Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03329690 · OUTCOME

Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full 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 first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 36 months postdose

What was measured

Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.

Analysis population: Duration of response (DOR) was assessed in the Full 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-8201a61
Physician's Choice Irinotecan7
Physician's Choice Paclitaxel1
Physician's Choice Overall8
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7
Exploratory: Naïve HER2 IHC 1+, DS-8201a4

Reported measurements

Unconfirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019)

Analysis denominator · Participants

GroupSource count
DS-8201a61
Physician's Choice Irinotecan7
Physician's Choice Paclitaxel1
Physician's Choice Overall8
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7
Exploratory: Naïve HER2 IHC 1+, DS-8201a4
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a8.4Not reported021.0Not reported
Physician's Choice Irinotecan4.1Not reported04.9Not reported
Physician's Choice Paclitaxel3.9Not reported3.93.9Not reported
Physician's Choice Overall3.9Not reported04.9Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a6.8Not reported1.49.7Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a7.1Not reported1.412.5Not reported
Unconfirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020)

Analysis denominator · Participants

GroupSource count
DS-8201a61
Physician's Choice Irinotecan7
Physician's Choice Paclitaxel1
Physician's Choice Overall8
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7
Exploratory: Naïve HER2 IHC 1+, DS-8201a4
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a11.3Not reported029.1Not reported
Physician's Choice Irinotecan4.1Not reported04.9Not reported
Physician's Choice Paclitaxel3.9Not reported3.93.9Not reported
Physician's Choice Overall3.9Not reported04.9Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a6.8Not reported1.412.5Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a5.8Not reported1.412.5Not reported
Confirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019)

Analysis denominator · Participants

GroupSource count
DS-8201a51
Physician's Choice Irinotecan6
Physician's Choice Paclitaxel1
Physician's Choice Overall7
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a5
Exploratory: Naïve HER2 IHC 1+, DS-8201a2
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a11.3Not reported1.421.0Not reported
Physician's Choice Irinotecan4.1Not reported1.44.9Not reported
Physician's Choice Paclitaxel3.9Not reported3.93.9Not reported
Physician's Choice Overall3.9Not reported1.44.9Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7.6Not reported2.49.7Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a12.5Not reported8.112.5Not reported
Confirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020)

Analysis denominator · Participants

GroupSource count
DS-8201a50
Physician's Choice Irinotecan6
Physician's Choice Paclitaxel1
Physician's Choice Overall7
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a5
Exploratory: Naïve HER2 IHC 1+, DS-8201a2
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
DS-8201a12.7Not reported1.429.1Not reported
Physician's Choice Irinotecan4.1Not reported1.44.9Not reported
Physician's Choice Paclitaxel3.9Not reported3.93.9Not reported
Physician's Choice Overall3.9Not reported1.44.9Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a7.6Not reported2.412.5Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a11.2Not reported10.012.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        21.0
        value
        8.4
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        4.9
        value
        4.1
      3. group Id
        OG002
        lower Limit
        3.9
        upper Limit
        3.9
        value
        3.9
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        4.9
        value
        3.9
      5. group Id
        OG004
        lower Limit
        1.4
        upper Limit
        9.7
        value
        6.8
      6. group Id
        OG005
        lower Limit
        1.4
        upper Limit
        12.5
        value
        7.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        4
      units
      Participants
    title
    Unconfirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        29.1
        value
        11.3
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        4.9
        value
        4.1
      3. group Id
        OG002
        lower Limit
        3.9
        upper Limit
        3.9
        value
        3.9
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        4.9
        value
        3.9
      5. group Id
        OG004
        lower Limit
        1.4
        upper Limit
        12.5
        value
        6.8
      6. group Id
        OG005
        lower Limit
        1.4
        upper Limit
        12.5
        value
        5.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        4
      units
      Participants
    title
    Unconfirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        21.0
        value
        11.3
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        4.9
        value
        4.1
      3. group Id
        OG002
        lower Limit
        3.9
        upper Limit
        3.9
        value
        3.9
      4. group Id
        OG003
        lower Limit
        1.4
        upper Limit
        4.9
        value
        3.9
      5. group Id
        OG004
        lower Limit
        2.4
        upper Limit
        9.7
        value
        7.6
      6. group Id
        OG005
        lower Limit
        8.1
        upper Limit
        12.5
        value
        12.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        2
      units
      Participants
    title
    Confirmed Duration of response (DOR), 25 months (DCO: Nov 8, 2019)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        29.1
        value
        12.7
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        4.9
        value
        4.1
      3. group Id
        OG002
        lower Limit
        3.9
        upper Limit
        3.9
        value
        3.9
      4. group Id
        OG003
        lower Limit
        1.4
        upper Limit
        4.9
        value
        3.9
      5. group Id
        OG004
        lower Limit
        2.4
        upper Limit
        12.5
        value
        7.6
      6. group Id
        OG005
        lower Limit
        10.0
        upper Limit
        12.5
        value
        11.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        2
      units
      Participants
    title
    Confirmed Duration of response (DOR), 36 months (DCO: Dec 11, 2020)
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      8
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      4
    units
    Participants
description
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.
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 response (DOR) was assessed in the Full Analysis Set.
reporting Status
POSTED
time Frame
From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 36 months postdose
title
Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice