TY - JOUR
T1 - Impact of renal function on non-hematologic toxicities in mCRC patients treated with TAS-102
T2 - a post-hoc analysis of the JASCC-CINV2001 study
AU - Fujii, Hironori
AU - Tsuchiya, Masami
AU - Watanabe, Daichi
AU - Chin, Miki
AU - Hirate, Daisuke
AU - Takahashi, Katsuyuki
AU - Go, Makiko
AU - Kudo, Toshihiro
AU - Shimomura, Kazuhiro
AU - Ando, Yosuke
AU - Tani, Shinya
AU - Takahashi, Takao
AU - Hayashi, Katsuhisa
AU - Hashimoto, Hironobu
AU - Matsunami, Naomi
AU - Takahashi, Masaya
AU - Hasegawa, Akiko
AU - Uchida, Takashi
AU - Kubo, Akiko
AU - Matsuhashi, Nobuhisa
AU - Suzuki, Akio
AU - Nishimura, Junichi
AU - Inui, Naoki
AU - Iihara, Hirotoshi
N1 - Publisher Copyright:
© The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2025.
PY - 2025/6
Y1 - 2025/6
N2 - 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.
AB - 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.
KW - Chemotherapy-induced nausea and vomiting
KW - Non-hematologic toxicities
KW - Renal function
KW - Trifluridine/tipiracil
KW - Unresectable colorectal cancer
UR - https://www.scopus.com/pages/publications/105005072611
UR - https://www.scopus.com/pages/publications/105005072611#tab=citedBy
U2 - 10.1007/s00520-025-09504-8
DO - 10.1007/s00520-025-09504-8
M3 - Article
C2 - 40358665
AN - SCOPUS:105005072611
SN - 0941-4355
VL - 33
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
IS - 6
M1 - 469
ER -
