非小细胞肺癌NCCN指南2017第4版讨论:西妥昔单抗

非小细胞肺癌NCCN指南2017第4版讨论:靶向治疗

Cetuximab 西妥昔单抗

Cetuximab is a monoclonal antibody that targets EGFR. A large phase 3 randomized trial (FLEX) assessed cisplatin/vinorelbine with (or without) cetuximab for patients with advanced NSCLC; most patients had stage IV disease. Adding cetuximab was reported to slightly increase overall survival (11.3 vs. 10.1 months, HR for death, 0.87 [95% CI, 0.762–0.996]; P=.044). Patients receiving cetuximab had increased grade 4 events versus control (62% vs. 52%, P < .01); cetuximab was also associated with grade 2 acne-like rash. 西妥昔单抗是一种靶向EGFR的单克隆抗体。一项大型3期随机试验（FLEX）评估了顺铂/长春瑞滨±西妥昔单抗治疗晚期NSCLC；大多数患者为Ⅳ期。报道增加西妥昔单抗总生存期略有改善（11.3个月对10.1个月，死亡风险比，0.87[95% CI，0.762–0.996]；P=0.044）。与对照组相比，接受西妥昔单抗的患者4度不良事件增加（62%对52%，P<0.01）；西妥昔单抗还与2度痤疮样皮疹有关。

The cetuximab/cisplatin/vinorelbine regimen was recently removed from the NCCN Guidelines. The benefits of this cetuximab-based regimen are very slight, it is a difficult regimen to administer, and patients have poorer tolerance for this regimen when compared with other regimens; for example, almost 40% of patients have grade 4 neutropenia. Patients may also have comorbid conditions that prevent them from receiving cisplatin such as poor kidney function. Cisplatin/vinorelbine with (or without) cetuximab is generally not used in the United States because of concerns about toxicity. Some oncologists feel that although the FLEX trial results were reported to be statistically significant they were not clinically significant. For the 2017 update (Version 1), the NCCN Panel deleted the cisplatin/vinorelbine and carboplatin/vinorelbine regimens from the list of recommended systemic therapy regimens for metastatic NSCLC with all histologies. 最近NCCN指南删除了西妥昔单抗/顺铂/长春瑞滨方案。与其他方案相比，这个以西妥昔单抗为基础的方案获益很少、实施困难，而且患者耐受性较差；例如，将近40%的患者有4度中性粒细胞减少症。患者也可能出现妨碍其接受顺铂的合并症，如肾功能差。因为担心毒性，在美国通常不会用顺铂/长春瑞滨±西妥昔单抗。一些肿瘤学家认为虽然FLEX试验报告的结果有显著的统计学意义，但是并没有临床意义。2017第1版更新，NCCN小组从推荐的治疗各种组织学的转移性NSCLC的全身治疗方案列表中删除了顺铂/长春瑞滨和卡铂/长春瑞滨方案。