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Efficacy and safety of neoadjuvant targeted therapy in non-small cell lung cancer: a systematic review and
Honglin Li1, Lan Yang1, Jiayi Sun1
1Department of Pulmonary and Critical Care Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, Institute of Respiratory Health and Multimorbidity, Institute of Respiratory Health, Frontiers Science Center for Disease-Related Molecular Network, Precision Medicine Center/Precision Medicine Key Laboratory of Sichuan Province, West China Hospital, Sichuan University, Chengdu, China.
Introduction:
Epidermal growth factor receptor (EGFR) mutations are major oncogenic drivers in non-small cell lung cancer (NSCLC), occurring in 30-50% of Asian patients. Neoadjuvant EGFR-tyrosine kinase inhibitors (EGFR-TKIs) may improve surgical outcomes in resectable EGFR-mutant NSCLC, but evidence from small, heterogeneous trials is inconsistent and the overall efficacy and safety remain unclear.
Objectives:
To evaluate the efficacy and safety of neoadjuvant EGFR-TKI monotherapy in sensitizing EGFR-mutant NSCLC.
Methods:
PubMed, Embase, the Cochrane Library, and Web of Science were searched from inception to June 30, 2025. Prospective studies of neoadjuvant EGFR-TKI monotherapy in adults with genetically confirmed sensitizing EGFR-mutant NSCLC were eligible. Two investigators independently extracted data. Heterogeneity was assessed using Cochran's Q test and the I2 statistic. Outcomes were pooled using random-effects (I2 > 50%) or fixed-effects (I2 ≤ 50%) meta-analyses. The primary outcomes were objective response rate (ORR) and incidence of grade ≥ 3 adverse events (AEs). Secondary outcomes included major pathological response (MPR) rate, pathologic complete response (pCR) rate, and complete (R0) resection rate. Predefined subgroup analyses were performed by age and ethnicity.
Results:
Fifteen prospective studies involving 452 patients were included. The pooled ORR was 0.61 (95% confidence interval [CI] 0.54-0.67). The incidence of grade ≥ 3 AEs was 0.11 (95% CI 0.08-0.15), indicating an acceptable safety profile. The pooled MPR and pCR rates were 0.21 (95% CI 0.15-0.29) and 0.11 (95% CI 0.08-0.15), respectively. The pooled R0 resection rate was 0.90 (95% CI 0.86-0.94). ORR was higher in patients aged ≥ 60 years than < 60 years (0.69 vs 0.54, P = 0.01). pCR was higher in Chinese than non-Chinese patients (0.10 vs 0.03, P = 0.04).
Conclusion:
Neoadjuvant EGFR-TKI monotherapy was associated with promising efficacy and a manageable safety profile in stage I-III EGFR-mutant NSCLC patients. However, the evidence is derived predominantly from single-arm prospective studies, limiting inference regarding comparative efficacy and survival benefit. Large randomized controlled trials with long-term follow-up are needed to confirm these findings.
Systematic Review Registration:
PROSPERO CRD420251064957.
Insights
Neoadjuvant EGFR-tyrosine kinase inhibitors (EGFR-TKIs) show promising efficacy and safety in EGFR-mutant non-small cell lung cancer (NSCLC). Further randomized trials are needed to confirm survival benefits.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Epidermal growth factor receptor (EGFR) mutations drive non-small cell lung cancer (NSCLC), particularly in Asian populations.
- Neoadjuvant EGFR-tyrosine kinase inhibitors (EGFR-TKIs) are being investigated to improve surgical outcomes in resectable EGFR-mutant NSCLC.
- Existing evidence on neoadjuvant EGFR-TKI efficacy and safety is limited by small, heterogeneous trials.
Purpose of the Study:
- To evaluate the efficacy and safety of neoadjuvant EGFR-TKI monotherapy in sensitizing EGFR-mutant NSCLC.
- To determine objective response rates (ORR), pathological response rates, and safety profiles.
- To assess rates of complete (R0) resection and adverse events (AEs).
Main Methods:
- A systematic review and meta-analysis of prospective studies published up to June 30, 2025.
- Searched databases included PubMed, Embase, Cochrane Library, and Web of Science.
- Pooled data from 15 studies involving 452 patients using random-effects or fixed-effects models based on heterogeneity.
Main Results:
- The pooled objective response rate (ORR) was 61%, with an acceptable safety profile (grade ≥3 AEs at 11%).
- Major pathological response (MPR) and pathologic complete response (pCR) rates were 21% and 11%, respectively.
- The R0 resection rate was high at 90%; ORR was higher in older patients, and pCR was higher in Chinese patients.
Conclusions:
- Neoadjuvant EGFR-TKI monotherapy demonstrates promising efficacy and a manageable safety profile for stage I-III EGFR-mutant NSCLC.
- Current evidence primarily comes from single-arm studies, limiting definitive conclusions on comparative efficacy and survival.
- Large, randomized controlled trials with long-term follow-up are essential to validate these findings.
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