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Neoadjuvant Immunotherapy—From Trials to Practice

A partir d'une revue systématique de la littérature publiée jusqu'en décembre 2023 (9 essais, 5 114 patientes), cette méta-analyse évalue l'efficacité, du point de vue du taux de réponse et de la survie sans événement, et la toxicité de l'ajout d'inhibiteurs de point de contrôle immunitaire à une chimiothérapie (néo)adjuvante chez des patientes atteintes d'un cancer du sein de stade précoce

Immunotherapy, including immune checkpoint inhibition, is a pillar of cancer care with approvals for use in multiple tumor types. In breast cancer, the immune checkpoint inhibitor (ICI) pembrolizumab is approved by the US Food and Drug Administration (FDA) in combination with chemotherapy for programmed cell death ligand 1 (PD-L1)–positive (PD-L1+) metastatic triple-negative breast cancer (TNBC) and in early-stage TNBC regardless of the tumor’s PD-L1 status. In early-stage disease, the combination is approved in the neoadjuvant setting (with continuation of pembrolizumab as adjuvant therapy) based on the KEYNOTE-522 trial that showed an increased pathologic complete response (pCR) rate and improved event-free survival (EFS) and overall survival for patients receiving immunotherapy. As detailed in the Villacampa et al meta-analysis, additional trials have investigated other ICI in early-stage TNBC, and among 2075 patients with TNBC included in the intention-to-treat population, the addition of an ICI resulted in an increase in pCR rate from 46.6% to 59.9% (difference of 13.3%; odds ratio [OR], 1.64; 95% CI, 1.49-2.36). The magnitude of benefit was similar regardless of the tumor’s PD-L1 status, supporting ICI use in early-stage TNBC without the need to assess an individual patient’s tumor for PD-L1 expression. Individual patient data in this meta-analysis also showed that ICI use improved EFS (hazard ratio [HR], 0.69; 95% CI, 0.57-0.84).

https://doi.org/10.1001/jamaoncol.2024.2924 2023

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