Nonoperative Management of Mismatch Repair-Deficient Tumors.
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Cercek Andrea, Foote Michael B, Rousseau Benoit, Smith J Joshua, Shia Jinru, Sinopoli Jenna, Weiss Jill, Lumish Melissa, Temple Lindsay, Patel Miteshkumar, Wilde Callahan, Saltz Leonard B, Argiles Guillem, Stadler Zsofia, Artz Oliver, Maron Steven, Ku Geoffrey, Gu Ping, Janjigian Yelena Y, Molena Daniela, Iyer Gopa, Coleman Jonathan, Abida Wassim, Cohen Seth, Soares Kevin, Schattner Mark, Strong Vivian E, Yaeger Rona, Paty Philip, Shcherba Marina, Sugarman Ryan, Romesser Paul B, Zervoudakis Alice, Desai Avni, Segal Neil H, El Dika Imane, Widmar Maria, Wei Iris, Pappou Emmanouil, Fumo Gerard, Aparo Santiago, Gonen Mithat, Gollub Marc, Jayaprakasam Vetri S, Kim Tae-Hyung, Garcia Aguilar Julio, Weiser Martin, Diaz Luis A
Аннотация
METHODS: We conducted a phase 2 study in which patients with stage I, II, or III dMMR solid tumors that were amenable to curative-intent surgery were treated with neoadjuvant dostarlimab, a programmed cell death 1 (PD-1) blocking agent, for 6 months. The response to treatment was assessed in two cohorts: patients in cohort 1 had dMMR, locally advanced rectal cancer, and patients in cohort 2 had dMMR nonrectal solid tumors. Patients with a clinical complete response could elect to proceed with nonoperative management; those with residual disease were to undergo resection. In this analysis, the primary end point, assessed in cohort 1, was a sustained clinical complete response at 12 months. Recurrence-free survival and safety were evaluated.
RESULTS: A total of 117 patients were included in the analysis. In cohort 1, all 49 patients who completed treatment had a clinical complete response and elected to proceed with nonoperative management. A total of 37 patients had a sustained clinical complete response at 12 months, a finding that met the criterion for efficacy. In cohort 2, a total of 35 of 54 patients who completed treatment had a clinical complete response, and 33 elected to proceed with nonoperative management. Among the 103 patients who completed treatment across both cohorts, 84 had a clinical complete response, and 82 did not undergo surgery. Among the 117 total patients, recurrence-free survival at 2 years was 92% (95% confidence interval, 86 to 99); the median follow-up for recurrence was 20.0 months (range, 0 to 60.8). The majority of patients (95%) had reversible, grade 1 or 2 adverse events (60%) or had no adverse events (35%). The option for curative resection was not compromised during or after treatment in any of the patients.
CONCLUSIONS: Among patients with early-stage dMMR solid tumors that were amenable to curative-intent surgery, neoadjuvant PD-1 blockade led to organ preservation in a high proportion of patients. (Funded by Swim Across America and others; ClinicalTrials.gov number, NCT04165772.).