S Valpione1, C Martinoli2, P Fava3, S Mocellin4, L G Campana5, P Quaglino3, P F Ferrucci2, J Pigozzo6, C Astrua3, A Testori2, V Chiarion-Sileni6. 1. Melanoma and Esophageal Oncology Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. Electronic address: sara.valpione@ioveneto.it. 2. Medical Oncology of Melanoma, European Institute of Oncology, Milan, Italy. 3. Department of Medical Sciences, Dermatologic Clinic, University of Torino, Torino, Italy. 4. Department of Oncology, Surgery and Gastroenterology, University of Padova, Padua, Italy. 5. Melanoma and Sarcoma Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. 6. Melanoma and Esophageal Oncology Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.
Abstract
PURPOSE: The purpose of this study was to set up a prognostic model for the identification of survival predictors specific for melanoma patients treated with ipilimumab. EXPERIMENTAL DESIGN: The following prospectively collected data were utilised: patient and primary tumour characteristics, relapse-free-interval, site and number of metastases, previous therapies and level of serum biomarkers (lactic dehydrogenase (LDH), C-reactive protein, β2-microglobulin, vascular endothelial growth factor (VEGF), IL2, IL6, S-100, alkaline phosphatase (ALP), transaminases, leucocyte count, lymphocytes subpopulations). A multivariate prognostic model was developed using the Cox regression model fitted to the data of 113 consecutive metastatic patients treated with ipilimumab (3 mg/kg, q3w) at Veneto Institute of Oncology (IOV). External validation was obtained using the data of 69 and 34 patients treated at European Oncology Institute (IEO) and University of Torino (UT), respectively. RESULTS: Median survival was 8.3, 4.9 and 7.1 months from first ipilimumab administration at IOV, IEO and UT, respectively. Both higher baseline levels of LDH (Hazard Ratio [HR] v=1.36, 95% Confidence Interval [CI] 1.16-1.58, P<.001) and neutrophils (HR=1.76, 95% CI 1.41-2.10, P<.001) were associated with worse prognosis. Model performance was satisfactory both upon internal validation (Dxy=0.42) and external validation (Dxy=0.40). Serum LDH and neutrophil count discriminated patients who lived more (low neutrophils and low LDH) or less (high LDH or neutrophils) than 24 months. CONCLUSION: Serum LDH and neutrophil count were significant independent prognostic factors. This externally validated prognostic nomogram, could help clinicians to identify the patients who would benefit most from ipilimumab and consequently to improve resource allocation. These easily available biomarkers deserve further validation.
PURPOSE: The purpose of this study was to set up a prognostic model for the identification of survival predictors specific for melanomapatients treated with ipilimumab. EXPERIMENTAL DESIGN: The following prospectively collected data were utilised: patient and primary tumour characteristics, relapse-free-interval, site and number of metastases, previous therapies and level of serum biomarkers (lactic dehydrogenase (LDH), C-reactive protein, β2-microglobulin, vascular endothelial growth factor (VEGF), IL2, IL6, S-100, alkaline phosphatase (ALP), transaminases, leucocyte count, lymphocytes subpopulations). A multivariate prognostic model was developed using the Cox regression model fitted to the data of 113 consecutive metastatic patients treated with ipilimumab (3 mg/kg, q3w) at Veneto Institute of Oncology (IOV). External validation was obtained using the data of 69 and 34 patients treated at European Oncology Institute (IEO) and University of Torino (UT), respectively. RESULTS: Median survival was 8.3, 4.9 and 7.1 months from first ipilimumab administration at IOV, IEO and UT, respectively. Both higher baseline levels of LDH (Hazard Ratio [HR] v=1.36, 95% Confidence Interval [CI] 1.16-1.58, P<.001) and neutrophils (HR=1.76, 95% CI 1.41-2.10, P<.001) were associated with worse prognosis. Model performance was satisfactory both upon internal validation (Dxy=0.42) and external validation (Dxy=0.40). Serum LDH and neutrophil count discriminated patients who lived more (low neutrophils and low LDH) or less (high LDH or neutrophils) than 24 months. CONCLUSION: Serum LDH and neutrophil count were significant independent prognostic factors. This externally validated prognostic nomogram, could help clinicians to identify the patients who would benefit most from ipilimumab and consequently to improve resource allocation. These easily available biomarkers deserve further validation.
Authors: Alexander Martens; Kilian Wistuba-Hamprecht; Marnix Geukes Foppen; Jianda Yuan; Michael A Postow; Phillip Wong; Emanuela Romano; Amir Khammari; Brigitte Dreno; Mariaelena Capone; Paolo A Ascierto; Anna Maria Di Giacomo; Michele Maio; Bastian Schilling; Antje Sucker; Dirk Schadendorf; Jessica C Hassel; Thomas K Eigentler; Peter Martus; Jedd D Wolchok; Christian Blank; Graham Pawelec; Claus Garbe; Benjamin Weide Journal: Clin Cancer Res Date: 2016-01-19 Impact factor: 12.531
Authors: Leila Khoja; Eshetu G Atenafu; Arnoud Templeton; Ye Qye; Mary Anne Chappell; Sam Saibil; David Hogg; Marcus O Butler; Anthony M Joshua Journal: Cancer Med Date: 2016-09-29 Impact factor: 4.452