Continuation of gefitinib after radiological disease progression on first-line gefitinib did not improve progression-free survival in patients with EGFR-mutation-positive non-small cell lung cancer (NSCLC) who received platinum-double based chemotherapy as subsequent line of treatment, a new study published in the journal The Lancet Oncology has shown.
For the multicenter, phase 3 IMPRESS trial, research sought to evaluate the safety and efficacy of continuing gefitinib, an EGFR tyrosine-kinase inhibitor, plus chemotherapy compared with chemotherapy alone in patients with EGFR-mutation-positive advanced NSCLC who acquired resistance to first-line treatment with gefitinib.
Researchers enrolled 265 patients with chemotherapy-naive, stage 3B-4 EGFR-mutation-positive NSCLC who previously responded to first-line gefitinib.
Patients were randomly assigned 1:1 to receive gefitinib 250 mg orally or placebo, in combination with cisplatin 75 mg/m2 IV plus pemetrexed 500 mg/m2 IV on day 1 of each cycle until disease progression or unacceptable toxicity.
Results showed that median progression-free survival was 5.4 months in both groups (95% CI: 4.5, 5.7 with gefitinib and 4.6, 5.5 with placebo). Researchers found that 74% of patients in the gefitinib group had experienced disease progression versus 81% of patients in the placebo group (HR = 0.86; 95% CI: 0.65, 1.13; P=0.27).
In regard to safety, grade 3 or worse anemia and neutropenia were more common in the gefitinib group than the placebo group.
The findings suggest that platinum-based double chemotherapy should remain the standard of care for patients with EGFR-mutation-positive advanced NSCLC who have progressed after first-line treatment with gefitinib.
Soria J-C, Wu Y-L, Nakagawa K, et al. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. The Lancet Oncology. 2015. [epub ahead of print]. doi: 10.1016/S1470-2045(15)00121-7.