NCT00628251 · OUTCOME

Progression Free Survival (PFS)

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer · Source last updated 2019-12-05

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

What was measured

PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)

Groups in this outcome

Olaparib 200 mg bd

Olaparib (AZD2281) 200 mg oral capsules twice daily

Olaparib 400 mg bd

Olaparib (AZD2281) 400 mg oral capsules twice daily

Liposomal Doxorubicin

Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks

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
Olaparib 200 mg bd	32
Olaparib 400 mg bd	32
Liposomal Doxorubicin	33

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Olaparib 200 mg bd	19	Not reported	Not reported	Not reported	Not reported
Olaparib 400 mg bd	20	Not reported	Not reported	Not reported	Not reported
Liposomal Doxorubicin	20	Not reported	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
0.51
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.56
group Description
Analysis of olaparib 200 or 400 mg bd (n=64) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.6604
p Value Comment
If the observed p-value for the combined olaparib groups is \<0.02 (1-sided) then the result will be regarded as statistically significant.
param Type
Hazard Ratio (HR)
param Value
0.88
statistical Comment
Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).
statistical Method
Regression, Cox
ci Lower Limit
0.48
ci Pct Value
95
ci Upper Limit
1.74
group Description
Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.7794
p Value Comment
An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.
param Type
Hazard Ratio (HR)
param Value
0.91
statistical Comment
Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).
statistical Method
Regression, Cox
ci Lower Limit
0.45
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.62
group Description
Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.6604
p Value Comment
An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.
param Type
Hazard Ratio (HR)
param Value
0.86
statistical Comment
Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.51
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.56
group Description
Analysis of olaparib 200 or 400 mg bd (n=64) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.6604
p Value Comment
If the observed p-value for the combined olaparib groups is \<0.02 (1-sided) then the result will be regarded as statistically significant.
param Type
Hazard Ratio (HR)
param Value
0.88
statistical Comment
Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).
statistical Method
Regression, Cox
ci Lower Limit
0.48
ci Pct Value
95
ci Upper Limit
1.74
group Description
Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.7794
p Value Comment
An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.
param Type
Hazard Ratio (HR)
param Value
0.91
statistical Comment
Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).
statistical Method
Regression, Cox
ci Lower Limit
0.45
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.62
group Description
Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.6604
p Value Comment
An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.
param Type
Hazard Ratio (HR)
param Value
0.86
statistical Comment
Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
value
19
group Id
OG001
value
20
group Id
OG002
value
20

denoms

counts
group Id
OG000
value
32
group Id
OG001
value
32
group Id
OG002
value
33
units
Participants

description

groups

description
Olaparib (AZD2281) 200 mg oral capsules twice daily
id
OG000
title
Olaparib 200 mg bd
description
Olaparib (AZD2281) 400 mg oral capsules twice daily
id
OG001
title
Olaparib 400 mg bd
description
Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
id
OG002
title
Liposomal Doxorubicin

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

title

Progression Free Survival (PFS)

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice