First-Line EGFR-1 Tyrosine Kinase Inhibition in Patients With NSCLC With Mutant EGFR Gene

Summary

Current chemotherapy for advanced non-small cell lung cancer, not amenable for curative local treatment (surgery or chemoradiotherapy), has a modest life-prolonging effect and can improve quality of life. There is however no potential for long-term cure for these patients. Chemotherapy also produces variable and often significant toxicity. Current retrospective evidence suggests that significant clinical responses can be obtained when patients whose cancer cells have an EGFR TKD mutation are treated with an EGFR TKI. The ease of administration and toxicity profile of TKI compare favourably with that of chemotherapy, even single agents such as for example gemcitabine The present study will establish the clinical benefit rate of TKI as a first line treatment in patients with EGFR mutations and thus estimate the proportion of patients who might benefit for a prolonged period from a treatment with a modest toxicity profile.

Timeline

Start

2006-01

Primary completion

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Completion

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Outcome

Met primary endpoint

paper With a progression free survival (PFS) of 81% at three months the study met its primary endpoint for presumed superiority over chemotherapy. PMID 27032107 ↗

Publications

• De Greve J, Van Meerbeeck J, Vansteenkiste JF, Decoster L, Meert AP, Vuylsteke P, Focan C, Canon JL, Humblet Y, Berchem G, Colinet B, Galdermans D, Bosquee L, Vermeij J, Dewaele A, Geers C, Schallier D, Teugels E. Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT). PLoS One. 2016 Mar 31;11(3):e0147599. doi: 10.1371/journal.pone.0147599. eCollection 2016.

Drugs

Indications