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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:西妥昔单抗 爱必妥

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

Cetuximab西妥昔单抗(ERBITUX爱必妥, 德国默克里昂制药公司)

Cetuximab is a monoclonal antibody that targets EGFR.  西妥昔单抗是一种靶向EGFR的单克隆抗体。山东省肿瘤医院呼吸肿瘤内科张品良

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).

一项大型3期随机试验(FLEX)评估了顺铂/长春瑞滨加(或不加)西妥昔单抗治疗晚期NSCLC(大多数患者为IV期)。

Adding cetuximab slightly increased overall survival (11.3 vs 10.1 months, P = .04).

增加西妥昔单抗略微改善总生存期(11.3对10.1个月,P = 0.04)。

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.

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.

最近NCCN指南删除了西妥昔单抗/顺铂/长春瑞滨方案。

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.

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

Patients may also have comorbid conditions that prevent them from receiving cisplatin such as poor kidney function.

患者也可能出现妨碍其接受顺铂的合并症,如肾功能差。

The cetuximab/cisplatin/vinorelbine regimen is generally not used in the United States because of concerns about toxicity.

因为担心毒性,在美国通常不会用西妥昔单抗/顺铂/长春瑞滨方案。

Some oncologists feel that although the FLEX trial results were statistically significant they were not clinically significant.

一些肿瘤学家认为虽然FLEX试验结果有显著的统计学意义,但是并没有临床意义。

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