Randomized Phase III Study of EGFR Tyrosine Kinase Inhibitor and Intercalated Platinum-Doublet Chemotherapy for Non-Small Cell Lung Cancer Harboring EGFR Mutation.

patients_and_methods

This was an open-label, multicenter, randomized phase III study.

这是一项开放标签、多中心、随机的III期研究。

Patients with chemotherapy-naïve advanced or recurrent NSqNSCLC harboring EGFR mutation (exon 19 deletion or exon 21 L858R point mutation) were randomly assigned (1:1) to EGFR-TKI monotherapy or the EGFR TKI plus intercalated chemotherapy group.

未接受过化疗的晚期或复发性非鳞状非小细胞肺癌（NSqNSCLC）患者，携带EGFR突变（外显子19缺失或外显子21 L858R点突变）被随机分配（1:1）至EGFR-TKI单药治疗组或EGFR-TKI联合间插化疗组。

The primary endpoint was OS, and the secondary endpoints included progression-free survival(PFS).

主要终点是总生存（OS），次要终点包括无进展生存期（PFS）。

Results

From December 2015 to October 2020, 501 patients were randomized.

2015年12月至2020年10月，共有501名患者被随机分组。

The EGFR TKI was changed from gefitinib to osimertinib in October 2018 (gefitinib cohort: n = 308 and osimertinib cohort: n = 193).

2018年10月，EGFR酪氨酸激酶抑制剂（EGFR TKI）从吉非替尼更换为奥希替尼（吉非替尼队列：n=308，奥希替尼队列：n=193）。

There was no survival advantage in the EGFR TKI plus intercalated chemotherapy group; the median survival time of both groups was 48.0 months (HR, 0.985; 91.4% confidence interval, 0.796-1.219; one-sided P = 0.4496).

在EGFR-TKI联合间插化疗组中没有生存优势；两组的中位生存时间均为48.0个月（风险比，0.985；91.4%置信区间，0.796-1.219；单侧P = 0.4496）。

The median PFS time was 12.0 months in the EGFR-TKI monotherapy group and 18.0 months in the EGFR TKI plus intercalated chemotherapy group (HR, 0.762; 95% confidence interval, 0.628-0.925; one-sided P = 0.003).

EGFR-TKI单药治疗组的中位无进展生存期为12.0个月，而EGFR-TKI联合间插化疗组为18.0个月（风险比，0.762；95%置信区间，0.628-0.925；单侧P = 0.003）。

The OS and PFS trends in both gefitinib and osimertinib cohorts were identical to those in the entire population.

在吉非替尼和奥希替尼队列中，总生存（OS）和无进展生存（PFS）的趋势与整个人群相同。

Conclusions

The intercalation of cisplatin plus pemetrexed after the response to EGFR TKI improved PFS but not OS compared with EGFR TKI monotherapy as the first-line treatment for patients with advanced NSqNSCLC harboring EGFR mutation.

在EGFR突变的晚期非鳞状非小细胞肺癌（NSqNSCLC）患者中，接受EGFR酪氨酸激酶抑制剂（TKI）治疗后，使用顺铂联合培美曲塞的介入治疗，与作为一线治疗的EGFR TKI单药治疗相比，改善了无进展生存（PFS），但并未改善总生存（OS）。