NCT02643420 · OUTCOME

Duration of Severe Neutropenia in Cycle 2, 3 and 4

SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) · Source last updated 2022-03-02

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

Measure: MEAN
Unit: days
Interval / dispersion: Standard Deviation
Time frame: Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days)

What was measured

DSN was defined as the number of days of severe neutropenia (ANC \<0.5×10\^9 /L) from the first occurrence of an ANC below the threshold in Cycles 2, 3, and 4.

Analysis population: The ITT population included all participants who were randomized.

Groups in this outcome

Arm 1: SPI-2012 and TC

Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.

Arm 2: Pegfilgrastim and TC

Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.

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 1: SPI-2012 and TC	196
Arm 2: Pegfilgrastim and TC	210

Reported measurements

Cycle 2

Values in days · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm 1: SPI-2012 and TC	0.13	0.383	Not reported	Not reported	Not reported
Arm 2: Pegfilgrastim and TC	0.09	0.374	Not reported	Not reported	Not reported

Cycle 3

Values in days · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm 1: SPI-2012 and TC	0.11	0.326	Not reported	Not reported	Not reported
Arm 2: Pegfilgrastim and TC	0.08	0.273	Not reported	Not reported	Not reported

Cycle 4

Values in days · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm 1: SPI-2012 and TC	0.11	0.362	Not reported	Not reported	Not reported
Arm 2: Pegfilgrastim and TC	0.09	0.281	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
-0.032
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.116
group Description
DSN in Cycle 2
group Ids
OG000
OG001
non Inferiority Comment
The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.
non Inferiority Type
NON_INFERIORITY
p Value
<0.0001
param Type
Mean Difference (Final Values)
param Value
0.042
statistical Method
t-statistics
ci Lower Limit
-0.032
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.085
group Description
DSN in Cycle 3
group Ids
OG000
OG001
non Inferiority Comment
The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.
non Inferiority Type
NON_INFERIORITY
p Value
<0.0001
param Type
Mean Difference (Final Values)
param Value
0.026
statistical Method
t-statistics
ci Lower Limit
-0.036
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.089
group Description
DSN in Cycle 4
group Ids
OG000
OG001
non Inferiority Comment
The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.
non Inferiority Type
NON_INFERIORITY
p Value
<0.0001
param Type
Mean Difference (Final Values)
param Value
0.027
statistical Method
t-statistics

Complete source fields

analyses

ci Lower Limit
-0.032
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.116
group Description
DSN in Cycle 2
group Ids
OG000
OG001
non Inferiority Comment
The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.
non Inferiority Type
NON_INFERIORITY
p Value
<0.0001
param Type
Mean Difference (Final Values)
param Value
0.042
statistical Method
t-statistics
ci Lower Limit
-0.032
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.085
group Description
DSN in Cycle 3
group Ids
OG000
OG001
non Inferiority Comment
The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.
non Inferiority Type
NON_INFERIORITY
p Value
<0.0001
param Type
Mean Difference (Final Values)
param Value
0.026
statistical Method
t-statistics
ci Lower Limit
-0.036
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.089
group Description
DSN in Cycle 4
group Ids
OG000
OG001
non Inferiority Comment
The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.
non Inferiority Type
NON_INFERIORITY
p Value
<0.0001
param Type
Mean Difference (Final Values)
param Value
0.027
statistical Method
t-statistics

classes

categories
measurements
group Id
OG000
spread
0.383
value
0.13
group Id
OG001
spread
0.374
value
0.09
title
Cycle 2
categories
measurements
group Id
OG000
spread
0.326
value
0.11
group Id
OG001
spread
0.273
value
0.08
title
Cycle 3
categories
measurements
group Id
OG000
spread
0.362
value
0.11
group Id
OG001
spread
0.281
value
0.09
title
Cycle 4

denoms

counts
group Id
OG000
value
196
group Id
OG001
value
210
units
Participants

description

DSN was defined as the number of days of severe neutropenia (ANC \<0.5×10\^9 /L) from the first occurrence of an ANC below the threshold in Cycles 2, 3, and 4.

dispersion Type

Standard Deviation

groups

description
Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.
id
OG000
title
Arm 1: SPI-2012 and TC
description
Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.
id
OG001
title
Arm 2: Pegfilgrastim and TC

param Type

MEAN

population Description

The ITT population included all participants who were randomized.

reporting Status

POSTED

time Frame

Days 1, 4, 7, 10, and 15 in cycles 2, 3, and 4 (each cycle was 21 days)

title

Duration of Severe Neutropenia in Cycle 2, 3 and 4

type

SECONDARY

unit Of Measure

days

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Preserved source evidence · Not medical advice