Adjuvant gefitinib did not prolong survival, compared with cisplatin plus vinorelbine, in patients with EGFR-mutated non-small cell lung cancer (NSCLC), according to phase 3 results published in the Journal of Clinical Oncology.

The phase 3 IMPACT trial enrolled patients with completely resected, stage II-III, EGFR-mutated NSCLC from 25 institutions in Japan. The 232 evaluable patients had a median age of 64 years (range, 34-74 years), 62% were women, and 65% had stage III disease.

Patients were randomly assigned 1:1 to receive gefitinib (250 mg once daily) for 24 months or cisplatin (80 mg/m2 on day 1) plus vinorelbine (25 mg/m2 on days 1 and 8) once every 3 weeks for 4 cycles.

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The median follow-up was 70 months, and the study’s primary endpoint was disease-free survival (DFS). Although gefitinib initially appeared to improve DFS, the Kaplan-Meier curves crossed around 4 years after surgery, so there was no significant difference in DFS between the arms.

The median DFS was 35.9 months in the gefitinib arm and 25.1 months in the cisplatin-vinorelbine arm (hazard ratio [HR], 0.92; 95% CI, 0.67-1.28; P =.63). The 5-year DFS rate was 31.8% and 34.1%, respectively.

Similarly, there was no significant difference in overall survival (OS) between the treatment arms (HR, 1.03; 95% CI, 0.65-1.65; P = .89). The 5-year OS rate was 78.0% in the gefitinib arm and 74.6% in the cisplatin-vinorelbine arm.

The incidence of grade 4 or higher adverse events (AEs) was 4% in the gefitinib arm and 62% in the cisplatin-vinorelbine arm. There were no treatment-related deaths in the gefitinib arm and 3 in the cisplatin-vinorelbine arm (1 each from cerebral hemorrhage, pneumonia, and suicide).

The most common AEs of any grade in the gefitinib arm were increased alanine aminotransferase levels (69%), increased aspartate aminotransferase levels (65%), dermatitis acneiform (58%), and rash (38%).

Based on these results, the researchers concluded that platinum-doublet adjuvant therapy should remain the standard of care for this patient population. However, adjuvant gefitinib might be an alternative for patients who are ineligible for platinum-doublet adjuvant therapy.  

Disclosures: This research was supported by AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Tada H, Mitsudomi T, Misumi T, et al. Randomized phase III study of gefitinib versus cisplatin plus vinorelbine for patients with resected stage II-IIIA non–small-cell lung cancer with EGFR mutation (IMPACT). J Clin Oncol. Published online November 02, 2021. doi:10.1200/JCO.21.01729