Ioka Tatsuya, Shindo Yoshitaro, Ueno Makoto, Nagano Hiroaki
Department of Oncology Center Yamaguchi University Hospital Ube Japan.
Department of Gastroenterological, Breast, and Endocrine Surgery Yamaguchi University Graduate School of Medicine Ube Japan.
Ann Gastroenterol Surg. 2023 May 16;7(4):565-571. doi: 10.1002/ags3.12691. eCollection 2023 Jul.
Biliary tract cancer (BTCs) is a heterogeneous malignancy divided into cholangiocarcinoma, gallbladder cancer, and ampullary cancer. Due to little or no symptoms, most patients with BTCs are diagnosed with unresectable or metastatic disease. Only 20%-30% of all BTCs are suitable for potentially resectable diseases. Although radical resection with a negative surgical margin is the only potentially curative method for BTCs, most patients develop postoperative recurrence, which is associated with poor prognosis. Therefore, perioperative treatment is necessary to improve survival. There are very few randomized phase III clinical trials of perioperative chemotherapy due to the relative rarity of BTCs. Adjuvant chemotherapy with S-1 for patients with resected BTC significantly increased overall survival compared with upfront surgery in a recent ASCOT trial. In East Asia, S-1 is currently considered the standard adjuvant chemotherapy, while capecitabine may still be used in other areas. Since then, our phase III trial (KHBO1401), gemcitabine and cisplatin plus S-1 (GCS) has become the standard chemotherapy for advanced BTCs. GCS not only improved overall survival but demonstrated a high response rate. The efficacy of GCS as a preoperative neoadjuvant chemotherapy for resectable BTCs has been investigated in a randomized phase III trial (JCOG1920) in Japan. In this review, we summarize the current and ongoing clinical trials focusing on adjuvant and neoadjuvant chemotherapy for BTCs.
胆道癌（BTCs）是一种异质性恶性肿瘤，分为胆管癌、胆囊癌和壶腹癌。由于症状很少或没有症状，大多数BTCs患者被诊断为不可切除或转移性疾病。所有BTCs中只有20%-30%适合潜在可切除疾病。尽管手术切缘阴性的根治性切除是BTCs唯一可能的治愈方法，但大多数患者术后会复发，这与预后不良有关。因此，围手术期治疗对于提高生存率是必要的。由于BTCs相对罕见，围手术期化疗的随机III期临床试验非常少。在最近的一项ASCOT试验中，与直接手术相比，S-1辅助化疗显著提高了BTCs切除患者的总生存率。在东亚，S-1目前被认为是标准的辅助化疗药物，而在其他地区可能仍使用卡培他滨。从那时起，我们的III期试验（KHBO1401），吉西他滨和顺铂加S-1（GCS）已成为晚期BTCs的标准化疗方案。GCS不仅提高了总生存率，而且显示出高缓解率。GCS作为可切除BTCs术前新辅助化疗的疗效已在日本的一项随机III期试验（JCOG1920）中进行了研究。在这篇综述中，我们总结了目前正在进行的聚焦于BTCs辅助和新辅助化疗的临床试验。
