西班牙初治的表皮生长因子受体外显子19缺失（Del19 EGFR）非小细胞肺癌患者使用阿法替尼的真实世界数据：加利西亚肺癌组的临床经验

Real-world data with afatinib in Spanish patients with treatment-naïve non-small-cell lung cancer harboring exon 19 deletions in epidermal growth factor receptor (Del19 EGFR): Clinical experience of the Galician Lung Cancer Group.

作者信息

Agraso Sara, Lázaro Martin, Firvida Xose Luis, Santomé Lucía, Fernández Natalia, Azpitarte Cristina, Leon Luis, Garcia Carme, Hudobro Gerardo, Areses Ma Carmen, Campos Begoña, Quiroga Nazaret, García Jorge, Casal Joaquín

机构信息

Hospital Arquitecto Marcide, Complexo Hospitalario Universitario de Ferrol, Av. da Residencia, S/N, Ferrol, A Coruña, Ferrol 15405, Spain.

Complexo Hospitalario Universitario de Vigo, Vigo, Spain.

出版信息

Cancer Treat Res Commun. 2022;33:100646. doi: 10.1016/j.ctarc.2022.100646. Epub 2022 Oct 4.

DOI:10.1016/j.ctarc.2022.100646

PMID:36335799

Abstract

BACKGROUND

In clinical studies, first-line afatinib demonstrated efficacy in Del19-EGFR NSCLC.

MATERIALS AND METHODS

This prospective, non-interventional study assessed efficacy and safety of first-line afatinib in patients with advanced/metastatic NSCLC with Del19-EGFR from Galicia (Spain), with a preplanned analysis by age (<70 vs ≥70 years).

RESULTS

Median age of 46 patients enrolled was 69.5 years (range 37-87). The objective response rate (ORR) was 78.2%, with median progression-free survival (PFS) of 20.5 months (95% CI 12.7, 28.3) and median overall survival (OS) of 37.5 months (95% CI 19.2-55.8). Outcomes by age (<70 vs ≥70 years) were ORR of 82.6% vs 73.9%, median PFS of 20.2 months (95% CI 14.8-25.6) vs 24.1 (9.8-38.3), and median OS of 45.1 months (95% CI, 17.0-73.1) vs 33.9 (28.7-39.1), respectively. Median treatment duration was 17.2 months (range 0.4-64.1) with 11 patients still on treatment; 14 patients received osimertinib at discontinuation due to T790M. Grade 3 adverse events included mucositis (n = 7, 15.2%), skin toxicity (n = 9, 19.6%), and diarrhea (n = 6, 13.0%) that were manageable with dose reductions. The afatinib dose was reduced in 31 patients (67.4%) and treatment was discontinued in 8 patients (17.4%) due to adverse events. By age (<70 vs ≥70 years), afatinib was dose-reduced in 13 (56.5%) vs 18 patients (78.3%) and discontinued in 3 (13.0%) vs 5 patients (21.7%), respectively.

CONCLUSIONS

PFS in our patients was longer than reported in clinical studies with similar response rates and toxicity, even in older patients, reflecting a good risk-benefit from afatinib in patients with Del19-EGFR NSCLC.

MICROABSTRACT

This real-world study of first-line afatinib in Caucasian patients with Del19 EGFR NSCLC reported durable efficacy and showed that older patients (> 70 years) benefitted from afatinib as much as younger patients. The safety profile of afatinib was as expected, albeit more dose reductions in older patients. Afatinib may be an option for patients with Del19 EGFR NSCLC, even in those who are older.

摘要

背景

在临床研究中，一线阿法替尼在Del19-EGFR非小细胞肺癌（NSCLC）中显示出疗效。

材料与方法

这项前瞻性、非干预性研究评估了一线阿法替尼在来自西班牙加利西亚的晚期/转移性Del19-EGFR NSCLC患者中的疗效和安全性，并按年龄（<70岁与≥70岁）进行了预先计划的分析。

结果

入组的46例患者中位年龄为69.5岁（范围37-87岁）。客观缓解率（ORR）为78.2%，中位无进展生存期（PFS）为20.5个月（95%置信区间12.7，28.3），中位总生存期（OS）为37.5个月（95%置信区间19.2-55.8）。按年龄（<70岁与≥70岁）分组的结果分别为：ORR为82.6%对73.9%，中位PFS为20.2个月（95%置信区间14.8-25.6）对24.1个月（9.8-38.3），中位OS为45.1个月（95%置信区间17.0-73.1）对33.9个月（28.7-39.1）。中位治疗持续时间为17.2个月（范围0.4-64.1），有11例患者仍在接受治疗；14例患者因T790M在停药时接受了奥希替尼治疗。3级不良事件包括黏膜炎（n = 7，15.2%）、皮肤毒性（n = 9，19.6%）和腹泻（n = 6，13.0%），可通过剂量减少进行管理。31例患者（67.4%）阿法替尼剂量减少，8例患者（17.4%）因不良事件停药。按年龄（<70岁与≥70岁）分组，阿法替尼剂量减少的患者分别为13例（56.5%）对18例（78.3%），停药的患者分别为3例（13.0%）对5例（21.7%）。