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Thématique :
- Foie
- Carcinome hépatocellulaire (CHC)
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Originalité :
Intermédiaire
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| Doit faire évoluer notre pratique : |
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Dans certains cas
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Nom du veilleur :
Docteur Jean-Louis PAYEN
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Journal of Hepatology
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2018/08
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2018 Aug;69(2):353-358.
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doi: 10.1016/j.jhep.2018.04.010
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Outcomes of sequential treatment with sorafenib followed by regorafenib for HCC: Additional analyses from the phase III RESORCE trial
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Finn RS, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Gerolami R, Caparello C, Cabrera R, Chang C, Sun W, LeBerre MA, Baumhauer A, Meinhardt G, Bruix J
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https://www.ncbi.nlm.nih.gov/pubmed/29704513
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Abstract
BACKGROUND & AIMS:
The RESORCE trial showed that regorafenib improves overall survival (OS) in patients with hepatocellular carcinoma progressing during sorafenib treatment (hazard ratio [HR] 0.62, 95% confidence interval [CI] 0.50-0.78; p <0.0001). This exploratory analysis describes outcomes of sequential treatment with sorafenib followed by regorafenib.
METHODS:
In RESORCE, 573 patients were randomized 2:1 to regorafenib 160 mg/day or placebo for 3 weeks on/1 week off. Efficacy and safety were evaluated by last sorafenib dose. The time from the start of sorafenib to death was assessed. Time to progression (TTP) in RESORCE was analyzed by TTP during prior sorafenib treatment.
RESULTS:
HRs (regorafenib/placebo) for OS by last sorafenib dose were similar (0.67 for 800 mg/day; 0.68 for <800 mg/day). Rates of grade 3, 4, and 5 adverse events with regorafenib by last sorafenib dose (800 mg/day vs. <800 mg/day) were 52%, 11%, and 15% vs. 60%, 10%, and 12%, respectively. Median times (95% CI) from the start of sorafenib to death were 26.0 months (22.6-28.1) for regorafenib and 19.2 months (16.3-22.8) for placebo. Median time from the start of sorafenib to progression on sorafenib was 7.2 months for the regorafenib arm and 7.1 months for the placebo arm. An analysis of TTP in RESORCE in subgroups defined by TTP during prior sorafenib in quartiles (Q) showed HRs (regorafenib/placebo; 95% CI) of 0.66 (0.45-0.96; Q1); 0.26 (0.17-0.40; Q2); 0.40 (0.27-0.60; Q3); and 0.54 (0.36-0.81; Q4).
CONCLUSIONS:
These exploratory analyses show that regorafenib conferred a clinical benefit regardless of the last sorafenib dose or TTP on prior sorafenib. Rates of adverse events were generally similar regardless of the last sorafenib dose.
LAY SUMMARY:
This analysis examined characteristics and outcomes of patients with hepatocellular carcinoma who were treated with regorafenib after they had disease progression during sorafenib treatment. Regorafenib provided clinical benefit to patients regardless of the pace of their disease progression during prior sorafenib treatment and regardless of their last sorafenib dose. The sequence of sorafenib followed by regorafenib for hepatocellular carcinoma may extend survival beyond what has been previously reported. ClinicalTrials.gov NCT01774344.
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Résultats du traitement séquentiel par le sorafénib suivi du régorafénib pour le carcinome hépato-cellulaire : analyses supplémentaires issues de l'essai de phase III RESORCE.
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Les temps médians (IC à 95%) du début du sorafénib au décès étaient de 26 mois (22,6-28,1) pour le régorafénib et de 19,2 mois (16,3-22,8) pour le placebo.
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A chacun de juger de l’interêt, dans le cadre de RCP, de ce nouveau schéma thérapeutique pour nos patients …
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