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NCT02485691 · OUTCOME

Radiographic Progression-Free Survival (rPFS)

Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent · Source last updated 2022-05-27

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 randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)

What was measured

Radiographic progression-free survival: time (in months) from randomization to occurrence of any one of following: radiological tumor progressions using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 2 (PCWG2) criteria or occurrence of death due to any cause. Progression as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with \>= 2 new lesions compared to Baseline observed less than (\<) 12 weeks from randomization and confirmed by a second bone scan performed \>=6 weeks; first bone scan with \>=2 new lesions compared to Baseline observed \>=12 weeks from randomization. In accordance with protocol, data cut-off date for final analysis of this endpoint was the date when 196 rPFS events had occurred. Analysis done by Kaplan-Meier method.

Analysis population: Analysis was performed on ITT population.

Groups in this outcome

Cabazitaxel

Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).

Abiraterone Acetate or Enzalutamide

Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).

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

Analysis denominator · Participants

GroupSource count
Cabazitaxel129
Abiraterone Acetate or Enzalutamide126

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabazitaxel8.0Not reported5.79.2Not reported
Abiraterone Acetate or Enzalutamide3.7Not reported2.85.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.73
    estimate Comment
    Cabazitaxel vs Abiraterone Acetate or Enzalutamide
    group Description
    Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    P-value from 2-sided stratified log-rank test, stratified for ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization. Significance threshold was at 0.05.
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.73
    estimate Comment
    Cabazitaxel vs Abiraterone Acetate or Enzalutamide
    group Description
    Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    P-value from 2-sided stratified log-rank test, stratified for ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization. Significance threshold was at 0.05.
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.7
        upper Limit
        9.2
        value
        8.0
      2. group Id
        OG001
        lower Limit
        2.8
        upper Limit
        5.1
        value
        3.7
denoms
  1. counts
    1. group Id
      OG000
      value
      129
    2. group Id
      OG001
      value
      126
    units
    Participants
description
Radiographic progression-free survival: time (in months) from randomization to occurrence of any one of following: radiological tumor progressions using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 2 (PCWG2) criteria or occurrence of death due to any cause. Progression as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with \>= 2 new lesions compared to Baseline observed less than (\<) 12 weeks from randomization and confirmed by a second bone scan performed \>=6 weeks; first bone scan with \>=2 new lesions compared to Baseline observed \>=12 weeks from randomization. In accordance with protocol, data cut-off date for final analysis of this endpoint was the date when 196 rPFS events had occurred. Analysis done by Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
    id
    OG000
    title
    Cabazitaxel
  2. description
    Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
    id
    OG001
    title
    Abiraterone Acetate or Enzalutamide
param Type
MEDIAN
population Description
Analysis was performed on ITT population.
reporting Status
POSTED
time Frame
From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
title
Radiographic Progression-Free Survival (rPFS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice