(Lung Cancer) Is Iressa + Cisplatin + Pemetrexed Effective?
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On November 4, 2019, Yukio Hosomi published in the medical journal "Journal of Clinical Oncology" the effectiveness and safety results of the NEJ009 Phase 3 clinical trial evaluating the combination of EGFR tyrosine kinase inhibitor Iressa (gefitinib) + Cisplatin + Pemetrexed in treatment-naive, EGFR-positive non-small cell lung cancer patients.
The NEJ009 Phase 3 clinical trial randomized treatment-naive, EGFR-positive non-small cell lung cancer patients (N=345) into two groups. Primary endpoints were progression-free survival (PFS), second progression-free survival (PFS2), and overall survival (OS). Secondary endpoints included objective response rate and safety.
Combination therapy group (3-week cycle: Iressa 250mg once daily + Cisplatin AUC5 + Pemetrexed 500mg/m², N=172)
Iressa monotherapy group (3-week cycle: Iressa 250mg once daily, N=173)
Patient Characteristics:
| Combination Group | Iressa Monotherapy | |
|---|---|---|
| Median age | 64.8 years | 64.0 years |
| Male / Female | 32.9% / 67.1% | 37.2% / 62.8% |
| Ever smoker / Never smoker | 42.9% / 56.5% | 43.6% / 56.4% |
| CNS metastasis | 29.4% | 22.1% |
| Exon19del / L858R / Other | 54.7% / 40.6% / 4.7% | 55.2% / 39.0% / 5.8% |
Results:
Primary endpoint — median PFS: combination group 20.9 months / Iressa monotherapy 11.2 months. The combination group showed a 51% reduction in PFS risk (HR 0.49), a significant improvement. Median OS: combination group 50.9 months / Iressa monotherapy 38.8 months. The combination group showed a 27.8% reduction in OS risk (HR 0.722), a significant improvement.
For the primary endpoint of PFS2, the median was 20.9 months in the combination group versus 18.0 months in the monotherapy group. Although there was an 18.2% reduction in risk (HR 0.81), this was not a statistically significant improvement. Secondary endpoint objective response rate: combination group 84% / Iressa monotherapy 67% — a significant improvement in the combination group.
Safety: The overall incidence of adverse events was 95.9% for the combination group and 98.2% for the Iressa monotherapy group. Grade 3 or higher adverse events were 65.3% for the combination group and 31.0% for the monotherapy group. The most common Grade 3+ events more frequent in the combination group included neutropenia (31.2% vs. 0.6%), anemia (21.2% vs. 2.3%), and thrombocytopenia (17.1% vs. 0%).
Based on the NEJ009 trial results, Yukio Hosomi concluded that in treatment-naive, EGFR-positive non-small cell lung cancer patients, the combination of EGFR tyrosine kinase inhibitor Iressa + Cisplatin + Pemetrexed improved both progression-free survival and overall survival compared to Iressa monotherapy.
Source: Gefitinib Alone Versus Gefitinib Plus Chemotherapy for Non–Small-Cell Lung Cancer With Mutated Epidermal Growth Factor Receptor: NEJ009 Study (J Clin Oncol. 2019 Oct 25:JCO1901740. doi: 10.1200/JCO.19.01740.)
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