Fukushi Koh, Imaoka Hiroshi, Ikeda Masafumi, Mizusawa Junki, Morizane Chigusa, Okusaka Takuji, Kobayashi Satoshi, Sasahira Naoki, Shimizu Satoshi, Yamazaki Kentaro, Okano Naohiro, Miwa Haruo, Hara Kazuo, Satoi Sohei, Sano Keiji, Sakai Kenji, Sugimoto Rie, Nakamura Kazuyoshi, Terashima Takeshi, Ozaka Masato, Ueno Makoto
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Japan Clinical Oncology Group Data Center, Clinical Research Support Office, National Cancer Center Hospital, Tokyo.
Jpn J Clin Oncol. 2025 Apr 6;55(4):355-361. doi: 10.1093/jjco/hyae188.
JCOG1113 is a randomized phase III trial that showed non-inferiority of gemcitabine plus S-1 to gemcitabine plus cisplatin in patients with advanced biliary tract cancer. Assessment of inter-institutional heterogeneity in chemotherapy contributes to confirm generalizability and reliability of the study itself. However, there have been no studies conducted to assess the heterogeneity among participating centers in randomized phase III trials for biliary tract cancer.
The objective of this post-hoc analysis was to assess the inter-institutional heterogeneity in the overall survival and progression-free survival of patients with advanced biliary tract cancer treated with first-line chemotherapy in the JCOG1113 trial. The heterogeneity in the overall survival and progression-free survival was assessed according to three factors: hospital volume, experience in medical oncology and experience in biliary intervention. A total of 300 advanced biliary tract cancer patients were analyzed. There were no statistically significant trends observed between hospital volume, experience in medical oncology, or experience in biliary intervention and overall survival (hospital volume: adjusted trend P value = 0.6796; experience in medical oncology: adjusted trend P value = 0.4092; experience in biliary intervention: adjusted trend P value = 0.6112). Similarly, no statistically significant trends were observed between these factors and progression-free survival (hospital volume: adjusted trend P value = 0.3000; experience in medical oncology: adjusted trend P value = 0.1108; experience in biliary intervention: adjusted trend P value = 0.2898).
This study revealed no inter-institutional heterogeneity in the overall survival and progression-free survival in the JCOG1113 study population of advanced biliary tract cancer patients.
JCOG1113是一项III期随机试验，结果显示吉西他滨联合S-1在晚期胆管癌患者中不劣于吉西他滨联合顺铂。评估化疗中的机构间异质性有助于确认研究本身的普遍性和可靠性。然而，尚未有研究评估胆管癌III期随机试验中参与中心之间的异质性。
这项事后分析的目的是评估JCOG1113试验中接受一线化疗的晚期胆管癌患者的总生存和无进展生存的机构间异质性。根据三个因素评估总生存和无进展生存的异质性：医院规模、肿瘤内科经验和胆道介入经验。共分析了300例晚期胆管癌患者。在医院规模、肿瘤内科经验或胆道介入经验与总生存之间未观察到统计学上的显著趋势（医院规模：校正趋势P值=0.6796；肿瘤内科经验：校正趋势P值=0.4092；胆道介入经验：校正趋势P值=0.6112）。同样，在这些因素与无进展生存之间也未观察到统计学上的显著趋势（医院规模：校正趋势P值=0.3000；肿瘤内科经验：校正趋势P值=0.1108；胆道介入经验：校正趋势P值=0.2898）。
本研究显示，在JCOG1113研究的晚期胆管癌患者群体中，总生存和无进展生存不存在机构间异质性。
