PMID- 32342599 OWN - NLM STAT- MEDLINE DCOM- 20210618 LR - 20221005 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 25 IP - 10 DP - 2020 Oct TI - Safety and Efficacy of Apatinib Monotherapy for Unresectable, Metastatic Esophageal Cancer: A Single-Arm, Open-Label, Phase II Study. PG - e1464-e1472 LID - 10.1634/theoncologist.2020-0310 [doi] AB - LESSONS LEARNED: Patient compliance with the oral dosage treatment was good, with no need for hospitalization. Patients with tracheal and esophageal fistulas can take crushed apatinib by nutrient tube, with the same bioavailability and efficacy. Apatinib may be an effective and safe second- or further-line treatment for advanced esophageal cancer. BACKGROUND: Apatinib is an inhibitor of vascular endothelial growth factor receptor-2 (VEGFR2), which is thought to play a role in esophageal cancer progression. Our goal was to evaluate the efficacy and safety of apatinib in patients with unresectable esophageal cancer and to examine whether VEGFR2 expression influenced the clinical response. METHODS: This single-arm, open-label, investigator-initiated phase II study enrolled patients with advanced squamous cell carcinoma (SCC) or adenocarcinoma of the esophagus or esophagogastric junction who were admitted to Tianjin Medical University Cancer Institute and Hospital between August 2017 and January 2019. Apatinib monotherapy (500 mg/day) was given orally or via an enteral tube until disease progression, unacceptable toxicity, withdrawal, or death. Patients were followed until treatment was discontinued or death. The main endpoints were tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs). RESULTS: Among 32 patients screened for inclusion, 30 were included in the safety and survival analyses (i.e., received apatinib), and 26 were included in the efficacy analysis (at least one imaging follow-up). Median follow-up time and exposure to apatinib were 5.34 months and 72 days, respectively. Among 26 patients included in the efficacy analysis, 2 had a partial response (PR; 7.7%) and 14 had stable disease (SD; 53.8%). The overall response rate (ORR) was 7.7%, and the disease control rate (DCR) was 61.5%. Median PFS and OS were 4.63 months (95% confidence interval, 2.11-7.16 months) and 6.57 months (4.90 months to not estimable), respectively. Fifteen patients (50.0%) experienced treatment-related AEs, most commonly hypertension (26.7%), diarrhea (20.0%), and hand-foot-skin reaction (10.0%). No patients had grade >/=4 treatment-related AEs. CONCLUSION: Apatinib was effective as second- or further-line treatment for advanced esophageal cancer. CI - (c) AlphaMed Press; the data published online to support this summary are the property of the authors. FAU - Yanwei, Li AU - Yanwei L AD - Academy of Medical Engineering and Translational Medicine, Tianjin University, Tianjin, People's Republic of China. AD - Tianjin Key Laboratory of Brain Science and Neural Engineering, Tianjin University, Tianjin, People's Republic of China. AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. FAU - Feng, He AU - Feng H AD - Academy of Medical Engineering and Translational Medicine, Tianjin University, Tianjin, People's Republic of China. AD - Tianjin Key Laboratory of Brain Science and Neural Engineering, Tianjin University, Tianjin, People's Republic of China. FAU - Ren, Peng AU - Ren P AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. FAU - Yue, Jie AU - Yue J AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. FAU - Zhang, Wencheng AU - Zhang W AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. FAU - Tang, Peng AU - Tang P AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. FAU - Shang, Xiaobin AU - Shang X AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. FAU - Pang, Qingsong AU - Pang Q AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. FAU - Liu, Dongying AU - Liu D AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. FAU - Chen, Chuangui AU - Chen C AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. FAU - Pan, Zhanyu AU - Pan Z AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. FAU - Tao, Yu Zhen AU - Tao YZ AD - Department of Integrative Oncology, Tianjin Medical University Cancer Institute and Hospital and Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20200529 PL - England TA - Oncologist JT - The oncologist JID - 9607837 RN - 0 (Antineoplastic Agents) RN - 0 (Pyridines) RN - 0 (Vascular Endothelial Growth Factor A) RN - 5S371K6132 (apatinib) SB - IM MH - *Antineoplastic Agents MH - *Esophageal Neoplasms/drug therapy MH - Humans MH - Pyridines MH - Treatment Outcome MH - Vascular Endothelial Growth Factor A PMC - PMC7543358 EDAT- 2020/04/29 06:00 MHDA- 2021/06/22 06:00 PMCR- 2020/10/01 CRDT- 2020/04/29 06:00 PHST- 2019/10/23 00:00 [received] PHST- 2020/04/06 00:00 [accepted] PHST- 2020/04/29 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2020/04/29 06:00 [entrez] PHST- 2020/10/01 00:00 [pmc-release] AID - ONCO13336 [pii] AID - 10.1634/theoncologist.2020-0310 [doi] PST - ppublish SO - Oncologist. 2020 Oct;25(10):e1464-e1472. doi: 10.1634/theoncologist.2020-0310. Epub 2020 May 29.