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Article Dans Une Revue New England Journal of Medicine Année : 2021

Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma

Dean F. Bajorin
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Johannes Alfred Witjes
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Jürgen Erich Gschwend
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M. Schenker
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Begoña Pérez Valderrama
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Yoshihiko Tomita
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A. Bamias
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Shahrokh F. Shariat
Se-Hoon Park
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Dingwei Ye
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Mads Agerbaek
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Deborah Enting
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Ray S. Mcdermott
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Pablo Gajate
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Avivit Peer
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Matthew Ivan Milowsky
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Alexander К. Nosov
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João Neif Jr Antonio
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Krzysztof Tupikowski
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Laurence Toms
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Bruce S. Fischer
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Anila Qureshi
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Sandra Collette
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Keziban Unsal-Kacmaz
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Edward Broughton
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Dimitrios Zardavas
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Henry B. Koon
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Matthew David Galsky
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Résumé

BACKGROUND The role of adjuvant treatment in high-risk muscle-invasive urothelial carcinoma after radical surgery is not clear. METHODS In a phase 3, multicenter, double-blind, randomized, controlled trial, we assigned patients with muscle-invasive urothelial carcinoma who had undergone radical surgery to receive, in a 1:1 ratio, either nivolumab (240 mg intravenously) or placebo every 2 weeks for up to 1 year. Neoadjuvant cisplatin-based chemotherapy before trial entry was allowed. The primary end points were disease-free survival among all the patients (intention-to-treat population) and among patients with a tumor programmed death ligand 1 (PD-L1) expression level of 1% or more. Survival free from recurrence outside the urothelial tract was a secondary end point. RESULTS A total of 353 patients were assigned to receive nivolumab and 356 to receive placebo. The median disease-free survival in the intention-to-treat population was 20.8 months (95% confidence interval [CI], 16.5 to 27.6) with nivolumab and 10.8 months (95% CI, 8.3 to 13.9) with placebo. The percentage of patients who were alive and disease-free at 6 months was 74.9% with nivolumab and 60.3% with placebo (hazard ratio for disease recurrence or death, 0.70; 98.22% CI, 0.55 to 0.90; P<0.001). Among patients with a PD-L1 expression level of 1% or more, the percentage of patients was 74.5% and 55.7%, respectively (hazard ratio, 0.55; 98.72% CI, 0.35 to 0.85; P<0.001). The median survival free from recurrence outside the urothelial tract in the intention-to-treat population was 22.9 months (95% CI, 19.2 to 33.4) with nivolumab and 13.7 months (95% CI, 8.4 to 20.3) with placebo. The percentage of patients who were alive and free from recurrence outside the urothelial tract at 6 months was 77.0% with nivolumab and 62.7% with placebo (hazard ratio for recurrence outside the urothelial tract or death, 0.72; 95% CI, 0.59 to 0.89). Among patients with a PD-L1 expression level of 1% or more, the percentage of patients was 75.3% and 56.7%, respectively (hazard ratio, 0.55; 95% CI, 0.39 to 0.79). Treatment-related adverse events of grade 3 or higher occurred in 17.9% of the nivolumab group and 7.2% of the placebo group. Two treatment-related deaths due to pneumonitis were noted in the nivolumab group. CONCLUSIONS In this trial involving patients with high-risk muscle-invasive urothelial carcinoma who had undergone radical surgery, disease-free survival was longer with adjuvant nivolumab than with placebo in the intention-to-treat population and among patients with a PD-L1 expression level of 1% or more.

Dates et versions

hal-03287320 , version 1 (15-07-2021)

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Dean F. Bajorin, Johannes Alfred Witjes, Jürgen Erich Gschwend, M. Schenker, Begoña Pérez Valderrama, et al.. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. New England Journal of Medicine, 2021, 384 (22), pp.2102-2114. ⟨10.1056/NEJMoa2034442⟩. ⟨hal-03287320⟩
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