Apatinib in the treatment of non-operable or advanced gastric cancer: Evidence of efficacy and safety in a real-world study.

person Ligang Xing Shandong Cancer Hospital, Jinan, China info_outline Ligang Xing, Wei Cao, Gang Cui, Huanhu Zhang, Yiran Shi, Xin Wei, Yuting Dong, Chengye Guo, Bingping Wang, Shu Zhang, Zhiqiang Zou, Zizhi Zhang, Yahong Sun, Guohua Yu, Hongliang Guo, Deyou Wang, Qi Meng, Changzheng Li, Xixun Wang, Jinming Yu

Authors person Ligang Xing Shandong Cancer Hospital, Jinan, China info_outline Ligang Xing, Wei Cao, Gang Cui, Huanhu Zhang, Yiran Shi, Xin Wei, Yuting Dong, Chengye Guo, Bingping Wang, Shu Zhang, Zhiqiang Zou, Zizhi Zhang, Yahong Sun, Guohua Yu, Hongliang Guo, Deyou Wang, Qi Meng, Changzheng Li, Xixun Wang, Jinming Yu Organizations Shandong Cancer Hospital, Jinan, China, Juxian People's Hospital, Rizhao, China, Taian City Central hospital, Taian, China, Weihai Municipal Hospital, Weihai, China, Weifang People's Hospital, Weifang, China, People,s Hospital Of Rizhao Lanshan, Rizhao, China, Dezhou People,s Hospital, Dezhou, China, Qingdao Municipal Hospital, Qingdao, China, Shengli Oilfield Central Hospital, Dongying, China, Department of Medical Oncology, Shandong Cancer Hospital, Jinan, China, The 96 0 Hospital of the PLA Joint Logistics Support Force, Jinan, China, Shouguang Hospital of T.C.M, Weifang, China, Affiliated Hospital of Shandong Academy of Medical Science, Jinan, China, Laiwu People's Hospital, Laiwu, China, Yantai Yuhuangding Hospital, Yantai, China, Department of Radiation Oncology, Shandong Cancer Hospital Affiliated to Shandong University, Jinan, China Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Background: Apatinib, a small molecule tyrosine kinase inhibitor, has been approved to use in patients with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma after at least two systemic chemotherapy regimens in China. This study aims to observe the efficacy and safety of apatinib in real word clinical practice and preliminarily explore the characteristics of population with more clinical benefit. Methods: This study included patients with non-operative or advanced gastric cancer confirmed by histopathology or cytology, and did not intervene the regimen which was entirely determined by the clinicians and patients. Results: From April 16, 2018 to January 12, 2019, 732 patients enrolled, and all patients had been followed up at least once. Total 342 patients were eligible for efficacy evaluation. Among them, 43 patients achieved partial response (PR), 209 patients achieved stable disease (SD) and 90 patients experienced progression disease (PD). The overall response rate (ORR) was 12.55%, and the disease control rate was 73.6%. The mPFS have not yet reached. For patients ≥65 years, the ORR was 26.32%, and for patients < 65 years, ORR was 8.33%. For patients with non-signet ring cell carcinoma and signet ring cell carcinoma, the ORRs were 15.22% and 6.0%. For patients with and without organ metastasis, the ORRs were 15.25% and 3.75% respectively. The PFS analysis showed that, Combined chemotherapy and age > 65 may predict longer PFS. The OS analysis showed that, ECOG 0-1, combined chemotherapy, AFP positive and male predict longer OS. The overall incidence of adverse events was 84%. The most common adverse events were hypertension (28.8%), fatigue (22.4%), hand-foot syndrome (17.3%), anorexia (12.8%) and nausea (10.5%). Conclusions: Apatinib showed promising antitumor activity in patients with non- operable or advanced Gastric Cancer in this real word study. The prolonging survival benefits maybe could be attenuated by age <65, without organ metastasis, ECOG score >1, treatment regimen, normal AFP, and pathological diagnosis of non-signet ring cell carcinoma. Clinical trial information: ChiCTR1800015701.