Lenci Edoardo, Marcantognini Giulia, Cognigni Valeria, Lupi Alessio, Rinaldi Silvia, Cantini Luca, Fiordoliva Ilaria, Carloni Anna Lisa, Rocchi Marco, Zuccatosta Lina, Gasparini Stefano, Berardi Rossana
Clinical Oncology, Università Politecnica delle Marche, Azienda Ospedaliero-Universitaria Ospedali Riuniti, 60126 Ancona, Italy.
Department of Biomolecular Sciences, University of Urbino Carlo Bo, 61029 Urbino, Italy.
Explor Target Antitumor Ther. 2021;2(3):227-239. doi: 10.37349/etat.2021.00043. Epub 2021 Jun 28.
The role of tumor burden (TB) for patients with non-small cell lung cancer (NSCLC) receiving immunotherapy is still unknown. The aim of this analysis was to analyze the prognostic value of TB in a real-world sample of advanced NSCLC patients.
Sixty-five consecutive patients with advanced NSCLC treated with immunotherapy as first or second line therapy were retrospectively analyzed between August 2015 and February 2018. TB was recorded at baseline considering sites and number of metastases, thoracic . extrathoracic disease, measurable disease (MD) . not-MD (NMD) and evaluating dimensional aspects as maximum lesion diameter (cut-off = 6.3 cm), sum of the 5 major lesions diameters (cut-off = 14.3 cm), and number of sites of metastases (cut-off > 4). All cut-offs were calculated by receiver operating characteristic curves. Median overall survival (OS) was estimated using Kaplan-Meier method. A Cox regression model was carried out for univariate and multivariate analyses.
Median age was 70 years and most patients (86.2%) had a good performance status (PS-Eastern Cooperative Oncology Group < 2). No significant difference in OS was noted between subgroups of patients according to TB. Bone metastases (BM) had a negative prognostic impact [median OS (mOS), 13.8 . 70.0 months, = 0.0009; median progression free survival in the second line (mPFS2) 2.97 . 8.63 months; = 0.0037]. Patients with NMD had a poorer prognosis (mOS, 15.9 months . not reached, < 0.0001; mPFS2 3.8 . 12.2 months; = 0.0199). Patients with disease limited to the thorax had a better prognosis compared to patients with involvement of extrathoracic sites (mOS, 70 . 17.3 months; = 0.0136). Having more than 4 metastatic sites resulted as a negative prognostic factor (mOS, 15.9 . 25.2 months; = 0.0106). At multivariate analysis, BM, NMD, extrathoracic disease and number of sites of metastases > 4 were negative prognostic factors ( < 0.0001).
This study underlines the negative prognostic impact of specific metastatic sites, presence of NMD and extrathoracic disease in advanced NSCLC patients treated with immunotherapy. However, TB does not appear to affect the outcome of these patients.
肿瘤负荷（TB）在接受免疫治疗的非小细胞肺癌（NSCLC）患者中的作用尚不清楚。本分析的目的是分析TB在晚期NSCLC患者真实世界样本中的预后价值。
回顾性分析2015年8月至2018年2月期间连续65例接受免疫治疗作为一线或二线治疗的晚期NSCLC患者。在基线时记录TB，考虑转移部位和数量、胸部。胸外疾病、可测量疾病（MD）。非MD（NMD），并评估维度方面，如最大病变直径（临界值 = 6.3 cm）、5个主要病变直径之和（临界值 = 14.3 cm）以及转移部位数量（临界值 > 4）。所有临界值均通过受试者工作特征曲线计算得出。采用Kaplan-Meier方法估计中位总生存期（OS）。进行Cox回归模型的单因素和多因素分析。
中位年龄为70岁，大多数患者（86.2%）具有良好的体能状态（东部肿瘤协作组体能状态 < 2）。根据TB分组的患者亚组之间OS无显著差异。骨转移（BM）具有负面预后影响[中位OS（mOS），13.8。70.0个月，P = 0.0009；二线中位无进展生存期（mPFS2）2.97。8.63个月；P = 0.0037]。NMD患者预后较差（mOS，15.9个月。未达到，P < 0.0001；mPFS2 3.8。12.2个月；P = 0.0199）。与胸外部位受累的患者相比，疾病局限于胸部的患者预后更好（mOS，70。17.3个月；P = 0.0136）。转移部位超过4个是负面预后因素（mOS，15.9。25.2个月；P = 0.0106）。在多因素分析中，BM、NMD、胸外疾病和转移部位数量 > 4是负面预后因素（P < 0.0001）。
本研究强调了特定转移部位、NMD的存在以及胸外疾病在接受免疫治疗的晚期NSCLC患者中的负面预后影响。然而，TB似乎不影响这些患者的结局。
