Chirurgia del Fegato a Firenze!

Dal 1° Marzo 2023, Chirurgia del Fegato sarà all'Università di Firenze
AOUC Azienda Ospedaliero-Universitaria Careggi - Largo Brambilla, 3 - 50134 Firenze

Sorafenib come terapia per l’epatocarcinoma

Sul The New England Journal of Medicine vengono pubblicati i risultati dello studio internazionale SHARP (ClinicalTrials.gov number, NCT00105443) sul trattamento medico dell’epatocarcinoma.

E’ il primo studio che riporta un aumento della sopravvivenza nei pazienti trattati con un farmaco, portatori di epatocarcinoma e che non possono essere operati.

La referenza bibliografica per questo evento è:

Josep M Llovet, Sergio Ricci, Vincenzo Mazzaferro, Philip Hilgard, Edward Gane, Jean-Frédéric Blanc, Andre Cosme de Oliveira, Armando Santoro, Jean-Luc Raoul, Alejandro Forner, Myron Schwartz, Camillo Porta, Stefan Zeuzem, Luigi Bolondi, Tim F Greten, Peter R Galle, Jean-François Seitz, Ivan Borbath, Dieter Häussinger, Tom Giannaris, Minghua Shan, Marius Moscovici, Dimitris Voliotis, Jordi Bruix: Sorafenib in advanced hepatocellular carcinoma. In: N Engl J Med, vol. 359, no. 4, pp. 378–390, 2008, ISSN: 1533-4406.

Abstract

BACKGROUND: No effective systemic therapy exists for patients with advanced hepatocellular carcinoma. A preliminary study suggested that sorafenib, an oral multikinase inhibitor of the vascular endothelial growth factor receptor, the platelet-derived growth factor receptor, and Raf may be effective in hepatocellular carcinoma.

METHODS: In this multicenter, phase 3, double-blind, placebo-controlled trial, we randomly assigned 602 patients with advanced hepatocellular carcinoma who had not received previous systemic treatment to receive either sorafenib (at a dose of 400 mg twice daily) or placebo. Primary outcomes were overall survival and the time to symptomatic progression. Secondary outcomes included the time to radiologic progression and safety.

RESULTS: At the second planned interim analysis, 321 deaths had occurred, and the study was stopped. Median overall survival was 10.7 months in the sorafenib group and 7.9 months in the placebo group (hazard ratio in the sorafenib group, 0.69; 95% confidence interval, 0.55 to 0.87; P<0.001). There was no significant difference between the two groups in the median time to symptomatic progression (4.1 months vs. 4.9 months, respectively, P=0.77). The median time to radiologic progression was 5.5 months in the sorafenib group and 2.8 months in the placebo group (P<0.001). Seven patients in the sorafenib group (2%) and two patients in the placebo group (1%) had a partial response; no patients had a complete response. Diarrhea, weight loss, hand-foot skin reaction, and hypophosphatemia were more frequent in the sorafenib group.

CONCLUSIONS: In patients with advanced hepatocellular carcinoma, median survival and the time to radiologic progression were nearly 3 months longer for patients treated with sorafenib than for those given placebo. (ClinicalTrials.gov number, NCT00105443.)

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Chirurgia del Fegato all'Università di Firenze!

Chirurgia Epato-Bilio-Pancreatica

AOUC Azienda Ospedaliero-Universitaria Careggi
Largo Brambilla, 3 – 50134 Firenze

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