In patients with stage II–IIIA epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), icotinib significantly improved disease-free survival in the adjuvant setting compared with standard chemotherapy, according to results of a phase 3 trial recently presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer.
"Recent studies have shown significant benefits of EGFR tyrosine kinase inhibitors in the adjuvant setting for patients with EGFR-mutated stage IB–IIIA resected NSCLC," write the investigators, led by Caicun Zhou, MD, PhD, Director of the Department of Oncology at Shanghai Pulmonary Hospital in China. "This study aimed to compare the efficacy and safety of icotinib with standard chemotherapy in the adjuvant setting in patients with EGFR-mutated stage II–IIIA NSCLC."
The EVIDENCE trial randomized 283 patients with completely resected, stage II-IIIA EGFR-mutated NSCLC to receive 125 mg icotinib three times daily for two years, or four-cycle chemotherapy consisting of cisplatin/vinorelbine or cisplatin/pemetrexed for those with non-squamous carcinoma. The primary end point was disease-free survival, with secondary end points of overall survival and safety.
At a median follow-up of 24.9 months, icotinib produced a median disease-free survival of 47.0 months compared with 22.1 months in the chemotherapy group. The disease-free survival benefit was consistent across clinical stage, EGFR mutation type, and resection method subgroups. Three-year disease-free survival was significantly higher in the icotinib group compared with chemotherapy (63.9% vs 32.5%). Patients receiving icotinib experienced a lower rate of treatment-related grade 3 or 4 adverse events (10.9% vs 61.2%) and serious adverse events (1.3% vs 13.7%) compared with those receiving chemotherapy. No instances of interstitial lung disease occurred in either treatment arm, and there were no treatment-related deaths.
"Adjuvant icotinib significantly improved disease-free survival in patients with EGFR-mutated stage II–IIIA NSCLC compared with standard chemotherapy and demonstrated a better tolerability profile," conclude Dr. Zhou and colleagues. "Icotinib can provide a new treatment option for stage II–IIIA NSCLC patients with activating EGFR mutations."
For More Information
Zhou C, et al (2021). Icotinib versus chemotherapy as adjuvant treatment for stage II–IIIA EGFR-mutant NSCLC (EVIDENCE): a randomized, open-label, phase 3 study. World Conference on Lung Cancer Abstracts. Abstract FP14.11.
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