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NCT00069095 · OUTCOME

Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone

A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer · Source last updated 2016-10-06

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

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
From baseline until disease progression/recurrence, approximately 2 years 6 months

What was measured

Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.

Analysis population: The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

Groups in this outcome

FOLFOX-4+P/XELOX+P

Participants from the 2x2 factorial part of the study including the following groups - 1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).

FOLFOX-4+BV/XELOX+BV

Participants from the 2x2 factorial part of the study including the following groups - 1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks). 2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 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
FOLFOX-4+P/XELOX+P675
FOLFOX-4+BV/XELOX+BV694

Reported measurements

General Approach
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FOLFOX-4+P/XELOX+P183.0Not reported176198Not reported
FOLFOX-4+BV/XELOX+BV209.0Not reported199220Not reported
On-treatment Approach
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FOLFOX-4+P/XELOX+P182.0Not reported175196Not reported
FOLFOX-4+BV/XELOX+BV208.0Not reported198220Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    0.96
    group Description
    General approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0030
    param Type
    Hazard Ratio (HR)
    param Value
    0.84
    statistical Method
    Log Rank
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.70
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    0.92
    group Description
    On treatment approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0004
    param Type
    Hazard Ratio (HR)
    param Value
    0.81
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    0.96
    group Description
    General approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0030
    param Type
    Hazard Ratio (HR)
    param Value
    0.84
    statistical Method
    Log Rank
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.70
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    0.92
    group Description
    On treatment approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0004
    param Type
    Hazard Ratio (HR)
    param Value
    0.81
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        176
        upper Limit
        198
        value
        183.0
      2. group Id
        OG001
        lower Limit
        199
        upper Limit
        220
        value
        209.0
    title
    General Approach
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        175
        upper Limit
        196
        value
        182.0
      2. group Id
        OG001
        lower Limit
        198
        upper Limit
        220
        value
        208.0
    title
    On-treatment Approach
denoms
  1. counts
    1. group Id
      OG000
      value
      675
    2. group Id
      OG001
      value
      694
    units
    Participants
description
Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants from the 2x2 factorial part of the study including the following groups - 1. Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).
    id
    OG000
    title
    FOLFOX-4+P/XELOX+P
  2. description
    Participants from the 2x2 factorial part of the study including the following groups - 1. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks). 2. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
    id
    OG001
    title
    FOLFOX-4+BV/XELOX+BV
param Type
MEDIAN
population Description
The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
reporting Status
POSTED
time Frame
From baseline until disease progression/recurrence, approximately 2 years 6 months
title
Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice