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NCT03329690 · OUTCOME

Disease Control Rate With and Without Confirmation by Independent Central Review 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline to date of first documented objective response (CR, PR, and SD), up to 36 months postdose

What was measured

Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

Analysis population: Disease control rate (DCR) was assessed in the Intent-to-Treat 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

DCR, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DS-8201a107Not reportedNot reportedNot reportedNot reported
Physician's Choice Irinotecan34Not reportedNot reportedNot reportedNot reported
Physician's Choice Paclitaxel4Not reportedNot reportedNot reportedNot reported
Physician's Choice Overall38Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a17Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a15Not reportedNot reportedNot reportedNot reported
DCR, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DS-8201a108Not reportedNot reportedNot reportedNot reported
Physician's Choice Irinotecan34Not reportedNot reportedNot reportedNot reported
Physician's Choice Paclitaxel4Not reportedNot reportedNot reportedNot reported
Physician's Choice Overall38Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a17Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        107
      2. group Id
        OG001
        value
        34
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        38
      5. group Id
        OG004
        value
        17
      6. group Id
        OG005
        value
        15
    title
    DCR, 25 months (DCO: Nov 8, 2019)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        34
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        38
      5. group Id
        OG004
        value
        17
      6. group Id
        OG005
        value
        15
    title
    DCR, 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
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
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
COUNT_OF_PARTICIPANTS
population Description
Disease control rate (DCR) was assessed in the Intent-to-Treat Set.
reporting Status
POSTED
time Frame
Baseline to date of first documented objective response (CR, PR, and SD), up to 36 months postdose
title
Disease Control Rate With and Without Confirmation by Independent Central Review 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
Participants

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

Preserved source evidence · Not medical advice