NCT01308567 · OUTCOME

Progression Free Survival (PFS)

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, PSA progression, pain progression or death (maximum duration: 51 months)

What was measured

PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. 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	5.3	Not reported	4.86	5.78	Not reported
Cabazitaxel 20 mg/m^2	4.4	Not reported	3.91	5.09	Not reported
Cabazitaxel 25 mg/m^2	5.1	Not reported	4.60	5.72	Not reported

Source statistical analyses

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

ci Lower Limit
0.849
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.152
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
0.989
ci Lower Limit
0.913
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.236
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
1.063

Complete source fields

analyses

ci Lower Limit
0.849
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.152
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
0.989
ci Lower Limit
0.913
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.236
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
1.063

classes

categories
measurements
group Id
OG000
lower Limit
4.86
upper Limit
5.78
value
5.3
group Id
OG001
lower Limit
3.91
upper Limit
5.09
value
4.4
group Id
OG002
lower Limit
4.60
upper Limit
5.72
value
5.1

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, PSA progression, pain progression or death (maximum duration: 51 months)

title

Progression Free Survival (PFS)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice