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Combining recombinant human endostatin with third-generation EGFR-TKIs in advanced EGFR-sensitive mutant non-small
Jinhong Chen1, Hongxiang Huang1, Peiyuan Zhong1,2
1Department of Oncology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China.
Background:
Third-generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are standard first-line options in advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC). This study aimed to compare the efficacy and safety of third generation EGFR-TKIs combined with recombinant human endostatin (Endostar) versus EGFR-TKIs alone in previously untreated advanced epidermal growth factor receptor (EGFR) mutant NSCLC patients.
Methods:
A total of 118 untreated advanced EGFR-sensitive-mutant NSCLC patients from a single center were retrospectively included in the study. Of the patients, 71 received third-generation EGFR-TKIs (the T group) and 47 received combination of Endostar and third-generation EGFR-TKIs therapy (the E + T group). Progression-free survival (PFS), overall survival (OS), the objective response rate (ORR), the disease control rate (DCR), and adverse events (AEs) were evaluated.
Results:
Compared to the T group, the E + T group had a significantly higher ORR (91.5% vs. 77.5%; P=0.047), and improved PFS (20.2 vs. 17.6 months; P=0.002) and OS (41.5 vs. 33.8 months; P=0.04). However, there was no significant difference in the DCR between the two groups (97.9% vs. 97.2%; P>0.99). Multivariate analysis identified the Eastern Cooperative Oncology Group performance status (ECOG-PS) score, brain metastasis, EGFR co-mutation, and treatment regimen as independent prognostic factors. Subgroup analysis showed that the E + T group had greater clinical benefits for patients with ≥2 distant metastatic organs (P=0.01) and EGFR/TP53 co-mutations (P=0.01). The incidence of AEs of any level was higher in the E + T group than the T group (53.2% vs. 45.1%, P=0.39).
Conclusions:
In this real-world study, the combination of recombinant human endostatin and third-generation EGFR-TKIs significantly improved the ORR, PFS, and OS in previously untreated advanced EGFR-mutant NSCLC patients and thus represents a promising treatment option that requires further prospective evaluation.
Insights
Adding recombinant human endostatin to third-generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) improved outcomes for advanced non-small cell lung cancer (NSCLC) patients. This combination therapy showed higher response rates and longer progression-free and overall survival.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Third-generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are a standard first-line treatment for advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC).
- Investigating novel therapeutic combinations to improve treatment efficacy in this patient population is crucial.
Purpose of the Study:
- To compare the efficacy and safety of third-generation EGFR-TKIs combined with recombinant human endostatin (Endostar) versus third-generation EGFR-TKIs alone.
- To evaluate this combination therapy in previously untreated advanced EGFR-mutant NSCLC patients.
Main Methods:
- Retrospective study including 118 untreated advanced EGFR-sensitive-mutant NSCLC patients.
- Patients were divided into two groups: third-generation EGFR-TKIs alone (T group, n=71) and combination therapy (Endostar + third-generation EGFR-TKIs; E + T group, n=47).
- Key outcomes assessed included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs).
Main Results:
- The E + T group demonstrated significantly higher ORR (91.5% vs. 77.5%) and improved PFS (20.2 vs. 17.6 months) and OS (41.5 vs. 33.8 months) compared to the T group.
- No significant difference in DCR was observed between the groups.
- Multivariate analysis identified treatment regimen, ECOG-PS score, brain metastasis, and EGFR co-mutation as independent prognostic factors. The E + T combination showed particular benefit in patients with ≥2 distant metastatic organs and EGFR/TP53 co-mutations.
Conclusions:
- The combination of recombinant human endostatin and third-generation EGFR-TKIs significantly enhances ORR, PFS, and OS in previously untreated advanced EGFR-mutant NSCLC.
- This combination represents a promising therapeutic strategy for advanced EGFR-mutant NSCLC.
- Further prospective studies are warranted to validate these findings.
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