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Purpose <p>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.</p> Methods <p>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.</p> Results <p>Among 100 patients, median Ccr was 80.5&#xa0;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 (<i>P</i> = 0.02).</p> Conclusion <p>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.</p>

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

  • 期刊论文

  • 发表日期：

    2025年5月13日

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  • 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

摘要

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.