409P - CARAMEL study: ClinicAl prognostic biomarkers for Ipilimumab-Related outcome in metastatic MELanoma patients
|Date||18 December 2016|
|Event||ESMO Asia 2016 Congress|
|Topics|| Cancer Immunology and Immunotherapy
Melanoma and other Skin Tumours
|Citation||Annals of Oncology (2016) 27 (suppl_9): ix126-ix129. 10.1093/annonc/mdw589|
L. Orgiano1, F. Bruder2, C. Madeddu1, R. Marconcini3, E. Gambale4, E. Galizia5, S. Stucci6, F. Spagnolo7, L. Di Guardo8, C. Loi2, A. Dessi'1, E. Massa1, D. Massa2, G. Astara1, M. Del Vecchio8, F. Silvestris6, M. De Tursi4, A. Falcone3, P. Queirolo7, M. Scartozzi1
Ipilimumab is an inhibitor of CTLA4 receptor of T lymphocytes approved by the FDA both as first and second line treatment for patients suffering from metastatic melanoma. Despite its efficacy in about 20% of patients, it still remains a therapy with a considerable outlay, mostly from its safety profile: the aim of our study was to find prognostic biomarkers among hematological parameters normally used in clinical practice.
This is an observational retrospective multicentric study which enrolled 120 patients with hystologically confirmed metastatic melanoma treated with Ipilimumab between January 2013 and January 2016 (mean age 62.2±14.58). Full blood count with absolute WBC (aWBC), neutrophil count, platelets count, neutrophil/lymphocyte ratio (NLR), platelets/lymphocyte ratio (PLR) and LDH serum levels were assessed at baseline and every 3 weeks during treatment. We also evaluated the age (younger/older than 65 years), gender (male/female), mutational BRAF status and the number of metastatic sites involved before treatment (more or less than 3 sites). The cut-off values for our parameters were determined with time-dependent receiver operating characteristic (ROC) analysis. To identify prognostic biomarkers the above parameters have been correlated with Progression Free Survival (PFS) and Overall Survival (OS).
After a median follow up of 21 months, median PFS was 4.5 months and median OS was 17months. Patients with lower serum LDH levels at baseline had significantly longer PFS (p = 0.018) and OS (p
Through an external validation cohort (work in progress), we want to see if the parameters that we have identified allow us to stratify our patients before strarting therapy, according to their clinical and hematological features.
Clinical trial indentification
Legal entity responsible for the study
Mario Scartozzi, Prof. University of Cagliari
All authors have declared no conflicts of interest.