Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs

PFS, defined as the time, in months, from Lutathera® treatment initiation to the date of first objective tumour progression, determined according to Response Evaluation Criteria in Solid Tumours (RECIST) Criteria, Version 1.1, or death due to any cause, whichever comes first.

ORR, defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1

DoR, defined as the time, in months, from the date when criteria for response are first met until the date of a progression event (according to the primary definition of PFS).

CBR, defined as the proportion of treated patients who achieve a best overall response of stable disease (SD), PR or CR according to RECIST 1.1.

Duration of clinical benefit, defined as the time, in months, from the date when criteria for clinical benefit are first met until the date of a progression event (according to the primary definition of PFS).

TTP, defined as the time, in months, from Lutathera® treatment initiation to the date of first objective tumour progression, assessed according to RECIST 1.1.

EORTC QLQ-C30 will be filled in by the patient prior to knowing computed tomography (CT) scan/magnetic resonance imaging (MRI) result.

The EORTC QLQ-C30 questionnaire is designed for use with a wide range of cancer patient populations and is intended to be supplemented by tumour-specific questionnaire modules. The EORTC QLQ-C30 incorporates different multi-item scales, i.e. functional scales, symptom scales and a Global Health Status/QoL scale. All parameters are evaluated using single or multi-item questions which are consequently converted into a 100-point score.

EORTC QLQG. I.NET-21 will be filled in by the patient prior to knowing computed tomography (CT) scan/magnetic resonance imaging (MRI) result.

EORTC QLQ-G.I.NET-21 questionnaire is a module specific for neuroendocrine tumours and comprises 21 questions assessing disease symptoms, side effects of treatment, body image, disease related worries, social functioning, communication and sexuality. Each subscale is based on the following items: endocrine scale (items 31-33); gastrointestinal scale (34-38); treatment scale (39, 40, and 46); social function scale (42, 44, and 49); disease related worries scale (41, 43, and 47); muscle/bone pain (48), sexual function (51), information/communication function (50), and body image (45).

All parameters are evaluated using single or multi-item questions which are consequently converted into a 100-point score

TTD, defined as the time, in months, from Lutathera® treatment initiation to the date of first deterioration of ≥10 points in the EORTC QLQ-C30 and EORTC QLQ-G.I.NET21 global health scale score compared to the baseline score for the same domain.

TTD, defined as the time, in months, from Lutathera® treatment initiation to the date of first deterioration of ≥10 points in the EORTC QLQ-C30 and EORTC QLQ-G.I.NET21 diarrhoea item score compared to the baseline score for the same domain.

TTD, defined as the time, in months, from Lutathera® treatment initiation to the date of first deterioration of ≥10 points in the EORTC QLQ-C30 and EORTC QLQ-G.I.NET21 fatigue item score compared to the baseline score for the same domain.

TTD, defined as the time, in months, from Lutathera® treatment initiation to the date of first deterioration of ≥10 points in the EORTC QLQ-C30 and EORTC QLQ-G.I.NET21 pain item score compared to the baseline score for the same domain.

Number of patients with Adverse Events (AEs) related to study drug will be reported

Seriousness and relationship to Lutathera® treatment will be reported

Incidence of deaths due to any cause will be reported

Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline.

Standard Lab parameters will be reported when performed as clinical practice.

Safety measured by the notable post-baseline changes in physical examination compared to baseline.

Physical examination will be reported when performed as clinical practice.

Safety measured by the notable post-baseline changes in vital signs compared to baseline.

Vital signs will be reported when performed as clinical practice.

Safety measured by the notable post-baseline changes in ECG compared to baseline.

ECG results will be reported when performed as clinical practice.

KPS scores will be reported when performed as clinical practice. Karnofsky Performance Status (KPS) is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The KPS score ranges from 0 to 100. A higher score means the patient is better able to carry out daily activities. KPS forms must be completed by the treating physician at each treatment and follow-up visit.

Baseline characteristics of patients prescribed with Lutathera® (medical and disease history, prior treatments for NETs, baseline and demographic characteristics).

Potential prognostic factors (e.g., somatostatin receptor (SSTR) expression levels (tumour uptake score) determined by Octreoscan® scintigraphy or 68Ga PET/CT according to clinical practice, standardized uptake value (SUV) of [18F]fluorodeoxyglucose (FDG) PET/CT (if performed), levels of the biomarkers collected in clinical routine, stage of disease at the time of first diagnosis, KPS score at baseline).

Radiation emission levels at one metre distance of patients treated with Lutathera® at the time of hospital discharge and as collected according to the local Summary of Product Characteristics (SmPC), the "Scheda di Monitoraggio AIFA" and as per clinical practice

Number of patients undergoing dosimetry, dosimetry method used and radiation-absorbed doses to tumour and normal organs after Lutathera® administration.

Number of days of hospitalization for Lutathera® treatment will be provided

Frequency of hospitalizations will be provided

Duration of hospitalizations will be provided

Extent of usage of concomitant medications for AE treatment will be provided

Changes in use of concomitant medications for symptoms management will be provided

Information about the patient's diagnosis-related group (DRG) will be provided