PMID- 33907117 OWN - NLM STAT- MEDLINE DCOM- 20210504 LR - 20230915 IS - 1536-5964 (Electronic) IS - 0025-7974 (Print) IS - 0025-7974 (Linking) VI - 100 IP - 17 DP - 2021 Apr 30 TI - Apatinib combined with S-1 as second-line therapy in advanced gastric cancer. PG - e25630 LID - 10.1097/MD.0000000000025630 [doi] LID - e25630 AB - Advanced gastric cancer (AGC) patients are not tolerant to the toxicities of traditional chemotherapy and its second-line therapeutic regimens are limited. The aim of the present study is to evaluate the efficacy and safety of apatinib combined with S-1 as the second-line therapy for AGC patients.Patients with AGC were enrolled in this study. Patients received oral apatinib (250 mg to 500 mg once daily) and S-1(40 mg/m2 twice daily) on days 1-14. Each cycle was 28 days and one course of treatment consisted of 2 cycles. Clinical efficacy and adverse events (AEs) were observed. Kaplan-Meier method was used for survival analysis.From November 2015 to December 2017, 58 AGC patients who failed first-line chemotherapy were enrolled and assessed retrospectively. According to the Response Evaluation Criteria in Solid Tumors (RECIST) standard, all patients were evaluable for response. None achieved CR, and 10 (17.2%) achieved PR (95% CI 7.2%-27.3%). SD was observed in 58.6% (34/58) of patients (95% CI 45.6%-71.7%) and NR in 24.1% (14/58) of patients (95% CI 12.8%-35.5%). The objective response rate (ORR) and the disease control rate (DCR) were 17.2% and 75.8% respectively. The median progression-free survival (PFS) and median overall survival (OS) were 143.1 days (95% CI 121.7-164.5) and 211.6 days (95% CI 162.9-219.7) respectively. The multivariate analysis showed that the ECOG PS was the independent factor of PFS and OS for AGC patients (PFS: HR = 3.565, 95% CI: 2.25-5.65, P < .001; OS: HR = 3.676, 95% CI: 2.29-5.89, P < .001). The main AEs were fatigue (72.4%), hypertension (46.6%), and leukopenia (48.3%).Apatinib combined with S-1 showed promising efficiency and was well tolerated as the second-line therapy for AGC patients. ECOG PS was the independent factor of PFS and OS for AGC patients. AEs were moderate and controllable, and leukopenia or hypertension was predictable factors for the PFS and OS of AGC patients. CI - Copyright (c) 2021 the Author(s). Published by Wolters Kluwer Health, Inc. FAU - Qiu, Zhi-Yuan AU - Qiu ZY AD - Department of Oncology. FAU - Qin, Rong AU - Qin R AD - Department of Oncology. FAU - Tian, Guang-Yu AU - Tian GY AD - Department of Oncology, People's Hospital of Jiangdu, Yangzhou 225200, Jiangsu, China. FAU - Zhang, Zhao AU - Zhang Z AD - Department of Oncology. FAU - Chen, Meifang AU - Chen M AD - Department of Oncology. FAU - He, Han AU - He H AD - Department of Oncology. FAU - Xi, Yan AU - Xi Y AD - Department of Geriatrics, The Affiliated People's Hospital of Jiangsu University, Zhenjiang. FAU - Wang, Yan AU - Wang Y AD - Department of Oncology. LA - eng PT - Evaluation Study PT - Journal Article PL - United States TA - Medicine (Baltimore) JT - Medicine JID - 2985248R RN - 0 (Drug Combinations) RN - 0 (Pyridines) RN - 150863-82-4 (S 1 (combination)) RN - 1548R74NSZ (Tegafur) RN - 5S371K6132 (apatinib) RN - 5VT6420TIG (Oxonic Acid) SB - IM MH - Adult MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage MH - Drug Combinations MH - Drug Therapy, Combination MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Multivariate Analysis MH - Oxonic Acid/*administration & dosage MH - Progression-Free Survival MH - Pyridines/*administration & dosage MH - Response Evaluation Criteria in Solid Tumors MH - Retrospective Studies MH - Stomach Neoplasms/*drug therapy/mortality/pathology MH - Tegafur/*administration & dosage MH - Young Adult PMC - PMC8084084 COIS- The authors declare no conflict of interest. EDAT- 2021/04/29 06:00 MHDA- 2021/05/05 06:00 PMCR- 2021/04/30 CRDT- 2021/04/28 05:47 PHST- 2020/09/15 00:00 [received] PHST- 2021/01/29 00:00 [accepted] PHST- 2021/04/28 05:47 [entrez] PHST- 2021/04/29 06:00 [pubmed] PHST- 2021/05/05 06:00 [medline] PHST- 2021/04/30 00:00 [pmc-release] AID - 00005792-202104300-00032 [pii] AID - MD-D-20-09193 [pii] AID - 10.1097/MD.0000000000025630 [doi] PST - ppublish SO - Medicine (Baltimore). 2021 Apr 30;100(17):e25630. doi: 10.1097/MD.0000000000025630.