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免疫化疗后二线阿法替尼或化疗治疗转移性肺鳞癌:来自美国多中心回顾性图表审查的真实世界疗效和安全性。

Second-line Afatinib or Chemotherapy Following Immunochemotherapy for the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: Real-world Effectiveness and Safety From a Multisite Retrospective Chart Review in the USA.

机构信息

Department of Solid Tumor Oncology, Levine Cancer Institute, Atrium Health, Charlotte, NC, USA.

Cardinal Health, Dublin, OH, USA.

出版信息

Clin Lung Cancer. 2021 Jul;22(4):292-300.e1. doi: 10.1016/j.cllc.2021.02.006. Epub 2021 Feb 16.

Abstract

BACKGROUND

The ErbB family blocker, afatinib, is approved for patients with squamous cell carcinoma (SqCC) of the lung following platinum-doublet chemotherapy but has not been explored following immunochemotherapy. Here, we assessed the characteristics and outcomes of patients with SqCC of the lung who received second-line afatinib or chemotherapy after first-line pembrolizumab plus chemotherapy in a "real-world" setting.

METHODS

In this retrospective, multisite cohort study, community oncologists identified eligible patients and extracted data from electronic health records. Primary outcome measures were patient demographics and clinical characteristics, time on treatment, and incidence of severe immune-related adverse events (irAEs).

RESULTS

Two hundred patients were included: 99 received second-line afatinib and 101 received second-line chemotherapy. Median age was 68 and 66 years, respectively; 35% and 3% of patients had mixed histology tumors, and 39% and 5% of tumors were epidermal growth factor receptor (EGFR) mutation-positive (EGFRm). Median time on treatment was 7.3 months with afatinib (mixed histology/SqCC tumors: 8.1/5.8 months; EGFRm/EGFRm tumors: 7.4/5.9 months) and 4.2 months with chemotherapy. Grade 3/4 irAEs were observed in 6 patients in the afatinib cohort (all had a prior grade 3/4 irAE during first-line therapy) and no patients in the chemotherapy cohort. The most common adverse drug reactions with afatinib were diarrhea (26%), rash (6%), stomatitis, fatigue, and nausea (5% each).

CONCLUSION

Encouraging time on treatment, and absence of newly diagnosed irAEs, indicate that afatinib is a treatment option following immunochemotherapy in patients with SqCC of the lung, and is currently the only approved oral agent in this setting.

摘要

背景

表皮生长因子受体(ErbB)家族阻滞剂阿法替尼获批用于铂类化疗后鳞状细胞癌(SqCC)患者,但尚未在免疫化疗后进行探索。在此,我们评估了在“真实世界”环境中,接受一线帕博利珠单抗联合化疗后接受二线阿法替尼或化疗的 SqCC 患者的特征和结局。

方法

在这项回顾性、多中心队列研究中,社区肿瘤学家确定了合格的患者,并从电子健康记录中提取数据。主要结局测量指标为患者的人口统计学和临床特征、治疗时间和严重免疫相关不良事件(irAE)的发生率。

结果

共纳入 200 例患者:99 例接受二线阿法替尼治疗,101 例接受二线化疗。中位年龄分别为 68 岁和 66 岁;35%和 3%的患者存在混合组织学肿瘤,39%和 5%的肿瘤存在表皮生长因子受体(EGFR)突变(EGFRm)。阿法替尼治疗的中位时间为 7.3 个月(混合组织学/SqCC 肿瘤:8.1/5.8 个月;EGFRm/EGFRm 肿瘤:7.4/5.9 个月),化疗的中位时间为 4.2 个月。阿法替尼组有 6 例(均在一线治疗期间发生过 3/4 级 irAE)和化疗组无患者出现 3/4 级 irAE。阿法替尼最常见的不良反应是腹泻(26%)、皮疹(6%)、口腔炎、疲劳和恶心(各 5%)。

结论

令人鼓舞的是,阿法替尼治疗时间长,且无新发 irAE,表明阿法替尼是 SqCC 患者免疫化疗后的一种治疗选择,并且是目前该治疗环境下唯一获批的口服药物。

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