Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
Conditions
Brief summary
A descriptive, prospective (partly retrospective), multisite, observational study conducted in France in adult patients treated for a well differentiated, unresectable or metastatic, pancreatic neuroendocrine tumor with disease progression.
Detailed description
prospective and retrospective Analyses will be performed using SAS® software
Interventions
DRUGchemotherapies recommended in france
depends on the chemotherapy prescribed (IV)
DRUGsunitinib
sunitinib 37.5mg/d orally
DRUGeverolimus
everolimus 10mg/d orally
Sponsors
Novartis
Keyrus Biopharma
Pfizer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age; * Patients treated with a targeted therapy (sunitinib, everolimus) or with other treatments (interferon, or metabolic radiotherapy, or chemotherapy or somatostatin analog)\* for: \*Patients whose treatment line (targeted therapy or other treatment) is initiated as a 1st, 2nd, 3rd or 4th line of therapy at the time of inclusion (incident patients) or patients receiving their 1st, 2nd, 3rd or 4th line of therapy provided that treatment was initiated in the site in which the patient is enrolled in the study (prevalent patients); a change of line is defined as a change in molecule or combination. * A histologically confirmed unresectable or metastatic pancreatic neuroendocrine tumor; * Well-differentiated; * Progressive prior to initiation of treatment in the investigator's judgment (clinical or radiological progression); * Patients who have been informed of the conditions of the study and who have signed the informed consent.
Exclusion criteria
* Patients with a diagnosis of poorly differentiated neuroendocrine carcinoma or an adenoneuroendocrine carcinoma. * Patients receiving targeted therapy (everolimus or sunitinib) already received in a previous line of treatment (rechallenged patient). * Patients refusing to give consent. * Patients receiving a fifth line or subsequent line of systemic treatment. * Patients participating in a clinical trial in a treatment arm not validated by the MA and the TNCD according to the version dated December 2013. * Patients randomized to the placebo arm of a placebo-controlled trial or to a double-blind trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion | At 2 years of prospective follow-up | PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of disease progression (PD) or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method. |
| PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | At 2 years of prospective follow-up | PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of PD or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method. |
| Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion | At 2 years of prospective follow-up | OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method. |
| OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion | At 2 years of prospective follow-up | OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method. |
| Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion | During 2 years of prospective follow-up | — |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | During 2 years of prospective follow-up | AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that: led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. Relatedness to treatment was assessed by investigator. Per CTCAE 4.0, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4=Life-threatening events Grade 5 (Death) events=death related to an AE. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion. |
| Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | During 2 years of prospective follow-up | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion. |
| Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study | During 2 years of prospective follow-up | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events leading to death are reported in this outcome measure. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | During 2 years of prospective follow-up | — |
| Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | During 2 years of prospective follow-up | The types of main lines of treatment included 1st line, 2nd line, 3rd line, 4th line, 5th line, 6th line, 7th line and 8th line. |
| Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | During 2 years of prospective follow-up | Frequency = number of tumor assessment visits /(\[last visit date - baseline date\]/365.25). |
| Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | During 2 years of prospective follow-up | The different types of investigations were performed for assessment of tumor regardless of treatment received. Investigations performed were Computed Tomography (CT) scan, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) scan, Octreoscan, Ultrasound. All the investigations were used at least once during the study for all treatments. |
| Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | During 2 years of prospective follow-up | In this outcome measure, number of participants with a change in treatment compared to treatment at inclusion is reported. |
| Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | During 2 years of prospective follow-up | Number of participants according to number of changes in doses of treatment is reported for this outcome measure. |
| Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion | During 2 years of prospective follow-up | Number of participants according to course of changes in doses of treatment is reported for this outcome measure. |
| Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | During 2 years of prospective follow-up | The number of lines of combined main treatment administered during the study were assessed. |
| Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | During 2 years of prospective follow-up | The number of main lines of treatment received during the study treatment are reported in this outcome measure. |
Countries
France
Participant flow
Recruitment details
This was an observational study carried out in France in adult participants treated for a well-differentiated, unresectable or metastatic, progressive pancreatic neuroendocrine tumor (pNET).
Participants by arm
| Arm | Count |
|---|---|
| Everolimus (Targeted Therapy) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with everolimus or were being treated with everolimus. Participants were prospectively followed-up for 2 years in this study. | 32 |
| Sunitinib (Targeted Therapy) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study. | 23 |
| Chemotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study. | 50 |
| Somatostatin Analogues (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study. | 28 |
| Metabolic Radiotherapy (Other Treatment) at Inclusion Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study. | 1 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Data Missing | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 9 | 8 | 13 | 5 | 0 | 0 | 1 |
| Overall Study | Inclusion/non-inclusion criteria not respected | 3 | 0 | 2 | 2 | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 1 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
| Overall Study | Participant decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Everolimus (Targeted Therapy) at Inclusion | Sunitinib (Targeted Therapy) at Inclusion | Chemotherapy (Other Treatment) at Inclusion | Somatostatin Analogues (Other Treatment) at Inclusion | Metabolic Radiotherapy (Other Treatment) at Inclusion | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 61.16 Years STANDARD_DEVIATION 12.56 | 64.19 Years STANDARD_DEVIATION 12.27 | 62.06 Years STANDARD_DEVIATION 12.39 | 66.77 Years STANDARD_DEVIATION 12.76 | 82.38 Years | 63.35 Years STANDARD_DEVIATION 12.58 |
| Race and Ethnicity Not Collected | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 5 Participants | 18 Participants | 11 Participants | 1 Participants | 53 Participants |
| Sex: Female, Male Male | 14 Participants | 18 Participants | 32 Participants | 17 Participants | 0 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 52 | 3 / 36 | 15 / 82 | 14 / 65 | 2 / 11 | 1 / 16 |
| other Total, other adverse events | 39 / 52 | 29 / 36 | 56 / 82 | 41 / 65 | 4 / 11 | 8 / 16 |
| serious Total, serious adverse events | 21 / 52 | 9 / 36 | 26 / 82 | 24 / 65 | 3 / 11 | 3 / 16 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study
AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that: led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. Relatedness to treatment was assessed by investigator. Per CTCAE 4.0, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4=Life-threatening events Grade 5 (Death) events=death related to an AE. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
Time frame: During 2 years of prospective follow-up
Population: Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | AE | 43 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 AE | 21 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related AE | 31 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one AE of grade 4 or higher | 6 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | SAE | 21 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 SAE | 14 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related SAE | 6 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related AE | 24 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related SAE | 2 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | SAE | 9 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 AE | 11 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | AE | 32 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one AE of grade 4 or higher | 2 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 SAE | 6 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | SAE | 26 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related AE | 48 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | AE | 63 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 AE | 18 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 SAE | 12 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related SAE | 5 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one AE of grade 4 or higher | 18 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related SAE | 1 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | AE | 48 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related AE | 13 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | SAE | 24 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 AE | 14 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 SAE | 12 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one AE of grade 4 or higher | 16 Participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | SAE | 3 Participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related AE | 2 Participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one AE of grade 4 or higher | 2 Participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | AE | 6 Participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 SAE | 0 Participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related SAE | 1 Participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 AE | 1 Participants |
| Other Than Study Treatments During Study | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one AE of grade 4 or higher | 1 Participants |
| Other Than Study Treatments During Study | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 AE | 3 Participants |
| Other Than Study Treatments During Study | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | SAE | 3 Participants |
| Other Than Study Treatments During Study | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related AE | 0 Participants |
| Other Than Study Treatments During Study | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | At least one grade 3 SAE | 0 Participants |
| Other Than Study Treatments During Study | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | AE | 8 Participants |
| Other Than Study Treatments During Study | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study | Treatment Related SAE | 0 Participants |
Primary
Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events leading to death are reported in this outcome measure. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
Time frame: During 2 years of prospective follow-up
Population: Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study | 3 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study | 2 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study | 11 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study | 12 Participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study | 2 Participants |
| Other Than Study Treatments During Study | Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study | 1 Participants |
Primary
Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.
Time frame: During 2 years of prospective follow-up
Population: Safety analysis set. Since participants were grouped on the basis of type of treatment they received at least once during 2 years of follow-up, participants are not exclusive per treatment arm. One participant could have received more than 1 type of treatment during these 2 years.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Temporary discontinuation of treatment | 15 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Permanent discontinuation of treatment | 14 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Temporary discontinuation of treatment | 9 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Permanent discontinuation of treatment | 10 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Temporary discontinuation of treatment | 11 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Permanent discontinuation of treatment | 12 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Temporary discontinuation of treatment | 8 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Permanent discontinuation of treatment | 12 Participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Temporary discontinuation of treatment | 0 Participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Permanent discontinuation of treatment | 0 Participants |
| Other Than Study Treatments During Study | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Temporary discontinuation of treatment | 1 Participants |
| Other Than Study Treatments During Study | Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study | Permanent discontinuation of treatment | 1 Participants |
Primary
Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion
Time frame: During 2 years of prospective follow-up
Population: Safety analysis set included participants who received at least one dose of the documented treatment in the study (targeted therapy or other treatment). If the participant was prevalent, the treatment must still be ongoing at the time of inclusion in the study and if the participant was incident, the treatment must be started at or after inclusion in the study. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion | Adverse event | 12 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion | Doctor's choice | 1 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion | Participant's choice | 3 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion | Other | 4 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion | Other | 2 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion | Adverse event | 6 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion | Participant's choice | 3 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion | Doctor's choice | 11 Participants |
Primary
OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion
OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.
Time frame: At 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here, Overall Number of Participants signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 63.9 Percentage of participants |
| Sunitinib (Targeted Therapy) at Inclusion | OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 71.7 Percentage of participants |
Primary
Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion
OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.
Time frame: At 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here, Overall Number of Participants signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion | 60.2 Percentage of participants |
| Sunitinib (Targeted Therapy) at Inclusion | Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion | 68.4 Percentage of participants |
| Chemotherapy (Other Treatment) at Inclusion | Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion | 69.6 Percentage of participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion | 79.7 Percentage of participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion | NA Percentage of participants |
Primary
PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of PD or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.
Time frame: At 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 19.9 Percentage of participants |
| Sunitinib (Targeted Therapy) at Inclusion | PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 29.0 Percentage of participants |
Primary
Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion
PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of disease progression (PD) or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.
Time frame: At 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion | 26.5 Percentage of participants |
| Sunitinib (Targeted Therapy) at Inclusion | Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion | 19.3 Percentage of participants |
| Chemotherapy (Other Treatment) at Inclusion | Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion | 36.5 Percentage of participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion | 38.6 Percentage of participants |
| Metabolic Radiotherapy (Other Treatment) at Inclusion | Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion | NA Percentage of participants |
Secondary
Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
Time frame: During 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 5.8 Visits | Standard Deviation 2.7 |
| Sunitinib (Targeted Therapy) at Inclusion | Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 5.5 Visits | Standard Deviation 2.7 |
Secondary
Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The number of lines of combined main treatment administered during the study were assessed.
Time frame: During 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 3.9 Treatment lines | Standard Deviation 1.7 |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 2.9 Treatment lines | Standard Deviation 1.6 |
Secondary
Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The number of main lines of treatment received during the study treatment are reported in this outcome measure.
Time frame: During 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 3.7 Treatment lines | Standard Deviation 1.7 |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 2.8 Treatment lines | Standard Deviation 1.5 |
Secondary
Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion
Number of participants according to course of changes in doses of treatment is reported for this outcome measure.
Time frame: During 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion | 0 | 0 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion | 1 | 0 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion | 2 | 0 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion | 4 | 1 Participants |
Secondary
Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
Frequency = number of tumor assessment visits /(\[last visit date - baseline date\]/365.25).
Time frame: During 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 0 tests per annum | 2 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 2 tests per annum | 3 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 3 tests per annum | 19 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 4 tests per annum | 18 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 5 tests per annum | 10 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 6 tests per annum | 2 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 7 tests per annum | 1 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 9 tests per annum | 0 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 9 tests per annum | 2 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 0 tests per annum | 3 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 5 tests per annum | 10 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 2 tests per annum | 4 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 7 tests per annum | 0 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 3 tests per annum | 26 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 6 tests per annum | 4 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 4 tests per annum | 30 Participants |
Secondary
Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion
Number of participants according to number of changes in doses of treatment is reported for this outcome measure.
Time frame: During 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 0 | 25 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 1 | 4 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 2 | 1 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 4 | 2 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 1 | 3 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 2 | 2 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 4 | 0 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 0 | 18 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 2 | 3 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 1 | 7 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 4 | 0 Participants |
| Chemotherapy (Other Treatment) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 0 | 40 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 4 | 0 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 1 | 7 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 0 | 21 Participants |
| Somatostatin Analogues (Other Treatment) at Inclusion | Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion | 2 | 0 Participants |
Secondary
Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
In this outcome measure, number of participants with a change in treatment compared to treatment at inclusion is reported.
Time frame: During 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 44 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 68 Participants |
Secondary
Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The different types of investigations were performed for assessment of tumor regardless of treatment received. Investigations performed were Computed Tomography (CT) scan, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) scan, Octreoscan, Ultrasound. All the investigations were used at least once during the study for all treatments.
Time frame: During 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data. Here Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | CT Scan | 48 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | MRI | 28 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | PET Scan | 11 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | Octreoscan | 13 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | Ultrasound | 6 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | Imaging (CT scan and/or MRI) | 52 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | Ultrasound | 4 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | CT Scan | 65 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | Octreoscan | 15 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | MRI | 45 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | Imaging (CT scan and/or MRI) | 74 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | PET Scan | 15 Participants |
Secondary
Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
The types of main lines of treatment included 1st line, 2nd line, 3rd line, 4th line, 5th line, 6th line, 7th line and 8th line.
Time frame: During 2 years of prospective follow-up
Population: FAS included participants who met eligibility criteria, received at least 1 dose of treatment during prospective follow-up period (treatment start date must be completed, treatment stop date must be after date of inclusion if start date is prior to date of inclusion) in the study (targeted therapy or other treatment) and excluded participants with no follow-up data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 1st line | 8 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 5th line | 15 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 3rd line | 25 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 6th line | 7 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 2nd line | 27 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 7th line | 4 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 4th line | 28 Participants |
| Everolimus (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 8th line | 2 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 4th line | 26 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 1st line | 38 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 2nd line | 43 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 3rd line | 30 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 8th line | 0 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 5th line | 15 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 6th line | 2 Participants |
| Sunitinib (Targeted Therapy) at Inclusion | Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion | 7th line | 1 Participants |