Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial - Archive ouverte HAL
Article Dans Une Revue ESMO Open Année : 2020

Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial

Robinkate Kelley
  • Fonction : Auteur
Baek-Yeol Ryoo
  • Fonction : Auteur
Joong-Won Park
  • Fonction : Auteur
Luigi Bolondi
  • Fonction : Auteur
Stephen L Chan
  • Fonction : Auteur
Hoyeong Lim
  • Fonction : Auteur
Ari D Baron
  • Fonction : Auteur
Francis Parnis
  • Fonction : Auteur
Jennifer Knox
  • Fonction : Auteur
Stéphane Cattan
  • Fonction : Auteur
Thomas Yau
  • Fonction : Auteur
Julie C Lougheed
  • Fonction : Auteur
Steven Milwee
  • Fonction : Auteur
Anthony B El-Khoueiry
  • Fonction : Auteur
Ann-Lii Cheng
  • Fonction : Auteur
Tim Meyer
  • Fonction : Auteur
Ghassan K Abou-Alfa
  • Fonction : Auteur

Résumé

Objective In the phase 3 CELESTIAL trial, cabozantinib improved overall survival (OS) and progression-free survival (PFS) compared with placebo in patients with previously treated advanced hepatocellular carcinoma (HCC). This subgroup analysis evaluated cabozantinib in patients who had received sorafenib as the only prior systemic therapy. Methods CELESTIAL randomised (2:1) patients with advanced HCC and Child-Pugh class A liver function to treatment with cabozantinib (60 mg daily) or placebo. Eligibility required prior treatment with sorafenib, and patients could have received ≤2 prior systemic regimens. The primary endpoint was OS. Outcomes in patients who had received sorafenib as the only prior therapy were analysed by duration of prior sorafenib (<3 months, 3 to <6 months and ≥6 months). Results Of patients who had received only prior sorafenib, 331 were randomised to cabozantinib and 164 to placebo; 136 patients had received sorafenib for <3 months, 141 for 3 to <6 months and 217 for ≥6 months. Cabozantinib improved OS relative to placebo in the overall secondline population who had received only prior sorafenib (median 11.3 vs 7.2 months; HR=0.70, 95% CI 0.55 to 0.88). This improvement was maintained in analyses by prior sorafenib duration with longer duration generally corresponding to longer median OS-median OS 8.9 vs 6.9 months (HR=0.72, 95% CI 0.47 to 1.10) for prior sorafenib <3 months, 11.5 vs 6.5 months (HR=0.65, 95% CI 0.43 to 1.00) for 3 to <6 months and 12.3 vs 9.2 months (HR=0.82, 95% CI 0.58 to 1.16) for ≥6 months. Cabozantinib also improved PFS in all duration subgroups. Safety data were consistent with the overall study population. Conclusion Cabozantinib improved efficacy outcomes versus placebo in the second-line population who had received only prior sorafenib irrespective of duration of prior sorafenib treatment, further supporting the utility of cabozantinib in the evolving treatment landscape of HCC. Clinical trial number NCT01908426.

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Cancer
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Dates et versions

hal-04160520 , version 1 (12-07-2023)

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Robinkate Kelley, Baek-Yeol Ryoo, Philippe Merle, Joong-Won Park, Luigi Bolondi, et al.. Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial. ESMO Open, 2020, 5, ⟨10.1136/esmoopen-2020-000714⟩. ⟨hal-04160520⟩

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