J Clin Oncol: Gefitinib vs gefitinib + carboplatin + pemetrexed in EGFR-mutant non-small cell lung cancer

The NEJ009 study is a multicenter, randomized, open-label Phase 3 trial evaluating gefitinib in combination with carboplatin and pemetrexed (GCP) versus gefitinib alone in EGFR-mutant non-small cells Efficacy and safety in lung cancer (NSCLC)
.
This article reports the results of an updated analysis of survival outcomes from the study's extended follow-up
.

In this trial, patients were randomly assigned to gefitinib (250 mg/day, orally) or gefitinib plus carboplatin + pemetrexed (GCP, 3-week course for 6 consecutive courses) followed by maintenance therapy with gefitinib and pemetrexed)
.

PFS (corrected and uncorrected) and OS for both groups

As of May 22, 2020, progression-free survival was significantly longer in the GCP group compared with the gefitinib group (20.
9 months vs 19.
0 months; hazard ratio 0.
77, p=0.
027)
.
However, the latest median overall survival (OS) was 38.
5 months and 49.
0 months in the gefitinib and GCP groups, respectively (HR 0.
82, p=0.
127)
.
Overall survival in both groups was similar to that in the overall population
.
There were no new severe adverse reactions
.

This updated analysis showed that compared with gefitinib alone, the GCP regimen significantly improved progression-free survival in patients tested with an acceptable safety profile
.
In conclusion, GCP regimen is more effective than gefitinib monotherapy as first-line therapy for patients with EGFR-mutated NSCLC
.

Original source:

Eisaku Miyauchi, et al.
Updated Analysis of NEJ009: Gefitinib-Alone Versus Gefitinib Plus Chemotherapy for Non–Small-Cell Lung Cancer With Mutated EGFR.
Journal of Clinical Oncology.
August 12, 2022.
https://ascopubs.
org/doi/ full/10.
1200/JCO.
21.
02911.