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  • Efficacy and Safety of Immune Checkpoint Inhibitors in MSI‑High Colorectal Cancer

  • Seyedeh Reyhaneh Lajevardi,1,* Gila Akbarzadeh Kasan,2 Bent Al-Hoda Khales Zadeh,3 Maryam Alavi Deylami,4 Zahra Razizadeh Sedehi,5 mohsen koolivand,6


  • Introduction: Background: Colorectal cancer (CRC) is the third most common malignancy worldwide. Approximately 15% of colorectal cancers exhibit microsatellite instability (MSI‑high), which is associated with a high tumor mutational burden and increased immunogenicity. Immune checkpoint inhibitors (ICIs) have emerged as a promising therapeutic strategy for MSI‑high CRC, but comprehensive data on their efficacy and safety profile remain limited.
  • Methods: Methods: This prospective observational study evaluated the efficacy and safety of PD‑1/PD‑L1 inhibitors in 45 patients with MSI‑high metastatic colorectal cancer treated at a tertiary referral center. Patients received either pembrolizumab (200 mg every 3 weeks) or nivolumab (240 mg every 2 weeks). Primary endpoints were objective response rate (ORR) and progression‑free survival (PFS). Secondary endpoints included overall survival (OS), disease control rate (DCR), and adverse event profile.
  • Results: Results: The objective response rate (ORR) was 42.2% (19/45), with 4 complete responses and 15 partial responses. The disease control rate (DCR) was 73.3%. Median progression‑free survival (PFS) was 16.8 months (95% CI: 12.4‑21.2), and median overall survival (OS) was not reached at 24 months. Treatment‑related adverse events occurred in 57.8% of patients, with grade ≥3 events in 11.1% (5/45). The most common adverse events were fatigue (28.9%), rash (22.2%), and diarrhea (17.8%).
  • Conclusion: Conclusion: Immune checkpoint inhibitors demonstrate significant and durable clinical efficacy with an acceptable safety profile in MSI‑high metastatic colorectal cancer. These findings support the use of PD‑1/PD‑L1 inhibitors as a standard treatment option in this patient population.  
  • Keywords: Colorectal cancer; MSI‑high; Immune checkpoint inhibitors; Pembrolizumab; Nivolumab; PD‑1/

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