Sorafenib alone vs. sorafenib plus GEMOX as 1st-line treatment for advanced HCC: the phase II randomised PRODIGE 10 trial

Abstract

BACKGROUND: 

Sorafenib remains one major first-line therapeutic options for advanced hepatocellular carcinoma(aHCC), with modest efficacy. We investigated the addition of gemcitabine and oxaliplatin (GEMOX) to sorafenib in aHCC patients.

 

METHODS: 

Our multicentre phase II trial randomised aHCC first-line patients to sorafenib (400 mg BID) or sorafenib-GEMOX every 2 weeks (1000 mg/m2 gemcitabine; 100 mg/m2 oxaliplatin). Primary endpoint was the 4-month progression-free survival (PFS) rate.

 

RESULTS: 

Ninety-four patients were randomised (sorafenib-GEMOX: n = 48; sorafenib: n = 46). Median age was 64 years, PS 0 (69%) or 1 (31%), 63% patients had cirrhosis, 29% portal vein thrombosis and 70% extra-hepatic disease. Median duration of sorafenib treatment was 4 months (1-51); median number of GEMOX cycles was 7 (1-16). The 4-month PFS rates were 64% and 61% in the sorafenib-GEMOX and sorafenib arms, respectively; median PFS and OS were 6.2 (95% CI: 3.8-6.8) and 13.5 (7.5-16.2) months, and 4.6 (3.9-6.2) months and 14.8 (12.2-22.2), respectively. The ORR/DCR were 9%/70% and 15%/77% in the sorafenib-GEMOX and sorafenib alone arms, respectively. Main toxicities were (sorafenib-GEMOX/sorafenib) neutropenia (23%/0), thrombocytopenia (33%/0), diarrhoea (18%/9), peripheral neuropathy (5%/0) and hand-foot syndrome (5%/18).

 

CONCLUSIONS: 

Addition of GEMOX had an inpact on ORR and was well-tolerated as frontline systemic therapy. The benefit on PFS seems moderate; no subsequent study was planned.

Authors

Assenat E1,2, Pageaux GP3, Thézenas S4, Peron JM5, Bécouarn Y6, Seitz JF7, Merle P8, Blanc JF9, Bouché O10, Ramdani M11, Poujol S4, de Forges H4, Ychou M4, Boige V12.

 

Br J Cancer. 2019 Apr 4. doi: 10.1038/s41416-019-0443-4. [Epub ahead of print]

Author Information

  1. Institut du Cancer de Montpellier (ICM), Université de Montpellier, Montpellier, France. eric.assenat@icm.unicancer.fr.

  2. Centre Hospitalier Universitaire de Montpellier, Université de Montpellier, Montpellier, France. eric.assenat@icm.unicancer.fr.

  3. Centre Hospitalier Universitaire de Montpellier, Université de Montpellier, Montpellier, France.

  4. Institut du Cancer de Montpellier (ICM), Université de Montpellier, Montpellier, France.

  5. Centre Hospitalier Universitaire de Toulouse, Toulouse, France.

  6. Bergonié Institute, Bordeaux, France.

  7. Centre Hospitalier Universitaire de Marseille, Marseille, France.

  8. Centre Hospitalier Universitaire de Lyon, Lyon, France.

  9. Saint-André Hospital, Bordeaux, France.

  10. Centre Hospitalier Universitaire de Reims, Reims, France.

  11. Centre Hospitalier Universitaire de Béziers, Béziers, France.

  12. Gustave Roussy, Villejuif, France.

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