Abstract
Aim: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.Methods: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 vs. extrathoracic disease, measurable disease (MD) vs. 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.Results: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 vs. 70.0 months, P = 0.0009; median progression free survival in the second line (mPFS2) 2.97 vs. 8.63 months; P = 0.0037]. Patients with NMD had a poorer prognosis (mOS, 15.9 months vs. not reached, P < 0.0001; mPFS2 3.8 vs. 12.2 months; P = 0.0199). Patients with disease limited to the thorax had a better prognosis compared to patients with involvement of extrathoracic sites (mOS, 70 vs. 17.3 months; P = 0.0136). Having more than 4 metastatic sites resulted as a negative prognostic factor (mOS, 15.9 vs. 25.2 months; P = 0.0106). At multivariate analysis, BM, NMD, extrathoracic disease and number of sites of metastases > 4 were negative prognostic factors (P < 0.0001).Conclusions: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.
Highlights
Lung cancer is the second most commonly diagnosed cancer in the world, recording 2,206 million new cases, corresponding to 11.4% of new diagnoses [1]
No significant difference in overall survival (OS) was noted between subgroups of patients according to tumor burden (TB)
Standard systemic treatment for advanced non oncogene-addicted non-small cell lung cancer (NSCLC) is represented by the combination of chemotherapy and immune checkpoint inhibitors (ICIs), which shown to be effective in all subgroups of patients regardless of programmed death-ligand 1 (PD-L1) expression, with the larger benefit being revealed when PD-L1 expression is upper than 50% [7, 8]
Summary
Lung cancer is the second most commonly diagnosed cancer in the world, recording 2,206 million new cases, corresponding to 11.4% of new diagnoses [1]. Standard systemic treatment for advanced non oncogene-addicted NSCLC is represented by the combination of chemotherapy and ICIs, which shown to be effective in all subgroups of patients regardless of programmed death-ligand 1 (PD-L1) expression, with the larger benefit being revealed when PD-L1 expression is upper than 50% [7, 8]. According to current approval in Italy, ICIs in combination with chemotherapy are used as first-line treatment for advanced NSCLC patients with PD-L1 expression lower than 50%, while monotherapy with pembrolizumab [a fully humanized immunoglobulin G4 (IgG4) monoclonal antibody against programmed cell death-1 (PD-1)] is indicated in the same setting when PD-L1 expression is ≥ 50% [9].
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