Τίτλος:
Safety and efficacy of nivolumab in patients with rare melanoma subtypes who progressed on or after ipilimumab treatment: a single-arm, open-label, phase II study (CheckMate 172)
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background: Nivolumab has been widely studied in non-acral cutaneous melanoma; however, limited data are available in other melanoma subtypes. We report outcomes by melanoma subtype in patients who received nivolumab after progression on prior ipilimumab. Patients and methods: CheckMate 172 was a phase II, single-arm, open-label, multicentre study that evaluated nivolumab in patients with advanced melanoma who progressed on or after ipilimumab. Patients received 3 mg/kg of nivolumab, every 2 weeks for up to 2 years. The primary end-point was incidence of grade ≥3, treatment-related select adverse events (AEs). Results: Among 1008 treated patients, we report data on patients with non-acral cutaneous melanoma (n = 723 [71.7%]), ocular melanoma (n = 103 [10.2%]), mucosal melanoma (n = 63 [6.3%]), acral cutaneous melanoma (n = 55 [5.5%]) and other melanoma subtypes (n = 64 [6.3%]). There were no meaningful differences in the incidence of grade ≥3, treatment-related select AEs among melanoma subtypes or compared with the total population. No new safety signals emerged. At a minimum follow-up of 18 months, median overall survival was 25.3 months for non-acral cutaneous melanoma and 25.8 months for acral cutaneous melanoma, with 18-month overall survival rates of 57.5% and 59.0%, respectively. Median overall survival was 12.6 months for ocular melanoma and 11.5 months for mucosal melanoma, with 18-month overall survival rates of 34.8% and 31.5%, respectively. Conclusions: The safety profile of nivolumab after ipilimumab is similar across melanoma subtypes. Compared with non-acral cutaneous melanoma, patients with acral cutaneous melanoma had similar survival outcomes, whereas those with ocular and mucosal melanoma had lower median overall survival. ClinicalTrials.gov ID: : NCT02156804. © 2019 Elsevier Ltd
Συγγραφείς:
Nathan, P.
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.
Schadendorf, D.
Περιοδικό:
EUROPEAN JOURNAL OF CANCER
Εκδότης:
Elsevier Ireland Ltd
Λέξεις-κλειδιά:
ipilimumab; nivolumab; antineoplastic agent; ipilimumab; nivolumab, adult; aged; Article; cancer immunotherapy; cancer patient; cancer staging; comparative study; computer assisted tomography; cutaneous melanoma; disease duration; drug efficacy; drug safety; eye melanoma; female; follow up; human; immunosuppressive treatment; major clinical study; male; melanoma; mucosal melanoma; multicenter study; nuclear magnetic resonance imaging; outcome assessment; overall survival; phase 2 clinical trial; priority journal; response evaluation criteria in solid tumors; risk assessment; treatment duration; adolescent; clinical trial; diarrhea; disease exacerbation; drug administration; Kaplan Meier method; melanoma; middle aged; pathology; skin disease; skin tumor; treatment outcome; very elderly; young adult, Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Diarrhea; Disease Progression; Drug Administration Schedule; Female; Humans; Ipilimumab; Kaplan-Meier Estimate; Male; Melanoma; Middle Aged; Nivolumab; Skin Diseases; Skin Neoplasms; Treatment Outcome; Young Adult
DOI:
10.1016/j.ejca.2019.07.010
