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Efficacy and safety of fruquintinib combined with immunotherapy in later‑line treatment of metastatic colorectal cancer

  • Authors:
    • Ying Peng
    • Sheng Li
    • Liangjun Zhu
  • View Affiliations / Copyright

    Affiliations: Department of Medical Oncology, Jiangsu Institute of Cancer Research, Jiangsu Cancer Hospital, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu 210000, P.R. China
    Copyright: © Peng et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
  • Article Number: 541
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    Published online on: September 22, 2025
       https://doi.org/10.3892/ol.2025.15287
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Abstract

For microsatellite‑stable (MSS) metastatic colorectal cancer (mCRC), later‑line treatments are limited and survival outcomes are poor. The present retrospective analysis evaluated the efficacy and safety of fruquintinib + immune checkpoint inhibitors (ICIs) in MSS/mismatch repair proficient (pMMR) mCRC, having aimed to identify effective, low‑toxicity regimens for personalized treatment. The present retrospective study evaluated patients with MSS/pMMR mCRC who had failed at least two prior lines of treatment (all patients had received standard first‑ and second‑line chemotherapy) and were treated with fruquintinib plus programmed death‑1 (PD‑1) (PD‑1 inhibitor combination group) or programmed death‑ligand 1 (PD‑L1) (PD‑L1 inhibitor combination group) inhibitors at the Jiangsu Cancer Hospital (Nanjing, China). Clinical characteristics were collected, and the efficacy, safety and prognostic factors of fruquintinib plus different ICIs were analyzed. A total of 78 patients (PD‑1 inhibitor combination group, n=63; PD‑L1 inhibitor combination group, n=15) were included. Clinical characteristics did not differ significantly between the two groups (all P>0.05). The objective response rate (7.9 vs. 20.0%; P=0.363), disease control rate (74.6 vs. 60.0%; P=0.418) and median progression‑free survival (PFS; 7.0 vs. 8.3 months; P=0.14) were comparable between the groups. Similarly, no significant difference in PFS was observed between patients treated with fruquintinib plus different PD‑1 inhibitors (P=0.37). Multivariate Cox regression analysis identified an Eastern Cooperative Oncology Group performance status of 1 (hazard ratio=0.28; P<0.001) as an independent prognostic factor for PFS. The most common adverse events (AEs) were hypothyroidism (31.7 vs. 26.7%), proteinuria (23.8 vs. 33.3%) and hand‑foot syndrome (20.6 vs. 33.3%). No AE‑related deaths occurred in either group. The present study showed that fruquintinib plus ICIs could improve PFS in MSS mCRC with manageable toxicity, but there was no survival difference between treatment with the PD‑1 and PD‑L1 combinations.
View Figures

Figure 1

Kaplan-Meier survival curves of
progression-free survival for the PD-1 and PD-L1 inhibitor
combination groups. PFS, progression-free survival; PD-1,
programmed death-1; PD-L1, programmed death-ligand 1.

Figure 2

Kaplan-Meier survival curves of
progression-free survival for fruquintinib plus different PD-1
inhibitors; PD-1, programmed death-1 inhibitors; PFS,
progression-free survival.
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Copy and paste a formatted citation
Spandidos Publications style
Peng Y, Li S and Zhu L: Efficacy and safety of fruquintinib combined with immunotherapy in later‑line treatment of metastatic colorectal cancer. Oncol Lett 30: 541, 2025.
APA
Peng, Y., Li, S., & Zhu, L. (2025). Efficacy and safety of fruquintinib combined with immunotherapy in later‑line treatment of metastatic colorectal cancer. Oncology Letters, 30, 541. https://doi.org/10.3892/ol.2025.15287
MLA
Peng, Y., Li, S., Zhu, L."Efficacy and safety of fruquintinib combined with immunotherapy in later‑line treatment of metastatic colorectal cancer". Oncology Letters 30.6 (2025): 541.
Chicago
Peng, Y., Li, S., Zhu, L."Efficacy and safety of fruquintinib combined with immunotherapy in later‑line treatment of metastatic colorectal cancer". Oncology Letters 30, no. 6 (2025): 541. https://doi.org/10.3892/ol.2025.15287
Copy and paste a formatted citation
x
Spandidos Publications style
Peng Y, Li S and Zhu L: Efficacy and safety of fruquintinib combined with immunotherapy in later‑line treatment of metastatic colorectal cancer. Oncol Lett 30: 541, 2025.
APA
Peng, Y., Li, S., & Zhu, L. (2025). Efficacy and safety of fruquintinib combined with immunotherapy in later‑line treatment of metastatic colorectal cancer. Oncology Letters, 30, 541. https://doi.org/10.3892/ol.2025.15287
MLA
Peng, Y., Li, S., Zhu, L."Efficacy and safety of fruquintinib combined with immunotherapy in later‑line treatment of metastatic colorectal cancer". Oncology Letters 30.6 (2025): 541.
Chicago
Peng, Y., Li, S., Zhu, L."Efficacy and safety of fruquintinib combined with immunotherapy in later‑line treatment of metastatic colorectal cancer". Oncology Letters 30, no. 6 (2025): 541. https://doi.org/10.3892/ol.2025.15287
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