Abstract 1366P
Background
Treatment failure frequently occurs in patients with EGFR-mutant non-small cell lung cancer (NSCLC) who respond to EGFR-TKI initially. 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 (a TKI against VEGFR-2) plus EGFR-TKIs (including erlotinib, gefitinib, icotinib, afatinib and osimertinib) compared with chemotherapy for EGFR-TKI resistant NSCLC patients.
Methods
From Mar 2017 to Nov 2019, this study enrolled 42 advanced NSCLC patients who acquired resistance to the EGFR-TKI therapy. 27 patients received apatinib plus EGFR-TKI (apatinib in start dose of 250 mg plus original EGFR-TKI dose), 15 patients received chemotherapy (pemetrexed or vinorelbine with platinum).
Results
In the apatinib group, 24/27 patients were available evaluated. The objective response rate was 21% (5/24) and the disease control rate was 96% (24/27). The most common adverse events in the apatinib group were diarrhea (63%, 17/27), hypertension (63%, 17/27) and hand-foot syndrome (41%, 11/27). The most common grade 3 or 4 toxicity was proteinuria (11%, 3/27). Most of adverse events were grade 1 or 2, as well as controllable and tolerable. Six patients with brain metastases in the apatinib group got long median progressive-free survival (PFS) of 15.7 months. In the chemotherapy group, 12/15 patients were available evaluated. The objective response rate was 25% (3/12) and the disease control rate was 92% (11/12). No new adverse event occured. The median PFS of apatinib group was 10.5 months, and chemotherapy group was 4.5 months. The longest PFS in the apatinib group was 29.8 months.
Conclusions
Apatinib plus EGFR-TKI shown a good clinical efficacy in patients with acquired EGFR-TKI (1st, 2nd or 3rd generation) resisitance. Patient's quality of life and the compliance of therapy had been increased by oral drugs. Besides, we found that patients’ PFS tended to be prolonged who with EGFR 21 mutation (15.7 months), or male (17 months).
Clinical trial identification
ChiCTR-OIN-17012051.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Chinese Anti-Cancer Association.
Disclosure
All authors have declared no conflicts of interest.