Clinical Efficacy And Safety Of Apatinib Combined With Egfr-Tkis In Advanced Non-Small Cell Lung Cancer With Egfr-Tkis Resistance

e21172 Background: Acquired resistance to EGFR-TKIs frequently occurs in advanced non-small cell lung cancer (NSCLC) patients (pts) with sensitizing EGFR mutations. Previous studies have shown that apatinib (a TKI against VEGFR-2) combined with EGFR-TKIs might improve the survival of EGFR-TKIs resistant NSCLC pts. We conducted this trial to investigate the efficacy and safety of apatinib combined with EGFR-TKIs(including erlotinib, gefitinib and icotinib) compared with traditional chemotherapy for EGFR-TKIs resistant NSCLC pts. Methods: This prospective study enrolled advanced NSCLC pts who acquired resistance to the EGFR-TKIs therapy. Pts received apatinib combined with EGFR-TKIs (apatinib in start dose of 250 mg+pior EGFR-TKIs dose) or chemotherapy ( pemetrexed or vinorelbine with platinum). Efficacy was evaluated every 6 weeks based on RECIST 1.1. Results: From Mar 2017 to Feb 2018,19 pts were enrolled, including 13 pts received apatinib combined with EGFR-TKIs,6 pts received chemotherapy, all pts had no disease progression till Feb 1, 2018. In the apatinib group, 92.31%(12/13) pts were available evaluated. The objective response rate was 25%(3/12) and the disease control rate was 100% (12/12). The most common adverse events in the apatinib group were hypertension (66.67%,8/12), proteinuria (33.33%,4/12 ), hand-foot syndrome(16.67%,2/12), diarrhea(16.67%,2/12). Main grade 3 or 4 toxicities were hypertension (25%, 3/12), hand-foot syndrome (8.33%, 1/12) and diarrhea(8.33%,1/12). Two pts with brain metastases in the apatinib group got metastases lesions decreased. Two progressive pts got lesions decreased after apatinib dose increasing to 500mg. Of the 6 pts receiving chemotherapy, 5 pts were available evaluated. The objective response rate was 20%(1/5) and the disease control rate was 100% (5/5). Major adverse reactions was hematological toxicity . Conclusions: Apatinib combined with EGFR-TKIs may provide a new therapy strategy for NSCLC pts with acquired EGFR-TKIs resistance. Further studys with lager samples are needed to validate our findings.Moreover, we will further explore the correlation between genetic mutations, biomarkers and therapeutic efficacy . Clinical trial information: ChiCTR-OIN-17012051.