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NCT01308567 · OUTCOME

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (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). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated 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	375
Cabazitaxel 20 mg/m^2	370
Cabazitaxel 25 mg/m^2	361

Reported measurements

Change at Cycle 1

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	333
Cabazitaxel 20 mg/m^2	323
Cabazitaxel 25 mg/m^2	321

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	4.17	Not reported	1.3	7.05	Not reported
Cabazitaxel 20 mg/m^2	7.66	Not reported	4.79	10.53	Not reported
Cabazitaxel 25 mg/m^2	6.93	Not reported	3.97	9.88	Not reported

Change at Cycle 2

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	339
Cabazitaxel 20 mg/m^2	339
Cabazitaxel 25 mg/m^2	323

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	5.33	Not reported	2.46	8.2	Not reported
Cabazitaxel 20 mg/m^2	7.15	Not reported	4.28	10.01	Not reported
Cabazitaxel 25 mg/m^2	5.28	Not reported	2.32	8.24	Not reported

Change at Cycle 3

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	330
Cabazitaxel 20 mg/m^2	332
Cabazitaxel 25 mg/m^2	316

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	4.94	Not reported	2.06	7.82	Not reported
Cabazitaxel 20 mg/m^2	6.79	Not reported	3.93	9.66	Not reported
Cabazitaxel 25 mg/m^2	4.61	Not reported	1.64	7.58	Not reported

Change at Cycle 4

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	316
Cabazitaxel 20 mg/m^2	323
Cabazitaxel 25 mg/m^2	302

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	4.07	Not reported	1.17	6.96	Not reported
Cabazitaxel 20 mg/m^2	5.22	Not reported	2.35	8.09	Not reported
Cabazitaxel 25 mg/m^2	4.01	Not reported	1.03	6.99	Not reported

Change at Cycle 5

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	293
Cabazitaxel 20 mg/m^2	290
Cabazitaxel 25 mg/m^2	283

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	4.36	Not reported	1.44	7.27	Not reported
Cabazitaxel 20 mg/m^2	5.16	Not reported	2.26	8.06	Not reported
Cabazitaxel 25 mg/m^2	4.09	Not reported	1.09	7.08	Not reported

Change at Cycle 6

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	272
Cabazitaxel 20 mg/m^2	267
Cabazitaxel 25 mg/m^2	262

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	3.46	Not reported	0.53	6.39	Not reported
Cabazitaxel 20 mg/m^2	3.8	Not reported	0.88	6.73	Not reported
Cabazitaxel 25 mg/m^2	3.37	Not reported	0.35	6.39	Not reported

Change at Cycle 7

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	244
Cabazitaxel 20 mg/m^2	246
Cabazitaxel 25 mg/m^2	241

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	3.16	Not reported	0.2	6.12	Not reported
Cabazitaxel 20 mg/m^2	3.66	Not reported	0.71	6.61	Not reported
Cabazitaxel 25 mg/m^2	3.42	Not reported	0.38	6.45	Not reported

Change at Cycle 8

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	228
Cabazitaxel 20 mg/m^2	222
Cabazitaxel 25 mg/m^2	225

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	2.61	Not reported	-0.37	5.59	Not reported
Cabazitaxel 20 mg/m^2	2.71	Not reported	-0.27	5.68	Not reported
Cabazitaxel 25 mg/m^2	1.67	Not reported	-1.39	4.73	Not reported

Change at Cycle 9

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	174
Cabazitaxel 20 mg/m^2	196
Cabazitaxel 25 mg/m^2	190

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	2.2	Not reported	-0.87	5.27	Not reported
Cabazitaxel 20 mg/m^2	2.67	Not reported	-0.35	5.68	Not reported
Cabazitaxel 25 mg/m^2	1.89	Not reported	-1.22	5.01	Not reported

Change at Cycle 10

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	149
Cabazitaxel 20 mg/m^2	164
Cabazitaxel 25 mg/m^2	166

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	2.08	Not reported	-1.05	5.21	Not reported
Cabazitaxel 20 mg/m^2	2.09	Not reported	-0.99	5.18	Not reported
Cabazitaxel 25 mg/m^2	1.84	Not reported	-1.32	5	Not reported

Change at Cycle 11

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	101
Cabazitaxel 20 mg/m^2	115
Cabazitaxel 25 mg/m^2	111

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	0.15	Not reported	-3.18	3.47	Not reported
Cabazitaxel 20 mg/m^2	3.35	Not reported	0.1	6.6	Not reported
Cabazitaxel 25 mg/m^2	2.68	Not reported	-0.67	6.02	Not reported

Change at Cycle 12

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	83
Cabazitaxel 20 mg/m^2	98
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	0.52	Not reported	-2.94	3.97	Not reported
Cabazitaxel 20 mg/m^2	3.95	Not reported	0.61	7.29	Not reported
Cabazitaxel 25 mg/m^2	0.63	Not reported	-2.78	4.05	Not reported

Change at Cycle 13

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	58
Cabazitaxel 20 mg/m^2	85
Cabazitaxel 25 mg/m^2	80

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	1.79	Not reported	-1.94	5.53	Not reported
Cabazitaxel 20 mg/m^2	2.48	Not reported	-0.95	5.91	Not reported
Cabazitaxel 25 mg/m^2	0.55	Not reported	-3	4.09	Not reported

Change at Cycle 14

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	55
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	-1.78	Not reported	-5.56	2	Not reported
Cabazitaxel 20 mg/m^2	2.2	Not reported	-1.29	5.69	Not reported
Cabazitaxel 25 mg/m^2	-0.42	Not reported	-4.06	3.21	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	-3.49	Not reported	-7.5	0.51	Not reported
Cabazitaxel 20 mg/m^2	1.74	Not reported	-1.82	5.3	Not reported
Cabazitaxel 25 mg/m^2	1.22	Not reported	-2.51	4.95	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	58

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-3.83	Not reported	-7.89	0.23	Not reported
Cabazitaxel 20 mg/m^2	1.62	Not reported	-2.11	5.35	Not reported
Cabazitaxel 25 mg/m^2	0.5	Not reported	-3.3	4.3	Not reported

Change at Follow-up 1

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	176
Cabazitaxel 20 mg/m^2	185
Cabazitaxel 25 mg/m^2	175

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-1.08	Not reported	-4.15	1.99	Not reported
Cabazitaxel 20 mg/m^2	-1.45	Not reported	-4.48	1.59	Not reported
Cabazitaxel 25 mg/m^2	-1.82	Not reported	-4.97	1.32	Not reported

Change at Follow-up 2

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	145
Cabazitaxel 20 mg/m^2	129
Cabazitaxel 25 mg/m^2	133

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-0.02	Not reported	-3.16	3.13	Not reported
Cabazitaxel 20 mg/m^2	-1.98	Not reported	-5.17	1.21	Not reported
Cabazitaxel 25 mg/m^2	-1.78	Not reported	-5.04	1.47	Not reported

Change at Follow-up 3

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	110
Cabazitaxel 20 mg/m^2	103
Cabazitaxel 25 mg/m^2	101

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Docetaxel 75 mg/m^2	-0.55	Not reported	-3.83	2.74	Not reported
Cabazitaxel 20 mg/m^2	-2.16	Not reported	-5.47	1.14	Not reported
Cabazitaxel 25 mg/m^2	-2.68	Not reported	-6.08	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	73
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	-1.19	Not reported	-4.61	2.23	Not reported
Cabazitaxel 20 mg/m^2	-3.64	Not reported	-7.18	-0.1	Not reported
Cabazitaxel 25 mg/m^2	-1.7	Not reported	-5.25	1.84	Not reported

Change at Follow-up 5

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	72
Cabazitaxel 20 mg/m^2	63
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	-2.05	Not reported	-5.61	1.51	Not reported
Cabazitaxel 20 mg/m^2	-6.73	Not reported	-10.39	-3.06	Not reported
Cabazitaxel 25 mg/m^2	-0.6	Not reported	-4.18	2.99	Not reported

Change at Follow-up 6

Analysis denominator · Participants

Group	Source count
Docetaxel 75 mg/m^2	58
Cabazitaxel 20 mg/m^2	46
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	-1.17	Not reported	-4.92	2.58	Not reported
Cabazitaxel 20 mg/m^2	-5.36	Not reported	-9.32	-1.4	Not reported
Cabazitaxel 25 mg/m^2	-4.05	Not reported	-7.87	-0.23	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.3
upper Limit
7.05
value
4.17
group Id
OG001
lower Limit
4.79
upper Limit
10.53
value
7.66
group Id
OG002
lower Limit
3.97
upper Limit
9.88
value
6.93
denoms
counts
group Id
OG000
value
333
group Id
OG001
value
323
group Id
OG002
value
321
units
Participants
title
Change at Cycle 1
categories
measurements
group Id
OG000
lower Limit
2.46
upper Limit
8.2
value
5.33
group Id
OG001
lower Limit
4.28
upper Limit
10.01
value
7.15
group Id
OG002
lower Limit
2.32
upper Limit
8.24
value
5.28
denoms
counts
group Id
OG000
value
339
group Id
OG001
value
339
group Id
OG002
value
323
units
Participants
title
Change at Cycle 2
categories
measurements
group Id
OG000
lower Limit
2.06
upper Limit
7.82
value
4.94
group Id
OG001
lower Limit
3.93
upper Limit
9.66
value
6.79
group Id
OG002
lower Limit
1.64
upper Limit
7.58
value
4.61
denoms
counts
group Id
OG000
value
330
group Id
OG001
value
332
group Id
OG002
value
316
units
Participants
title
Change at Cycle 3
categories
measurements
group Id
OG000
lower Limit
1.17
upper Limit
6.96
value
4.07
group Id
OG001
lower Limit
2.35
upper Limit
8.09
value
5.22
group Id
OG002
lower Limit
1.03
upper Limit
6.99
value
4.01
denoms
counts
group Id
OG000
value
316
group Id
OG001
value
323
group Id
OG002
value
302
units
Participants
title
Change at Cycle 4
categories
measurements
group Id
OG000
lower Limit
1.44
upper Limit
7.27
value
4.36
group Id
OG001
lower Limit
2.26
upper Limit
8.06
value
5.16
group Id
OG002
lower Limit
1.09
upper Limit
7.08
value
4.09
denoms
counts
group Id
OG000
value
293
group Id
OG001
value
290
group Id
OG002
value
283
units
Participants
title
Change at Cycle 5
categories
measurements
group Id
OG000
lower Limit
0.53
upper Limit
6.39
value
3.46
group Id
OG001
lower Limit
0.88
upper Limit
6.73
value
3.8
group Id
OG002
lower Limit
0.35
upper Limit
6.39
value
3.37
denoms
counts
group Id
OG000
value
272
group Id
OG001
value
267
group Id
OG002
value
262
units
Participants
title
Change at Cycle 6
categories
measurements
group Id
OG000
lower Limit
0.2
upper Limit
6.12
value
3.16
group Id
OG001
lower Limit
0.71
upper Limit
6.61
value
3.66
group Id
OG002
lower Limit
0.38
upper Limit
6.45
value
3.42
denoms
counts
group Id
OG000
value
244
group Id
OG001
value
246
group Id
OG002
value
241
units
Participants
title
Change at Cycle 7
categories
measurements
group Id
OG000
lower Limit
-0.37
upper Limit
5.59
value
2.61
group Id
OG001
lower Limit
-0.27
upper Limit
5.68
value
2.71
group Id
OG002
lower Limit
-1.39
upper Limit
4.73
value
1.67
denoms
counts
group Id
OG000
value
228
group Id
OG001
value
222
group Id
OG002
value
225
units
Participants
title
Change at Cycle 8
categories
measurements
group Id
OG000
lower Limit
-0.87
upper Limit
5.27
value
2.2
group Id
OG001
lower Limit
-0.35
upper Limit
5.68
value
2.67
group Id
OG002
lower Limit
-1.22
upper Limit
5.01
value
1.89
denoms
counts
group Id
OG000
value
174
group Id
OG001
value
196
group Id
OG002
value
190
units
Participants
title
Change at Cycle 9
categories
measurements
group Id
OG000
lower Limit
-1.05
upper Limit
5.21
value
2.08
group Id
OG001
lower Limit
-0.99
upper Limit
5.18
value
2.09
group Id
OG002
lower Limit
-1.32
upper Limit
5
value
1.84
denoms
counts
group Id
OG000
value
149
group Id
OG001
value
164
group Id
OG002
value
166
units
Participants
title
Change at Cycle 10
categories
measurements
group Id
OG000
lower Limit
-3.18
upper Limit
3.47
value
0.15
group Id
OG001
lower Limit
0.1
upper Limit
6.6
value
3.35
group Id
OG002
lower Limit
-0.67
upper Limit
6.02
value
2.68
denoms
counts
group Id
OG000
value
101
group Id
OG001
value
115
group Id
OG002
value
111
units
Participants
title
Change at Cycle 11
categories
measurements
group Id
OG000
lower Limit
-2.94
upper Limit
3.97
value
0.52
group Id
OG001
lower Limit
0.61
upper Limit
7.29
value
3.95
group Id
OG002
lower Limit
-2.78
upper Limit
4.05
value
0.63
denoms
counts
group Id
OG000
value
83
group Id
OG001
value
98
group Id
OG002
value
98
units
Participants
title
Change at Cycle 12

denoms

counts
group Id
OG000
value
375
group Id
OG001
value
370
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). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated 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) Total Score as a Measure of Health Related Quality of Life (HRQoL)

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice