Abstract 1434P
Background
Locally advanced gastric cancer (LAGC) has a worse prognosis. Neoadjuvant therapy has been widely utilized in many cancer types. Apatinib (Apa) and FLOT chemotherapy have already shown good effects in the treatment of gastric cancer. We conducted this phase III trial to evaluate the safety and efficacy of Apa plus FLOT protocol as neoadjuvant therapy for LAGC treatment.
Methods
Patients(pts) aged>18 years, with a histological or cytological diagnosis of untreated LAGC were eligible and assigned to experimental group (Apa+FLOT) or control group (FLOT). Pts in experimental group received three 14-day cycles of Apa (oral,500mg,qd;discontinued in the last cycle) and four 14-day cycles of FLOT protocol including oxaliplatin (iv, 85 mg/m2, day1), docetaxel (iv, 50mg/m2,day1),5-Fluorouracil(iv,2600mg/m2,day1) and calcium folinate(iv ,200mg/m2, day1), followed by radical surgery after 4 weeks. Pts in the control group only received four 14-day cycles of FLOT protocol, followed by radical surgery after 4 weeks. All pts continued four cycles of FLOT protocol after surgery. The primary endpoint is R0 resection rate. Secondary endpoints are tumor regression grade(TRG), disease-free survival(DFS), overall survival(OS), relapse/recurrence rate, and safety. The target sample was 230 pts; eligibled pts were non-randomized 1:1 to Apa +FLOT or FLOT group.
Results
From Feb 2018 to May 2020, 64 pts ( Apa+FLOT vs FLOT : 33 vs 31) were enrolled, 44 pts completed the surgery (20[60.6%] vs 24[77.4%]). Among the surgical patients, 39 pts achieved R0 resection (19[95.0%)] vs 20[83.4%]), 31 pts achieved TRG 1-3(14[70.0%] vs 17[70.8%]).Adverse events (AEs) of any cause were 28(84.8%) vs 29(93.5%). Garde 3/4 AEs were 11(33.3%) vs 10(32.3%).The most common AEs were decreased hemoglobin (26[78.8%] vs 26[83.9%]), leukopenia (16[48.5%] vs 15[48.4%]), granulocytopenia (14[42.4%] vs 19[61.3%]), increase of aspartate aminotransferase (12[36.4%] vs 16[51.6%]).
Conclusions
Neoadjuvant therapy of Apa plus FLOT followed by radical surgery for pts with LAGC showed acceptable toxicity and promising efficacy.
Clinical trial identification
ChiCTR-IIR-17012911.
Editorial acknowledgement
Legal entity responsible for the study
Liaoning Cancer Hospital & Institute.
Funding
Liaoning Natural Science Foundation.
Disclosure
All authors have declared no conflicts of interest.