Impact of renal function on non-hematologic toxicities in mCRC patients treated with TAS-102: a post-hoc analysis of the JASCC-CINV2001 study.

IF 2.8 3区医学 Q2 HEALTH CARE SCIENCES & SERVICES

Supportive Care in Cancer Pub Date : 2025-05-13 DOI:10.1007/s00520-025-09504-8

Hironori Fujii, Masami Tsuchiya, Daichi Watanabe, Miki Chin, Daisuke Hirate, Katsuyuki Takahashi, Makiko Go, Toshihiro Kudo, Kazuhiro Shimomura, Yosuke Ando, Shinya Tani, Takao Takahashi, Katsuhisa Hayashi, Hironobu Hashimoto, Naomi Matsunami, Masaya Takahashi, Akiko Hasegawa, Takashi Uchida, Akiko Kubo, Nobuhisa Matsuhashi, Akio Suzuki, Junichi Nishimura, Naoki Inui, Hirotoshi Iihara

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引用次数: 0

Abstract

Purpose: Although the efficacy of trifluridine/tipiracil hydrochloride (TAS-102) in treating metastatic colorectal cancer (mCRC) is well established, its non-hematologic toxicities in relation to renal function remain unclear. This study aimed to assess the impact of creatinine clearance (Ccr) on non-hematologic toxicities, including nausea and vomiting, in patients with mCRC treated with TAS-102.

Methods: This study was conducted as a post-hoc analysis of the JASCC-CINV2001 study, a multicenter observational study of mCRC patients. Using a Cox proportional hazards model, we assessed the relationship between Ccr and nausea or vomiting, and used a generalized estimating equations (GEE) logistic regression model to analyze the association between Ccr and additional toxicities, including fatigue, constipation, diarrhea, insomnia, and dysgeusia. Toxicities were evaluated at weekly intervals over four weeks.

Results: Among 100 patients, median Ccr was 80.5 ml/min. The primary analysis showed no significant association between Ccr and nausea or vomiting. However, the secondary analysis revealed a significant link between lower Ccr and the incidence of diarrhea (P = 0.02).

Conclusion: These results suggest that although TAS-102-induced nausea and vomiting are not strongly influenced by renal function, decreased renal function increases the risk of diarrhea. Enhanced antiemetic measures may not be necessary for TAS-102 patients with impaired renal function, but monitoring for diarrhea is recommended.

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在接受TAS-102治疗的mCRC患者中，肾功能对非血液学毒性的影响：JASCC-CINV2001研究的事后分析

目的：虽然trifluridine/tipiracil hydrochloride （TAS-102）治疗转移性结直肠癌（mCRC）的疗效已经确定，但其与肾功能相关的非血液学毒性尚不清楚。本研究旨在评估肌酐清除率（Ccr）对接受TAS-102治疗的mCRC患者的非血液学毒性（包括恶心和呕吐）的影响。方法：本研究是对JASCC-CINV2001研究（一项针对mCRC患者的多中心观察性研究）的事后分析。使用Cox比例风险模型，我们评估了Ccr与恶心或呕吐之间的关系，并使用广义估计方程（GEE）逻辑回归模型来分析Ccr与其他毒性（包括疲劳、便秘、腹泻、失眠和记忆障碍）之间的关系。毒性在四周内每隔一周评估一次。结果：100例患者中位Ccr为80.5 ml/min。初步分析显示Ccr与恶心或呕吐之间无显著关联。然而，二次分析显示较低的Ccr与腹泻发生率之间存在显著联系（P = 0.02）。结论：这些结果提示，虽然tas -102引起的恶心和呕吐不受肾功能的强烈影响，但肾功能下降会增加腹泻的风险。对于肾功能受损的TAS-102患者，可能不需要加强止吐措施，但建议监测腹泻。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Supportive Care in Cancer 医学-康复医学

CiteScore

5.70

自引率

9.70%

发文量

751

审稿时长

3 months

期刊介绍： Supportive Care in Cancer provides members of the Multinational Association of Supportive Care in Cancer (MASCC) and all other interested individuals, groups and institutions with the most recent scientific and social information on all aspects of supportive care in cancer patients. It covers primarily medical, technical and surgical topics concerning supportive therapy and care which may supplement or substitute basic cancer treatment at all stages of the disease. Nursing, rehabilitative, psychosocial and spiritual issues of support are also included.