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NCT01308580 · OUTCOME

Overall Survival (OS)

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer · Source last updated 2017-04-17

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
From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

What was measured

OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.

Analysis population: Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants.

Groups in this outcome

Cabazitaxel 20 mg/m^2

Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

Cabazitaxel 25 mg/m^2

Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

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

Analysis denominator · Participants

GroupSource count
Cabazitaxel 20 mg/m^2598
Cabazitaxel 25 mg/m^2602

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel 20 mg/m^213.4Not reported12.1914.88Not reported
Cabazitaxel 25 mg/m^214.5Not reported13.4715.28Not reported

Source statistical analyses

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

  1. ci Num Sides
    ONE_SIDED
    ci Pct Value
    98.89
    ci Upper Limit
    1.184
    estimate Comment
    Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2
    group Description
    The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 20 mg/m\^2 relative to 25 mg/m\^2 dose group was considered non-inferior if the upper bound of 1-sided 98.89% confidence interval of hazard ratio (20 mg/m\^2 versus 25 mg/m\^2) was less than the non-inferiority margin of 1.214.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Non-inferiority margin of 1.214
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Hazard Ratio (HR)
    param Value
    1.024
  2. ci Lower Limit
    0.922
    ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    estimate Comment
    Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2
    group Description
    The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 25 mg/m\^2 was considered to be superior to 20 mg/m\^2 dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    1.024
Complete source fields
analyses
  1. ci Num Sides
    ONE_SIDED
    ci Pct Value
    98.89
    ci Upper Limit
    1.184
    estimate Comment
    Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2
    group Description
    The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 20 mg/m\^2 relative to 25 mg/m\^2 dose group was considered non-inferior if the upper bound of 1-sided 98.89% confidence interval of hazard ratio (20 mg/m\^2 versus 25 mg/m\^2) was less than the non-inferiority margin of 1.214.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Non-inferiority margin of 1.214
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Hazard Ratio (HR)
    param Value
    1.024
  2. ci Lower Limit
    0.922
    ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    estimate Comment
    Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2
    group Description
    The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 25 mg/m\^2 was considered to be superior to 20 mg/m\^2 dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    1.024
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.19
        upper Limit
        14.88
        value
        13.4
      2. group Id
        OG001
        lower Limit
        13.47
        upper Limit
        15.28
        value
        14.5
denoms
  1. counts
    1. group Id
      OG000
      value
      598
    2. group Id
      OG001
      value
      602
    units
    Participants
description
OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    OG000
    title
    Cabazitaxel 20 mg/m^2
  2. description
    Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    OG001
    title
    Cabazitaxel 25 mg/m^2
param Type
MEDIAN
population Description
Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants.
reporting Status
POSTED
time Frame
From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice