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NCT00789373 · OUTCOME

Investigator-assessed Objective Progression-free Survival (PFS)

A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer · Source last updated 2018-12-14

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
Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)

What was measured

Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

Analysis population: All randomized participants

Groups in this outcome

Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed

pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care

Pemetrexed + Cisplatin Followed by Placebo

pemetrexed + cisplatin followed by placebo plus best supportive care

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

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed359
Pemetrexed + Cisplatin Followed by Placebo180

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed4.11Not reported3.154.57Not reported
Pemetrexed + Cisplatin Followed by Placebo2.83Not reported2.603.12Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.79
    group Description
    900 patients were planned to be enrolled in order to randomize 558 pts to maintenance therapy. This trial was powered for the primary endpoint, PFS (90% power, assuming 238 events with 52% censoring and a PFS Hazard Ratio (HR)=0.65, alpha=0.05). This trial was also powered for a secondary endpoint, OS (93% power, assuming 390 events with 30% censoring and an OS HR=0.70). Alpha was controlled for both a preliminary analysis (alpha=0.0001) and final analysis of OS (alpha=0.0499).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.00006
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.79
    group Description
    900 patients were planned to be enrolled in order to randomize 558 pts to maintenance therapy. This trial was powered for the primary endpoint, PFS (90% power, assuming 238 events with 52% censoring and a PFS Hazard Ratio (HR)=0.65, alpha=0.05). This trial was also powered for a secondary endpoint, OS (93% power, assuming 390 events with 30% censoring and an OS HR=0.70). Alpha was controlled for both a preliminary analysis (alpha=0.0001) and final analysis of OS (alpha=0.0499).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.00006
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.15
        upper Limit
        4.57
        value
        4.11
      2. group Id
        OG001
        lower Limit
        2.60
        upper Limit
        3.12
        value
        2.83
denoms
  1. counts
    1. group Id
      OG000
      value
      359
    2. group Id
      OG001
      value
      180
    units
    Participants
description
Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
    id
    OG000
    title
    Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
  2. description
    pemetrexed + cisplatin followed by placebo plus best supportive care
    id
    OG001
    title
    Pemetrexed + Cisplatin Followed by Placebo
param Type
MEDIAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)
title
Investigator-assessed Objective Progression-free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice