Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Neuroendocrine Tumors

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Adenoma

Adenoma, Islet Cell

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Glandular and Epithelial

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Sunitinib

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

sunitinib

everolimus

depends on the chemotherapy prescribed (IV)

chemotherapies recommended in france

Pfizer CT.gov Call Center

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.

prospective and retrospective Analyses will be performed using SAS® software

OPALINE : A Study Of Morbidity And Mortality At 2 Years

AN OBSERVATIONAL REAL-WORLD STUDY OF THE SYSTEMIC TREATMENT OF WELL-DIFFERENTIATED, UNRESECTABLE OR METASTATIC, PROGRESSIVE PANCREATIC NEUROENDOCRINE TUMOURS (PNET): A STUDY OF MORBIDITY AND MORTALITY AT 2 YEARS

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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 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.

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.

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.

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.

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.

Frequency = number of tumor assessment visits /(\[last visit date - baseline date\]/365.25).

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.

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 is reported for this outcome measure.

Number of participants according to course of changes in doses of treatment is reported for this outcome measure.

The number of lines of combined main treatment administered during the study were assessed.

The number of main lines of treatment received during the study treatment are reported in this outcome measure.

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.

Novartis

Keyrus Biopharma

Pfizer

Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Participants during course of study changed their treatment, irrespective of treatment at the time of inclusion. Safety data reported is according to treatment taken at least once during the study.

Participants who received everolimus at least once in the study.

Everolimus During Study

Participants who received sunitinib at least once in the study.

Sunitinib During Study

Participants who received chemotherapy at least once in the study.

Chemotherapy During Study

Participants who received somatostatin analogues at least once in the study.

Somatostatin Analogues During Study

Participants who received metabolic radiotherapy at least once in the study.

Metabolic Radiotherapy During Study

Participants who received treatment other than the study treatments at least once in the study.

Other Than Study Treatment During Study

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.

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 sunitinib or were being treated with sunitinib. Participants were prospectively followed-up for 2 years in this study.

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 chemotherapy or were being treated with chemotherapy. Participants were prospectively followed-up for 2 years in this study.

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 somatostatin analogues or were being treated with somatostatin analogues. Participants were prospectively followed-up for 2 years in this study.

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 metabolic radiotherapy or were being treated with metabolic radiotherapy. Participants were prospectively followed-up for 2 years in this study.

Metabolic Radiotherapy (Other Treatment) at Inclusion

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

The full analysis (FAS) (reference) set included participants who met the eligibility criteria and had received at least 1 dose of the treatment documented during the prospective follow-up period (the treatment start date must be completed and the treatment stop date must be after the date of inclusion if the start date is prior to the date of inclusion) in the study (targeted therapy or other treatment) and excluded the participants with no follow-up data.

Pfizer ClinicalTrials.gov Call Center

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.

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

Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with targeted therapies or were being treated with targeted therapies. Participants were prospectively followed-up for 2 years in this study.

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 other treatments or were being treated with other treatments. Participants were prospectively followed-up for 2 years in this study.

Other Treatments at Inclusion

PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

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.

Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion

OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion

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.

Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion

Treatment Related AE

Treatment Related SAE

At least one grade 3 AE

At least one grade 3 SAE

At least one AE of grade 4 or higher

Other Than Study Treatments During Study

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.

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

Temporary discontinuation of treatment

Permanent discontinuation of treatment

Somatostatin Analogues During Study at Inclusion

Participants who received metabolic radiotherapy at least once in the study

Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study

Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study

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.

Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

CT Scan

PET Scan

Octreoscan

Ultrasound

Imaging (CT scan and/or MRI)

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.

Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group 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

Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion

Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

1st line

2nd line

3rd line

4th line

5th line

6th line

7th line

8th line

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

Participants included in this reporting group were those who at the time of inclusion in the study either initiated treatment with interferon-alpha or were being treated with interferon-alpha. Participants were prospectively followed-up for 2 years in this study.

Interferon-alpha (Other Treatment) at Inclusion

This reporting group consisted of those participants whose treatment was not documented at time of inclusion.

Spots Global Cancer Trial Database for pancreatic neuroendocrine tumor, well differentiated and progressive