Clinical Categorization Algorithm (Clical) and Machine-Learning Approach (Srf-clical) to Predict Clinical Benefit to Immunotherapy in Metastatic Melanoma Patients: Real-world Evidence from Istituto Nazionale Tumori Irccs Fondazione Pascale, Napoli, Italy.

Raw-data related to a manuscript submitted to "Cancers" journal - MDPI - https://www.mdpi.com/journal/cancers

Manuscript Title: Clinical Categorization Algorithm (Clical) and Machine-Learning Approach (Srf-clical) to Predict Clinical Benefit to Immunotherapy in Metastatic Melanoma Patients: Real-world Evidence from Istituto Nazionale Tumori Irccs Fondazione Pascale, Napoli, Italy.

Authors: Gabriele Madonna1,#, Giuseppe V. Masucci2,3,#, Mariaelena Capone1, Domenico Mallardo1, Antonio Maria Grimaldi1, Ester Simeone1, Vito Vanella1, Lucia Festino1, Marco Palla1, Luigi Scarpato1, Marilena Tuffanelli1, Grazia D’angelo1, Lisa Villabona2, Isabelle Krakowski2,4, Hanna Eriksson2,3, Felipe Simao5, Rolf Lewensohn2,3, Paolo Antonio Ascierto1,+

Affiliations:

1 Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale", Napoli, Italy

2 Theme Cancer, Karolinska University Hospital, Stockholm, Sweden

3 Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden

4 Theme Inflammation, Karolinska University Hospital Stockholm, Sweden

5 Genevia technologies OY, Tampere, Finland

# these authors equally contributed

+ Corresponding author

Abstract of submitted Manuscript: The real-life application of immune checkpoint inhibitors (ICI) may yield different outcomes compared to the benefit presented in clinical trials. For this reason, there is a need to define the group of patients that may benefit from treatment. We retrospectively investigated 578 metastatic melanoma patients treated with ICI at Istituto Nazionale Tumori IRCCS Fondazione “G. Pascale” of Napoli Italy (INT-NA). To compare patients’ clinical variables (age, Lactate Dehydrogenase (LDH), Neutrophil-Lymphocyte Ratio (NLR), eosinophil, BRAF status, previous treatment) and their predictive and prognostic power in a comprehensive non-hierarchical way, a Clinical Categorization Algorithm (CLICAL) was defined and validated by the application of machine learning, Survival Random Forest (SRF-CLICAL). The comprehensive analysis of the clinical parameters by log risk-based algorithms convened into predictive signatures that could identify groups of patients with great benefit or not, regardless of the ICI received. From a real-life retrospective analysis of metastatic melanoma patients, we generated and validated an algorithm based on machine learning that could assist with the clinical decision of whether or not to apply ICI therapy by defining five signatures of predictability with a 95% accuracy.

Funding: This research was funded by Italian Ministry of Health (IT-MOH) through “Ricerca Corrente”, grants number M2-2. Additional funding [N#184093) from the Stockholm Cancer Society and King Gustav V’s Jubilee foundation Stockholm.