Abstract：
OBJECTIVE: To describe the treatment patterns and survival status of advanced gastric cancer (AGC) in China in the past two decades, and objectively evaluate the impact of standardized Chinese medicine (CM) treatment on the survival of AGC patients.
METHODS: This multicenter registry designed and propensity score analysis study described the diagnosis characteristics, treatment-pattern development and survival status of AGC from 10 hospitals in China between January 1, 2000 and July 31, 2021. Overall survival (OS) was evaluated between non-CM cohort (standard medical treatment) and CM cohort (integrated standard CM treatment ≥3 months). Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were performed to adjust any difference in average outcomes for bias.
RESULTS: A total of 2,001 patients histologically confirmed locally advanced and/or metastasis stomach and gastroesophageal junction adenocarcinoma were enrolled. Among them, 1,607 received systemic chemotherapy, 215 (10.74%) accepted molecular targeted therapy, 44 (2.2%) received checkpoint inhibitor therapy, and 769 (38.43%) received CM. Two-drug regimen was the main choice for first-line treatment, with fluoropyrimidine plus platinum as the most common regimen (530 cases, 60.09%). While 45.71% (16 cases) of patients with HER2 amplification received trastuzumab in first-line. The application of apatinib increased (33.33%) in third-line. The application of checkpoint inhibitors has increased since 2020. COX analysis showed that Lauren mixed type (P=0.017), cycles of first-line treatment >6 (P=0.000), CM (P=0.000), palliative gastrectomy (P=0.000), trastuzumab (P=0.011), and apatinib (P=0.008) were independent prognostic factors for the OS of AGC. After PSM and IPTW, the median OS of CM cohort and non-CM cohort was 18.17 and 12.45 months, respectively (P<0.001).
CONCLUSIONS: In real-world practice for AGC in China, therapy choices consisted with guidelines. Two-drug regimen was the main first-line choice. Standardized CM treatment was an independent prognostic factor and could prolong the OS of Chinese patients with AGC. (Registration No. NCT02781285).
METHODS: This multicenter registry designed and propensity score analysis study described the diagnosis characteristics, treatment-pattern development and survival status of AGC from 10 hospitals in China between January 1, 2000 and July 31, 2021. Overall survival (OS) was evaluated between non-CM cohort (standard medical treatment) and CM cohort (integrated standard CM treatment ≥3 months). Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were performed to adjust any difference in average outcomes for bias.
RESULTS: A total of 2,001 patients histologically confirmed locally advanced and/or metastasis stomach and gastroesophageal junction adenocarcinoma were enrolled. Among them, 1,607 received systemic chemotherapy, 215 (10.74%) accepted molecular targeted therapy, 44 (2.2%) received checkpoint inhibitor therapy, and 769 (38.43%) received CM. Two-drug regimen was the main choice for first-line treatment, with fluoropyrimidine plus platinum as the most common regimen (530 cases, 60.09%). While 45.71% (16 cases) of patients with HER2 amplification received trastuzumab in first-line. The application of apatinib increased (33.33%) in third-line. The application of checkpoint inhibitors has increased since 2020. COX analysis showed that Lauren mixed type (P=0.017), cycles of first-line treatment >6 (P=0.000), CM (P=0.000), palliative gastrectomy (P=0.000), trastuzumab (P=0.011), and apatinib (P=0.008) were independent prognostic factors for the OS of AGC. After PSM and IPTW, the median OS of CM cohort and non-CM cohort was 18.17 and 12.45 months, respectively (P<0.001).
CONCLUSIONS: In real-world practice for AGC in China, therapy choices consisted with guidelines. Two-drug regimen was the main first-line choice. Standardized CM treatment was an independent prognostic factor and could prolong the OS of Chinese patients with AGC. (Registration No. NCT02781285).
摘要：
目的：描述中国近二十年来晚期胃癌（AGC）的治疗方式和生存状况，并客观评价规范化中医治疗对AGC患者生存的影响。
方法：这项多中心注册设计和倾向评分分析研究描述了诊断特征，2000年1月1日至2021年7月31日，中国10家医院的AGC治疗模式发展和生存状况。评估非CM队列（标准药物治疗）和CM队列（综合标准CM治疗≥3个月）之间的总生存期（OS）。进行倾向评分匹配（PSM）和治疗加权逆概率（IPTW），以调整平均结果中的任何偏差差异。
结果：共纳入2,001例经组织学证实为局部晚期和/或转移的胃和胃食管交界处腺癌。其中,1,607人接受全身化疗,215（10.74%）接受分子靶向治疗，44（2.2%）接受了检查点抑制剂治疗，769（38.43%）收到CM。两药方案是一线治疗的主要选择,以氟嘧啶加铂为最常见的方案(530例，60.09%）。而45.71％（16例）的HER2扩增患者一线接受曲妥珠单抗治疗。三线阿帕替尼的应用增加（33.33%）。自2020年以来，检查点抑制剂的应用有所增加。COX分析显示,Lauren混合型(P=0.017),一线治疗周期>6（P=0.000），CM（P=0.000），姑息性胃切除术(P=0.000),曲妥珠单抗（P=0.011），和阿帕替尼（P=0.008）是AGCOS的独立预后因素。在PSM和IPTW之后，CM队列和非CM队列的中位OS分别为18.17和12.45个月，分别(P<0.001)。
结论：在中国AGC的实际实践中，治疗选择与指南相关.两药方案是主要的一线选择。规范化CM治疗是中国AGC患者的独立预后因素，可以延长OS。(登记号NCT02781285)。
方法：这项多中心注册设计和倾向评分分析研究描述了诊断特征，2000年1月1日至2021年7月31日，中国10家医院的AGC治疗模式发展和生存状况。评估非CM队列（标准药物治疗）和CM队列（综合标准CM治疗≥3个月）之间的总生存期（OS）。进行倾向评分匹配（PSM）和治疗加权逆概率（IPTW），以调整平均结果中的任何偏差差异。
结果：共纳入2,001例经组织学证实为局部晚期和/或转移的胃和胃食管交界处腺癌。其中,1,607人接受全身化疗,215（10.74%）接受分子靶向治疗，44（2.2%）接受了检查点抑制剂治疗，769（38.43%）收到CM。两药方案是一线治疗的主要选择,以氟嘧啶加铂为最常见的方案(530例，60.09%）。而45.71％（16例）的HER2扩增患者一线接受曲妥珠单抗治疗。三线阿帕替尼的应用增加（33.33%）。自2020年以来，检查点抑制剂的应用有所增加。COX分析显示,Lauren混合型(P=0.017),一线治疗周期>6（P=0.000），CM（P=0.000），姑息性胃切除术(P=0.000),曲妥珠单抗（P=0.011），和阿帕替尼（P=0.008）是AGCOS的独立预后因素。在PSM和IPTW之后，CM队列和非CM队列的中位OS分别为18.17和12.45个月，分别(P<0.001)。
结论：在中国AGC的实际实践中，治疗选择与指南相关.两药方案是主要的一线选择。规范化CM治疗是中国AGC患者的独立预后因素，可以延长OS。(登记号NCT02781285)。
