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NCT03329690 · OUTCOME

Time to Treatment Failure 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
95% Confidence Interval
Time frame
From date of randomization to first documentation of PD, death due to any cause, or treatment discontinuation (whichever comes first), up to 36 months postdose

What was measured

Time to treatment failure (TTF) was defined as the time from the date of randomization (the date of the registration for Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD), death due to any cause, or treatment discontinuation.

Analysis population: Time to treatment failure (TTF) 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-8201a125
Physician's Choice Irinotecan55
Physician's Choice Paclitaxel7
Physician's Choice Overall62
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a20
Exploratory: Naïve HER2 IHC 1+, DS-8201a22

Reported measurements

TTF, 25 months (DCO: Nov 8, 2019)
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
DS-8201a4.2Not reported3.95.1Not reported
Physician's Choice Irinotecan2.6Not reported1.62.8Not reported
Physician's Choice Paclitaxel2.9Not reported1.16.8Not reported
Physician's Choice Overall2.6Not reported1.62.8Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a3.7Not reported1.75.5Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a2.2Not reported1.43.0Not reported
TTF, 36 months (DCO: Dec 11, 2020)
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
DS-8201a4.3Not reported3.95.4Not reported
Physician's Choice Irinotecan2.6Not reported1.62.8Not reported
Physician's Choice Paclitaxel2.9Not reported1.16.8Not reported
Physician's Choice Overall2.6Not reported1.62.8Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a3.7Not reported1.75.5Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a2.2Not reported1.43.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.9
        upper Limit
        5.1
        value
        4.2
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        2.8
        value
        2.6
      3. group Id
        OG002
        lower Limit
        1.1
        upper Limit
        6.8
        value
        2.9
      4. group Id
        OG003
        lower Limit
        1.6
        upper Limit
        2.8
        value
        2.6
      5. group Id
        OG004
        lower Limit
        1.7
        upper Limit
        5.5
        value
        3.7
      6. group Id
        OG005
        lower Limit
        1.4
        upper Limit
        3.0
        value
        2.2
    title
    TTF, 25 months (DCO: Nov 8, 2019)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.9
        upper Limit
        5.4
        value
        4.3
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        2.8
        value
        2.6
      3. group Id
        OG002
        lower Limit
        1.1
        upper Limit
        6.8
        value
        2.9
      4. group Id
        OG003
        lower Limit
        1.6
        upper Limit
        2.8
        value
        2.6
      5. group Id
        OG004
        lower Limit
        1.7
        upper Limit
        5.5
        value
        3.7
      6. group Id
        OG005
        lower Limit
        1.4
        upper Limit
        3.0
        value
        2.2
    title
    TTF, 36 months (DCO: Dec 11, 2020)
denoms
  1. counts
    1. group Id
      OG000
      value
      125
    2. group Id
      OG001
      value
      55
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      62
    5. group Id
      OG004
      value
      20
    6. group Id
      OG005
      value
      22
    units
    Participants
description
Time to treatment failure (TTF) was defined as the time from the date of randomization (the date of the registration for Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD), death due to any cause, or treatment discontinuation.
dispersion Type
95% Confidence Interval
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
Time to treatment failure (TTF) was assessed in the Full Analysis Set.
reporting Status
POSTED
time Frame
From date of randomization to first documentation of PD, death due to any cause, or treatment discontinuation (whichever comes first), up to 36 months postdose
title
Time to Treatment Failure 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

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Preserved source evidence · Not medical advice