Apatinib Combined with Paclitaxel and Cisplatin Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous...

We conducted a trial to evaluate the efficacy and safety of apatinib, a tyrosine inhibitor against vascular endothelial growth factor receptor 2, combined with neoadjuvant chemotherapy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). One hundred twenty six patients were randomized into two cycles of paclitaxel and cisplatin (TP) (n = 61) or combined with apatinib (Apa+TP) (n = 65), followed by surgery. The primary endpoint was objective response rate (ORR). Secondary endpoints included pathological complete response (pCR), safety, R0 resection rate, and operative complication rates. Compared with TP chemotherapy alone, adding apatinib to neoadjuvant treatment significantly increased ORR (Apa+TP: 80.0% vs. TP: 54.1%, respectively; p = 0.004). Apa+TP achieved higher pCR rate compared with TP alone (15.4% vs. 4.92%, respectively; p = 0.101). Similar incidences of toxic effects were found between those two groups. No grade 3 or 4 adverse events (AEs) were observed. Meanwhile, apatinib-related AEs, including hypertension, proteinuria, and hand-and-foot syndrome, were mild. The R0 resection rate was 100% in both groups. No significant differences in operation time, intraoperative bleeding, and postoperative complications were observed, and no serious complications occurred. Adding apatinib to TP neoadjuvant chemotherapy significantly increased ORR, suggesting an advantage of anti-angiogenesis in ESCC. Clinical Trials.gov ID: ChiCTR-TRC-1800017662.