Overall Survival of Large Cell Neuroendocrine Lung Cancer Patients - a Retrospective Study

Study Overview
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Brief Summary
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This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months.

Detailed Description
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This is a retrospective study. 132 patients with LCNEC and combined LCNEC were included to the analysis. Patients were treated with radical, palliative or symptomatic intension between 2002-2018 in central and north-eastern centres in Poland. The group of patients consists of 47 women (36%) and 85 men (64%). Ratio of women to men is 1:1,81. The observation period ranged from 0 to 192 months. For all patients included to the analysis, the clinical stage was estimated according to TNM Classification of Malignant Tumours - UICC from 2017. The degree of pathomorphic stage (pTNM) was assessed in 60 patients treated with intention to treat (ITT), which is 45% of the total population. The degree of clinical stage (cTNM) was assessed in 72 patients based on the imaging examinations (including PET, CT, MRI, bone scintigraphy, etc.) and fine needle aspiration biopsy (FNA) (including EBUS, with pathological confirmation of LCNEC, which is 55% of the total population. The clinical stage (cTNM) was used in case of patients disqualified from radical surgery due to: advanced disease, contraindications to surgery, no patient's consent for treatment.

Official Title
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Overall Survival and Progression Free Survival of Patients With Large Cell Neuroendocrine Lung Cancer and Combined Large Cell Neuroendocrine Lung Cancer Treated in Clinical Stage I-IV

Conditions
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Survival Outcomes of Patients With Pulmonary LCNEC

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥18 years old, male or female, with pathologically confirmed primary neuroendocrine lung cancer based on histopathological examination: LCNEC combined type LCNEC Patients with LCNEC, combined LCNEC without prior treatment independently from the clinical stage according to the 8th edition of TNM 2017 Patients with generalized, unresectable of LCNEC, combined LCNEC before, during and after palliative treatment Patients with generalized, unresectable LCNEC, combined LCNEC treated only symptomatically Patients with locally advanced, unresectable LCNEC,combined LCNEC before, during and after radical treatment Patients with locally advanced, resectable LCNEC, combined LCNEC before, during and after treatment Exclusion Criteria: NA

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS - Progression Free Survival | the time from the start of treatment date to the date of first observation of documented local recurrence, metastases or disease progression. Patients without progression at the time of analysis will be censored. | 16 years | 
| OS - Overall Survival | is defined as the time from the histopathological confirmation to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off. | 16 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Log-rank test | assessment of differences in survival of patients between subgroups | 16 years | 
| Cox proportional-hazards model | multivariate analyses used for investigating the association between the survival time of patients and prognostic factors | 16 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LCNEC-Large cell neuroendocrine carcinoma, Lung cancer