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.
Ipilimumab prognostic score in progressive metastatic melanoma patients. A retrospective analysis on behalf on Italian Melanoma Intergroup. with anti-PD1 in first line, based on baseline clinical factors: an Italian Melanoma Intergroup Study.
Tucci M;Todisco A;
2021-01-01
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
