Gefitinib improved survival vs. cisplatin/docetaxel in patients with NSCLC, EGFR mutations

Patients with non–small cell lung cancer who have epidermal growth factor receptor mutations had superior PFS when assigned to gefitinib compared with standard platinum doublet chemotherapy.

Researchers with the West Japan Oncology Group performed an open-label, phase-3 trial of 172 patients. All patients were aged 75 years or younger and had been diagnosed with stage IIIb/IV NSCLC or postoperative recurrence harboring EGFR mutations. No patient had undergone chemotherapy.

The researchers randomly assigned patients to 250-mg daily oral gefitinib (Iressa, AstraZeneca) or 60 mg/m² IV docetaxel followed by 80 mg/m² IV cisplatin at a 1:1 ratio. Median follow-up was 81 days.

Median PFS was 9.2 months in the gefitinib group compared with 6.3 months in the docetaxel and cisplatin group (HR=0.489; 95% CI, 0.336-0.710). The researchers said gefitinib was associated with longer PFS both for patients with stage IIIb/IV disease and those with postoperative recurrent disease.

The objective response rate was 62.1% in the gefitinib group vs. 32.2% in the docetaxel and cisplatin group — a 29.9% difference (95% CI, 12.6%-47.1%). The researchers also said the disease control rate was superior in the gefitinib group: 93.1% vs. 78%. Grade-3/4 adverse events were rare in both groups.

“Gefitinib significantly prolonged the PFS of patients with NSCLC who carry EGFR mutations compared with cisplatin plus docetaxel,” the researchers wrote. “It is not yet known whether the prolonged PFS conferred by gefitinib will translate into prolonged OS.”

Mitsudomi T. Lancet. 2009;doi:10.1016/S1470-2045(09)70364-X.