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NCT03329690 · OUTCOME

Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01] · Source last updated 2022-03-18

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
From the date of randomization to the date of death (due to any cause), up to 36 months postdose

What was measured

Duration of survival follow-up (months) was defined as the date of last contact - date of randomization/ registration + 1.Overall Survival (OS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the date of death due to any cause.

Analysis population: Duration of survival and overall survival were assessed in the Intent-to-Treat Analysis Set.

Groups in this outcome

DS-8201a

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.

Physician's Choice Irinotecan

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.

Physician's Choice Paclitaxel

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.

Physician's Choice Overall

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.

Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a

Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.

Exploratory: Naïve HER2 IHC 1+, DS-8201a

Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once 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
DS-8201a126
Physician's Choice Irinotecan55
Physician's Choice Paclitaxel7
Physician's Choice Overall62
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a21
Exploratory: Naïve HER2 IHC 1+, DS-8201a22

Reported measurements

Duration of survival follow up, 25 months (DCO: Nov 8, 2019)
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a8.0Not reported0.423.1Not reported
Physician's Choice Irinotecan7.1Not reported0.320.3Not reported
Physician's Choice Paclitaxel5.5Not reported2.014.3Not reported
Physician's Choice Overall7.0Not reported0.320.3Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7.3Not reported0.219.6Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a8.4Not reported1.814.8Not reported
Duration of survival follow up, 36 months (DCO: Dec 11, 2020)
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a12.3Not reported0.433.2Not reported
Physician's Choice Irinotecan8.4Not reported0.329.3Not reported
Physician's Choice Paclitaxel14.3Not reported2.022.1Not reported
Physician's Choice Overall8.5Not reported0.329.3Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7.3Not reported0.227.7Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a8.5Not reported1.823.1Not reported
Overall survival, 25 months (DCO: Nov 8, 2019)
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a12.5Not reported0.423.1Not reported
Physician's Choice Irinotecan8.4Not reported0.320.3Not reported
Physician's Choice Paclitaxel14.3Not reported2.014.3Not reported
Physician's Choice Overall8.4Not reported0.320.3Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7.8Not reported0.219.6Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a8.5Not reported1.814.8Not reported
Overall survival, 36 months (DCO: Dec 11, 2020)
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a12.6Not reported0.433.2Not reported
Physician's Choice Irinotecan8.6Not reported0.329.3Not reported
Physician's Choice Paclitaxel14.3Not reported2.022.1Not reported
Physician's Choice Overall8.9Not reported0.329.3Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7.8Not reported0.227.7Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a8.5Not reported1.823.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        23.1
        value
        8.0
      2. group Id
        OG001
        lower Limit
        0.3
        upper Limit
        20.3
        value
        7.1
      3. group Id
        OG002
        lower Limit
        2.0
        upper Limit
        14.3
        value
        5.5
      4. group Id
        OG003
        lower Limit
        0.3
        upper Limit
        20.3
        value
        7.0
      5. group Id
        OG004
        lower Limit
        0.2
        upper Limit
        19.6
        value
        7.3
      6. group Id
        OG005
        lower Limit
        1.8
        upper Limit
        14.8
        value
        8.4
    title
    Duration of survival follow up, 25 months (DCO: Nov 8, 2019)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        33.2
        value
        12.3
      2. group Id
        OG001
        lower Limit
        0.3
        upper Limit
        29.3
        value
        8.4
      3. group Id
        OG002
        lower Limit
        2.0
        upper Limit
        22.1
        value
        14.3
      4. group Id
        OG003
        lower Limit
        0.3
        upper Limit
        29.3
        value
        8.5
      5. group Id
        OG004
        lower Limit
        0.2
        upper Limit
        27.7
        value
        7.3
      6. group Id
        OG005
        lower Limit
        1.8
        upper Limit
        23.1
        value
        8.5
    title
    Duration of survival follow up, 36 months (DCO: Dec 11, 2020)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        23.1
        value
        12.5
      2. group Id
        OG001
        lower Limit
        0.3
        upper Limit
        20.3
        value
        8.4
      3. group Id
        OG002
        lower Limit
        2.0
        upper Limit
        14.3
        value
        14.3
      4. group Id
        OG003
        lower Limit
        0.3
        upper Limit
        20.3
        value
        8.4
      5. group Id
        OG004
        lower Limit
        0.2
        upper Limit
        19.6
        value
        7.8
      6. group Id
        OG005
        lower Limit
        1.8
        upper Limit
        14.8
        value
        8.5
    title
    Overall survival, 25 months (DCO: Nov 8, 2019)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        33.2
        value
        12.6
      2. group Id
        OG001
        lower Limit
        0.3
        upper Limit
        29.3
        value
        8.6
      3. group Id
        OG002
        lower Limit
        2.0
        upper Limit
        22.1
        value
        14.3
      4. group Id
        OG003
        lower Limit
        0.3
        upper Limit
        29.3
        value
        8.9
      5. group Id
        OG004
        lower Limit
        0.2
        upper Limit
        27.7
        value
        7.8
      6. group Id
        OG005
        lower Limit
        1.8
        upper Limit
        23.1
        value
        8.5
    title
    Overall survival, 36 months (DCO: Dec 11, 2020)
denoms
  1. counts
    1. group Id
      OG000
      value
      126
    2. group Id
      OG001
      value
      55
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      62
    5. group Id
      OG004
      value
      21
    6. group Id
      OG005
      value
      22
    units
    Participants
description
Duration of survival follow-up (months) was defined as the date of last contact - date of randomization/ registration + 1.Overall Survival (OS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the date of death due to any cause.
dispersion Type
Full Range
groups
  1. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
    id
    OG000
    title
    DS-8201a
  2. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
    id
    OG001
    title
    Physician's Choice Irinotecan
  3. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
    id
    OG002
    title
    Physician's Choice Paclitaxel
  4. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
    id
    OG003
    title
    Physician's Choice Overall
  5. description
    Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
    id
    OG004
    title
    Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
  6. description
    Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
    id
    OG005
    title
    Exploratory: Naïve HER2 IHC 1+, DS-8201a
param Type
MEDIAN
population Description
Duration of survival and overall survival were assessed in the Intent-to-Treat Analysis Set.
reporting Status
POSTED
time Frame
From the date of randomization to the date of death (due to any cause), up to 36 months postdose
title
Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice