Safety and efficacy of immunotherapy using a double-dose regimen in advanced non-small cell lung cancer (NSCLC): results of IDEE study.

Autor:	Pierre C; Pneumology Department, CHU Pontchaillou, Rennes, France.; INSERM U1242 COSS, CLCC Eugène Marquis, Rennes, France., Le Guen Y; Pneumology Department, CHU Pontchaillou, Rennes, France.; INSERM U1242 COSS, CLCC Eugène Marquis, Rennes, France., Giordanengo C; Pneumology Department, CHU Pontchaillou, Rennes, France., Goter T; Pneumology Department, CHU Pontchaillou, Rennes, France., Léna H; Pneumology Department, CHU Pontchaillou, Rennes, France.; INSERM U1242 COSS, CLCC Eugène Marquis, Rennes, France., Niel C; Pneumology Department, Centre Hospitalier De Morlaix, Morlaix, France., De Chabot G; Pneumology Department, Centre Hospitalier Bretagne Atlantique, Vannes, France., Tiercin M; Pneumology Department, Centre Hospitaliser De Saint Malo, Saint Malo, France., Le Garff G; Pneumology Department, Centre Hospitalier De Saint Brieuc, Saint Brieuc, France., Zimmermann F; Internal Medicine Department, CHU Pontchaillou, Rennes, France., Le Cornu Q; Clinical Pharmacology Department, CIC INSERM 14 14, Rennes, France., Ricordel C; Pneumology Department, CHU Pontchaillou, Rennes, France.; INSERM U1242 COSS, CLCC Eugène Marquis, Rennes, France.
Jazyk:	angličtina
Zdroj:	Translational lung cancer research [Transl Lung Cancer Res] 2024 Aug 31; Vol. 13 (8), pp. 1807-1815. Date of Electronic Publication: 2024 Aug 23.
DOI:	10.21037/tlcr-24-141
Abstrakt:	Background: Pembrolizumab 400 mg every six weeks (Q6W) and nivolumab 480 mg every four weeks (Q4W) are used since 2020 and the coronavirus disease 2019 (COVID-19) pandemic. This recommendation relied on pharmacokinetic and pharmacodynamic models. The objective of the IDEE (Immunothérapie Double dose Etendue: Experience bretonne) study is to determine the safety and efficacy of this treatment regimen in real life conditions. Methods: We conducted an observational, retrospective, multicentric study including 117 patients with advanced non-small cell lung cancer (NSCLC) who received pembrolizumab Q6W or nivolumab Q4W between March 2020 and March 2021. Results: The median age was 67 years, 68% were men with predominantly lung adenocarcinoma. The median time to double-dose regimen failure (TDDF) was 9.2 months. The survival rate at 12 months was 79%. TDDF was not influenced by sex, line of treatment, pathologic subtypes or anti-programmed cell death protein 1 (PD-1) antibody. There was no correlation between TDDF and duration of prior exposition to immunotherapy before switching. Sixty-eight patients experienced double-dose treatment failure, 28% because of toxicity including five definitive discontinuations. Five grade ≥3 immune-adverse events were reported included two cases of pneumonitis, all responding to corticosteroid therapy. Conclusions: Our multicentric cohort supports the feasibility of pembrolizumab Q6W and nivolumab Q4W for patients with advanced NSCLC. There is no warning signal regarding safety neither efficacy in our real-life data. Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-24-141/coif). H.L. receives honoraria, participation on Advisory Board and support for meeting travel from Roche, MSD, Bristol Myers Squibb, Astrazeneca, Sanofi. G.D.C. reports participation on a Data Safety Monitoring Board or Advisory Board for MSD, BMS, Roche, Astrazeneca, Takeda and Sanofi and support for attending meetings by Pfizer. C.R. reports consulting fees from Astrazeneca, MSD, Takeda and BMS. The other authors have no conflicts of interest to declare. (2024 Translational Lung Cancer Research. All rights reserved.)
Databáze:	MEDLINE
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