一种用于评估接受免疫治疗的晚期癌症患者早期死亡率的新工具的开发与验证。
Development and validation of a new tool to estimate early mortality in patients with advanced cancer treated with immunotherapy.
作者信息
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
机构信息
Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Via Massarenti, 9, 40138, Bologna, Italy.
Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Bologna, Italy.
出版信息
Cancer Immunol Immunother. 2024 Oct 3;73(12):246. doi: 10.1007/s00262-024-03836-w.
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.
背景
免疫检查点抑制剂（ICI）是晚期实体癌的标准治疗方法。对ICI的原发性和继发性耐药均带来挑战，30 - 90天内的早期死亡率（EM）表明未获得益处。包括肺免疫预后指数（LIPI）在内的EM预后因素仍未得到充分研究。
方法
我们进行了一项回顾性观察研究，纳入接受ICI单药治疗或与其他药物联合治疗的晚期实体瘤患者。逻辑回归模型确定了与EM和90天进展风险相关的因素。构建了一个预测90天死亡率的列线图，并在外部队列中进行验证。
结果
共有637例患者接受ICI（单药或与其他药物联合）治疗晚期实体瘤。大多数患者为男性（61.9%），最常见的肿瘤是NSCLC（61.8%）。在该队列中，21.3%的患者在90天内死亡，8.4%在30天内死亡，34.5%出现早期进展。与90天死亡率独立相关的因素包括东部肿瘤协作组（ECOG）体能状态评分为2分以及LIPI评分高/中等。对于30天死亡率，肺转移和LIPI评分高/中等是独立危险因素。关于早期进展，LIPI评分高/中等与之独立相关。结合LIPI和ECOG PS的90天死亡率预测列线图的曲线下面积（AUC）为0.76（95%置信区间[CI] 0.71 - 0.81）。列线图的判别能力在外部验证队列（n = 255）中得到证实（AUC 0.72，95% CI 0.64 - 0.80）。
结论
LIPI和ECOG PS能够独立估计90天死亡率，LIPI对30天死亡率和早期进展也具有预后有效性。
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