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.
Women aged ≥ 18 years at the time of screening.
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 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.
150 patients with documented primary advanced (FIGO stage III or IV) or recurrent EC of epithelial histology (excluding sarcomas) who are eligible for first-line therapy with CPD followed by durvalumab or durvalumab and olaparib in line with the applicable SmPC within routine clinical practice will be recruited in Germany. The study allows recruitment of patients that already started and may have received up to 2 cycles of CPD. Inclusion of patients having started CPD will be capped to 25% for each cohort of the study population. Testing results for MMR status of the patients' tumor must be available. Patients must be willing and able to report PROs. Eligible patients will be included into the study after and independently of the treating physician's treatment and diagnostic decisions.
Cohort
Prospective
Not listed
Real-world Time To Next Treatment (rwTTNT)
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).
Real-world Progression-free Survival (rwPFS)
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
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
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
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.
Safety: Collection of Adverse Events (AE)
Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness.
Change in timed up and go test (TUG)
The Timed up and go test (TUG) is a reliable and validated measure of functional mobility that can be used to assess frailty and functional impairment and to predict the risk of postoperative complications. The TUG records the time it takes a patient to get up from an armchair, walk 3 meters, turn around, walk back, and sit down again. Aids such as walking aids are permitted but help from other people is not. TUG should be assesd at every routine visit.
Change in EORTC QLQ-C30
Changes of patient-reported outcomes (PROs) based on the European Organisation for Research and Treatment of Cancer Quality of Life - Core Questionnaire 30 (EORTC QLQ-C30) questionnaire from baseline (defined as ≤ 14 days before first application of maintenance therapy) over time in: * Physical functioning score of EORTC QLQC30 * Role functioning score of the EORTC QLQ-C30 * Global health status/quality of life (QoL) score of the EORTC QLQ-C30 * All other functioning and symptom subscale scores of the EORTC QLQ-C30.
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AstraZeneca
Lead sponsor
North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)
Collaborator
