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Afatinib in locally advanced/metastatic NSCLC harboring common EGFR mutations, after chemotherapy: a Phase IV study.

ABSTRACT: Aim:The current study evaluated the efficacy and tolerability of second-line afatinib in patients with EGFR mutation-positive (EGFRm+) non-small-cell lung cancer (NSCLC) following chemotherapy. Patients & methods:In this open-label, single-arm Phase IV study, patients with EGFRm+ (Del19/L858R) NSCLC who had progressed following platinum-based chemotherapy received afatinib (starting dose 40 mg/day). The primary end point was confirmed objective response. Results:60 patients received afatinib for a median duration of 11.5 months. 50% of patients had a confirmed objective response, of median duration 13.8 months. Median progression-free survival was 10.9 months. The most common treatment-related adverse events were diarrhea (72%), rash (28%) and paronychia (23%). Conclusion:Our data support the use of afatinib (40 mg/day) as an effective and well-tolerated second-line treatment in EGFRm+ NSCLC.

SUBMITTER: Thongprasert S 

PROVIDER: S-EPMC6891940 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Afatinib in locally advanced/metastatic NSCLC harboring common <i>EGFR</i> mutations, after chemotherapy: a Phase IV study.

Thongprasert Sumitra S   Geater Sarayut L SL   Clement Dana D   Abdelaziz Amr A   Reyes-Igama Jasmin J   Jovanovic Dragana D   Alexandru Aurelia A   Schenker Michael M   Sriuranpong Virote V   Serwatowski Piotr P   Suresh Sheethal S   Cseh Agnieszka A   Gaafar Rabab R  

Lung cancer management 20190902 3

<h4>Aim</h4>The current study evaluated the efficacy and tolerability of second-line afatinib in patients with <i>EGFR</i> mutation-positive (<i>EGFR</i>m+) non-small-cell lung cancer (NSCLC) following chemotherapy.<h4>Patients & methods</h4>In this open-label, single-arm Phase IV study, patients with <i>EGFR</i>m+ (Del19/L858R) NSCLC who had progressed following platinum-based chemotherapy received afatinib (starting dose 40 mg/day). The primary end point was confirmed objective response.<h4>Re  ...[more]

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