Gefitinib Delayed Recurrence in Intermediate-Stage EGFR-Positive NSCLC

Targeted therapy with adjuvant gefitinib significantly prolonged time to recurrence compared with standard-of-care vinorelbine/cisplatin among patients with completely resected stage II to IIIa non–small-cell lung cancer (NSCLC) with EGFR-activating mutations, according to the results of the ADJUVANT trial (abstract #8500) presented at a press conference ahead of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.

Treatment with gefitinib resulted in a 10-month longer disease-free survival compared with chemotherapy.

“We have to conclude that adjuvant gefitinib should be considered as an important option for stage II–IIIa lung cancer patients with an active EGFR mutation,” said study author Yi-Long Wu, MD, director of the Guangdong Lung Cancer Institute at Guangdong General Hospital in China, during the press conference.

According to Wu, about 20% to 25% of patients diagnosed with NSCLC are suitable for curative surgical resection. Adjuvant chemotherapy is the standard of care for patients with intermediate-stage lung cancer, but there is only a 5% increased survival benefit. EGFR tyrosine kinase inhibitors (TKIs) are standard first-line therapy for EGFR-mutated advanced lung cancer. Wu and colleagues hypothesized that EGFR TKIs might replace adjuvant chemotherapy for patients with EGFR-mutated lung cancer.

The ADJUVANT trial included 220 patients with resected stage II–IIIa NSCLC and EGFR mutations and randomly assigned them to gefitinib 250 mg once daily for 24 months or vinorelbine 25 mg/m² plus cisplatin 75 mg/m² every 3 weeks for up to 4 cycles.

With a median follow-up of 36.5 months, patients assigned gefitinib had a median disease-free survival of 28.7 months compared with 18.0 months for patients assigned vinorelbine/cisplatin (hazard ratio [HR], 0.60; 95% CI, 0.42–0.87; P = .005). The 3-year disease-free survival rate was significantly better for gefitinib compared with standard of care (34.0% vs 27.0%; P = .013).

The researchers also conducted a subgroup analysis that revealed that lymph node status (pN1/N2) was significantly correlated with disease-free survival (P < .05).

Finally, patients assigned gefitinib had significantly fewer grade 3 or higher adverse events compared with vinorelbine/cisplatin (12.3% vs 48.3%; P < .001). The most common serious adverse event in the gefitinib group was elevated liver enzymes; patients in the chemotherapy group had more severe quality-of-life concerns, including vomiting, nausea, low blood counts, and anemia.