Masumoto Takanori, Yamai Takuo, Nakamura Kazuki, Kamizono Kohei, Sugioka Hiroki, Miyazaki Tetsuro, Kiyota Ryosuke, Maegawa Yuki, Shimizu Takeshi, Kawai Shoichiro, Tawara Seiichi, Inoue Takuya, Yakushijin Takayuki
Department of Gastroenterology and Hepatology, Osaka General Medical Center, Osaka, Japan.
J Gastrointest Oncol. 2024 Oct 31;15(5):2277-2285. doi: 10.21037/jgo-24-330. Epub 2024 Oct 24.
Gemcitabine (GEM) and cisplatin (CDDP) combination therapy (GC therapy) is the standard 1st-line regimen for incurable biliary tract cancers (BTCs). However, the correlation between dynamic changes in renal function and the outcomes of GC therapy remains unclear. This study aimed to clarify the association between renal function alterations and treatment outcomes after GC therapy.
We retrospectively examined 44 patients with incurable BTC who underwent GC therapy (January 2015 to December 2022). The patients were stratified according to their baseline estimated glomerular filtration rate (eGFR). Changes in eGFR, overall survival (OS), and progression-free survival (PFS).
The median baseline eGFRs were 65.0 mL/min/1.73 m (low group, n=22) and 90.7 mL/min/1.73 m (high group, n=22). No significant background differences were observed between the groups. During the 1st course, 86.4% and 54.5% of patients in the low and high groups underwent dose adjustments and/or administration postponement, which was found to be significantly greater in the low group. In the high group, eGFR decreased with an increase in the CDDP dose (100 mg =-12.0, 200 mg =-12.7, 300 mg =-25.9, and 400 mg =-25.7 mL/min/1.73 m). In the low group, eGFR remained stable (100 mg =0.8, 200 mg =7.5, 300 mg =4.5, and 400 mg =-0.3 mL/min/1.73 m). The decrease in the eGFR in the high group was significantly greater at each CDDP dose. However, the median OS and PFS were longer in the low group (OS: 16.3 9.2 months, P=0.02; PFS: 5.4 3.6 months, P=0.02). No significant differences in adverse events were observed between the groups.
Adjusting GC therapy based on baseline estimated glomerular eGFR may be pivotal for therapeutic benefits and renal function protection in patients with incurable BTC.
吉西他滨(GEM)和顺铂(CDDP)联合疗法(GC疗法)是不可切除胆管癌(BTC)的标准一线治疗方案。然而,肾功能的动态变化与GC疗法疗效之间的相关性仍不明确。本研究旨在阐明GC疗法后肾功能改变与治疗结果之间的关联。
我们回顾性研究了44例接受GC疗法的不可切除BTC患者(2015年1月至2022年12月)。根据患者的基线估计肾小球滤过率(eGFR)进行分层。观察eGFR、总生存期(OS)和无进展生存期(PFS)的变化。
基线eGFR中位数分别为65.0 mL/min/1.73 m²(低分组,n = 22)和90.7 mL/min/1.73 m²(高分组,n = 22)。两组之间未观察到显著的背景差异。在第1疗程中,低分组和高分组分别有86.4%和54.5%的患者进行了剂量调整和/或推迟给药,低分组的这一比例显著更高。在高分组中,eGFR随CDDP剂量增加而降低(100 mg时降低12.0 mL/min/1.73 m²,200 mg时降低12.7 mL/min/1.73 m²,300 mg时降低25.9 mL/min/1.73 m²,400 mg时降低25.7 mL/min/1.73 m²)。在低分组中,eGFR保持稳定(100 mg时升高0.8 mL/min/1.73 m²,200 mg时升高7.5 mL/min/1.73 m²,300 mg时升高4.5 mL/min/1.73 m²,400 mg时降低0.3 mL/min/1.73 m²)。在每个CDDP剂量下,高分组的eGFR下降幅度均显著更大。然而,低分组的中位OS和PFS更长(OS:16.3±9.2个月,P = 0.02;PFS:5.4±3.6个月,P = 0.02)。两组之间不良事件无显著差异。
根据基线估计肾小球滤过率eGFR调整GC疗法,对于不可切除BTC患者的治疗获益和肾功能保护可能至关重要。