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NCT00069095 · OUTCOME

Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4

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 took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during 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/FOLFOX-4+P/FOLFOX-4+BV

Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: 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 (given on day 1). 2. Folfox-4+P: 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 placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. 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).

XELOX/XELOX+P/XELOX+BV

Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: 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 (given on day 1). 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). 3. 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/FOLFOX-4+P/FOLFOX-4+BV990
XELOX/XELOX+P/XELOX+BV1008

Reported measurements

General Approach
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV191.0Not reported183202Not reported
XELOX/XELOX+P/XELOX+BV179.0Not reported171187Not reported
On-treatment Approach
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV190.0Not reported182200Not reported
XELOX/XELOX+P/XELOX+BV176.0Not reported170185Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.20
    group Description
    General approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    No formal statistical testing was done.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Hazard Ratio (HR)
    param Value
    1.08
    tested Non Inferiority
    true
  2. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.23
    group Description
    On-treatment Approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Fewer events were expected in analyses using the on-treatment approach than in the analyses using the general approach, thus leading to reduced power.Therefore, no formal statistical testing was performed.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Hazard Ratio (HR)
    param Value
    1.10
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Lower Limit
    0.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.20
    group Description
    General approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    No formal statistical testing was done.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Hazard Ratio (HR)
    param Value
    1.08
    tested Non Inferiority
    true
  2. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.23
    group Description
    On-treatment Approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Fewer events were expected in analyses using the on-treatment approach than in the analyses using the general approach, thus leading to reduced power.Therefore, no formal statistical testing was performed.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Hazard Ratio (HR)
    param Value
    1.10
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        183
        upper Limit
        202
        value
        191.0
      2. group Id
        OG001
        lower Limit
        171
        upper Limit
        187
        value
        179.0
    title
    General Approach
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        182
        upper Limit
        200
        value
        190.0
      2. group Id
        OG001
        lower Limit
        170
        upper Limit
        185
        value
        176.0
    title
    On-treatment Approach
denoms
  1. counts
    1. group Id
      OG000
      value
      990
    2. group Id
      OG001
      value
      1008
    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 took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during 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 initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: 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 (given on day 1). 2. Folfox-4+P: 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 placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. 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).
    id
    OG000
    title
    FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
  2. description
    Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: 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 (given on day 1). 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). 3. 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
    XELOX/XELOX+P/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 (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
type
SECONDARY
unit Of Measure
days

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