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Chalabi, Myriam; Fanchi, Lorenzo F; Dijkstra, Krijn K; Van den Berg, José G; Aalbers, Arend G; Sikorska, Karolina; Lopez-Yurda, Marta; Grootscholten, Cecile; Beets, Geerard L; Snaebjornsson, Petur; Maas, Monique; Mertz, Marjolijn; Veninga, Vivien; Bounova, Gergana; Broeks, Annegien; Beets-Tan, Regina G; de Wijkerslooth, Thomas R; van Lent, Anja U; Marsman, Hendrik A; Nuijten, Elvira; Kok, Niels F; Kuiper, Maria; Verbeek, Wieke H; Kok, Marleen; Van Leerdam, Monique E; Schumacher, Ton N; Voest, Emile E; Haanen, John B
Nature medicine, 04/2020, Letnik: 26, Številka: 4Journal Article
PD-1 plus CTLA-4 blockade is highly effective in advanced-stage, mismatch repair (MMR)-deficient (dMMR) colorectal cancers, yet not in MMR-proficient (pMMR) tumors. We postulated a higher efficacy of neoadjuvant immunotherapy in early-stage colon cancers. In the exploratory NICHE study (ClinicalTrials.gov: NCT03026140), patients with dMMR or pMMR tumors received a single dose of ipilimumab and two doses of nivolumab before surgery, the pMMR group with or without celecoxib. The primary objective was safety and feasibility; 40 patients with 21 dMMR and 20 pMMR tumors were treated, and 3 patients received nivolumab monotherapy in the safety run-in. Treatment was well tolerated and all patients underwent radical resections without delays, meeting the primary endpoint. Of the patients who received ipilimumab + nivolumab (20 dMMR and 15 pMMR tumors), 35 were evaluable for efficacy and translational endpoints. Pathological response was observed in 20/20 (100%; 95% exact confidence interval (CI): 86-100%) dMMR tumors, with 19 major pathological responses (MPRs, ≤10% residual viable tumor) and 12 pathological complete responses. In pMMR tumors, 4/15 (27%; 95% exact CI: 8-55%) showed pathological responses, with 3 MPRs and 1 partial response. CD8 PD-1 T cell infiltration was predictive of response in pMMR tumors. These data indicate that neoadjuvant immunotherapy may have the potential to become the standard of care for a defined group of colon cancer patients when validated in larger studies with at least 3 years of disease-free survival data.
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in: SICRIS
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