Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi ku, Yokohama, 241-0815, Japan.
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Sci Rep. 2021 Jun 18;11(1):12885. doi: 10.1038/s41598-021-92166-3.
JCOG1113 is a randomized phase III trial in patients with advanced biliary tract cancers (BTCs) (UMIN000001685), and gemcitabine plus S-1 (GS) was not inferior to gemcitabine plus cisplatin (GC). However, poor renal function often results in high toxicity of S-1. Therefore, we examined whether GS can be recommended for patients with low creatinine clearance (CCr). Renal function was classified by CCr as calculated by the Cockcroft-Gault formula: high CCr (CCr ≥ 80 ml/min) and low CCr (80 > CCr ≥ 50 ml/min). Of 354 patients, 87 patients on GC and 91 on GS were included in the low CCr group, while there were 88 patients on GC and 88 patients on GS in the high CCr group. The HR of overall survival for GS compared with GC was 0.687 (95% CI 0.504-0.937) in the low CCr group. Although the total number of incidences of all Grade 3-4 non-haematological adverse reactions was higher (36.0% vs. 11.8%, p = 0.0002), the number of patients who discontinued treatment was not different (14.1% vs. 16.9%, p = 0.679) for GS compared with GC in the low CCr group. This study suggests that GS should be selected for the treatment of advanced BTC patients with reduced renal function.
JCOG1113 是一项针对晚期胆道癌（BTC）患者的随机 III 期临床试验（UMIN000001685），吉西他滨加 S-1（GS）并不劣于吉西他滨加顺铂（GC）。然而，肾功能不佳通常会导致 S-1 毒性增加。因此，我们研究了 GS 是否可用于肌酐清除率（CCr）较低的患者。肾功能通过 Cockcroft-Gault 公式计算的 CCr 进行分类：高 CCr（CCr≥80 ml/min）和低 CCr（80>CCr≥50 ml/min）。在 354 例患者中，87 例接受 GC 治疗和 91 例接受 GS 治疗的患者被纳入低 CCr 组，而 88 例接受 GC 治疗和 88 例接受 GS 治疗的患者被纳入高 CCr 组。低 CCr 组中，GS 与 GC 相比，总生存期的 HR 为 0.687（95%CI 0.504-0.937）。尽管所有 3-4 级非血液学不良事件的总发生率较高（36.0% vs. 11.8%，p=0.0002），但在低 CCr 组中，GS 与 GC 相比，停止治疗的患者人数没有差异（14.1% vs. 16.9%，p=0.679）。这项研究表明，对于肾功能降低的晚期 BTC 患者，应选择 GS 进行治疗。
