Τίτλος:
Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172)
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background: Limited data are available on nivolumab in challenging subgroups with advanced melanoma. We report outcomes of nivolumab after prior ipilimumab in patients who are typically excluded from clinical trials. Patients and methods: In this phase II, single-arm, open-label, multicentre study (CheckMate 172), patients with advanced melanoma who progressed on or after ipilimumab received nivolumab 3 mg/kg, every 2 weeks for up to 2 years. The primary objective was incidence of grade ≥3, treatment-related select adverse events (AEs). Results: At a minimum follow-up of 18 months, grade ≥3 treatment-related select AEs with the most variation across subgroups were diarrhoea and colitis (1.1% [n = 11] and 0.3% [n = 3] for the total population [n = 1008]; 0.6% [n = 1] and 0.6% [n = 1] for patients with an asymptomatic central nervous system [CNS] metastasis [n = 165; 16.4%]; 4.5% [n = 3] and 3.0% [n = 2] for patients with an Eastern Cooperative Oncology Group performance status [ECOG PS] of 2 [n = 66; 6.5%]; 2.4% [n = 2] and 0% for those who experienced a grade 3/4 immune-related AE [irAE] with prior ipilimumab [n = 84; 8.3%]; and 0% and 0% for autoimmune disease [n = 25; 2.5%], respectively). Median overall survival was 21.4 months in the total population and was 11.6, 2.4, 21.5, and 18.6 months in patients with a CNS metastasis, ECOG PS 2, a grade 3/4 irAE with prior ipilimumab, and autoimmune disease, respectively. Conclusions: In this large, phase II clinical trial of patients with advanced melanoma who progressed on or after ipilimumab, nivolumab demonstrated a safety profile consistent with that of prior clinical trials. ClinicalTrials.gov ID: NCT02156804. © 2019 Elsevier Ltd
Συγγραφείς:
Schadendorf, D.
Ascierto, P.A.
Haanen, J.
Espinosa, E.
Demidov, L.
Garbe, C.
Guida, M.
Lorigan, P.
Chiarion-Sileni, V.
Gogas, H.
Maio, M.
Fierro, M.T.
Hoeller, C.
Terheyden, P.
Gutzmer, R.
Guren, T.K.
Bafaloukos, D.
Rutkowski, P.
Plummer, R.
Waterston, A.
Kaatz, M.
Mandala, M.
Marquez-Rodas, I.
Muñoz-Couselo, E.
Dummer, R.
Grigoryeva, E.
Young, T.C.
Nathan, P.
Περιοδικό:
EUROPEAN JOURNAL OF CANCER
Εκδότης:
Elsevier Ireland Ltd
Λέξεις-κλειδιά:
ipilimumab; nivolumab; antineoplastic agent; ipilimumab; nivolumab, advanced cancer; aged; Article; autoimmune disease; central nervous system metastasis; colitis; diarrhea; disease exacerbation; drug efficacy; drug safety; female; follow up; human; major clinical study; male; melanoma; multicenter study; overall survival; phase 2 clinical trial; priority journal; unspecified side effect; adult; cancer staging; clinical trial; disease exacerbation; drug effect; drug resistance; melanoma; middle aged; mortality; pathology; skin tumor; survival analysis; treatment outcome; very elderly; young adult, Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Disease Progression; Drug Resistance, Neoplasm; Female; Follow-Up Studies; Humans; Ipilimumab; Male; Melanoma; Middle Aged; Neoplasm Staging; Nivolumab; Skin Neoplasms; Survival Analysis; Treatment Outcome; Young Adult
DOI:
10.1016/j.ejca.2019.08.014
