Abstract

Efficacy of pembrolizumab in advanced pretreated NSCLC was documented in prospective trials. We aimed to confirm the benefits of pembrolizumab in daily practice. This study was a retrospective analysis of patients (pts) treated in the Expanded Access Program in Poland. Median of progression-free (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Analyses were performed with R 3.6.0 software. A total of 34 pts were qualified to pembrolizumab in second or third line of NSCLC treatment. Poor performance status (ECOG 2) was found in 14.7% of pts, brain and liver metastases were diagnosed in 8.8% and 17.6%, respectively. 38% of pts ended the treatment before radiological assessment mainly due to clinical deterioration. In the landmark of 12 and 24 months 35% and 17.6% pts remained alive. Median PFS and OS were 4.4 months (95% confidence interval [CI]: 3.4–9.0) and 8.2 months (95% CI: 4.1–16.1). Immune related adverse events (irAE) were reported in 23% of pts. No treatment-related deaths were reported. In an univariate analysis an ECOG PS 2 (p < 0.001), tumor diameter of >100 mm (p = 0.019), PD during previous chemotherapy (p = 0.037), platelet count (PLT) >409 109/L (p = 0.011), a neutrophil-to-lymphocyte ratio (NLR) ≥3.1 (p = 0.0001) and platelet-to-lymphocyte ratio (PLR) of >183 (p = 0.018) had a negative impact on PFS. The age, sex, histology, location of metastases, PD-L1 expression, level of tumor-infiltrating lymphocytes and comorbidities had no impact. In terms of OS, an ECOG 2 (p < 0.001), PD during chemotherapy (p = 0.037), lack of irAE (p = 0.026), NLR of ≥3.1 (p < 0.001), PLT of ≥409 109 /L (p = 0.011), and PLR of ≥183 (p = 0.018) were negative prognostic factors. ECOG 2 (hazard ratio [HR] 72.63, 95% CI 6.64–794.4; p <0.001), PD during chemotherapy (HR 8.18, 95% CI 1.32–50.4; p = 0.024), and a PLT >409 109 /L (HR 6.18, 95% CI 1.35–28.32; p = 0.019) were independent prognostic factors for OS in multivariate analysis. Pembrolizumab produces durable benefit in 20% of pts with pretreated NSCLC. Clinical and laboratory factors may help to indicate subgroups likely to benefit. Poor PS and lack of response to previous chemotherapy are major determinants of worse prognosis.

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