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NCT01308567 · OUTCOME

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer · Source last updated 2019-06-05

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

Measure: LEAST_SQUARES_MEAN
Unit: units on a scale
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)

What was measured

FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.

Analysis population: Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, 'number analyzed' = participants with available data for each specified category.

Groups in this outcome

Docetaxel 75 mg/m^2

Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Cabazitaxel 20 mg/m^2

Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Cabazitaxel 25 mg/m^2

Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

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
Docetaxel 75 mg/m^2	376
Cabazitaxel 20 mg/m^2	371
Cabazitaxel 25 mg/m^2	361

Reported measurements

Change at Cycle 1

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	331
Cabazitaxel 20 mg/m^2	324
Cabazitaxel 25 mg/m^2	318

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	3.31	Not reported	1.05	5.58	Not reported
Cabazitaxel 20 mg/m^2	6.09	Not reported	3.83	8.35	Not reported
Cabazitaxel 25 mg/m^2	5.76	Not reported	3.43	8.09	Not reported

Change at Cycle 2

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	334
Cabazitaxel 20 mg/m^2	337
Cabazitaxel 25 mg/m^2	318

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	4.37	Not reported	2.1	6.64	Not reported
Cabazitaxel 20 mg/m^2	5.96	Not reported	3.7	8.21	Not reported
Cabazitaxel 25 mg/m^2	4.26	Not reported	1.92	6.59	Not reported

Change at Cycle 3

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	325
Cabazitaxel 20 mg/m^2	332
Cabazitaxel 25 mg/m^2	314

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	4.31	Not reported	2.04	6.58	Not reported
Cabazitaxel 20 mg/m^2	5.28	Not reported	3.02	7.53	Not reported
Cabazitaxel 25 mg/m^2	3.65	Not reported	1.31	5.99	Not reported

Change at Cycle 4

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	313
Cabazitaxel 20 mg/m^2	321
Cabazitaxel 25 mg/m^2	301

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	3.39	Not reported	1.11	5.67	Not reported
Cabazitaxel 20 mg/m^2	4.1	Not reported	1.83	6.36	Not reported
Cabazitaxel 25 mg/m^2	3.2	Not reported	0.85	5.55	Not reported

Change at Cycle 5

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	289
Cabazitaxel 20 mg/m^2	285
Cabazitaxel 25 mg/m^2	282

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	3.41	Not reported	1.11	5.7	Not reported
Cabazitaxel 20 mg/m^2	4.05	Not reported	1.76	6.34	Not reported
Cabazitaxel 25 mg/m^2	3.1	Not reported	0.74	5.46	Not reported

Change at Cycle 6

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	270
Cabazitaxel 20 mg/m^2	264
Cabazitaxel 25 mg/m^2	260

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	2.76	Not reported	0.45	5.07	Not reported
Cabazitaxel 20 mg/m^2	3.15	Not reported	0.85	5.46	Not reported
Cabazitaxel 25 mg/m^2	2.88	Not reported	0.5	5.26	Not reported

Change at Cycle 7

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	239
Cabazitaxel 20 mg/m^2	241
Cabazitaxel 25 mg/m^2	240

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	2.29	Not reported	-0.05	4.62	Not reported
Cabazitaxel 20 mg/m^2	3.14	Not reported	0.81	5.47	Not reported
Cabazitaxel 25 mg/m^2	2.94	Not reported	0.54	5.34	Not reported

Change at Cycle 8

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	223
Cabazitaxel 20 mg/m^2	220
Cabazitaxel 25 mg/m^2	222

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	1.67	Not reported	-0.69	4.02	Not reported
Cabazitaxel 20 mg/m^2	2.26	Not reported	-0.09	4.61	Not reported
Cabazitaxel 25 mg/m^2	1.49	Not reported	-0.92	3.91	Not reported

Change at Cycle 9

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	174
Cabazitaxel 20 mg/m^2	192
Cabazitaxel 25 mg/m^2	189

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	1.75	Not reported	-0.67	4.18	Not reported
Cabazitaxel 20 mg/m^2	2.15	Not reported	-0.24	4.53	Not reported
Cabazitaxel 25 mg/m^2	1.73	Not reported	-0.73	4.19	Not reported

Change at Cycle 10

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	148
Cabazitaxel 20 mg/m^2	163
Cabazitaxel 25 mg/m^2	163

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	1.52	Not reported	-0.96	4	Not reported
Cabazitaxel 20 mg/m^2	1.56	Not reported	-0.88	3.99	Not reported
Cabazitaxel 25 mg/m^2	1.62	Not reported	-0.89	4.12	Not reported

Change at Cycle 11

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	99
Cabazitaxel 20 mg/m^2	115
Cabazitaxel 25 mg/m^2	110

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	0.35	Not reported	-2.29	3	Not reported
Cabazitaxel 20 mg/m^2	2.72	Not reported	0.15	5.3	Not reported
Cabazitaxel 25 mg/m^2	2.19	Not reported	-0.46	4.84	Not reported

Change at Cycle 12

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	82
Cabazitaxel 20 mg/m^2	97
Cabazitaxel 25 mg/m^2	98

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	1.04	Not reported	-1.7	3.79	Not reported
Cabazitaxel 20 mg/m^2	3.08	Not reported	0.43	5.73	Not reported
Cabazitaxel 25 mg/m^2	0.75	Not reported	-1.95	3.46	Not reported

Change at Cycle 13

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	57
Cabazitaxel 20 mg/m^2	85
Cabazitaxel 25 mg/m^2	81

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	2.13	Not reported	-0.85	5.11	Not reported
Cabazitaxel 20 mg/m^2	1.78	Not reported	-0.94	4.5	Not reported
Cabazitaxel 25 mg/m^2	0.82	Not reported	-1.98	3.62	Not reported

Change at Cycle 14

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	54
Cabazitaxel 20 mg/m^2	78
Cabazitaxel 25 mg/m^2	71

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-0.13	Not reported	-3.15	2.89	Not reported
Cabazitaxel 20 mg/m^2	1.59	Not reported	-1.18	4.36	Not reported
Cabazitaxel 25 mg/m^2	-0.07	Not reported	-2.95	2.81	Not reported

Change at Cycle 15

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	44
Cabazitaxel 20 mg/m^2	71
Cabazitaxel 25 mg/m^2	63

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-2.1	Not reported	-5.29	1.09	Not reported
Cabazitaxel 20 mg/m^2	1.29	Not reported	-1.53	4.11	Not reported
Cabazitaxel 25 mg/m^2	1.49	Not reported	-1.47	4.45	Not reported

Change at Cycle 16

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	42
Cabazitaxel 20 mg/m^2	58
Cabazitaxel 25 mg/m^2	57

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-2.26	Not reported	-5.49	0.97	Not reported
Cabazitaxel 20 mg/m^2	1.23	Not reported	-1.73	4.19	Not reported
Cabazitaxel 25 mg/m^2	1.44	Not reported	-1.59	4.47	Not reported

Change at Follow-up 1

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	173
Cabazitaxel 20 mg/m^2	183
Cabazitaxel 25 mg/m^2	171

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-0.96	Not reported	-3.38	1.47	Not reported
Cabazitaxel 20 mg/m^2	-1.26	Not reported	-3.66	1.14	Not reported
Cabazitaxel 25 mg/m^2	-1.62	Not reported	-4.11	0.86	Not reported

Change at Follow-up 2

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	143
Cabazitaxel 20 mg/m^2	127
Cabazitaxel 25 mg/m^2	132

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-0.07	Not reported	-2.56	2.42	Not reported
Cabazitaxel 20 mg/m^2	-1.12	Not reported	-3.65	1.41	Not reported
Cabazitaxel 25 mg/m^2	-1.05	Not reported	-3.62	1.53	Not reported

Change at Follow-up 3

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	109
Cabazitaxel 20 mg/m^2	101
Cabazitaxel 25 mg/m^2	99

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-0.32	Not reported	-2.92	2.28	Not reported
Cabazitaxel 20 mg/m^2	-1.67	Not reported	-4.29	0.96	Not reported
Cabazitaxel 25 mg/m^2	-1.98	Not reported	-4.68	0.72	Not reported

Change at Follow-up 4

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	87
Cabazitaxel 20 mg/m^2	71
Cabazitaxel 25 mg/m^2	81

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-0.91	Not reported	-3.62	1.8	Not reported
Cabazitaxel 20 mg/m^2	-2.54	Not reported	-5.36	0.29	Not reported
Cabazitaxel 25 mg/m^2	-1.03	Not reported	-3.84	1.78	Not reported

Change at Follow-up 5

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	70
Cabazitaxel 20 mg/m^2	62
Cabazitaxel 25 mg/m^2	76

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-2.15	Not reported	-4.99	0.69	Not reported
Cabazitaxel 20 mg/m^2	-5.36	Not reported	-8.27	-2.44	Not reported
Cabazitaxel 25 mg/m^2	-0.82	Not reported	-3.67	2.02	Not reported

Change at Follow-up 6

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	58
Cabazitaxel 20 mg/m^2	45
Cabazitaxel 25 mg/m^2	55

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-1.77	Not reported	-4.75	1.2	Not reported
Cabazitaxel 20 mg/m^2	-5.32	Not reported	-8.49	-2.16	Not reported
Cabazitaxel 25 mg/m^2	-2.76	Not reported	-5.82	0.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.05
upper Limit
5.58
value
3.31
group Id
OG001
lower Limit
3.83
upper Limit
8.35
value
6.09
group Id
OG002
lower Limit
3.43
upper Limit
8.09
value
5.76
denoms
counts
group Id
OG000
value
331
group Id
OG001
value
324
group Id
OG002
value
318
units
Participants
title
Change at Cycle 1
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
6.64
value
4.37
group Id
OG001
lower Limit
3.7
upper Limit
8.21
value
5.96
group Id
OG002
lower Limit
1.92
upper Limit
6.59
value
4.26
denoms
counts
group Id
OG000
value
334
group Id
OG001
value
337
group Id
OG002
value
318
units
Participants
title
Change at Cycle 2
categories
measurements
group Id
OG000
lower Limit
2.04
upper Limit
6.58
value
4.31
group Id
OG001
lower Limit
3.02
upper Limit
7.53
value
5.28
group Id
OG002
lower Limit
1.31
upper Limit
5.99
value
3.65
denoms
counts
group Id
OG000
value
325
group Id
OG001
value
332
group Id
OG002
value
314
units
Participants
title
Change at Cycle 3
categories
measurements
group Id
OG000
lower Limit
1.11
upper Limit
5.67
value
3.39
group Id
OG001
lower Limit
1.83
upper Limit
6.36
value
4.1
group Id
OG002
lower Limit
0.85
upper Limit
5.55
value
3.2
denoms
counts
group Id
OG000
value
313
group Id
OG001
value
321
group Id
OG002
value
301
units
Participants
title
Change at Cycle 4
categories
measurements
group Id
OG000
lower Limit
1.11
upper Limit
5.7
value
3.41
group Id
OG001
lower Limit
1.76
upper Limit
6.34
value
4.05
group Id
OG002
lower Limit
0.74
upper Limit
5.46
value
3.1
denoms
counts
group Id
OG000
value
289
group Id
OG001
value
285
group Id
OG002
value
282
units
Participants
title
Change at Cycle 5
categories
measurements
group Id
OG000
lower Limit
0.45
upper Limit
5.07
value
2.76
group Id
OG001
lower Limit
0.85
upper Limit
5.46
value
3.15
group Id
OG002
lower Limit
0.5
upper Limit
5.26
value
2.88
denoms
counts
group Id
OG000
value
270
group Id
OG001
value
264
group Id
OG002
value
260
units
Participants
title
Change at Cycle 6
categories
measurements
group Id
OG000
lower Limit
-0.05
upper Limit
4.62
value
2.29
group Id
OG001
lower Limit
0.81
upper Limit
5.47
value
3.14
group Id
OG002
lower Limit
0.54
upper Limit
5.34
value
2.94
denoms
counts
group Id
OG000
value
239
group Id
OG001
value
241
group Id
OG002
value
240
units
Participants
title
Change at Cycle 7
categories
measurements
group Id
OG000
lower Limit
-0.69
upper Limit
4.02
value
1.67
group Id
OG001
lower Limit
-0.09
upper Limit
4.61
value
2.26
group Id
OG002
lower Limit
-0.92
upper Limit
3.91
value
1.49
denoms
counts
group Id
OG000
value
223
group Id
OG001
value
220
group Id
OG002
value
222
units
Participants
title
Change at Cycle 8
categories
measurements
group Id
OG000
lower Limit
-0.67
upper Limit
4.18
value
1.75
group Id
OG001
lower Limit
-0.24
upper Limit
4.53
value
2.15
group Id
OG002
lower Limit
-0.73
upper Limit
4.19
value
1.73
denoms
counts
group Id
OG000
value
174
group Id
OG001
value
192
group Id
OG002
value
189
units
Participants
title
Change at Cycle 9
categories
measurements
group Id
OG000
lower Limit
-0.96
upper Limit
4
value
1.52
group Id
OG001
lower Limit
-0.88
upper Limit
3.99
value
1.56
group Id
OG002
lower Limit
-0.89
upper Limit
4.12
value
1.62
denoms
counts
group Id
OG000
value
148
group Id
OG001
value
163
group Id
OG002
value
163
units
Participants
title
Change at Cycle 10
categories
measurements
group Id
OG000
lower Limit
-2.29
upper Limit
3
value
0.35
group Id
OG001
lower Limit
0.15
upper Limit
5.3
value
2.72
group Id
OG002
lower Limit
-0.46
upper Limit
4.84
value
2.19
denoms
counts
group Id
OG000
value
99
group Id
OG001
value
115
group Id
OG002
value
110
units
Participants
title
Change at Cycle 11
categories
measurements
group Id
OG000
lower Limit
-1.7
upper Limit
3.79
value
1.04
group Id
OG001
lower Limit
0.43
upper Limit
5.73
value
3.08
group Id
OG002
lower Limit
-1.95
upper Limit
3.46
value
0.75
denoms
counts
group Id
OG000
value
82
group Id
OG001
value
97
group Id
OG002
value
98
units
Participants
title
Change at Cycle 12

denoms

counts
group Id
OG000
value
376
group Id
OG001
value
371
group Id
OG002
value
361
units
Participants

description

FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.

dispersion Type

95% Confidence Interval

groups

description
Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
id
OG000
title
Docetaxel 75 mg/m^2
description
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
id
OG001
title
Cabazitaxel 20 mg/m^2
description
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
id
OG002
title
Cabazitaxel 25 mg/m^2

param Type

LEAST_SQUARES_MEAN

population Description

Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains. Here, 'number analyzed' = participants with available data for each specified category.

reporting Status

POSTED

time Frame

Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)

title

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice