Endometrial Cancer
Conditions
Keywords
Durvalumab, Olaparib, Primary advanced endometrial cancer (1L), FIGO III or IV, Recurrent endometrial cancer (1L), dMMR, pMMR, Real-World Evidence, Patient-Reported Outcome
Brief summary
This is a German multi-center, prospective, non-interventional study (NIS) to collect real-world clinical data in patients with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer (EC) receiving first-line (1L) regimens with Carboplatin/Paclitaxel/Durvalumab (CPD) followed by maintenance therapy with durvalumab or durvalumab and olaparib in line with the applicable european summary of product characteristics (SmPC). Additionally, patient-reported outcomes after 1L treatment with CPD will be assessed.
Detailed description
This is a multi-center, prospective, non-interventional study (NIS) to collect real-world clinical and PRO data in patients with primary advanced (FIGO stage III or IV) or recurrent EC receiving 1L CPD followed by maintenance therapy with durvalumab (DNA mismatch repair deficient; dMMR cohort) or durvalumab and olaparib (DNA mismatch repair proficient, pMMR cohort) in accordance with the applicable SmPC within routine clinical practice. Following surgery and/or radiation (if applicable) the decision to initiate 1L CPD followed by durvalumab or durvalumab and olaparib is made in a shared decision between the patient and the treating physician as part of routine care outside of and independent of this study. The aim of the NIS is to describe the outcomes including effectiveness and safety of patients with primary advanced and recurrent EC treated with the two approved 1L regimens of CPD followed by durvalumab maintenance and CPD followed by durvalumab and olaparib maintenance, as well as patient-reported outcomes after chemotherapy-phase (CPD) in Germany. The study also aims to better understand characteristics of patients with primary advanced or recurrent EC that benefit from maintenance therapy with durvalumab or durvalumab and olaparib.
Interventions
None listed
Sponsors
AstraZeneca
North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* Women aged ≥ 18 years at the time of screening. * Patient has pathologically documented: * Primary advanced (FIGO III and IV) epithelial EC OR * Recurrent disease that is unlikely to be cured and where the multidisciplinary tumor board decision is systemic therapy. Carcinosarcomas are allowed, * Patient is intended or initiated to receive 1L CPD followed by maintenance therapy with durvalumab (dMMR cohort) or with durvalumab and olaparib (pMMR cohort) according to the SmPC of IMFINZI® and Lynparza®\* prior to enrollment. Recruitment of patients that already started and may have received up to 2 cycles of CPD is allowed but will be capped to 25% for each cohort of the study population. * Patient is eligible for treatment with durvalumab and/or olaparib as specified in the IMFINZI® and Lynparza® SmPC. The prescription of the medicinal product is clearly separated from the decision to include the patient in the study. * MMR-testing results of the patient's tumor are known. * Patient is willing and able to complete PRO questionnaires. * Patient can read and understand German, English, Arab, Russian or Turkish. * Signed written informed consent.
Exclusion criteria
* Patient has already received \>2 cycles of 1L CPD * Known hypersensitivity to carboplatin, paclitaxel, durvalumab and/or olaparib or any of the excipients of the drug. * Pregnancy or breast-feeding. * Unable to swallow orally administered medication. * Current or planned participation in an interventional clinical trial. * Current or planned systemic treatment of any tumor other than primary advanced or recurrent EC. * Patient has pathologically documented sarcoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Time To Next Treatment (rwTTNT) | At 12 months | rwTTNT is defined as time from start of 1L CPD until first dose of next systemic therapy or start of any other next anticancer therapy or death from any cause. 1L maintenance therapy with durvalumab or durvalumab+olaparib is not considered as next systemic therapy. The measure of interest is the landmark at 12 months of time to first next therapy or death (rwTTNT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Progression-free Survival (rwPFS) | At 12 months | rwPFS is defined as time from start of 1L CPD until progression or death from any cause. The measure of interest is the landmark at 12 months of progression-free survival (rwPFS). |
| Time to deterioration in health-related quality of life (HRQoL) based on EORTC QLQ-C30 questionnaire compared to baseline over time | Baseline to first clinically meaningful deterioration, up to 46 months | The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30), is a validated 30-item self-administered core questionnaire designed to assess HRQoL, functioning, and symptoms in all cancer patients or survivors. Time to deterioration is defined as time from baseline (≤ 14 days before first application of maintenance therapy) to date of first clinically meaningful deterioration i.e. a decrease by ≥10 points for the functional scales and an increase by ≥ 10 points for the symptom scales or death in: * Physical functioning score * Role functioning score |
| Time to deterioration in HRQoL based on EORTC QLQ-EN24 questionnaire compared to baseline over time | Baseline to first clinically meaningful deterioration, up to 46 months | The Endometrial Cancer Module EORTC QLQ-EN24, is a validated disease-specific extension to the EORTC QLQ-C30 designed to assess disease and treatment specific aspects of the QoLof patients with all stages of EC. The module consists of 24 questions grouped into 13 scales. Time to deterioration is defined as time from baseline (≤ 14 days before first application of maintenance therapy) to date of first clinically meaningful deterioration i.e. a decrease by ≥10 points for the functional scales and an increase by ≥ 10 points for the symptom scales or death in: * Back/pelvic pain * Gastrointestinal (GI) symptoms * Urological symptoms |
| Duration of maintenance therapy | From first dose of maintenance therapy up to 46 months | Time from first dose of maintenance therapy with durvalumab or durvalumab+olaparib to the last dose/cyle of durvalumab or olaparib, whatever is last, including number and duration of treatment interruptions. |
| Duration of 1L CPD | Assessed up to 46 months | Duration of therapy with durvalumab with carboplatin and/or paclitaxel |
| Time between end of CPD until start of maintenance therapy | Assessed up to 46 months | Time to start maintenance therapy defined as date of last cycle of chemotherapy until date of first dose of maintenance therapy |
| Usage of treatment therapy | Assessed up to 46 months | Dose, dose change, treatment interruption, number of cycles, cumulative dose of durvalumab. |
Countries
Germany
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed