲁单抗可能会发生免疫相关不良事件如肺炎

Intravenous high-dose corticosteroids should be administered based on the severity of the reaction for patients with immune-mediated adverse events.
对于具有免疫介导不良事件的患者,应该根据反应的严重程度给予静脉注射大剂量皮质类固醇激素。

Nivolumab should be discontinued for patients with severe or life-threatening pneumonitis and should be withheld or discontinued for other severe or life-threatening immune-mediated adverse events when indicated (see prescribing information).
对于重度或危及生命的肺炎患者,应该停止尼鲁单抗,而对于其他严重或危及生命的免疫介导不良事件,当有指征时(见处方信息)应该拒绝或中止给药 。

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