Neoadjuvant apatinib therapy for locally advanced gastric cancer associated with high R0 resection rate

1. Neoadjuvant treatment of apatinib combined with S-1 plus oxaliplatin (SOX) was shown to be an effective treatment modality, resulting in a 75% R0 resection rate in patients with locally advanced gastric cancer.

2. Apatinib demonstrated a satisfactory safety profile, with no grade 4 adverse events or death from apatinib plus SOX therapy in this study.

Evidence Rating Level: 2 (Good)

Study Rundown: Locally advanced gastric cancer (GC) has been shown to respond poorly to chemotherapy. High vascular endothelial growth factor (VEGF) expression is a feature of many gastric tumours. Apatinib, a selective inhibitor of vascular endothelial growth factor receptor 2 (VEGFR2), may be an effective treatment option for locally advanced GC. This phase 2 trial investigated whether apatinib combined with S-1 plus oxaliplatin (SOX) is an effective and safe treatment for locally advanced GC. Participants (48 patients; mean [SD] age: 63.2 [8.2] years) in this study were recruited from 10 centres in Southern China and were included if they had primary gastric adenocarcinoma with no previous treatment or distant metastases. Participants underwent 2-5 preoperative cycles of apatinib plus SOX every three weeks followed by a gastrectomy. The primary outcome was the R0 resection rate (proportion of patients with margin-free resection); secondary outcomes were response rate, toxic effects, and surgical outcome. Forty out of forty-eight patients underwent surgery. R0 resection rate of the enrolled population was 75% (95% CI: 60.4-86.4; 36/48 patients) and of those who underwent surgery was 90% (95% CI: 76.3-97.2; 36/40 patients). A radiologic response was observed in 75% of patients. A pathological response (grade Ib or better) was observed in 26/48 patients (54.2% [95% CI: 39.2-68.6%]), including a complete pathological response in 3/48 patients (6.3% [95% CI: 1.3-17.2]). The most common adverse effects were hematologic. Sixteen patients (33%) suffered from grade 3 adverse events, and there were no grade 4 adverse events or preoperative deaths. Overall, this trial demonstrated that the neoadjuvant treatment for locally advanced GC of apatinib and SOX was effective with a reasonable safety profile. Notably, this trial was nonrandomized (no control group), and the sample size was small. A large, randomized control trial is required to verify the effectiveness and safety of this therapy regimen.

Click to read the study in JAMA Network Open

Relevant Reading: Randomized, double-blind, placebo-controlled phase III trial of apatinib in patients with chemotherapy-refractory advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction

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