NCT00262847 · OUTCOME

Progression-free Survival

Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer · Source last updated 2019-07-23

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: From study entry until first disease progression, death or date of last contact, up to 6 years

What was measured

Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).

Groups in this outcome

Arm I (Placebo, Paclitaxel, Carboplatin)

Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.

Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.

Arm III (Paclitaxel, Carboplatin, Bevacizumab)

Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg 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

Group	Source count
Arm I (Placebo, Paclitaxel, Carboplatin)	625
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)	625
Arm III (Paclitaxel, Carboplatin, Bevacizumab)	623

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo, Paclitaxel, Carboplatin)	11.0	Not reported	10.2	12.0	Not reported
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)	12.3	Not reported	11.4	12.8	Not reported
Arm III (Paclitaxel, Carboplatin, Bevacizumab)	15.3	Not reported	14.2	16.1	Not reported

Source statistical analyses

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

ci Lower Limit
0.844
ci Pct Value
95
ci Upper Limit
1.078
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.448
param Type
Hazard Ratio (HR)
param Value
0.954
statistical Comment
Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
statistical Method
Regression, Cox
ci Lower Limit
0.676
ci Pct Value
95
ci Upper Limit
0.866
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
param Type
Hazard Ratio (HR)
param Value
0.765
statistical Comment
Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.844
ci Pct Value
95
ci Upper Limit
1.078
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.448
param Type
Hazard Ratio (HR)
param Value
0.954
statistical Comment
Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
statistical Method
Regression, Cox
ci Lower Limit
0.676
ci Pct Value
95
ci Upper Limit
0.866
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
param Type
Hazard Ratio (HR)
param Value
0.765
statistical Comment
Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
lower Limit
10.2
upper Limit
12.0
value
11.0
group Id
OG001
lower Limit
11.4
upper Limit
12.8
value
12.3
group Id
OG002
lower Limit
14.2
upper Limit
16.1
value
15.3

denoms

counts
group Id
OG000
value
625
group Id
OG001
value
625
group Id
OG002
value
623
units
Participants

description

Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).

dispersion Type

95% Confidence Interval

groups

description
Control therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
id
OG000
title
Arm I (Placebo, Paclitaxel, Carboplatin)
description
Bevacizumab-initiation therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received placebo every 3 weeks.
id
OG001
title
Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
description
Bevacizumab-throughout therapy: Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks. Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.
id
OG002
title
Arm III (Paclitaxel, Carboplatin, Bevacizumab)

param Type

MEDIAN

reporting Status

POSTED

time Frame

From study entry until first disease progression, death or date of last contact, up to 6 years

title

Progression-free Survival

type

PRIMARY

unit Of Measure

months

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Preserved source evidence · Not medical advice