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NCT00561470 · OUTCOME

Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen · Source last updated 2012-09-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
Inter-Quartile Range
Time frame
From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)

What was measured

PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC. PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model. The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred.

Analysis population: Intent to Treat (ITT) population included all participants who gave informed consent and were randomized.

Groups in this outcome

Placebo/FOLFIRI

Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks

Aflibercept/FOLFIRI

Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two 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
Placebo/FOLFIRI614
Aflibercept/FOLFIRI612

Analysis denominator · First PFS Events

GroupSource count
Placebo/FOLFIRI454
Aflibercept/FOLFIRI393

Reported measurements

Source class 1
Values in months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Placebo/FOLFIRI4.67Not reported2.609.10Not reported
Aflibercept/FOLFIRI6.90Not reported3.8410.05Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.578
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99.99
    ci Upper Limit
    0.995
    estimate Comment
    Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.00007
    p Value Comment
    Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS
    param Type
    Stratified Hazard ratio
    param Value
    0.758
    statistical Method
    Stratified Log-Rank test
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.578
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99.99
    ci Upper Limit
    0.995
    estimate Comment
    Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.00007
    p Value Comment
    Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS
    param Type
    Stratified Hazard ratio
    param Value
    0.758
    statistical Method
    Stratified Log-Rank test
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.60
        upper Limit
        9.10
        value
        4.67
      2. group Id
        OG001
        lower Limit
        3.84
        upper Limit
        10.05
        value
        6.90
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      614
    2. group Id
      OG001
      value
      612
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      454
    2. group Id
      OG001
      value
      393
    units
    First PFS Events
description
PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC. PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model. The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
    id
    OG000
    title
    Placebo/FOLFIRI
  2. description
    Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
    id
    OG001
    title
    Aflibercept/FOLFIRI
param Type
MEDIAN
population Description
Intent to Treat (ITT) population included all participants who gave informed consent and were randomized.
reporting Status
POSTED
time Frame
From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)
title
Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)
type
SECONDARY
type Units Analyzed
First PFS Events
unit Of Measure
months

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Preserved source evidence · Not medical advice