Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01308580 · OUTCOME

Time to Tumor Progression

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

What was measured

Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method.

Analysis population: Analysis was performed on ITT population.

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^29.0Not reported8.389.79Not reported
Cabazitaxel 25 mg/m^29.3Not reported8.619.92Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.902
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.331
    estimate Comment
    Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2
    group Description
    Hazard ratio was estimated using a 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.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    1.096
Complete source fields
analyses
  1. ci Lower Limit
    0.902
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.331
    estimate Comment
    Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2
    group Description
    Hazard ratio was estimated using a 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.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    1.096
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.38
        upper Limit
        9.79
        value
        9.0
      2. group Id
        OG001
        lower Limit
        8.61
        upper Limit
        9.92
        value
        9.3
denoms
  1. counts
    1. group Id
      OG000
      value
      598
    2. group Id
      OG001
      value
      602
    units
    Participants
description
Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. 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 ITT population.
reporting Status
POSTED
time Frame
From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)
title
Time to Tumor Progression
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice