Development and validation of a new tool to estimate early mortality in patients with advanced cancer treated with immunotherapy

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2024年10月3日

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Andrea De Giglio,
Alessandro Leonetti,
Francesca Comito,
Daria Maria Filippini,
Veronica Mollica,
Karim Rihawi,
Marianna Peroni,
Giulia Mazzaschi,
Ilaria Ricciotti,
Francesca Carosi,
Andrea Marchetti,
Matteo Rosellini,
Ambrogio Gagliano,
Valentina Favorito,
Elisabetta Nobili,
Francesco Gelsomino,
Barbara Melotti,
Paola Valeria Marchese,
Francesca Sperandi,
Alessandro Di Federico,
Sebastiano Buti,
Fabiana Perrone,
Francesco Massari,
Maria Abbondanza Pantaleo,
Marcello Tiseo,
Andrea Ardizzoni

摘要

Background

Immune checkpoint inhibitors (ICIs) are standard treatments for advanced solid cancers. Resistance to ICIs, both primary and secondary, poses challenges, with early mortality (EM) within 30–90 days indicating a lack of benefit. Prognostic factors for EM, including the lung immune prognostic index (LIPI), remain underexplored.

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.