PMID- 34003545 OWN - NLM STAT- MEDLINE DCOM- 20210928 LR - 20210928 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 26 IP - 9 DP - 2021 Sep TI - Treatment Patterns and Outcomes in Chinese Patients with Gastric Cancer by HER2 Status: A Noninterventional Registry Study (EVIDENCE). PG - e1567-e1580 LID - 10.1002/onco.13826 [doi] AB - BACKGROUND: Real-world safety and effectiveness data for trastuzumab plus chemotherapy treatment of patients with HER2-positive metastatic gastric cancer (mGC) in China are lacking. PATIENTS AND METHODS: EVIDENCE was a prospective, multicenter, noninterventional registry study evaluating the safety and effectiveness of trastuzumab in five cohorts of Chinese patients with gastric cancer, stratified by HER2 status and trastuzumab treatment. Effectiveness was analyzed for cohorts I (HER2-positive, trastuzumab treated), II (HER2-positive, trastuzumab untreated), and IV (HER2-negative, trastuzumab untreated); trastuzumab-related adverse events (AEs) were analyzed for cohort I. RESULTS: Cohorts I, II, and IV included 174, 113, and 422 patients, respectively. Most patients received first-line chemotherapy (87.6%). Median overall survival (OS1) for first-line treatment was 22.3, 17.2, and 17.4 months in cohorts I, II, and IV, respectively. After excluding patients who had surgery, respective median OS1 was 19.9, 15.3, and 12.9 months. Respective first-line progression-free survival (PFS1) was 8.2, 6.9, and 6.2 months; and respective first-line response rates (RR) were 51.7%, 18.4%, and 32.8%. Cohort I was significantly favored over cohort II for propensity score-matched first-line median OS1 (hazard ratio [HR], 0.61), PFS1 (HR, 0.64), and RR (odds ratio, 4.93). Trastuzumab-related AEs, grade 3-5 AEs, serious AEs, and AEs with a fatal outcome occurred in 23.6%, 3.4%, 2.3%, and 0.6% of cohort I patients, respectively. CONCLUSION: Safety profiles were consistent with those known for trastuzumab and chemotherapy; trastuzumab treatment improved outcomes. Our study provides real-world data supporting first-line trastuzumab plus chemotherapy in Chinese patients with HER2-positive mGC. IMPLICATIONS FOR PRACTICE: This prospective, noninterventional registry study aimed to provide safety and effectiveness data for the use of trastuzumab in combination with chemotherapy in Chinese patients with HER2-positive metastatic gastric cancer (mGC) from the real-world clinical setting. Trastuzumab plus first-line chemotherapy was shown to be safe and to improve outcomes when compared with patients treated with chemotherapy alone. Trastuzumab was effective within a range of treatment regimens; subgroup analysis showed that trastuzumab paired most effectively with the XELOX regimen. This study provides real-world clinical safety and effectiveness data supporting the use of trastuzumab in the treatment of Chinese patients with HER2-positive mGC. CI - (c) 2021 AlphaMed Press. FAU - Qin, Shukui AU - Qin S AD - Nanjing Bayi Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, People's Republic of China. FAU - Ji, Jiafu AU - Ji J AD - Peking University Cancer Hospital and Institute, Beijing, People's Republic of China. FAU - Xu, Rui-Hua AU - Xu RH AD - Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. FAU - Wang, Wei AU - Wang W AD - The First People's Hospital of Foshan, Foshan, Guangdong, People's Republic of China. FAU - Tang, Yong AU - Tang Y AD - Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, Xinjiang, People's Republic of China. FAU - Bi, Feng AU - Bi F AD - West China Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China. FAU - Li, Jin AU - Li J AD - Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China. FAU - Wang, Kang AU - Wang K AD - Sichuan Provincial People's Hospital, Chengdu, Sichuan, People's Republic of China. FAU - Xu, Jian-Ming AU - Xu JM AD - Chinese People's Liberation Army 307 Hospital, Beijing, People's Republic of China. FAU - Fan, Qingxia AU - Fan Q AD - The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, People's Republic of China. FAU - Su, Wuyun AU - Su W AD - Affiliated Hospital, Inner Mongolia Medical College, Hohhot, Inner Mongolia, People's Republic of China. FAU - Shen, Lin AU - Shen L AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, People's Republic of China. LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20210803 PL - England TA - Oncologist JT - The oncologist JID - 9607837 RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P188ANX8CK (Trastuzumab) SB - IM MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - *Breast Neoplasms MH - China MH - Female MH - Humans MH - Prospective Studies MH - Receptor, ErbB-2/genetics/therapeutic use MH - Registries MH - *Stomach Neoplasms/drug therapy MH - Trastuzumab/therapeutic use PMC - PMC8417850 OTO - NOTNLM OT - China OT - Epidermal growth factor receptor OT - Gastric cancer OT - Registries OT - Trastuzumab COIS- Disclosures of potential conflicts of interest may be found at the end of this article. EDAT- 2021/05/19 06:00 MHDA- 2021/09/29 06:00 PMCR- 2021/09/01 CRDT- 2021/05/18 12:30 PHST- 2019/09/18 00:00 [received] PHST- 2020/12/21 00:00 [accepted] PHST- 2021/05/19 06:00 [pubmed] PHST- 2021/09/29 06:00 [medline] PHST- 2021/05/18 12:30 [entrez] PHST- 2021/09/01 00:00 [pmc-release] AID - ONCO13826 [pii] AID - 10.1002/onco.13826 [doi] PST - ppublish SO - Oncologist. 2021 Sep;26(9):e1567-e1580. doi: 10.1002/onco.13826. Epub 2021 Aug 3.