EGFR変異陽性非小細胞肺癌患者に対する周術期治療の検討：リアルワールド多施設共同コホート研究

For patients with resectable epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC), the optimal neoadjuvant regimen remains undefined. In this multicenter retrospective cohort study, we explored the efficacy and safety of immunochemotherapy, tyrosine kinase inhibitors (TKIs), and chemotherapy as perioperative treatments for patients with resectable NSCLC harboring EGFR mutations.

Patients with untreated stage IIA-IIIB NSCLC and EGFR mutations were enrolled in the study. Neoadjuvant treatment comprised immunotherapy combined with chemotherapy, chemotherapy or TKI followed by surgery and optional adjuvant treatment. The primary endpoint was pathological response, including the pathological complete response (pCR) rate and major pathological response (MPR). The secondary endpoints included event-free survival (EFS), objective response rate (ORR), lymph node downgrade rate, and safety.

Between January 13, 2020, and September 1, 2023, of 64 patients screened, 41 patients from seven centers were included in the final efficacy analysis. The ORR of the immunochemotherapy group, the TKI group, and the chemotherapy group was 63.0% [95% confidence interval (CI): 42.4-80.6%], 41.7% (95% CI: 15.2-72.3%), and 100% (95% CI: 15.8-100%), respectively. A total of 40 patients (97.5%) underwent definitive surgery, and 55.9% of the patients achieved lymph node downgrade. Among all 40 patients receiving definitive surgery, 10 patients achieved MPR, and the MPR rate was 25.0% (95% CI: 12.7-41.2%). The pCR rate was 10.0% (95% CI: 2.8-23.7%). For the immunochemotherapy group, the MPR rate was 30.8%, and for the TKI group, the MPR rate was 8.3% (P=0.08). The pCR rates of the immunochemotherapy group and the TKI group were 15.4% and 0%, respectively (P=0.18). With a follow-up of 24.0 months, the median EFS was not reached, and the 12-month and 24-month EFS rates were 94.2% and 75.8%, respectively. Treatment-related adverse events were manageable.

The combination of immunotherapy and chemotherapy as neoadjuvant treatment demonstrated a promising pathological response among patients with EGFR-mutant NSCLC.