Adjuvant gefitinib significantly prolongs disease-free survival (DFS) compared with vinorelbine plus cisplatin (VP) among patients with stage II to III non–small cell lung cancer (NSCLC), according to a study that will be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
The survival benefit of adjuvant standard of care chemotherapy for NSCLC is around 5%. EGFR tyrosine kinase inhibitors (TKIs) are now the standard of care for the first-line treatment of NSCLC with EGFR-activating mutations for advanced, non-resectable disease. The purpose of this trial was to determine if an EGFR TKI could benefit patients in the adjuvant setting.
The phase 3 CTONG 1104 trial (ClinicalTrials.gov Identifier: NCT01405079) randomly assigned 222 patients with completely resected stage II-IIIA (N1-N2) NSCLC with EGFR-activating mutations to receive gefitinib for 24 months or VP every 3 weeks for 4 cycles. The EGFR-activating mutations included exon 19 deletions or exon 21 L858R.
Adjuvant gefitinib significantly prolonged DFS with a median of 28.7 months (95% CI, 24.9-32.5) compared with 18.0 months (95% CI, 13.6-22.3) with VP (hazard ratio [HR], 0.60; 95% CI, 0.42-0.87; P = .005). The 3-year DFS rate was 34% with gefitinib and 27% with VP.
The rate of grade 3 or higher adverse events (AEs) was 12.3% with gefitinib and 48.3% with VP. Hematologic AEs, nausea, vomiting, and anorexia occurred more frequently with VP, though rash, elevated liver enzymes, and diarrhea occurred more often with gefitinib.
These data suggest that adjuvant treatment of NSCLC with gefitinib for 2 years was well-tolerated and improved DFS. These results differ from earlier trials that evaluated other EGFR TKIs.
According to the investigators, “adjuvant gefitinib should be considered as an important option for stage II-IIIA lung cancer patients with an active EGFR mutation.”
Wu YL, Zhong W, Wang Q, et al. Gefintinib (G) versus vinorelbine+cisplatin (VP) as adjuvant treatment in state II-IIIA (N1-N2) non-small-cell lung cancer (NSCLC) with EGFR-activating mutation (ADJUVANT): a randomized, phase III trial (CTONG 1104). J Clin Oncol. 2017;34(suppl; abstr 8500).
This article originally appeared on Cancer Therapy Advisor