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Immunotherapy in advanced Non-Small Cell Lung Cancer patients with poor performance status: The role of clinical-pathological variables and inflammatory biomarkers

医学 内科学 肺癌 危险系数 免疫疗法 性能状态 比例危险模型 病态的 单变量分析 肿瘤科 多元分析 胃肠病学 临床试验 癌症 置信区间
作者
Riccardo Lobefaro,Giuseppe Viscardi,Raimondo Di Liello,Giacomo Massa,Maria Lucia Iacovino,Francesca Sparano,Carminia Maria Della Corte,Roberto Ferrara,Diego Signorelli,Claudia Proto,Arsela Prelaj,Giulia Galli,Alessandro De Toma,Marta Brambilla,Monica Ganzinelli,Benedetta Trevisan,Fortunato Ciardiello,Filippo de Braud,Marina Chiara Garassino,Giuseppe Lo Russo
出处
期刊:Lung Cancer [Elsevier BV]
卷期号:152: 165-173 被引量:24
标识
DOI:10.1016/j.lungcan.2020.12.027
摘要

Background The introduction of immunotherapy has improved the prognosis of patients with Non-Small Cell Lung Cancer (NSCLC). However, data in poor ECOG Performance Status (PS) patients remain scant due to their exclusion from randomized trials. Material and methods We analyzed data of patients with advanced NSCLC treated with immunotherapy in two Italian Centers, to evaluate the impact of PS (0-1 vs 2) on disease control rate (DCR), progression free survival (PFS) and overall survival (OS). Chi-square test was used to compare clinical-pathological variables, their impact on survival was evaluated through Cox proportional hazard models. Results Among 404 patients included, PS was 0 in 137 (33.9 %), 1 in 208 (51.5 %) and 2 in 59 (14.6 %) patients; 143 were female and 90 had squamous NSCLC. Clinical-pathological variables were uniformly distributed except for higher prevalence of liver metastases in patients with poor PS. We found that PS2 patients showed worse outcomes in terms of DCR (21.8 % vs 50.3 %, p = 0.001), PFS [2.0 (95 % CI 1.6–3.0) vs 3.0 (95 % CI 2.7–4.0) months, p < 0.0001] and OS [4.0 (95 % CI 2.8–5.7) vs 13.2 (95 % CI 11.0−15.8) months, p < 0.0001]. PS2 status, negative PDL1 expression and early corticosteroids exposure as well as higher Neutrophil to Lymphocyte Ratio and LDH at baseline were associated with worse outcomes at univariate and multivariable analysis. Subgroup analysis confirmed poor outcomes in PS2 patients with high LDH and concomitant corticosteroid therapies. The incidence of Grade 3/4 adverse events was 11.3 % in PS 0−1 and 10.2 % in PS 2 patients (p = 0.81). Conclusion Our data confirm reduced efficacy of immunotherapy in patients with poor PS even though a good safety. Despite PS remains the most powerful independent prognostic factor for NSCLC, LDH levels and steroids exposure could support the decision making in PS2 patients.
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