409P - CARAMEL study: ClinicAl prognostic biomarkers for Ipilimumab-Related outcome in metastatic MELanoma patients

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Cancer Immunology and Immunotherapy
Melanoma and other Skin Tumours
Presenter Laura Orgiano
Citation Annals of Oncology (2016) 27 (suppl_9): ix126-ix129. 10.1093/annonc/mdw589
Authors 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
  • 1Medical Sciences, Medical Oncology, Azienda Ospedaliero Universitaria di Cagliari, 9042 - Monserrato/IT
  • 2Medical Oncology, Ospedale Oncologico "A. Businco", 09100 - Cagliari/IT
  • 3U.o. Oncologia Medica 2 Universitaria, Azienda Ospedaliera Universitaria S.Chiara, 56100 - Pisa/IT
  • 4Oncologia Medica, P.O. Clinicizzato Ss. Annunziata Universita' Degli Studi, 66100 - Chieti/IT
  • 5Medical Oncology, Ospedale E. Profili U.O. Oncologia Medica, Fabriano/IT
  • 6Medical Oncology, Istituto Oncologico Bari, Bari/IT
  • 7Medical Oncology, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, Genova/IT
  • 8Oncologia Medica 1, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milano/IT



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.