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

  • seyedeh reyhaneh lajevardi,1,* Gila Akbarzadeh Kasani,2 Bent Al-Hoda Khales Zadeh,3 Maryam Alavi Deylami,4 Zahra Razizadeh Sedehi,5 Saber Abbas Zadeh,6
    1. Student Research Committee, School of medicine, Guilan University of Medical Sciences, Rasht, Iran
    2. Student Research Committee, School of medicine, Guilan University of Medical Sciences, Rasht, Iran
    3. Student Research Committee, School of medicine, Guilan University of Medical Sciences, Rasht, Iran
    4. Student Research Committee, School of medicine, Guilan University of Medical Sciences, Rasht, Iran
    5. Student Research Committee, School of medicine, Guilan University of Medical Sciences, Rasht, Iran
    6. Student Research Committee, School of medicine, Guilan University of Medical Sciences, Rasht, Iran


  • Introduction: Background: Colorectal cancer (CRC) is the third most common malignancy worldwide. Approximately 15% of colorectal cancers exhibit high‑level 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 this subgroup; however, comprehensive evaluation of both efficacy and safety in clinical settings is essential.
  • Methods: Methods: This prospective observational study evaluated 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 treatment‑related adverse events.
  • 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, 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, rash, and diarrhea.
  • Conclusion: Conclusion: PD‑1/PD‑L1 inhibitors demonstrate significant and durable clinical activity with an acceptable safety profile in MSI‑high metastatic colorectal cancer. These findings support the role of these agents as a standard treatment option in this patient population.
  • Keywords: Colorectal cancer, MSI‑high, Immune checkpoint inhibitors, Pembrolizumab

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