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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 132
- Primary Endpoint
- PFS - Progression Free Survival
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 86 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults ≥18 years old, male or female, with pathologically confirmed primary neuroendocrine lung cancer based on histopathological examination:
- •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
- Not provided
Outcomes
Primary Outcomes
PFS - Progression Free Survival
Time Frame: 16 years
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.
OS - Overall Survival
Time Frame: 16 years
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.
Secondary Outcomes
- Log-rank test(16 years)
- Cox proportional-hazards model(16 years)
Investigators
Jaroslaw B. Cwikla, MD, PhD, Professor UWM
Head of Department of Radiology
University of Warmia and Mazury