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Soledad Medina Valdivieso



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    P09 - Health Services Research/Health Economics - Real World Outcomes (ID 121)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Health Services Research/Health Economics
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P09.16 - Immunotherapy for Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC). Real-Life Experience from Castile and Leon (ID 3710)

      00:00 - 00:00  |  Presenting Author(s): Soledad Medina Valdivieso

      • Abstract
      • Slides

      Introduction

      Immune checkpoints inhibitors (ICI) have emerged as a standard of care for advanced NSCLC thanks to its effectiveness in both untreated and previously treated patients. Despite this, real world data (RWD) studies are limited. The aim of this retrospective RWD, is to report our experience in the real practice with ICI for previously treated advanced NSLCC.

      Methods

      Retrospective multicenter observational trial. Data from patients with previously treated advanced NSCLC who had undergone ICI from June 2015 to June 2019 were collected from medical records in 8 hospitals from the region Castile and Leon in Spain. Efficacy and safety were evaluated. Univariate subgroup analysis was performed for overall survival (OS) and multivariate Cox proportional hazard regression algorithm was used to identify independent predictors of OS.

      Results

      478 patients were included. Mean age was 64 years (SD± 9,55), 77.8% were males, 6.5% non-smokers and 71.8% stage IV; 14,4% had ECOG0, 58.6% ECOG1 and 26.7% had ≥ ECOG2; 70.5% had more than one comorbidity. Histological subtype was 55.4% adenocarcinoma, 38.5% squamous-cell and 6.1% NOS; PDL-1 was reported in 182 (38.1%) patients. Of the total, 85.1% received Nivolumab, 9.8% atezolizumab and 5% pembrolizumab; and 28% received ≥ 2 lines before ICI. Immune-related adverse events (IRAEs) were present in 26.4%; 75.7% were grade 1-2. The most frequent IRAEs were hypothyroidism (7%) and pneumonitis (7%), followed by cutaneous toxicity (4.2%) and diarrhoea (3.5%).Response was evaluable in 430 patients of whom 3.8% had complete response, 22.8% partial response and 20.3% stable disease. At the final analysis, 74.8% had stopped ICI due to progression and 9.5% due to related toxicity. Median duration response was 14,4 months (95%CI 10,5–18,2). Median progression free survival (PFS) was 4 months (95%CI 3,4–4,6), and median OS was 10.3 months (95%CI 8,7–11,8) with a 50-month survival rate of 14.3%. There were differences in the univariate analysis of OS by subgroups according to baseline characteristics in favour of ECOG 0-1, no comorbidities, PDL-1≥50% versus PDL-1<1%, IRAEs and responders (table 1.a); in this last subgroup the 50-month survival rate was 47.1%. In the multivariate analysis, PDL-1≥1%, ECOG 0, no comorbidities, and IRAEs were associated with longer OS (p<0.05, table 1.b).

      table 1.jpg

      Conclusion

      Our RWD reproduces the ICI effectiveness observed in clinical trials. The incidence of pneumonitis was higher than expected and could be justified by a better pharmacovigilance and knowledge of IRAEs, but requires further study.

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