OPALINE : A Study Of Morbidity And Mortality At 2 Years

Pfizer144 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

144

Conditions

Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive

Interventions

sunitinibDRUG

sunitinib 37.5mg/d orally

everolimusDRUG

everolimus 10mg/d orally

chemotherapies recommended in franceDRUG

depends on the chemotherapy prescribed (IV)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (35)

Outcomes

Primary Outcomes

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

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

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.

Data from ClinicalTrials.gov

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CHU d'Amiens

Amiens, France

CHU d'Angers

Angers, France

Hopital Saint-Andre

Bordeaux, France

CHU de Caen

Caen, France

Cabinet Medical

Challes-les-Eaux, France

CHRU de Tours - Hôpital TROUSSEAU

Chambray-lès-Tours, France

Hopital d'Estaing

Clermont-Ferrand, France

Hopital du Bocage

Dijon, France

Unite d'Oncologie Digestive, Departement d'HGE

Grenoble, France

Centre Oscar Lambret

Lille, France

...and 25 more locations

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.