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The New England Journal of MedicineNeoadjuvant Immunotherapy in Locally Advanced Mismatch Repair–Deficient Colon Cancer

Neoadjuvant nivolumab plus ipilimumab demonstrates high pathological response rates and an acceptable safety profile in nonmetastatic, locally advanced dMMR colon cancer, highlighting its potential role in clinical practice for this patient subset.

A recent phase 2 study investigated the safety and efficacy of neoadjuvant nivolumab plus ipilimumab in patients with nonmetastatic, locally advanced, previously untreated mismatch repair-deficient (dMMR) colon cancer. This research addresses the limitations of chemotherapy in this subset of colon cancer patients, focusing on timely surgery and long-term disease-free survival as primary endpoints.

Study Design:

  • Participants: 115 patients with nonmetastatic, locally advanced, previously untreated dMMR colon cancer.
  • Intervention: Treatment with neoadjuvant nivolumab plus ipilimumab.
  • Primary Endpoints: Safety (timely surgery defined as ≤2-week delay due to treatment-related toxic events) and 3-year disease-free survival.
  • Secondary Endpoints: Pathological response and results of genomic analyses.

Key Findings:

  • Safety: 98% (113/115) of patients underwent timely surgery; 2 patients experienced delays of more than 2 weeks.
  • Adverse Events: Grade 3 or 4 immune-related adverse events occurred in 4% (5 patients); no treatment discontinuations due to adverse events.
  • Pathological Response: 98% (109/111) of patients showed a pathological response; 95% (105/111) had a major pathological response (≤10% residual viable tumor); 68% (75/111) achieved a pathological complete response (0% residual viable tumor).
  • Disease Recurrence: With a median follow-up of 26 months, no patients experienced disease recurrence.

HCN Medical Memo
This study suggests that neoadjuvant immunotherapy with nivolumab and ipilimumab can be a viable option for patients with locally advanced dMMR colon cancer, achieving significant pathological responses without compromising surgical timelines.

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