Title Biomarker subset analysis of a phase IIIb, open-label study of afatinib in EGFR tyrosine kinase inhibitor-naive patients with EGFRm plus non-small-cell lung cancer
Authors Zhao, Jun
Bai, Hua
Wang, Xin
Wang, Yuyan
Duan, Jianchun
Chen, Hanxiao
Xue, Zhiyi
Tian, Yahui
Cseh, Agnieszka
Huang, Dennis Chin-Lun
Wu, Yi-Long
Wang, Jie
Affiliation Peking Univ, Dept Thorac Med Oncol 1, Key Lab Carcinogenesis & Translat Res, Minist Educ,Canc Hosp & Inst, 52 Fucheng Rd, Beijing 100142, Peoples R China
Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr, Dept Med Oncol, Canc Hosp,Mol Oncol, Panjiayuannanli 17, Beijing 100121, Peoples R China
Boehringer Ingelheim China Investment Co Ltd, 29-F Pk Pl,1601 Nanjing Rd West, Shanghai 200040, Peoples R China
Boehringer Ingelheim Int GmbH, Binger Str 173, D-55216 Ingelheim, Germany
Boehringer Ingelheim Taiwan Ltd, 12F,2 Sec 3,Minsheng E Rd, Taipei 104, Taiwan
Guangdong Prov Peoples Hosp, Guangdong Lung Canc Inst, 106 Zhongshan 2nd Rd, Guangzhou 510080, Peoples R China
Guangdong Acad Med Sci, 106 Zhongshan 2nd Rd, Guangzhou 510080, Peoples R China
Chinese Acad Med Sci & Peking Union Med Coll, Natl Canc Ctr, Dept Med Oncol, Canc Hosp, Panjiayuannanli 17, Beijing 10021, Peoples R China
Merck Sharp & Dohme IA LLC, Taiwan Branch, Taipei, Taiwan
Keywords MOLECULAR TESTING GUIDELINE
MUTATION-POSITIVE NSCLC
ADENOCARCINOMA HISTOLOGY
AMERICAN SOCIETY
ASIAN PATIENTS
THERAPY
OSIMERTINIB
RESISTANCE
T790M
ASSOCIATION
Issue Date Feb-2022
Publisher FUTURE ONCOLOGY
Abstract Aim: To explore the relationship between mutations in cfDNA and response to afatinib. Patients & methods: In total, 64 patients from one Chinese site with locally advanced/metastatic EGFRm+ non-small-cell lung cancer, who received afatinib 40 mg once daily, were included. Results: Overall, 33 (82.5%) patients became EGFRm- by visit 3; median progression-free survival was longer in these patients vs those who did not (11.0 vs 5.5 months). Progression-free survival was shorter in 42 (45.2%) patients with non-EGFR co-mutations at baseline vs those without (8.1 vs 12.5 months). Neither difference was significant. Conclusion: Afatinib provided clinical benefit for patients with EGFRm+ non-small-cell lung cancer across all subgroups. EGFRm status assessment in plasma cfDNA is a useful method of monitoring treatment. Plain language summary: We conducted a study in 64 Chinese patients with non-small-cell lung cancer to investigate the relationship between cancer mutations detected in the blood and the response to treatment with afatinib, which is known to be effective against EGFR mutations. Technology is now available to detect these mutations in the blood, as an alternative to obtaining and testing lung tissue samples. All 64 patients had EGFR mutations (and some patients had additional types of mutations) when afatinib was started (visit 1 in the study). By visit 3, most patients (82.5%) no longer had EGFR mutations detected in their blood, and these patients responded better to afatinib than those who still had EGFR mutations in their blood. Patients with additional types of mutations generally did not respond as well as those who had only EGFR mutations. Although results showed clinical benefit with afatinib using assessment of mutation status in the blood, statistical significance could not be shown due to the small size of the study.
URI http://hdl.handle.net/20.500.11897/637637
ISSN 1479-6694
DOI 10.2217/fon-2021-0394
Indexed SCI(E)
Appears in Collections: 北京肿瘤医院

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