PMID- 34524004 OWN - NLM STAT- MEDLINE DCOM- 20220516 LR - 20220531 IS - 1557-8852 (Electronic) IS - 1084-9785 (Linking) VI - 37 IP - 4 DP - 2022 May TI - Apatinib Combined with Paclitaxel and Cisplatin Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma. PG - 324-331 LID - 10.1089/cbr.2021.0086 [doi] AB - Background: 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). Materials and Methods: 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. Results: 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. Conclusions: Adding apatinib to TP neoadjuvant chemotherapy significantly increased ORR, suggesting an advantage of anti-angiogenesis in ESCC. Clinical Trials.gov ID: ChiCTR-TRC-1800017662. FAU - Zhao, Jidong AU - Zhao J AD - Department of Thoracic Surgery, Fourth Hospital of Hebei Medical University, Shijiazhuang, China. FAU - He, Ming AU - He M AD - Department of Thoracic Surgery, Fourth Hospital of Hebei Medical University, Shijiazhuang, China. FAU - Li, Jie AU - Li J AD - Department of Medical Affairs, Fourth Hospital of Hebei Medical University, Shijiazhuang, China. FAU - Li, Dan AU - Li D AD - Department of Thoracic Surgery, Hospital of Jingxing County, Jingxing, China. FAU - Zhao, Yang AU - Zhao Y AD - Office of Academic Research, Fourth Hospital of Hebei Medical University, Shijiazhuang, China. FAU - Li, Xinhui AU - Li X AD - Cancer Institute, Fourth Hospital of Hebei Medical University, Shijiazhuang, China. FAU - Zhang, Xiangmei AU - Zhang X AD - Research Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, China. FAU - Chen, Xin AU - Chen X AD - Department of Thoracic Surgery, Fourth Hospital of Hebei Medical University, Shijiazhuang, China. FAU - Liu, Yunjiang AU - Liu Y AUID- ORCID: 0000-0001-7202-2004 AD - Breast Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, China. FAU - Zhao, Liyan AU - Zhao L AD - Department of Internal Medicine, First Hospital of Xingtai City, Xingtai, China. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20210915 PL - United States TA - Cancer Biother Radiopharm JT - Cancer biotherapy & radiopharmaceuticals JID - 9605408 RN - 0 (Pyridines) RN - 5S371K6132 (apatinib) RN - P88XT4IS4D (Paclitaxel) RN - Q20Q21Q62J (Cisplatin) SB - IM MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Cisplatin/therapeutic use MH - *Esophageal Neoplasms/drug therapy/pathology MH - *Esophageal Squamous Cell Carcinoma/drug therapy/pathology MH - Humans MH - Neoadjuvant Therapy MH - Paclitaxel/therapeutic use MH - *Pyridines/therapeutic use OTO - NOTNLM OT - apatinib OT - cisplatin OT - esophageal squamous cell carcinoma OT - neoadjuvant chemotherapy OT - paclitaxel EDAT- 2021/09/16 06:00 MHDA- 2022/05/17 06:00 CRDT- 2021/09/15 12:21 PHST- 2021/09/16 06:00 [pubmed] PHST- 2022/05/17 06:00 [medline] PHST- 2021/09/15 12:21 [entrez] AID - 10.1089/cbr.2021.0086 [doi] PST - ppublish SO - Cancer Biother Radiopharm. 2022 May;37(4):324-331. doi: 10.1089/cbr.2021.0086. Epub 2021 Sep 15.