Suzuki Yuko, Ikeda Masafumi, Mizusawa Junki, Sano Yusuke, Morizane Chigusa, Okusaka Takuji, Kobayashi Satoshi, Imaoka Hiroshi, Terashima Takeshi, Okano Naohiro, Miwa Haruo, Todaka Akiko, Shimizu Satoshi, Mizuno Nobumasa, Satoi Sohei, Sano Keiji, Tobimatsu Kazutoshi, Katanuma Akio, Ozaka Masato, Ueno Makoto
Department of Gastroenterology, Saitama Cancer Center, 780 Komuro, Kitaadachi-Gun, Saitama, 362-0806, Japan.
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Int J Clin Oncol. 2025 Jul 24. doi: 10.1007/s10147-025-02834-x.
Biliary tract cancers (BTCs) are heterogenous malignancies including gallbladder cancer (GBC), intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), and ampulla of Vater cancer (AVC). The reported data about the differences between the primary sites are limited to data that have just evaluated the efficacy of the treatment arms by primary site in randomized controlled trials. We aimed to compare the clinical features and treatment efficacy among the primary sites of BTCs using data from JCOG1113, a randomized trial.
Among the 354 patients enrolled in JCOG1113, 352 patients were included in this analysis. We compared the patient characteristics, and efficacy outcomes among the primary sites.
There were more women (58.4%), and more patients with metastatic disease (78.1%) and multiple organs involving metastases (49.3%) in GBC compared to other primary sites. The median progression-free survival (PFS) was 5.7 months, 6.2 months, 8.7 months and 4.1 months for GBC, IHCC, EHCC and AVC, respectively. The median OS was 12.6 months, 15.7 months, 16.3 months and 11.5 months for GBC, IHCC, EHCC and AVC, respectively. Multivariable analysis revealed that GBC was identified as one of the prognostic factors for PFS compared with EHCC but was not significant for OS.
In this study, there were several findings regarding the differences in the clinical features, treatment efficacy, and prognosis among the primary sites. Patients with GBC were more likely to have metastatic disease and multiple metastases. GBC was an independent prognostic factor for PFS compared with EHCC, but was not for OS.
JCOG1113 was registered with University hospital Medical Information Network Clinical Trials Regisry (UMIN000010667).
胆道癌（BTC）是一种异质性恶性肿瘤，包括胆囊癌（GBC）、肝内胆管癌（IHCC）、肝外胆管癌（EHCC）和壶腹癌（AVC）。关于这些原发部位差异的报道数据仅限于在随机对照试验中按原发部位评估治疗组疗效的数据。我们旨在利用JCOG1113（一项随机试验）的数据，比较BTC各原发部位的临床特征和治疗效果。
在JCOG1113研究纳入的354例患者中，352例患者纳入本分析。我们比较了各原发部位的患者特征和疗效结果。
与其他原发部位相比，GBC患者中女性更多（58.4%），转移性疾病患者更多（78.1%），多器官转移患者更多（49.3%）。GBC、IHCC、EHCC和AVC的中位无进展生存期（PFS）分别为5.7个月、6.2个月、8.7个月和4.1个月。GBC、IHCC、EHCC和AVC的中位总生存期（OS）分别为12.6个月、15.7个月、16.3个月和11.5个月。多变量分析显示，与EHCC相比，GBC被确定为PFS的预后因素之一，但对OS无显著意义。
在本研究中，关于各原发部位在临床特征、治疗效果和预后方面的差异有多项发现。GBC患者更易发生转移性疾病和多处转移。与EHCC相比，GBC是PFS的独立预后因素，但不是OS的独立预后因素。
JCOG1113在大学医院医学信息网络临床试验注册中心（UMIN000010667）注册。
