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Phase 2 trial comparing sorafenib, pravastatin, their combination or supportive care in HCC with Child–Pugh B cirrhosis
Jean-Frédéric Blanc, Faiza Khemissa, Jean-Pierre Bronowicki, Carole Monterymard, Jean-Marc Perarnau, Vincent Bourgeois, Stéphane Obled, Meher Ben Abdelghani, Isabelle Mabile-Archambeaud, Roger Faroux, Jean-François Seitz, Christophe Locher, Hélène Senellart, Anne-Laure Villing, Franck Audemar, Charlotte Costentin, Gaël Deplanque, Sylvain Manfredi & Julien Edeline for the PRODIGE 21 collaborators
Hepatology International volume 15, pages93–104(2021)Cite this article
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Abstract
Background and aims
There is limited data regarding the role for systemic treatment in patients with Hepatocellular Carcinoma with Child–Pugh B cirrhosis.
Methods
PRODIGE 21 was a multicentric prospective non-comparative randomized trial. Patients were randomized to receive sorafenib (Arm A), pravastatin (Arm B), sorafenib–pravastatin (Arm C) combination, or best supportive care (Arm D). Primary endpoint was time to progression (TTP), secondary endpoints included safety and overall survival (OS).
Results
160 patients were randomized and 157 patients were included in the final analysis. 86% of patients were BCLC C and 55% had macrovascular invasion. The safety profiles of the drugs were as expected. Median TTP was 3.5, 2.8, 2.0 and 2.2 months in arms A, B, C and D, respectively, but analysis was limited by the number of patients deceased without radiological progression (59%). Median OS was similar between the four arms: 3.8 [95% CI: 2.4–6.5], 3.1 [95% CI: 1.9–4.3], 4.0 [95% CI: 3.2–5.5] and 3.5 months [95% CI: 2.2–5.4] in arms A, B, C and D, respectively. Median OS was 4.0 months [95% CI: 3.3–5.5] for patients treated with sorafenib, vs 2.9 months [95% CI: 2.2–3.9] for patients not treated with sorafenib. In patients with ALBI grade 1/2, median OS was 6.1 months [95% CI: 3.8–8.3] in patients treated with sorafenib vs 3.1 months [95% CI: 1.9–4.8] for patients not treated with sorafenib.
Conclusion
In the overall Child–Pugh B population, neither sorafenib nor pravastatin seemed to provide benefit. In the ALBI grade 1/2 sub-population, our trial suggests potential benefit of sorafenib.
Clinical trial registration
The study was referenced in clinicaltrials.gov (NCT01357486). |
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