361P - 8-year long term survival status in a phase III randomized study in EGFR mutated advanced lung cancer patients in the first-line

Background

This was phase 3 randomized study comparing Gefitinib with pemetrexed with carboplatin in EGFR mutated advanced lung cancer in the first line. The initial interim analysis had proven the superiority of gefitinib over chemotherapy in prolonging the progression free survival (PFS) this group of patients. Gefitinib also had a more favorable safety profile with different associated toxicities. Here we report the updated OS analysis of this study.

Methods

This was an open-labelled, randomized, parallel group study comparing gefitinib (250 mg orally daily) with pemetrexed (500 mg/m2) and carboplatin (area under the curve 5) doublet intravenous induction chemotherapy regimen followed by maintenance pemetrexed (500 mg/m2) in patients with EGFR-activating mutation-positive stage IIIB or stage IV adenocarcinoma lung in the first-line setting. The primary endpoint for the study was PFS. Secondary end points included OS, adverse events and quality of life.

Results

Overall, 290 patients were randomized, 145 in each arm, between February 2012 and April 2016. As of June 2022 (median follow up duration of 96 months), the updated median OS was 18.9 months (95% CI, 15.91-21.86) with gefitinib against 22.6 months (95% CI, 18.91-21.86) with pemetrexed/carboplatin with HR = 0.909 (95% CI, 0.718-1.149), P=0.423. The updated median PFS) was 8.4 months with gefitinib against 6.2 months with pemetrexed/carboplatin with HR= 1.287 (95% CI, 1.019-1.625), p= 0.034. Thus, similar to the initial reports results, this this 8-year survival update revealed that although the primary endpoint was achieved in terms of PFS benefit, but there was no statistically difference in OS between both these arms, indicating the efficacy of salvage therapy at progression in both the arms.

Conclusions

This study established the advantage of using the oral TKI, gefitinib, in the first line setting over chemotherapy in terms of PFS advantage and safety profile. Because of crossover post progression it has failed to show an advantage in terms of OS.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.