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NCT01001377 · OUTCOME

Progression-free Survival

ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer · Source last updated 2022-09-21

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.

What was measured

Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions.

Analysis population: Primary analysis set

Groups in this outcome

Cetuximab

Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.

Panitumumab

Panitumumab 6 mg/kg IV every 14 days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cetuximab500
Panitumumab499

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cetuximab4.4Not reported3.24.8Not reported
Panitumumab4.1Not reported3.24.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.2
        upper Limit
        4.8
        value
        4.4
      2. group Id
        OG001
        lower Limit
        3.2
        upper Limit
        4.8
        value
        4.1
denoms
  1. counts
    1. group Id
      OG000
      value
      500
    2. group Id
      OG001
      value
      499
    units
    Participants
description
Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.
    id
    OG000
    title
    Cetuximab
  2. description
    Panitumumab 6 mg/kg IV every 14 days.
    id
    OG001
    title
    Panitumumab
param Type
MEDIAN
population Description
Primary analysis set
reporting Status
POSTED
time Frame
From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
title
Progression-free Survival
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice