NCT00753688 · OUTCOME

PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)

Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy · Source last updated 2013-08-22

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

Measure: MEDIAN
Unit: weeks
Interval / dispersion: 95% Confidence Interval
Time frame: From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months)

What was measured

PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. Participants were analyzed for PFS in histology subgroups of STS (as per the World Health Organization \[WHO\] classification, 2008): leiomyosarcoma (malignant cancer of smooth muscle), synovial sarcoma (cancer near the joints of the arm or leg), and other STS (without the tumor type of leiomyosarcoma or synovial sarcoma), based on independent review.The Kaplan-Meier method was used for PFS estimates.

Analysis population: ITT Population. The "n"s in the category titles represent the number of participants in each treatment arm with the indicated STS.

Groups in this outcome

Placebo

Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent

Pazopanib

Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent

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
Placebo	123
Pazopanib	246

Reported measurements

Leiomyosarcoma, n=49, 109

Values in weeks · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo	8.1	Not reported	7.6	9.3	Not reported
Pazopanib	20.1	Not reported	13.3	23.1	Not reported

Synovial sarcoma, n=13, 25

Values in weeks · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo	4.1	Not reported	3.7	8.9	Not reported
Pazopanib	17.9	Not reported	8.9	27.1	Not reported

Other STS, n=61, 112

Values in weeks · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo	4.3	Not reported	4.0	7.9	Not reported
Pazopanib	20.1	Not reported	13.0	27.1	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.23
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.60
estimate Comment
The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
p Value Comment
Stratified two-sided log rank p-value for leiomyosarcoma
param Type
Hazard Ratio (HR)
param Value
0.37
statistical Method
Log Rank
tested Non Inferiority
false
ci Lower Limit
0.19
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.98
estimate Comment
The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.005
p Value Comment
Stratified two-sided log rank p-value for synovial sarcoma
param Type
Hazard Ratio (HR)
param Value
0.43
statistical Method
Log Rank
tested Non Inferiority
false
ci Lower Limit
0.25
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.60
estimate Comment
The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
p Value Comment
Stratified two-sided log rank p-value for other STS histologies
param Type
Hazard Ratio (HR)
param Value
0.39
statistical Method
Log Rank
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.23
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.60
estimate Comment
The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
p Value Comment
Stratified two-sided log rank p-value for leiomyosarcoma
param Type
Hazard Ratio (HR)
param Value
0.37
statistical Method
Log Rank
tested Non Inferiority
false
ci Lower Limit
0.19
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.98
estimate Comment
The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.005
p Value Comment
Stratified two-sided log rank p-value for synovial sarcoma
param Type
Hazard Ratio (HR)
param Value
0.43
statistical Method
Log Rank
tested Non Inferiority
false
ci Lower Limit
0.25
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.60
estimate Comment
The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
p Value Comment
Stratified two-sided log rank p-value for other STS histologies
param Type
Hazard Ratio (HR)
param Value
0.39
statistical Method
Log Rank
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
lower Limit
7.6
upper Limit
9.3
value
8.1
group Id
OG001
lower Limit
13.3
upper Limit
23.1
value
20.1
title
Leiomyosarcoma, n=49, 109
categories
measurements
group Id
OG000
lower Limit
3.7
upper Limit
8.9
value
4.1
group Id
OG001
lower Limit
8.9
upper Limit
27.1
value
17.9
title
Synovial sarcoma, n=13, 25
categories
measurements
group Id
OG000
lower Limit
4.0
upper Limit
7.9
value
4.3
group Id
OG001
lower Limit
13.0
upper Limit
27.1
value
20.1
title
Other STS, n=61, 112

denoms

counts
group Id
OG000
value
123
group Id
OG001
value
246
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
id
OG000
title
Placebo
description
Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
id
OG001
title
Pazopanib

param Type

MEDIAN

population Description

ITT Population. The "n"s in the category titles represent the number of participants in each treatment arm with the indicated STS.

reporting Status

POSTED

time Frame

From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months)

title

PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)

type

SECONDARY

unit Of Measure

weeks

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Preserved source evidence · Not medical advice