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NCT02564263 · OUTCOME

Overall Survival (OS) in All Participants

Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181) · Source last updated 2023-03-13

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
Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

What was measured

OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.

Analysis population: The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.

Groups in this outcome

Pembrolizumab

Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).

Chemotherapy

Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab314
Chemotherapy314

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab7.1Not reported6.28.1Not reported
Chemotherapy7.1Not reported6.38.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    estimate Comment
    Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0531
    p Value Comment
    One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic
    param Type
    Hazard Ratio (HR)
    param Value
    0.89
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    estimate Comment
    Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0531
    p Value Comment
    One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic
    param Type
    Hazard Ratio (HR)
    param Value
    0.89
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.2
        upper Limit
        8.1
        value
        7.1
      2. group Id
        OG001
        lower Limit
        6.3
        upper Limit
        8.0
        value
        7.1
denoms
  1. counts
    1. group Id
      OG000
      value
      314
    2. group Id
      OG001
      value
      314
    units
    Participants
description
OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
    id
    OG000
    title
    Pembrolizumab
  2. description
    Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
reporting Status
POSTED
time Frame
Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
title
Overall Survival (OS) in All Participants
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice