Satake Souichi, Arigami Takaaki, Matsushita Daisuke, Okubo Keishi, Shimonosono Masataka, Sasaki Ken, Tsuruda Yusuke, Tanabe Kan, Mori Shinichiro, Yanagita Shigehiro, Uenosono Yoshikazu, Nakajo Akihiro, Kurahara Hiroshi, Ohtsuka Takao
Department of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Gastroenterology Center, Kagoshima University Hospital, Kagoshima, Japan.
Oncology. 2023;101(1):12-21. doi: 10.1159/000527114. Epub 2022 Oct 5.
This study aimed to assess the clinical significance of eligibility criteria determined by phase 3 clinical trials in the clinical practice of patients with advanced gastric cancer who underwent chemotherapy.
Patients with stage IV gastric cancer who received chemotherapy between February 2002 and December 2021 were retrospectively enrolled and divided into two groups (the eligible vs. ineligible group) based on eligibility criteria determined by the SPIRITS (S-1 vs. S-1 plus cisplatin) trial.
Among the 207 patients, 103 (49.8%) and 104 (50.2%) patients were classified into eligible and ineligible groups, respectively. Eligibility criteria were significantly correlated with age, the first-line regimen of chemotherapy, the presence or absence of conversion surgery, and tumor response to the first-line chemotherapy (all p < 0.01). The eligible group had a significantly higher induction of post-progression chemotherapy after first- and second-line chemotherapy than did the ineligible group (all p < 0.01). The ineligible group had significantly poorer prognoses than the eligible group (p < 0.0001). Multivariate analysis showed that peritoneal dissemination, tumor response, conversion surgery, and eligibility criteria were independent prognostic factors (all p < 0.05).
Eligibility criteria determined by the SPIRITS trial may have clinical utility for predicting tumor response, the induction of conversion surgery, and prognosis in patients with advanced gastric cancer who underwent chemotherapy.
本研究旨在评估Ⅲ期临床试验确定的入选标准在接受化疗的晚期胃癌患者临床实践中的临床意义。
回顾性纳入2002年2月至2021年12月期间接受化疗的Ⅳ期胃癌患者，并根据SPIRITS（S-1对比S-1加顺铂）试验确定的入选标准将其分为两组（入选组与未入选组）。
在207例患者中，分别有103例（49.8%）和104例（50.2%）患者被分类为入选组和未入选组。入选标准与年龄、一线化疗方案、是否进行转化手术以及肿瘤对一线化疗的反应显著相关（均p<0.01）。入选组在一线和二线化疗后进展后化疗的诱导率显著高于未入选组（均p<0.01）。未入选组的预后明显比入选组差（p<0.0001）。多因素分析显示，腹膜播散、肿瘤反应、转化手术和入选标准是独立的预后因素（均p<0.05）。
SPIRITS试验确定的入选标准可能对预测接受化疗的晚期胃癌患者的肿瘤反应、转化手术的诱导及预后具有临床实用价值。
