TY - JOUR
TI - 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)
AU - Nathan, P.
AU - Ascierto, P.A.
AU - Haanen, J.
AU - Espinosa, E.
AU - Demidov, L.
AU - Garbe, C.
AU - Guida, M.
AU - Lorigan, P.
AU - Chiarion-Sileni, V.
AU - Gogas, H.
AU - Maio, M.
AU - Fierro, M.T.
AU - Hoeller, C.
AU - Terheyden, P.
AU - Gutzmer, R.
AU - Guren, T.K.
AU - Bafaloukos, D.
AU - Rutkowski, P.
AU - Plummer, R.
AU - Waterston, A.
AU - Kaatz, M.
AU - Mandala, M.
AU - Marquez-Rodas, I.
AU - Muñoz-Couselo, E.
AU - Dummer, R.
AU - Grigoryeva, E.
AU - Young, T.C.
AU - Schadendorf, D.
JO - EUROPEAN JOURNAL OF CANCER
PY - 2019
VL - 119
TODO - null
SP - 168-178
PB - Elsevier Ireland Ltd
SN - null
TODO - 10.1016/j.ejca.2019.07.010
TODO - 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
TODO - 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
ER -