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NCT00069095 · OUTCOME

Overall Survival: 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
Baseline until disease progression or death, approximately 2 years 6 months

What was measured

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Analysis population: The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive 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+BV937
XELOX/XELOX+P/XELOX+BV967

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV549.0Not reported528576Not reported
XELOX/XELOX+P/XELOX+BV577.0Not reported535615Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.84
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.14
    group Description
    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
    This study was not powered for testing non-inferiority of XELOX vs FOLFOX-4 with respect to overall survival and no margin could be derived following the effect retention concept. The same margins used for the PFS analysis \[Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin)\] were therefore applied to OS as well.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Hazard Ratio (HR)
    param Value
    0.97
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Lower Limit
    0.84
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.14
    group Description
    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
    This study was not powered for testing non-inferiority of XELOX vs FOLFOX-4 with respect to overall survival and no margin could be derived following the effect retention concept. The same margins used for the PFS analysis \[Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin)\] were therefore applied to OS as well.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Hazard Ratio (HR)
    param Value
    0.97
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        528
        upper Limit
        576
        value
        549.0
      2. group Id
        OG001
        lower Limit
        535
        upper Limit
        615
        value
        577.0
denoms
  1. counts
    1. group Id
      OG000
      value
      937
    2. group Id
      OG001
      value
      967
    units
    Participants
description
Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.
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 EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
reporting Status
POSTED
time Frame
Baseline until disease progression or death, approximately 2 years 6 months
title
Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice