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Gefitinib produced higher response rate, better PFS in advanced lung cancer
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13th World Congress on Lung Cancer
Gefitinib did not improve OS for patients with advanced lung cancer but did improve response rates and PFS, leading researchers to believe the tyrosine kinase inhibitor might be appropriate to treat never-smokers in a first-line setting.
Jin S. Lee, MD, of the National Cancer Center Korea, discussed results from the First-SIGNAL trial during a press conference at the 13th World Conference on Lung Cancer. The phase-3 trial compared gefitinib (Iressa, AstraZeneca) with gemcitabine and cisplatin as a first-line treatment for never smokers with advanced or metastatic adenocarcinoma of the lung. Lee said the study failed to meet the primary endpoint of significant OS improvement because 81% of patients in the chemotherapy group received second- or third-line EGFR-tyrosine kinase inhibitors.
“Gefitinib did not improve OS over the standard chemotherapy,” Lee said in a press release. “However, a promising survival outcome along with high overall response rate and better toxicity profile suggests that gefitinib might be a reasonable first-line therapy for this group of never-smoker lung cancer patients.”
Gefitinib had a median OS of 21.3 months and a one-year OS of 74.2% compared with a median OS of 23.3 months and a one-year OS of 76.2% for chemotherapy. However, PFS was superior in the gefitinib group at one year (20.3% vs. 5.0%) and two years (4.2% vs. 0.7%)
Objective response was 53.5% for gefitinib compared with 45.3% for chemotherapy.
Additionally, in the gefitinib group, PFS in the EGFR mutation-negative subgroup was shorter than that of the mutation-positive group (with a median of 2.1 vs. 8.4 months). There was no difference between these two subgroups in the chemotherapy group.
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