Efficacy and Safety of Gefitinib as Third-line Treatment in NSCLC Patients With Activating EGFR Mutations Treated With First-line Gefitinib Followed by Second-line Chemotherapy: A Single-Arm, Prospective, Multicenter Phase II Study (RE-CHALLENGE, CTONG1304).

ABSTRACT:

Objective

There is no standard care for advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation in the third line. Our study aimed to assess the efficacy and safety of gefitinib as a third-line re-challenge treatment for advanced NSCLC patients with EGFR mutation.

Materials and methods

It was a multicenter, open-label, single-arm, phase II study. Stage IIIB/IV NSCLC patients with EGFR exon 19del/L858R mutation, who had benefited from first-line gefitinib treatment followed by second-line chemotherapy, received gefitinib 250 mg/d. The primary objective was disease control rate (DCR) at week 8.

Results

Predefined DCR was achieved in 69.8% (95% confidence interval, 49.87-74.91) patients and objective response rate was re

SUBMITTER: Song Y 

PROVIDER: S-EPMC6493697 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature