e15503 Background: Locally advanced gastric cancer (LAGC) has a poor prognosis. Neoadjuvant chemotherapy can reduce tumor loading, degrade staging and increase possibility of complete resection, thus prolonging the survival of LAGC patients (pts). We conducted a phase II trial to assess the feasibility of SOX regimen in combination with apatinib (an anti-angiogenic agent) as neoadjuvant therapy in LAGC. Methods: This study recruited untreated LAGC pts with pathologically and/or cytologically confirmed adenocarcinoma. Treatment included three 21-day cycles of apatinib (oral, 500 mg qd; discontinued in the last cycle), S-1 (oral, 40-60 mg, bid, day 1-day 14) and oxaliplatin (iv, 130 mg/m2, day 1), followed by radical surgery after 4 weeks. The primary outcome was neoadjuvant therapy related toxicity, and the secondary outcomes included tumor response, R0 resection rate, postoperative pathological evaluation and surgical morbidity. Results: Between December 2, 2016 and August 1, 2018, 31 patients were enrolled. Total 29 patients were eligible for safety and efficacy analyses of SOXA as NAC. During NAC treatment, the incidence of adverse events (AEs, any grade) was 100%, and the incidence of grade 3/4 AEs was 34.48%. No treatment-related death. The ORR of 79.31% (95%CI, 60.28-92.01%) and DCR of 96.55% (95%CI, 82.24-99.91%) were achieved. One patient was evaluated as PD with hepatic metastasis after 3 cycles of preoperative chemotherapy, and this case was inoperable. Resection with curative intent was undertaken in 28 patients with R0 resection rate of 100%. Operative morbidity was observed in 12 of 28 patients including fever (9, 32.14%), anastomotic leakage (1, 3.57%), fat liquefaction of post-surgical incision (1, 3.57%), and gastroparesis (1, 3.57%). Additionally, after surgery 1 patient had pulmonary infection and 1 patient had pleural effusion. The median tumor regression was 90% on pathological findings after surgery. Conclusions: Neoadjuvant therapy with apatinib plus SOX for LAGC showed acceptable toxicity and promising efficacy.
Complete mesogastric excision for locally advanced gastric cancer: short-term outcomes of a randomized clinical trial
