Early dermatologic adverse events predict better outcome in HCC patients treated with sorafenib

Maria Reig, Ferran Torres, Carlos Rodriguez-Lope, Alejandro Forner, Neus Llarch, Jordi Rimola, Anna Darnell, José Ríos, Carmen Ayuso, Jordi Bruix

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    Abstract

    Background & Aims There are no clinical data/markers to predict improved survival in patients with hepatocellular carcinoma treated with sorafenib. Majority of sorafenib adverse events appear within the first 60 days of treatment and studies correlating them with outcome are needed. Methods We prospectively studied 147 hepatocellular carcinoma patients (97% cirrhotic, 82% Child-Pugh A, BCLC-B 77, BCLC-C 69) treated with sorafenib. Follow-up included monthly clinical and laboratory monitoring and tumor staging at week 4 and every 8 weeks. Results After a median follow up of 11.6 months (treatment duration 6.7 months), time to progression and overall survival were 5.1 and 12.7 months. All but one patient presented at least one adverse event (median time to appearance 56 days). Time dependent covariate analysis (HR [95% CI]) identified baseline performance status (2.86 [1.75 to 4.55], p <0.001), BCLC (1.69 [1.18 to 2.50], p = 0.005), and dermatologic adverse event requiring dose adjustment within the first 60 days (0.58 [0.36 to 0.92], p = 0.022) as independent predictors of better outcome. Other early adverse events did not have an impact in outcome. The predictive value of dermatologic adverse events for survival was confirmed by the landmark analysis (p = 0.0270). Conclusions Development of dermatologic adverse events within 60 days of sorafenib initiation is associated with better survival. Therefore, this should not to be taken as a negative event and discourage treatment maintenance. Likewise, second line clinical trials should be designed and/or evaluated considering this information to avoid significant bias.
    Original languageEnglish
    Pages (from-to)318-324
    JournalJournal of Hepatology
    Volume61
    Issue number2
    DOIs
    Publication statusPublished - 1 Jan 2014

    Keywords

    • Clinical marker
    • Early adverse events
    • Hepatocellular carcinoma
    • Overall survival
    • Sorafenib

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    Reig, M., Torres, F., Rodriguez-Lope, C., Forner, A., Llarch, N., Rimola, J., Darnell, A., Ríos, J., Ayuso, C., & Bruix, J. (2014). Early dermatologic adverse events predict better outcome in HCC patients treated with sorafenib. Journal of Hepatology, 61(2), 318-324. https://doi.org/10.1016/j.jhep.2014.03.030