Observational studyBMC cancer2026
First-line treatment outcomes in HER2-altered advanced NSCLC: a real-world multi-center study comparing trastuzumab deruxtecan with conventional therapies and analysis by HER2/EGFR co-alteration status.
Observational study in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundFirst-line treatment options for HER2-altered advanced non-small cell lung cancer (NSCLC) remain limited, especially in cases with HER2-EGFR co-alterations. While new agents like trastuzumab deruxtecan (T-DXd) have emerged, its real-world evidence in first line remains limited.
methodsThis study included patients with advanced NSCLC who had HER2 mutations or amplification and received first-line systemic therapy at six medical centers. Outcomes were evaluated following chemotherapy-based combinations, pan-HER tyrosine kinase inhibitors (TKIs), and T-DXd. Endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), one-year and two-year survival rates, and toxicity.
resultsA total of 69 patients were enrolled, comprising 45 with only HER2 alterations and 24 with HER2-EGFR co-alterations. In patients with only HER2-altered NSCLC, those receiving first-line T-DXd had an mPFS of 15.7 months (95% CI, 12.5-18.9), an ORR of 85.7%, and a DCR of 100.0%. The mPFS for patients receiving chemotherapy-based regimens, pan-HER TKIs, and chemotherapy plus pan-HER TKIs were 7.6 (95% CI, 6.6-8.5) months, 4.4 (95% CI, 4.0-4.9) months, and 7.0 (95% CI, 6.1-9.1) months, respectively. The ORR for the three groups above was 33.3%, 0, and 0, respectively. In subgroup analysis, patients with only HER2 alterations who did not harbor TP53 mutations had a longer PFS than those with TP53 co-mutations (8.7 m vs. 7.2 m; HR: 0.35; 95% CI: 0.11-0.99; P = 0.048). In patients with EGFR-HER2 co-alterations, first-line EGFR-TKI monotherapy yielded an mPFS of 9.7 (95% CI, 8.6-10.8) months, an ORR of 40.0%, and a DCR of 93.3%. Regarding safety, we did not observe Grade ≥ 3 TRAEs in first-line T-DXd treatment.
conclusionsFirst-line T-DXd showed promising activity signals in only HER2-altered NSCLC. In EGFR-HER2 co-altered patients, the EGFR-TKI monotherapy showed limited efficacy. The findings underscored the urgent need for prospective randomised trials.
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