Okuno Tatsuya, Morizane Chigusa, Mizusawa Junki, Yanagimoto Hiroaki, Kobayashi Satoshi, Imaoka Hiroshi, Terashima Takeshi, Kawakami Hisato, Sano Yusuke, Okusaka Takuji, Ikeda Masafumi, Ozaka Masato, Miwa Haruo, Todaka Akiko, Shimizu Satoshi, Mizuno Nobumasa, Sekimoto Mitsugu, Sano Keiji, Tobimatsu Kazutoshi, Katanuma Akio, Gotoh Kunihito, Yamaguchi Hironori, Ishii Hiroshi, Furuse Junji, Ueno Makoto
Department of Medical Oncology, Faculty of Medicine, Kindai University, Osakasayama City, 377-2, Ohno-Higashi, Osaka, 589-8511, Japan.
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Int J Clin Oncol. 2025 Jan;30(1):83-91. doi: 10.1007/s10147-024-02642-9. Epub 2024 Oct 23.
Major hepatectomy (MH) can increase the risk of adverse events (AEs) owing to impaired drug metabolism due to decreased liver volume and surgical injury. Thus, we performed this subgroup analysis using data from JCOG1113, a phase III trial comparing gemcitabine plus S-1 (GS) and gemcitabine plus cisplatin (GC) in patients with advanced and recurrent biliary tract cancer (BTC), to evaluate the effect of MH on the safety and efficacy of GC and GS regimens in patients with recurrent BTC.
Of the 354 patients with advanced BTC enrolled in JCOG1113, 76 patients with postoperative recurrence (30 in the MH group and 46 in the non-MH group) were analyzed.
Grade ≥ 3 platelet count decreased in both arms was more frequent in the MH group than in non-MH group (GC, 0.0 vs. 17.6%; GS, 3.9 vs. 15.4%). However, in the MH group, the white blood cell decreased (GC, 55.0 vs. 38.5%; GS, 23.1 vs. 7.7%) and anemia (GC, 15.0 vs. 11.8%; GS, 23.1 vs. 7.7%) were less common than in the non-MH group. The MH and non-MH groups showed no significant difference in overall survival (OS) in both GC [median OS, 23.0 in MH vs. 16.9 months in non-MH (hazard ratio, 0.857; 95% CI 0.387-1.899)], and GS [median OS, 21.5 vs. 14.9 months (hazard ratio, 0.670; 95% CI 0.310-1.447)] arms.
The safety and efficacy of gemcitabine-based chemotherapy were comparable between patients who underwent MH and those who underwent other surgeries.
由于肝体积减小和手术损伤导致药物代谢受损，大肝切除术（MH）会增加不良事件（AE）的风险。因此，我们使用JCOG1113的数据进行了这项亚组分析，这是一项III期试验，比较吉西他滨联合S-1（GS）和吉西他滨联合顺铂（GC）在晚期和复发性胆管癌（BTC）患者中的疗效，以评估MH对复发性BTC患者GC和GS方案安全性和疗效的影响。
在JCOG1113研究中纳入的354例晚期BTC患者中，分析了76例术后复发患者（MH组30例，非MH组46例）。
MH组双臂中血小板计数≥3级下降的发生率高于非MH组（GC组：0.0%对17.6%；GS组：3.9%对15.4%）。然而，在MH组中，白细胞减少（GC组：55.0%对38.5%；GS组：23.1%对7.7%）和贫血（GC组：15.0%对11.8%；GS组：23.1%对7.7%）比非MH组少见。MH组和非MH组在GC组[中位总生存期（OS）：MH组为23.0个月，非MH组为16.9个月（风险比，0.857；95%置信区间0.387-1.899）]和GS组[中位OS：21.5个月对14.9个月（风险比，0.670；95%置信区间0.310-1.447）]的总生存期（OS）方面均无显著差异。
接受MH手术的患者和接受其他手术的患者在基于吉西他滨的化疗的安全性和疗效方面具有可比性。
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