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NCT00069095 · OUTCOME

Duration of Overall Response 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

Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. 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+BV239.0Not reported225256Not reported
XELOX/XELOX+P/XELOX+BV226.0Not reported211246Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.22
    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
    No formal statistical testing was performed for duration of overall response.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Hazard Ratio (HR)
    param Value
    1.02
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Lower Limit
    0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    1.22
    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
    No formal statistical testing was performed for duration of overall response.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    param Type
    Hazard Ratio (HR)
    param Value
    1.02
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        225
        upper Limit
        256
        value
        239.0
      2. group Id
        OG001
        lower Limit
        211
        upper Limit
        246
        value
        226.0
denoms
  1. counts
    1. group Id
      OG000
      value
      937
    2. group Id
      OG001
      value
      967
    units
    Participants
description
Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. 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
From baseline until disease progression/recurrence, approximately 2 years 6 months
title
Duration of Overall Response 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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