Ipilimumab Prognostic Score in Progressive Metastatic Melanoma Patients. A Retrospective Analysis on Behalf of Italian Melanoma Intergroup Volume 4 - Issue 2

Marconcini Riccardo¹, Nuzzo Amedeo¹, Manacorda Simona¹, De Rosa Francesco², Palla Marco³, Fava Paolo⁴, Astrua Chiara⁴, Di Guardo Lorenza Alessia⁵, Raimondi Alessandra⁵, Tucci Marco⁶, Todisco Annalisa⁶, Cortellini Alessio⁷, Bersanelli Melissa⁸, Nigro Olga⁹, Stucci Luigia Stefania⁶, Crucitta Stefania¹⁰, Palmieri Giuseppe1¹, Falcone Alfredo¹

• ¹Medical Oncology Unit, Azienda Ospedaliero Universitaria Pisana, University of Pisa, Pisa (Italy)
• ²Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) – IRCCS – Meldola (Italy)
• ³Melanoma Unit, Cancer Immunotherapy and Innovative Therapies, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy
• ⁴SC Dermatologia U. AOU Città della salute e della Scienza, Torino (Italy)
• ⁵S.S. Oncologia Medica Melanomi, Dipartimento Oncologia Medica ed Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano (Italy)
• ⁶Medical Oncology Unit, Department of Biomedical Sciences and Clinical Oncology, University of Bari, (Italy)
• ⁷Department of Biotechnology and Applied Clinical Sciences, University of L’Aquila, L’Aquila, Italy
• ⁸Unità Operativa di Oncologia Medica, Azienda Ospedaliero-Universitaria di Parma
• ⁹U.O. Oncologia Medica, ASST-Settelaghi, Ospedale di Circolo di Varese, Varese (Italy)
• ¹⁰Department of Clinical and experimental Medicine- University of Pisa (italy)
• ¹¹Unit of Cancer Genetics, Head Institute of Biomolecular Chemistry (ICB) National Research Council (CNR) Sassari, Italy

Received: March 8, 2021   Published: March 26, 2021

Corresponding author: Riccardo Marconcini, Medical oncologist Azienda ospedaliero universitaria Pisana, Pisa-Unità Operativa Oncologia Medica 2 universitaria, Roma 67, 56100 Pisa Italy

DOI: 10.32474/OAJOM.2021.04.000187

 

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Abstract

Background: Ipilimumab is an option in Metastatic Melanoma patients in case of disease progression after antiPD1 treatment and BRAF+MEK inhibitors administration (for BRAF mutated melanoma). We evaluate the prognostic role of some relevant clinical or laboratories parameters for Ipilimumab used in late line after AntiPD1 progression to define patients that benefit most from Ipilimumab monotherapy in this setting.

Methods: A retrospective multicenter study was conducted in 8 Italian Oncology Centers, evaluating metastatic melanoma patients treated with Ipilimumab after AntiPD1 and/or BRAF plus Mek inhibitors progression. Endpoints were overall survival (OS) and Progression free survival (PFS), Kaplan Mayer and Cox regression were applied for survival analysis.

Results: Among patients that received AntiPD1 and-or Bramber inhibitors, 54 were treated with Ipilimumab monotherapy in 2nd/3rd line. Before Ipilimumab treatment, Number of metastatic sites were equal or less than 3 in 22 (40,7%) patients, ECOG Performance status was 0 in 32 (59%) patients, baseline LDH levels were within normal range in 25 (46,3%) patients, NLR (neutrophile/lymphocyte ratio) was equal or less than 0.7 in 33 (59%) patients. In Univariate analysis, ECOG PS 0 and NLR<0.7 resulted statistically significant good prognostic. In multivariate analysis for PFS, only NLR maintained statistically significance, while in multivariate analysis for OS both ECOG PS and NLR maintained a statistical significance. A score was counted for each patient considering the sum of number of negative factors associated with OS worse prognosis (ECOG PS>0, NLR more than 0.7). For patients with SCORE 0,1,2 median OS was respectively 11.4, 7.87 and 2.77 (p value<0.0001).

Conclusions: ECOG PS 0 and NLR<0.7 resulted prognostic factors associated with favorable OS of metastatic melanoma patients treated with Ipilimumab after AntiPD1 progression. Subgroup with all these factors has a better prognosis. These data can help treatment choice and should be evaluated prospectively.

Keywords: Metastatic Melanoma; Ipilimumab; prognostic score; anti-PD1; NLR ratio; immunotherapy

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