Background: The efficacy of immunotherapies in soft-tissue sarcomas (STSs) is limited, and biomarkers of response are lacking. The lung immune prognostic index (LIPI) is a prognostic biomarker used with immunotherapy across cancer types. This study investigates the association of LIPI with the disease control rate (DCR) and progression-free survival (PFS) in patients with STS treated with immunotherapy versus other therapies in early-phase trials. Methods: This post hoc analysis was conducted with patients with STS from Gustave Roussy and Centre Léon Bérard between January 2012 and June 2021. The LIPI was calculated based on a derived neutrophil-to-lymphocyte ratio > 3 and elevated lactate dehydrogenase. Patients were categorized based on treatment (immunotherapy or other) and LIPI (good, intermediate, or poor). DCR was defined as the sum of stable disease and complete and partial response. Results: A total of 82 patients were enrolled in immunotherapy trials and 126 in the other therapy trials. In the immunotherapy group, DCR was higher in patients with good LIPI (76%;n= 23/30) compared with the intermediate (50%;n= 13/26) and poor LIPI groups (8%;n= 1/12;p< 0.001). The other-therapy group did not show significant differences in DCR by LIPI: DCR was 70% (n= 48/69), 70% (n= 21/30), and 60% (n= 6/10) in patients with good, intermediate, and poor LIPI, respectively (p= 0.86). In multivariate analyses, LIPI was independently associated with PFS in the immunotherapy group (hazard ratio = 5.97,p= 0.0001) and not in the control group (p= 0.71). Conclusions: LIPI is a significant independent prognostic marker for DCR in patients with STS treated with immunotherapy. In early-phase trials, LIPI could be used as a screening tool for stratification at inclusion. High neutrophil levels, which correlate with a poorer LIPI score, are likely associated with immunotherapy resistance. This relationship could explain the statistical impact of poor LIPI in the immunotherapy group.
背景：免疫疗法在软组织肉瘤（STS）中的疗效有限，且缺乏有效的疗效预测生物标志物。肺免疫预后指数（LIPI）是一种在多种癌症免疫治疗中应用的预后生物标志物。本研究旨在探讨早期临床试验中，接受免疫疗法与其他疗法的STS患者的LIPI与疾病控制率（DCR）及无进展生存期（PFS）之间的关联。 方法：本研究对2012年1月至2021年6月期间在古斯塔夫·鲁西研究所和莱昂·贝拉尔中心收治的STS患者进行事后分析。LIPI的计算基于衍生中性粒细胞与淋巴细胞比值>3以及乳酸脱氢酶升高。根据治疗方案（免疫疗法或其他疗法）和LIPI评分（良好、中等或不良）对患者进行分类。DCR定义为疾病稳定、完全缓解和部分缓解的总和。 结果：共有82名患者参与了免疫疗法试验，126名患者参与了其他疗法试验。在免疫治疗组中，LIPI良好患者的DCR（76%；n=23/30）高于LIPI中等（50%；n=13/26）和不良组（8%；n=1/12；p<0.001）。其他疗法组中，不同LIPI分组的DCR无显著差异：LIPI良好、中等和不良患者的DCR分别为70%（n=48/69）、70%（n=21/30）和60%（n=6/10）（p=0.86）。多变量分析显示，LIPI与免疫治疗组的PFS独立相关（风险比=5.97，p=0.0001），而在对照组中无此关联（p=0.71）。 结论：LIPI是接受免疫治疗的STS患者DCR的重要独立预后标志物。在早期临床试验中，LIPI可作为入组分层的筛选工具。中性粒细胞水平升高与较差的LIPI评分相关，可能预示着免疫治疗耐药性，这可以解释不良LIPI在免疫治疗组中产生的统计学影响。
肿瘤(癌症)患者之家