| Autor: |
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. |
| Jazyk: |
angličtina |
| Rok vydání: |
2019 |
| Předmět: |
|
| Popis: |
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 |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
