Proteinuria as the cause of early dose modification in Japanese patients with metastatic colorectal cancer treated with fruquintinib: a multicenter real-world study
- 1Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Ariake 3-8-3, Koto-ku, Tokyo, Japan
- 2Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan
- 3Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan
Abstract
Background: Fruquintinib has demonstrated survival benefits in patients with previously treated metastatic colorectal cancer (mCRC) in phase III trials. However, real-world data in Japanese patients remain limited. This study evaluated the effectiveness and safety of fruquintinib in routine clinical practice.
Methods: We conducted a retrospective observational study at two cancer centers. Patients treated with fruquintinib for mCRC between November 2024 and December 2025 were included. Clinical outcomes and safety were evaluated, and exploratory analyses were performed according to starting dose, relative dose intensity (RDI), and selected adverse events (AEs).
Results: A total of 92 patients were included. Fruquintinib was initiated at 5 mg in 72 patients (78.3%) and at 4 mg in 19 patients (20.7%). The disease control rate was 37.4%, and no objective responses were observed. Median time to treatment failure was 2.57 months (95% confidence interval [CI], 2.23–3.33), and median overall survival was 8.83 months (95% CI, 7.46–not estimable). The median follow-up period was 5.48 months. Grade ≥ 3 AEs occurred in 39 patients (42.4%), and treatment discontinuation due to AEs occurred in 4 patients (4.3%). Proteinuria was the leading cause of early dose reduction, with 39.1% of dose modifications occurring within 28 days. In exploratory analyses, no clear differences in outcomes were observed according to starting dose, RDI, hypertension, or proteinuria.
Conclusions: Fruquintinib demonstrated feasible effectiveness and manageable toxicity in Japanese patients with mCRC. Proteinuria was a major determinant of treatment feasibility and frequently led to early dose modification.
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s10147-026-03181-1.
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BibTeX
@article{udagawa2026proteinuria,
title = {{Proteinuria as the cause of early dose modification in Japanese patients with metastatic colorectal cancer treated with fruquintinib: a multicenter real-world study}},
author = {Shohei Udagawa and Chihiro Ishizuka and Hiroki Osumi and Toshiharu Hirose and Natsuko Okita and Hidekazu Hirano and Hirokazu Shoji and Ken Kato and Koichiro Yoshino and Keitaro Shimozaki and Shota Fukuoka and Takeru Wakatsuki and Mariko Ogura and Akira Ooki and Keisho Chin and Kensei Yamaguchi and Atsuo Takashima and Eiji Shinozaki},
journal = {International Journal of Clinical Oncology},
year = {2026},
month = aug,
doi = {10.1007/s10147-026-03181-1},
url = {https://doi.org/10.1007/s10147-026-03181-1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Proteinuria as the cause of early dose modification in Japanese patients with metastatic colorectal cancer treated with fruquintinib: a multicenter real-world study
AU - Shohei Udagawa
AU - Chihiro Ishizuka
AU - Hiroki Osumi
AU - Toshiharu Hirose
AU - Natsuko Okita
AU - Hidekazu Hirano
AU - Hirokazu Shoji
AU - Ken Kato
AU - Koichiro Yoshino
AU - Keitaro Shimozaki
AU - Shota Fukuoka
AU - Takeru Wakatsuki
AU - Mariko Ogura
AU - Akira Ooki
AU - Keisho Chin
AU - Kensei Yamaguchi
AU - Atsuo Takashima
AU - Eiji Shinozaki
PY - 2026
DA - 2026/08/27
JO - International Journal of Clinical Oncology
DO - 10.1007/s10147-026-03181-1
UR - https://doi.org/10.1007/s10147-026-03181-1
AB - Background: Fruquintinib has demonstrated survival benefits in patients with previously treated metastatic colorectal cancer (mCRC) in phase III trials. However, real-world data in Japanese patients remain limited. This study evaluated the effectiveness and safety of fruquintinib in routine clinical practice. Methods: We conducted a retrospective observational study at two cancer centers. Patients treated with fruquintinib for mCRC between November 2024 and December 2025 were included. Clinical outcomes and safety were evaluated, and exploratory analyses were performed according to starting dose, relative dose intensity (RDI), and selected adverse events (AEs). Results: A total of 92 patients were included. Fruquintinib was initiated at 5 mg in 72 patients (78.3%) and at 4 mg in 19 patients (20.7%). The disease control rate was 37.4%, and no objective responses were observed. Median time to treatment failure was 2.57 months (95% confidence interval [CI], 2.23–3.33), and median overall survival was 8.83 months (95% CI, 7.46–not estimable). The median follow-up period was 5.48 months. Grade ≥ 3 AEs occurred in 39 patients (42.4%), and treatment discontinuation due to AEs occurred in 4 patients (4.3%). Proteinuria was the leading cause of early dose reduction, with 39.1% of dose modifications occurring within 28 days. In exploratory analyses, no clear differences in outcomes were observed according to starting dose, RDI, hypertension, or proteinuria. Conclusions: Fruquintinib demonstrated feasible effectiveness and manageable toxicity in Japanese patients with mCRC. Proteinuria was a major determinant of treatment feasibility and frequently led to early dose modification. Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s10147-026-03181-1.
SN - 1341-9625
SN - 1437-7772
ER -