NCT01308567 · OUTCOME

Time to Tumor Progression Free Survival

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer · Source last updated 2019-06-05

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

What was measured

Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.

Analysis population: ITT population included all randomized participants.

Groups in this outcome

Docetaxel 75 mg/m^2

Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Cabazitaxel 20 mg/m^2

Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Cabazitaxel 25 mg/m^2

Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

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
Docetaxel 75 mg/m^2	391
Cabazitaxel 20 mg/m^2	389
Cabazitaxel 25 mg/m^2	388

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	12.1	Not reported	11.30	13.77	Not reported
Cabazitaxel 20 mg/m^2	13.4	Not reported	11.37	14.75	Not reported
Cabazitaxel 25 mg/m^2	13.1	Not reported	11.66	14.32	Not reported

Source statistical analyses

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

ci Lower Limit
0.785
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.17
estimate Comment
Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2
group Description
Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.958
ci Lower Limit
0.75
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.118
estimate Comment
Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2
group Description
Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.916

Complete source fields

analyses

ci Lower Limit
0.785
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.17
estimate Comment
Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2
group Description
Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.958
ci Lower Limit
0.75
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.118
estimate Comment
Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2
group Description
Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.916

classes

categories
measurements
group Id
OG000
lower Limit
11.30
upper Limit
13.77
value
12.1
group Id
OG001
lower Limit
11.37
upper Limit
14.75
value
13.4
group Id
OG002
lower Limit
11.66
upper Limit
14.32
value
13.1

denoms

counts
group Id
OG000
value
391
group Id
OG001
value
389
group Id
OG002
value
388
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
id
OG000
title
Docetaxel 75 mg/m^2
description
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
id
OG001
title
Cabazitaxel 20 mg/m^2
description
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
id
OG002
title
Cabazitaxel 25 mg/m^2

param Type

MEDIAN

population Description

ITT population included all randomized participants.

reporting Status

POSTED

time Frame

Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

title

Time to Tumor Progression Free Survival

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice