BMC cancer · 2026
Adjuvant chemotherapy with or without EGFR-TKIs for resected EGFR-mutated non-small cell lung cancer: a pooled analysis of four randomized controlled trials.
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Chen Sui, Guo Feilong, Zhu Jiafu, Lin Jiangbo
Аннотация
BACKGROUND: The role of adding adjuvant epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) to chemotherapy (ETC) among patients with completely resected EGFR-mutated non-small cell lung cancer (NSCLC) remains unclear, particularly with respect to overall survival (OS). A meta-analysis was performed using randomized controlled trials (RCTs), aiming to assess both efficacy and safety profiles of adjuvant chemotherapy plus EGFR-TKIs versus chemotherapy alone.
METHODS: Six databases were systematically screened to retrieve eligible RCTs evaluating ETC versus placebo plus chemotherapy (PC) as adjuvant therapy. Overall survival (OS) and disease-free survival (DFS) were defined as the primary endpoints, while disease relapse together with treatment-related adverse events (TRAEs) constituted the secondary endpoints.
RESULTS: A total of five RCTs comprising 890 patients were included. Baseline patient characteristics (e.g., age, sex, and disease stage) were comparable between groups. ETC significantly improved OS (HR: 0.56 [0.41, 0.77], P = 0.0003) and DFS (HR: 0.36 [0.23, 0.57], P < 0.0001), with consistent benefits observed across all predefined subgroups. OS rates at 30-60 months and DFS rates at 6-60 months were significantly higher in the ETC group. More tumor recurrences were found in the PC group (RR: 0.37 [0.21, 0.66], P = 0.0007), predominantly due to distant metastases. TRAEs (RR: 1.35 [1.05, 1.73], P = 0.02) and TRAE-related treatment discontinuation or dose reduction (RR: 5.00 [1.12, 22.28], P = 0.03) were more frequent in the ETC group.
CONCLUSIONS: Adjuvant ETC significantly improves survival and reduces distant recurrence for resected EGFR-mutated NSCLC; however, these benefits should be weighed against a higher but manageable risk of toxicity.
PROSPERO ID: CRD420261381478.
METHODS: Six databases were systematically screened to retrieve eligible RCTs evaluating ETC versus placebo plus chemotherapy (PC) as adjuvant therapy. Overall survival (OS) and disease-free survival (DFS) were defined as the primary endpoints, while disease relapse together with treatment-related adverse events (TRAEs) constituted the secondary endpoints.
RESULTS: A total of five RCTs comprising 890 patients were included. Baseline patient characteristics (e.g., age, sex, and disease stage) were comparable between groups. ETC significantly improved OS (HR: 0.56 [0.41, 0.77], P = 0.0003) and DFS (HR: 0.36 [0.23, 0.57], P < 0.0001), with consistent benefits observed across all predefined subgroups. OS rates at 30-60 months and DFS rates at 6-60 months were significantly higher in the ETC group. More tumor recurrences were found in the PC group (RR: 0.37 [0.21, 0.66], P = 0.0007), predominantly due to distant metastases. TRAEs (RR: 1.35 [1.05, 1.73], P = 0.02) and TRAE-related treatment discontinuation or dose reduction (RR: 5.00 [1.12, 22.28], P = 0.03) were more frequent in the ETC group.
CONCLUSIONS: Adjuvant ETC significantly improves survival and reduces distant recurrence for resected EGFR-mutated NSCLC; however, these benefits should be weighed against a higher but manageable risk of toxicity.
PROSPERO ID: CRD420261381478.