Metastatic Endometrial Cancer
Conditions
Keywords
metastatic, endometrial, cancer, endometrial cancer, metastatic cancer
Brief summary
LARENA is a multicentric retrospective study (secondary use of data) of consecutive patients prospectively registered in the lenvatinib plus pembrolizumab French early access program (Temporary Authorisation for Use). The source of data will be the patient's medical file. We will manually review all files of the participating centers.
Interventions
None listed
Sponsors
Institut Curie
ARCAGY/ GINECO GROUP
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients having received at least one dose of lenvatinib plus pembrolizumab in the context of the French early access program (Temporary Authorisation for Use) approved by the French Health Autority. * Patients with advanced or recurrent endometrial cancer whose disease is progressing during or following prior platinum-based chemotherapy at any stage and who are not eligible for curative surgery or radiotherapy, according to the French early access program (Temporary Authorisation for Use) approved by the French Health Autority criteria.
Exclusion criteria
* Patients who refuse the collection and use of their personal data in the course of this research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median progression free survival (PFS) | An estimated median follow-up of 5 months from March 2022 to May 2024. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical benefit rate (CBR: SD, CR, PR). | An estimated median follow-up of 5 months from March 2022 to May 2024. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. |
| Safety according to NCI CTCAE criteria v5.0. | An estimated median follow-up of 5 months from March 2022 to May 2024. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. |
| Frequency and type of oncogeriatric testing. | an estimated median follow-up of 5 months from March 2022 to May 2024. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. |
| Overall survival (OS) | An estimated median follow-up of 5 months from March 2022 to May 2024. | Time from the initial diagnosis of metastatic endometrial cancer to the date of death |
| PFS with lenvatinib+pembrolizumab according to MMR/MSI status. | An estimated median follow-up of 5 months from March 2022 to May 2024. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. |
| Frequency and type of medical and paramedical follow-up procedures. | an estimated median follow-up of 5 months from March 2022 to May 2024. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. |
| Objective response rate (ORR: CR, PR) | An estimated median follow-up of 5 months from March 2022 to May 2024. | Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first. |
Countries
France
Outcome results
None listed