2911 - Apatinib combined with EGFR - TKI in treating advanced non-small cell lung cancer with EGFR - TKI resistance

Background

EGFR-TKI have been widely used in patients (pts) with EGFR mutations in NSCLC and brought significant benefits. But resistance to EGFR-TKI is inevitable. Previous studies have shown that apatinib (a TKI against VEGFR-2) combined with EGFR-TKI might prevent progression of the disease. We conducted this trial to investigate the efficacy and safety of apatinib combined with EGFR-TKIs (including erlotinib, gefitinib, icotinib, afatinib and osimertinib) compared with traditional chemotherapy for EGFR-TKI-resistant NSCLC pts.

Methods

This study enrolled 39 advanced NSCLC pts who acquired resistance to EGFR-TKI therapy from Mar 2017 to Jan 2019. 25 pts received apatinib combined with EGFR-TKI (apatinib in start dose of 250 mg+prior EGFR-TKI dose),14 pts received chemotherapy (pemetrexed or vinorelbine with platinum).

Results

In the apatinib group, 88% (22/25) pts were available evaluated. The objective response rate was 17% (3/22) and the disease control rate was 96% (21/22). The most common adverse events in the apatinib group were diarrhea (60%,15/25), hypertension (56%,14/25), hand-foot syndrome (40%,10/25), fatigue (30%,7/23). Main grade 3 or 4 toxicities were proteinuria (12%, 3/25). Two pts with brain metastases in the apatinib group showed a decrease of metastatic lesions. The lesions of two pts who having taken the dose of 250mg apatinib and progressed decreased when they changed the dose to 500mg. In the chemotherapy group, 79% (11/14) pts were available to be evaluated. The objective response rate was 27% (3/11) and the disease control rate was 91% (10/11). No new adverse events occurred. The median length of treatment of the apatinib group was 8.7 monthsand of chemotherapy group was 4.3 months. The longest treatment period in the apatinib group was 24 months.

Conclusions

Apatinib combined with EGFR-TKI showed a good clinical efficacy in pts with acquired EGFR-TKI (1st 2nd or 3rd generation) resistance. Patient’s quality of life and the compliance with therapy hads been increased by use of oral drugs. We found that in the patients who were treated with erlotinib, or patients with EGFR 21 mutation, or male, their PFS tended to be prolonged compared to other patients.

Clinical trial identification

ChiCTR-OIN-17012051.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

China Anti-Cancer Association.

Disclosure

All authors have declared no conflicts of interest.