Irinotecan as first-line chemotherapy in patients with advanced hepatocellular carcinoma: A multicenter phase II study with dose adjustment according to baseline serum bilirubin level

Valérie Boige, Julien Taïeb, Mohamed Hebbar, David Malka, Thierry Debaere, Laurent Hannoun, Emmanuelle Magherini, Dominique Mignard, Thierry Poynard, Michel Ducreux

    Résultats de recherche: Contribution à un journalArticleRevue par des pairs

    62 Citations (Scopus)

    Résumé

    This study assessed the clinical activity and safety of irinotecan (CPT-11) in patients with advanced hepatocellular carcinoma (HCC) using dose adjustment according to baseline serum bilirubin level. Patients with advanced HCC received CPT-11 at a dose of 350 mg/m2 when total bilirubin level was ≤1.5 times upper limit of normal (ULN) (group A), or 200 mg/m2 when total bilirubin level was between 1.51 and 3 ULN (group B). No objective response, one minor response and 12 disease stabilizations were observed in the 29 patients (group A, 23; group B, 6) enrolled. Median time to progression and overall survival were 3.1 months (95% confidence interval [CI]: 2.0-4.0) and 7.4 months (95% CI: 3.9-12.0), respectively. Grade 3-4 adverse events (mostly neutropenia [47%], anaemia [24%], and diarrhoea [17%]) were more frequent in group A (74%) than in group B (33%) (P = 0.086). This study found favourable toxicity profile using dosage adjustment to the baseline total bilirubin level in patients with bilirubin level comprised between 1.51 and 3 ULN. However, the antitumour activity of single agent CPT-11 was not significant in advanced HCC.

    langue originaleAnglais
    Pages (de - à)456-459
    Nombre de pages4
    journalEuropean Journal of Cancer
    Volume42
    Numéro de publication4
    Les DOIs
    étatPublié - 1 mars 2006

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