Impact de la corticothérapie sur l’efficacité de l’immunothérapie dans le traitement du carcinome rénal à cellules claires métastatique

Abstract : Purpose: Nivolumab is now a standard for the treatment of metastatic clear-cell renal cell carcinoma (mccRCC). The immunosuppressive effect of corticosteroids may reduce efficacy of nivolumab. We evaluated the impact of corticosteroids during nivolumab treatment in patients with mccRCC. Patients and Methods: we conducted an ancillary study of NIVOREN (NCT03013335), a French multicenter prospective phase II safety study of nivolumab in mccRCC in case of progression after anti-angiogenic therapy. We compared patients exposed or not exposed to corticosteroids before disease progression. We performed a landmark analysis using a timepoint at 12 weeks for overall survival (OS) and progression free survival (PFS) assessment. Results: among the 666 evaluable patients, 114 (17.1%) and 552 (82.9%) patients were exposed or not exposed to corticosteroids before progression respectively. Among exposed patients, 73.3% received corticosteroids for an immune-related adverse event (irAEs). Median OS was not reached and 25.4 months respectively in patients exposed or not exposed to corticosteroids (hazard ratio (HR), 0.57; p = 0.0017). Median PFS was 16.4 months versus 9.6 months respectively in patients exposed or not exposed to corticosteroids (HR, 0.63; p = 0.0065). Objective response rate was 32.7 % and 18.6 % respectively in patients exposed or not exposed to corticosteroids. Among patients with at least one treatment-related adverse event of grade 3-5, the 12-month overall survival rate was 82.2% for patients exposed to corticosteroids versus 59.5% patients not exposed to corticosteroids. Conclusion: the use of corticosteroids during nivolumab treatment of metastatic ccRCC is not associated with an adverse effect on survival outcomes. irAEs requiring corticosteroids were associated with better response to immunotherapy but further investigation is needed to confirm these results.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-02112002
Contributor : Bu Carreire Université de Bordeaux <>
Submitted on : Friday, April 26, 2019 - 1:03:50 PM
Last modification on : Saturday, June 29, 2019 - 1:25:09 AM

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Félix Lefort. Impact de la corticothérapie sur l’efficacité de l’immunothérapie dans le traitement du carcinome rénal à cellules claires métastatique. Médecine humaine et pathologie. 2019. ⟨dumas-02112002⟩

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