N/A
N=144
OPALINE : A Study Of Morbidity And Mortality At 2 Years
Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
Bottom Line
View on ClinicalTrials.gov: NCT02264665 ↗Enrolled (actual)
144
Serious AEs
32.8%
Results posted
Nov 2023
Primary outcome: 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 — 26.5; 19.3; 36.5; 38.6 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- sunitinib (Drug); everolimus (Drug); chemotherapies recommended in france (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
26.5; 19.3; 36.5; 38.6; NA | — |
| PRIMARY PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion |
19.9; 29.0 | — |
| PRIMARY Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion |
60.2; 68.4; 69.6; 79.7; NA | — |
| PRIMARY OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion |
63.9; 71.7 | — |
| PRIMARY Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion |
12; 6; 1; 11; 3; 3 | — |
| 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 |
43; 32; 63; 48; 6; 8 | — |
| PRIMARY Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study |
15; 9; 11; 8; 0; 1 | — |
| PRIMARY Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study |
3; 2; 11; 12; 2; 1 | — |
| SECONDARY Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion |
5.8; 5.5 | — |
| SECONDARY Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion |
2; 3; 3; 4; 19; 26 | — |
| SECONDARY Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion |
48; 65; 28; 45; 11; 15 | — |
| SECONDARY Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion |
44; 68 | — |
| 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 |
25; 18; 40; 21; 4; 3 | — |
| SECONDARY Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion |
0; 0; 0; 1 | — |
| SECONDARY Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion |
3.9; 2.9 | — |
| SECONDARY Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion |
3.7; 2.8 | — |
| 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 |
8; 38; 27; 43; 25; 30 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02264665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.