Adjuvant EGFR inhibition with gefitinib improves disease-free survival (DFS) compared with chemotherapy among patients with resected stage II-IIIA (N1-N2) non–small cell lung cancer (NSCLC), according to a study published in The Lancet Oncology.1
Cisplatin-based chemotherapy is the standard adjuvant therapy for patients with resected stage II-IIIA disease, though 5-year survival rates are still low and adverse events are common. While EGFR inhibition is a standard first-line therapy for patients with EGFR-mutant disease, it is unknown whether this strategy benefits patients over chemotherapy in the adjuvant setting.
For the 1:1 randomized phase 3 ADJUVANT study (ClinicalTrials.gov Identifier: NCT01405079), researchers enrolled 222 patients with completely resected stage II-IIIA (N1-N2) NSCLC to receive adjuvant gefitinib or cisplatin plus vinorelbine. All patients were Chinese (among whom EGFR mutations are more common), the median age was 58 years, and 92% of patients had an adenocarcinoma.
Of the 222 initially assigned patients, 24 did not receive treatment in the chemotherapy group and 5 did not receive treatment in the gefitinib group, leaving 87 patients and 106 patients in the respective modified intention-to-treat populations.
The median follow-up was 36.5 months. Patients in the gefitinib group had a median DFS of 28.7 months vs 18 months with chemotherapy (hazard ratio, 0.6; P = .0054). Overall survival data are not, however, yet mature.
While the grade 1 to 2 adverse event (AE) rate was higher in the gefitinib group (45%) than in the chemotherapy group (32%), fewer patients in the gefitinib group (12%) had a grade 3 to 4 AE than those in the chemotherapy group (48%). The most common grade 3 or worse AEs in the gefitinib group were elevated alanine aminotransferase and elevated aspartate aminotransferase; the most common grade 3 or worse AEs in the chemotherapy group were neutropenia and leucopenia.
The authors concluded that “gefitinib could be considered a treatment option for this population of patients; however, mature data for overall survival are needed.”
- Zhong WZ, Wang Q, Mao WM, et al. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II–IIIA (N1–N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study. Lancet Oncol. 2017 Nov 21. doi: 10.1016/S1470-2045(17)30729-5 [Epub ahead of print]