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NCT00417079 · OUTCOME

Overall Survival

XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer · Source last updated 2011-03-10

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 the date of randomization up to 104 weeks (study cut-off)

What was measured

Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.

Analysis population: Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).

Groups in this outcome

Mitoxantrone + Prednisone

mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily

Cabazitaxel + Prednisone

cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily

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

Analysis denominator · Participants

GroupSource count
Mitoxantrone + Prednisone377
Cabazitaxel + Prednisone378

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mitoxantrone + Prednisone12.7Not reported11.613.7Not reported
Cabazitaxel + Prednisone15.1Not reported14.116.3Not reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Description
    The study required an estimated sample size of 720 patients (360 per arm) in order to detect a 25% reduction in the hazard ratio for death in the cabazitaxel group relative to the mitoxantrone group with 90% power. The final analysis was planned for when 511 deaths had occurred.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    A 2-sided significance level of 0.0452 was used for the final analysis based on an interim analysis performed after 307 events with an adjusted significance level of 0.016 based on the O'Brien-Fleming type 1 error spending function.
    statistical Comment
    Analysis was performed by using a log-rank comparisons stratified according to disease measurability and ECOG performance status (0-1 versus 2)
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Description
    The study required an estimated sample size of 720 patients (360 per arm) in order to detect a 25% reduction in the hazard ratio for death in the cabazitaxel group relative to the mitoxantrone group with 90% power. The final analysis was planned for when 511 deaths had occurred.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    A 2-sided significance level of 0.0452 was used for the final analysis based on an interim analysis performed after 307 events with an adjusted significance level of 0.016 based on the O'Brien-Fleming type 1 error spending function.
    statistical Comment
    Analysis was performed by using a log-rank comparisons stratified according to disease measurability and ECOG performance status (0-1 versus 2)
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.6
        upper Limit
        13.7
        value
        12.7
      2. group Id
        OG001
        lower Limit
        14.1
        upper Limit
        16.3
        value
        15.1
denoms
  1. counts
    1. group Id
      OG000
      value
      377
    2. group Id
      OG001
      value
      378
    units
    Participants
description
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.
dispersion Type
95% Confidence Interval
groups
  1. description
    mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    id
    OG000
    title
    Mitoxantrone + Prednisone
  2. description
    cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
    id
    OG001
    title
    Cabazitaxel + Prednisone
param Type
MEDIAN
population Description
Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).
reporting Status
POSTED
time Frame
From the date of randomization up to 104 weeks (study cut-off)
title
Overall Survival
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice