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NCT00122460 · OUTCOME

Best Overall Response

Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME) · Source last updated 2014-07-23

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

What was measured

The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments according to investigator (based on modified WHO criteria).

Analysis population: Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.

Groups in this outcome

Cetuximab Plus Chemotherapy

Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.

Chemotherapy Alone

All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) 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
Cetuximab Plus Chemotherapy222
Chemotherapy Alone220

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cetuximab Plus Chemotherapy35.6Not reported29.342.3Not reported
Chemotherapy Alone19.5Not reported14.525.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.504
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.600
    group Description
    A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0001
    param Type
    Odds Ratio (OR)
    param Value
    2.326
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.504
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.600
    group Description
    A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0001
    param Type
    Odds Ratio (OR)
    param Value
    2.326
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.3
        upper Limit
        42.3
        value
        35.6
      2. group Id
        OG001
        lower Limit
        14.5
        upper Limit
        25.4
        value
        19.5
denoms
  1. counts
    1. group Id
      OG000
      value
      222
    2. group Id
      OG001
      value
      220
    units
    Participants
description
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments according to investigator (based on modified WHO criteria).
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
    id
    OG000
    title
    Cetuximab Plus Chemotherapy
  2. description
    All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
    id
    OG001
    title
    Chemotherapy Alone
param Type
NUMBER
population Description
Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.
reporting Status
POSTED
time Frame
evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007
title
Best Overall Response
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice