NCT04269200 · OUTCOME

Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer · Source last updated 2026-08-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: LEAST_SQUARES_MEAN
Unit: Score on a scale
Interval / dispersion: Standard Error
Time frame: At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.

What was measured

To determine effects on symptoms, functioning, and overall HRQoL of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function.

Analysis population: FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline global health status/QoL available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.

Groups in this outcome

Global Cohort - SoC

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.

Global Cohort - SoC + Durvalumab

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.

Global Cohort - SoC + Durvalumab + Olaparib

Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Global Cohort - SoC	187
Global Cohort - SoC + Durvalumab	190
Global Cohort - SoC + Durvalumab + Olaparib	199

Reported measurements

Source class 1

Values in Score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Global Cohort - SoC	-2.8	0.93	Not reported	Not reported	Not reported
Global Cohort - SoC + Durvalumab	-2.7	0.92	Not reported	Not reported	Not reported
Global Cohort - SoC + Durvalumab + Olaparib	-3.6	0.88	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
-2.5
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.6
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Least-squares Mean Difference
param Value
0.0
statistical Comment
Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
statistical Method
Mixed model for repeated measures
ci Lower Limit
-3.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.6
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Least-squares Mean Difference
param Value
-0.9
statistical Comment
Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
statistical Method
Mixed model for repeated measures

Complete source fields

analyses

ci Lower Limit
-2.5
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.6
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Least-squares Mean Difference
param Value
0.0
statistical Comment
Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
statistical Method
Mixed model for repeated measures
ci Lower Limit
-3.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.6
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value Comment
Descriptive analysis only.
param Type
Least-squares Mean Difference
param Value
-0.9
statistical Comment
Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.
statistical Method
Mixed model for repeated measures

classes

categories
measurements
group Id
OG000
spread
0.93
value
-2.8
group Id
OG001
spread
0.92
value
-2.7
group Id
OG002
spread
0.88
value
-3.6

denoms

counts
group Id
OG000
value
187
group Id
OG001
value
190
group Id
OG002
value
199
units
Participants

description

dispersion Type

Standard Error

groups

description
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
id
OG000
title
Global Cohort - SoC
description
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
id
OG001
title
Global Cohort - SoC + Durvalumab
description
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
id
OG002
title
Global Cohort - SoC + Durvalumab + Olaparib

param Type

LEAST_SQUARES_MEAN

population Description

FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline global health status/QoL available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.

reporting Status

POSTED

time Frame

At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.

title

Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30

type

SECONDARY

unit Of Measure

Score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice