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Background <p>Colorectal cancer (CRC) is the third most frequently diagnosed malignancy worldwide and the second leading cause of cancer-related mortality. Despite immune checkpoint inhibitors improving outcomes for patients with microsatellite instability high (MSI-H) CRC, their effectiveness against microsatellite-stable (MSS) cancers remains restricted. Nivolumab-based combination regimens, which include ipilimumab or binimetinib as components, have shown potential to improve treatment results, but existing studies provide incomplete evidence for their effectiveness.</p> Methods <p>The researchers conducted a systematic review and meta-analysis, which included three randomized controlled trials that studied 1085 patients with metastatic CRC. The researchers evaluated two outcomes, which were best overall response (BOR) and treatment-related adverse events (TRAEs). The study utilized random-effects models to manage the clinical and methodological variations that existed between different studies. The researchers conducted subgroup analyses along with sensitivity assessments and publication bias assessments to determine how reliable the findings were.</p> Results <p>The pooled analysis demonstrated no statistically significant difference in overall BOR between nivolumab-based combination therapy and control regimens (RR 1.01; 95% CI 0.79–1.30; <i>p</i> = 0.94) with moderate heterogeneity (I<sup>2</sup> = 56%). Nivolumab-based combinations showed statistically significant improvement in partial response rates, but complete response, stable disease and progressive disease rates stayed unchanged. The safety analysis showed a numerical but non-significant increase in TRAEs (RR 1.19; 95% CI 0.86–1.65; <i>p</i> = 0.30), which occurred alongside differences between trial sites about serious adverse events and treatment halts. The researchers found little evidence of publication bias.</p> Conclusion <p>In metastatic CRC patients who receive nivolumab-based combination therapies demonstrate partial tumor responses that increase while their safety profile remains acceptable, but their overall response rates do not improve. The research demonstrates how immunotherapy serves as a standard treatment method for MSI-H disease while emphasizing the need to develop biomarker-driven approaches that enhance treatment selection methods, especially for MSS CRC.</p> Graphical abstract <p></p>

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Comparative efficacy and safety of nivolumab-based combination therapies (with ipilimumab or binimetinib) in patients with microsatellite-stable and microsatellite-instability-high metastatic colorectal cancer: a systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2026年4月4日

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  • Hussain Abbas,
  • Humayou Ahmed,
  • Hafsa Shuja,
  • Ghazi Uddin Ahmed,
  • F. N. U. Muskan,
  • Rithik Kumar Khiani,
  • Umer Wamiq,
  • Ali Abdullah,
  • Syeda Elezeh Sabahat,
  • Ahzam Khan Ghori,
  • Syed Shah Hussain Jafry,
  • Muhammad Liaquat Raza

摘要

Background

Colorectal cancer (CRC) is the third most frequently diagnosed malignancy worldwide and the second leading cause of cancer-related mortality. Despite immune checkpoint inhibitors improving outcomes for patients with microsatellite instability high (MSI-H) CRC, their effectiveness against microsatellite-stable (MSS) cancers remains restricted. Nivolumab-based combination regimens, which include ipilimumab or binimetinib as components, have shown potential to improve treatment results, but existing studies provide incomplete evidence for their effectiveness.

Methods

The researchers conducted a systematic review and meta-analysis, which included three randomized controlled trials that studied 1085 patients with metastatic CRC. The researchers evaluated two outcomes, which were best overall response (BOR) and treatment-related adverse events (TRAEs). The study utilized random-effects models to manage the clinical and methodological variations that existed between different studies. The researchers conducted subgroup analyses along with sensitivity assessments and publication bias assessments to determine how reliable the findings were.

Results

The pooled analysis demonstrated no statistically significant difference in overall BOR between nivolumab-based combination therapy and control regimens (RR 1.01; 95% CI 0.79–1.30; p = 0.94) with moderate heterogeneity (I2 = 56%). Nivolumab-based combinations showed statistically significant improvement in partial response rates, but complete response, stable disease and progressive disease rates stayed unchanged. The safety analysis showed a numerical but non-significant increase in TRAEs (RR 1.19; 95% CI 0.86–1.65; p = 0.30), which occurred alongside differences between trial sites about serious adverse events and treatment halts. The researchers found little evidence of publication bias.

Conclusion

In metastatic CRC patients who receive nivolumab-based combination therapies demonstrate partial tumor responses that increase while their safety profile remains acceptable, but their overall response rates do not improve. The research demonstrates how immunotherapy serves as a standard treatment method for MSI-H disease while emphasizing the need to develop biomarker-driven approaches that enhance treatment selection methods, especially for MSS CRC.

Graphical abstract