Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine,European Journal of Nuclear Medicine and Molecular Imaging

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Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine
European Journal of Nuclear Medicine and Molecular Imaging ( IF 8.6 ) Pub Date : 2024-08-12 , DOI: 10.1007/s00259-024-06853-0
Solfrid Thunold , Eivor Hernes , Saima Farooqi , Åsa Kristina Öjlert , Roslyn J. Francis , Anna K. Nowak , Weronika Maria Szejniuk , Søren Steen Nielsen , Susana Cedres , Marc Simo Perdigo , Jens Benn Sørensen , Carin Meltzer , Lars Tore Gyland Mikalsen , Åslaug Helland , Eirik Malinen , Vilde Drageset Haakensen

Purpose

The introduction of immunotherapy in pleural mesothelioma (PM) has highlighted the need for effective outcome predictors. This study explores the role of [18F]FDG PET/CT in predicting outcomes in PM treated with immunotherapy.

Methods

Patients from the NIPU trial, receiving ipilimumab and nivolumab +/- telomerase vaccine in second-line, were included. [18F]FDG PET/CT was obtained at baseline (n = 100) and at week-5 (n = 76). Metabolic tumour volume (MTV) and peak standardised uptake value (SUV_peak) were evaluated in relation to survival outcomes. Wilcoxon rank-sum test was used to assess differences in MTV, total lesion glycolysis (TLG), maximum standardised uptake value (SUV_max) and SUV_peak between patients exhibiting an objective response, defined as either partial response or complete response according to the modified Response Criteria in Solid Tumours (mRECIST) and immune RECIST (iRECIST), and non-responders, defined as either stable disease or progressive disease as their best overall response.

Results

Univariate Cox regression revealed significant associations of MTV with OS (HR 1.36, CI: 1.14, 1.62, p < 0.001) and PFS (HR 1.18, CI: 1.03, 1.34, p = 0.02), while multivariate analysis showed a significant association with OS only (HR 1.35, CI: 1.09, 1.68, p = 0.007). While SUV_peak was not significantly associated with OS or PFS in univariate analyses, it was significantly associated with OS in multivariate analysis (HR 0.43, CI: 0.23, 0.80, p = 0.008). Objective responders had significant reductions in TLG, SUV_max and SUV_peak at week-5.

Conclusion

MTV provides prognostic value in PM treated with immunotherapy. High SUV_peak was not associated with inferior outcomes, which could be attributed to the distinct mechanisms of immunotherapy. Early reductions in PET metrics correlated with treatment response.

Study registration

The NIPU trial (NCT04300244) is registered at clinicaltrials.gov. https://classic.clinicaltrials.gov/ct2/show/NCT04300244?cond=Pleural+Mesothelioma&cntry=NO&draw=2&rank=4

中文翻译：

基于 [18F]FDG PET/CT 对接受伊匹单抗和纳武单抗 +/- UV1 端粒酶疫苗治疗的胸膜间皮瘤患者的结果预测

目的

胸膜间皮瘤 (PM) 免疫疗法的引入凸显了对有效结果预测因子的需求。本研究探讨 [18F]FDG PET/CT 在预测免疫治疗 PM 治疗结果中的作用。

方法

NIPU 试验中接受二线 ipilimumab 和 nivolumab +/- 端粒酶疫苗治疗的患者均被纳入其中。 [18F]FDG PET/CT 是在基线 (n = 100) 和第 5 周 (n = 76) 时获得的。评估代谢肿瘤体积（MTV）和标准化摄取峰值（SUV_峰值）与生存结果的关系。 Wilcoxon 秩和检验用于评估表现出客观缓解的患者之间 MTV、总病变糖酵解 (TLG)、最大标准化摄取值 (SUV _max ) 和 SUV_峰值的差异，根据修改后的客观缓解定义为部分缓解或完全缓解实体瘤 (mRECIST) 和免疫 RECIST (iRECIST) 的缓解标准以及无应答者，将疾病稳定或疾病进展定义为其最佳总体缓解。

结果

单变量 Cox 回归显示 MTV 与 OS（HR 1.36，CI：1.14、1.62，p < 0.001）和 PFS（HR 1.18，CI：1.03、1.34，p = 0.02）显着相关，而多变量分析显示与 OS 显着相关仅（HR 1.35，CI：1.09、1.68，p = 0.007）。虽然在单变量分析中 SUV_峰值与 OS 或 PFS 不显着相关，但在多变量分析中它与 OS 显着相关（HR 0.43，CI：0.23、0.80，p = 0.008）。客观反应者在第 5 周的 TLG、SUV _max和 SUV _Peak显着降低。