Percentage of Participants With Best Overall Response Based on 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, up to 36 months postdose
What was measured
The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by independent central imaging review (ICR) based on RECIST version 1.1. 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 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. Unconfirmed BOR (not confirmed by ICR) and confirmed BOR (confirmed by ICR) are reported.
Analysis population: Best overall response was assessed in the Primary Cohort 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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
DS-8201a
126
Physician's Choice Irinotecan
55
Physician's Choice Paclitaxel
7
Physician's Choice Overall
62
Reported measurements
Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
11
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
0
Not reported
Not reported
Not reported
Not reported
Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
10
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
0
Not reported
Not reported
Not reported
Not reported
Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
50
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
7
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
1
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
8
Not reported
Not reported
Not reported
Not reported
Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
51
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
7
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
1
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
8
Not reported
Not reported
Not reported
Not reported
Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
46
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
27
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
30
Not reported
Not reported
Not reported
Not reported
Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
47
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
27
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
30
Not reported
Not reported
Not reported
Not reported
Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
15
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
18
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
18
Not reported
Not reported
Not reported
Not reported
Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
15
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
18
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
18
Not reported
Not reported
Not reported
Not reported
Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
4
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
6
Not reported
Not reported
Not reported
Not reported
Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
6
Not reported
Not reported
Not reported
Not reported
Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
10
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
0
Not reported
Not reported
Not reported
Not reported
Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
9
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
0
Not reported
Not reported
Not reported
Not reported
Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
41
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
6
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
1
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
7
Not reported
Not reported
Not reported
Not reported
Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
41
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
6
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
1
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
7
Not reported
Not reported
Not reported
Not reported
Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
55
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
28
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
31
Not reported
Not reported
Not reported
Not reported
Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
57
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
28
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
31
Not reported
Not reported
Not reported
Not reported
Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
15
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
18
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
18
Not reported
Not reported
Not reported
Not reported
Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
15
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
18
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
18
Not reported
Not reported
Not reported
Not reported
Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
5
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
6
Not reported
Not reported
Not reported
Not reported
Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
4
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
6
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
50
group Id
OG001
value
7
group Id
OG002
value
1
group Id
OG003
value
8
title
Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
51
group Id
OG001
value
7
group Id
OG002
value
1
group Id
OG003
value
8
title
Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
46
group Id
OG001
value
27
group Id
OG002
value
3
group Id
OG003
value
30
title
Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
47
group Id
OG001
value
27
group Id
OG002
value
3
group Id
OG003
value
30
title
Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
18
group Id
OG002
value
0
group Id
OG003
value
18
title
Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
18
group Id
OG002
value
0
group Id
OG003
value
18
title
Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
6
title
Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
6
title
Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
denoms
counts
group Id
OG000
value
126
group Id
OG001
value
55
group Id
OG002
value
7
group Id
OG003
value
62
units
Participants
description
The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by independent central imaging review (ICR) based on RECIST version 1.1. 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 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. Unconfirmed BOR (not confirmed by ICR) and confirmed BOR (confirmed by ICR) are reported.
groups
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
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
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
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
param Type
COUNT_OF_PARTICIPANTS
population Description
Best overall response was assessed in the Primary Cohort in the Intent-to-Treat Analysis Set.
reporting Status
POSTED
time Frame
Baseline to date of first documented objective response, up to 36 months postdose
title
Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
Triangle