Gefitinib with concurrent thoracic radiotherapy in unresectable locally advanced non-small cell lung cancer with EGFR mutation; West Japan Oncology Group 6911L

J Thorac Oncol. 2021 Jun 8:S1556-0864(21)02190-0. doi: 10.1016/j.jtho.2021.05.019. Online ahead of print.


INTRODUCTION: About 10% of locally-advanced non-small cell lung cancer (LA-NSCLC) patients harbor epidermal growth factor receptor (EGFR) mutation and recent reports suggested the declined benefit with immune-checkpoint inhibitor in this population. The attempt that introduces EGFR-tyrosine kinase inhibitor (TKI) into the treatment of LA-NSCLC with EGFR mutation has been warranted.

METHODS: Chemotherapy-naïve, unresectable LA-NSCLC patients with sensitive EGFR mutation (exon 19 deletion or exon 21 L858R point mutation) were enrolled. Patients were treated with gefitinib (250mg/day for 2 years) plus concurrent TRT (64Gy/32frs). Primary endpoint was progression-free survival (PFS) at 2 years (Trial Identifier, UMIN000008366).

RESULTS: Between August 2012 and November 2017, 28 patients were enrolled and 27 were eligible. Median age was 67 years (range, 45-74); never / current or former smoker 15 / 12; ECOG performance status 0 / 1 19 / 8; EGFR exon 19 deletion / exon 21 L858R 13 / 14; and c-stage IIIA / IIIB 14 / 13. The PFS rate at two years by independent review was 29.6% (one-sided 95% confidence interval [CI]: 17.6%-). ORR was 81.5% (95% CI: 63.3-91.3%), median PFS was 18.6 months (95% CI: 12.0-24.5 months) and median OS was 61.1 months (95% CI: 38.1 months to not reached). Approximately half of patients showed solitary brain metastasis as their first site of relapse. Adverse events ≥ Gr 3 were fatigue, skin reaction and appetite loss (3.7% each).

CONCLUSION: This prospective study showed the tolerability and the possible efficacy of gefitinib plus concurrent TRT in LA- NSCLC patients with EGFR mutation.

PMID:34116229 | DOI:10.1016/j.jtho.2021.05.019