Development and validation of a new tool to estimate early mortality in patients with advanced cancer treated with immunotherapy.
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De Giglio Andrea, Leonetti Alessandro, Comito Francesca, Filippini Daria Maria, Mollica Veronica, Rihawi Karim, Peroni Marianna, Mazzaschi Giulia, Ricciotti Ilaria, Carosi Francesca, Marchetti Andrea, Rosellini Matteo, Gagliano Ambrogio, Favorito Valentina, Nobili Elisabetta, Gelsomino Francesco, Melotti Barbara, Marchese Paola Valeria, Sperandi Francesca, Di Federico Alessandro, Buti Sebastiano, Perrone Fabiana, Massari Francesco, Pantaleo Maria Abbondanza, Tiseo Marcello, Ardizzoni Andrea
Аннотация
METHODS: We performed a retrospective, observational study including patients affected by advanced solid tumors, treated with ICI as single agent or combined with other agents. Logistic regression models identified factors associated with EM and 90-day progression risks. A nomogram for predicting 90-day mortality was built and validated within an external cohort.
RESULTS: In total, 637 patients received ICIs (single agent or in combination with other drugs) for advanced solid tumors. Most patients were male (61.9%), with NSCLC as the prevalent tumor (61.8%). Within the cohort, 21.3% died within 90 days, 8.4% died within 30 days, and 34.5% experienced early progression. Factors independently associated with 90-day mortality included ECOG PS 2 and a high/intermediate LIPI score. For 30-day mortality, lung metastasis and a high/intermediate LIPI score were independent risk factors. Regarding early progression, high/intermediate LIPI score was independently associated. A predictive nomogram for 90-day mortality combining LIPI and ECOG PS achieved an AUC of 0.76 (95% CI 0.71-0.81). The discrimination ability of the nomogram was confirmed in the external validation cohort (n = 255) (AUC 0.72, 95% CI 0.64-0.80).
CONCLUSION: LIPI and ECOG PS independently were able to estimate 90-day mortality, with LIPI also demonstrating prognostic validity for 30-day mortality and early progression.