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NCT00417079 · OUTCOME

Time to Pain Progression

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 baseline up to 104 weeks (study cut-off)

What was measured

Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score \& noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy. Evaluation of the PPI \& analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)

Analysis population: Analysis was performed on the intention To Treat (ITT) population. Data from 265 and 279 patients in the cabazitaxel and mitoxantrone groups, respectively, were censored as a results of \> 2 PPI and/or AS assessments being missed during the same week (unless a complete evaluation of ≥5 values showed pain progression).

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 + PrednisoneNANot reportedNANAMedian not reached
Cabazitaxel + Prednisone11.1Not reported8.1NAUpper confidence interval unevaluable

Source statistical analyses

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

  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5192
    param Type
    Cox Proportional Hazard
    param Value
    0.91
    statistical Comment
    Log-rank comparisons stratified according to disease measurability and ECOG performance status.
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.5192
    param Type
    Cox Proportional Hazard
    param Value
    0.91
    statistical Comment
    Log-rank comparisons stratified according to disease measurability and ECOG performance status.
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. comment
        Median not reached
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Upper confidence interval unevaluable
        group Id
        OG001
        lower Limit
        8.1
        upper Limit
        NA
        value
        11.1
denoms
  1. counts
    1. group Id
      OG000
      value
      377
    2. group Id
      OG001
      value
      378
    units
    Participants
description
Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score \& noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy. Evaluation of the PPI \& analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)
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. Data from 265 and 279 patients in the cabazitaxel and mitoxantrone groups, respectively, were censored as a results of \> 2 PPI and/or AS assessments being missed during the same week (unless a complete evaluation of ≥5 values showed pain progression).
reporting Status
POSTED
time Frame
from baseline up to 104 weeks (study cut-off)
title
Time to Pain Progression
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice