Cristin-resultat-ID: 1890694
Sist endret: 17. februar 2021, 09:36
NVI-rapporteringsår: 2020
Resultat
Vitenskapelig artikkel
2020

Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma

Bidragsytere:
  • Paolo Antonio Ascierto
  • Michele Del Vecchio
  • Andrzej Mackiewicz
  • Caroline Robert
  • Vanna Chiarion-Sileni
  • Ana Arance
  • mfl.

Tidsskrift

Journal for ImmunoTherapy of Cancer (JITC)
e-ISSN 2051-1426
NVI-nivå 2

Om resultatet

Vitenskapelig artikkel
Publiseringsår: 2020
Volum: 8
Hefte: 1
Open Access

Importkilder

Scopus-ID: 2-s2.0-85086051365

Beskrivelse Beskrivelse

Tittel

Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma

Sammendrag

Abstract Background We have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety. Methods This randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS. Results At a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 months (95% CI 9.9 to 13.3) at 3 mg/kg (HR 0.84, 95% CI 0.71 to 0.99; p=0.04). In a subgroup analysis, median OS of patients with asymptomatic brain metastasis was 7.0 months (95% CI 4.0 to 12.8) in the 10 mg/kg group and 5.7 months (95% CI 4.2 to 7.0) in the 3 mg/kg group. In patients with wild-type or mutant BRAF tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively. The incidence of grade 3/4 treatment-related AEs was 36% in the 10 mg/kg group vs 20% in the 3 mg/kg group, and deaths due to treatment-related AEs occurred in four (1%) and two patients (1%), respectively. Conclusions This 61-month follow-up of a phase III trial showed sustained long-term survival in patients with advanced melanoma who started metastatic treatment with ipilimumab monotherapy, and confirmed the significant benefit for those who received ipilimumab 10 mg/kg vs 3 mg/kg. These results suggest the emergence of a plateau in the OS curve, consistent with previous ipilimumab studies.

Bidragsytere

Paolo Antonio Ascierto

  • Tilknyttet:
    Forfatter
    ved Fondaziona IRCCS Istituto Nazionale dei Tumori

Michele Del Vecchio

  • Tilknyttet:
    Forfatter
    ved Fondaziona IRCCS Istituto Nazionale dei Tumori

Andrzej Mackiewicz

  • Tilknyttet:
    Forfatter
    ved Uniwersytet im. Adama Mickiewicza w Poznaniu

Caroline Robert

  • Tilknyttet:
    Forfatter
    ved Institut Gustave-Roussy

Vanna Chiarion-Sileni

  • Tilknyttet:
    Forfatter
    ved Italia
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