Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice.

Study Overview
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Brief Summary
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The purpose of the protocol is to estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment, at 24 months after treatment initiation with lanreotide 120 mg every 28 days.

Official Title
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Lanreotide 120 mg Effectiveness in Subjects With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice

Conditions
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Pancreatic Neuroendocrine Tumor

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged ≥ 18 Subjects diagnosed of functioning or non-functioning PanNET, G1/ G2 (Ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months Subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation Subject with Eastern Cooperative Oncology Group (ECOG) ≤2 Exclusion Criteria: Subject who is participating in an interventional study Pregnant or breast-feeding women Subject who has received any previous therapy for PanNET (such as octreotide LAR, Molecular Targeted Therapy (MTT), Peptide receptor radionuclide therapy (PRRT), chemotherapy, etc.) except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- | --- |
| Progression-free survival (PFS) rate at 24 months | To estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) rate at 12 months | PFS rate at 12 months after lanreotide treatment initiation according to investigator assessment | 12 months | 
| Medical tumour-related intervention | Description of the disease history management of subjects with PanNET will be collected by the investigator and recorded in an electronic CRF (eCRF) designed for the study | Baseline | 
| Time from diagnosis to first therapeutic intervention | Description of the disease history management of subjects with PanNET | Baseline | 
| Quality of Life (QoL) | To describe the change in Quality of Life (QoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire for gastrointestinal neuroendocrine tumours (QLQ-GINET21) questionnaires.Where the patient assess experienced symptoms or problems using the scale from 1 to 4. Where 1 represents not at all and 4 very much. | From baseline up to 24 months | 
| Median time to lanreotide discontinuation |  | Up to 24 months | 
| Changes of Chromogranin A (CgA) levels | Changes in CgA levels between last CgA value prior to lanreotide start (if available) and values at each study visit | Every 6 months up to 24 months | 
| Changes of Glycated hemoglobin (HbA1c) levels | Changes in HbA1c levels between last HbA1c value prior to lanreotide start (if available) and values at each study visit | Every 6 months up to 24 months | 
| Changes of urine 5-Hydroxyindoleacetic Acid (5-HIAA) levels | Changes in 5-HIAA levels between last 5-HIAA value prior to lanreotide start (if available) and values at each study visit | Every 6 months up to 24 months | 
| Changes of pro-Brain Natriuretic Peptide (proBNP) levels | Changes in proBNP levels between last proBNP value prior to lanreotide start (if available) and values at each study visit | Every 6 months up to 24 months | 
| Patient satisfaction | To evaluate patient' satisfaction (TSQM-9 questionnaire) at inclusion visit. Treatment Satisfaction Questionnaire for Medication (TSQM) is an instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. The effectiveness scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the convenience scored as 1(extremely difficult) to 7 (extremely easy). | Baseline visit and 12 months |