Influence of major hepatectomy on gemcitabine-based chemotherapy for recurrent biliary tract cancer after surgery: a subgroup analysis of JCOG1113

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发表日期：

2024年10月23日

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Tatsuya Okuno,
Chigusa Morizane,
Junki Mizusawa,
Hiroaki Yanagimoto,
Satoshi Kobayashi,
Hiroshi Imaoka,
Takeshi Terashima,
Hisato Kawakami,
Yusuke Sano,
Takuji Okusaka,
Masafumi Ikeda,
Masato Ozaka,
Haruo Miwa,
Akiko Todaka,
Satoshi Shimizu,
Nobumasa Mizuno,
Mitsugu Sekimoto,
Keiji Sano,
Kazutoshi Tobimatsu,
Akio Katanuma,
Kunihito Gotoh,
Hironori Yamaguchi,
Hiroshi Ishii,
Junji Furuse,
Makoto Ueno

摘要

Background

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.

Methods

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.

Results

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.

Conclusions

The safety and efficacy of gemcitabine-based chemotherapy were comparable between patients who underwent MH and those who underwent other surgeries.