What is the role of erlotinib in the treatment of non–small cell lung cancer (NSCLC)?

Updated: Jul 15, 2021
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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A second EGFR TKI, erlotinib, improved survival rates compared with placebo in the second- and third-line setting. [156, 157] Erlotinib demonstrated improved response rates (8% vs < 1%), and overall survival (6.7 vs 4.6 mo). This led to the initial FDA approval of erlotinib in the second-line setting. In late 2016, approval was extended to use for first-line treatment, maintenance treatment, or second- or subsequent-line treatment after progression following at least 1 prior chemotherapy regimen in patients with NSCLC that has EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. as detected by an FDA-approved test.

In an open-label, randomized, phase III trial of Chinese patients with adenocarcinoma of the lung with an EGFR mutation, progression-free survival was longer in patients treated with erlotinib than in those receiving standard chemotherapy with gemcitabine plus carboplatin (13.1 mo vs 4.6 mo). [158]

An open-label randomized phase III trial in European patients with NSCLC also found erlotinib to be superior to standard chemotherapy for first-line treatment of NSCLC with EGFR mutations. In this study, progression-free survival in patients with either of two specific types of EGFR mutations (exon 19 deletions or exon 21 [L858R] substitution mutations) was 9.7 months with erlotinib treatment, compared with 5.2 months for those who received standard therapy. [59]


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