Gefitinib Plus Platinum-Doublet Chemotherapy May Improve Overall Survival in EGFR-Positive NSCLC
EGFR tyrosine kinase inhibitor monotherapy has improved progression-free survival (PFS) but not overall survival (OS) compared with chemotherapy in non-small cell lung cancer.
|The following article features coverage from the American Society of Clinical Oncology (ASCO) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
CHICAGO—The combination therapy of gefitinib, carboplatin, and pemetrexed (GCP) may lead to superior survival outcomes compared with gefitinib monotherapy among patients with advanced epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC), according to data presented at the 2018 American Society of Clinical Oncology Annual Meeting on Monday, June 4.1
The standard of care among patients with advanced EGFR-mutated NSCLC — EGFR tyrosine kinase inhibitor (TKI) monotherapy — has improved progression-free survival (PFS) but not overall survival (OS) when compared with chemotherapy. A previous study has shown that the gefitinib plus platinum doublet chemotherapy may improve overall survival in this population.
For this open-label phase 3 NEJ009 study, researchers randomly assigned 344 previously untreated patients with advanced stage (stage III/IV) and recurrent NSCLC harboring EGFR-activating mutations to receive oral gefitinib 250 mg alone once daily or gefitinib 250 mg, carboplatin AUC 5, and pemetrexed 500 mg/m2 (GCP) every 3 weeks. The baseline characteristics between the 2 study groups were comparable. The primary outcomes were progression-free survival (PFS), progression after the next line of therapy (PFS2), and overall survival (OS).
Results showed that patients who received GCP had a significantly prolonged PFS compared with patients treated with gefitinib alone (20.9 vs 11.2 months; hazard ratio [HR], 0.492; 95% CI, 0.391-0.625; P < .001). The OS was also increased among patients treated with GCP with 52.2 months versus 38.8 months among patients treated with gefitinib alone (hazard ratio [HR], 0.695; P = .013). The overall response rate was 84.0% and 67.4% in the combination group and monotherapy group, respectively.
Further analysis showed, however, that PFS2 did not differ significantly between the study arms; median PFS2 among patients who received GCP was 20.9 months versus 20.7 months among patients who received gefitinib monotherapy (HR, 0.966; 95% CI, 0.766-1.220; P = .774).
Grade 3 or worse adverse effects observed with greater frequency in the GCP arm included neutropenia, anemia, and thrombocytopenia.
The authors concluded that “gefitinib combined with carboplatin and pemetrexed may be an effective treatment option for first-line treatment of advanced EGFR-mutated NSCLC.”
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- Nakamura A, Inoue A, Morita S, et al. Phase III study comparing gefitinib monotherapy (G) to combination therapy with gefitinib, carboplatin, and pemetrexed (GCP) for untreated patients (pts) with advanced non-small cell lung cancer (NSCLC) with EGFR mutations (NEJ009). Oral presentation at: 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL.