Trial Outcomes & Findings for Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy (NCT NCT02178475)
NCT ID: NCT02178475
Last Updated: 2018-07-23
Results Overview
Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
COMPLETED
943 participants
Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
2018-07-23
Participant Flow
The study was conducted at 66 centers in Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Poland, and Romania. The first participant enrolled on 18 July 2014 and the last participant enrolled on 28 April 2016.
Participants were enrolled at sites where they were receiving treatment as part of their routine standard of care. No specific interventional tests, investigations, procedures or changes to routine practice were conducted as part of this study.
Participant milestones
| Measure |
Chemotherapy + Pegfilgrastim
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
943
|
|
Overall Study
Primary Analysis Set
|
844
|
|
Overall Study
COMPLETED
|
814
|
|
Overall Study
NOT COMPLETED
|
129
|
Reasons for withdrawal
| Measure |
Chemotherapy + Pegfilgrastim
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Death
|
13
|
|
Overall Study
Protocol-specified Criteria
|
99
|
Baseline Characteristics
Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy
Baseline characteristics by cohort
| Measure |
Chemotherapy + Pegfilgrastim
n=844 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Age, Customized
< 65 years
|
563 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
281 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
723 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
673 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
166 Participants
n=5 Participants
|
|
Tumor Type
Non-Hodgkin's lymphoma (NHL)
|
190 Participants
n=5 Participants
|
|
Tumor Type
Breast cancer
|
654 Participants
n=5 Participants
|
|
Baseline Comorbidities
Liver disease
|
18 participants
n=5 Participants
|
|
Baseline Comorbidities
Cardiovascular disease
|
211 participants
n=5 Participants
|
|
Baseline Comorbidities
Diabetes mellitus
|
75 participants
n=5 Participants
|
|
Baseline Comorbidities
COPD/Pulmonary disease
|
41 participants
n=5 Participants
|
|
Baseline Comorbidities
Renal disease/impaired clearance
|
16 participants
n=5 Participants
|
|
Baseline Comorbidities
Current infection
|
8 participants
n=5 Participants
|
|
Baseline Comorbidities
Open wound
|
3 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully active)
|
645 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Restrictive but ambulatory)
|
129 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 (Ambulatory but unable to work)
|
14 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3 (Limited self-care)
|
6 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4 (Disabled, confined to bed/chair)
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
49 Participants
n=5 Participants
|
|
History of Febrile Neutropenia
Yes
|
5 Participants
n=5 Participants
|
|
History of Febrile Neutropenia
No
|
839 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Primary analysis set
Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=844 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Percentage of Participants With Febrile Neutropenia
Overall
|
3.3 percentage of participants
Interval 2.3 to 4.8
|
|
Percentage of Participants With Febrile Neutropenia
Cycle 1
|
1.9 percentage of participants
Interval 1.2 to 3.1
|
|
Percentage of Participants With Febrile Neutropenia
Cycle 2
|
0.4 percentage of participants
Interval 0.1 to 1.1
|
|
Percentage of Participants With Febrile Neutropenia
Cycle 3
|
0.5 percentage of participants
Interval 0.2 to 1.3
|
|
Percentage of Participants With Febrile Neutropenia
Cycle 4
|
0.5 percentage of participants
Interval 0.2 to 1.3
|
|
Percentage of Participants With Febrile Neutropenia
Cycle 5
|
0.3 percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Febrile Neutropenia
Cycle 6
|
0.3 percentage of participants
Interval 0.1 to 1.1
|
|
Percentage of Participants With Febrile Neutropenia
Cycle 7
|
0.0 percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With Febrile Neutropenia
Cycle 8
|
0.0 percentage of participants
Interval 0.0 to 1.7
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Primary analysis set
Participants who discontinued pegfilgrastim prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other granulocyte colony-stimulating factor (G-CSF) prophylaxis was administered. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles. Discontinuation was categorized as either temporary (participant received pegfilgrastim prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no pegfilgrastim prophylaxis was administered, and other G-CSF prophylaxis (i.e. not pegfilgrastim) was administered in all subsequent cycles, OR participant did not receive pegfilgrastim prophylaxis in the last cycle of chemotherapy, and other G-CSF prophylaxis was administered).
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=844 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Number of Participants Who Discontinued Pegfilgrastim Prophylaxis
Discontinuation of pegfilgrastim prophylaxis
|
26 participants
|
|
Number of Participants Who Discontinued Pegfilgrastim Prophylaxis
Temporary discontinuation
|
4 participants
|
|
Number of Participants Who Discontinued Pegfilgrastim Prophylaxis
Permanent discontinuation
|
22 participants
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Primary analysis set
Participants who discontinued G-CSF prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Discontinuation was categorized as either temporary (participant received G-CSF prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no G-CSF prophylaxis was administered, and no G-CSF prophylaxis was administered in any subsequent cycle, OR participant did not receive G-CSF prophylaxis in the last cycle of chemotherapy).
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=844 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Number of Participants Who Discontinued G-CSF Prophylaxis
Discontinuation of G-CSF prophylaxis
|
44 participants
|
|
Number of Participants Who Discontinued G-CSF Prophylaxis
Temporary discontinuation
|
9 participants
|
|
Number of Participants Who Discontinued G-CSF Prophylaxis
Permanent discontinuation
|
35 participants
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Participants who received at least 1 cycle of chemotherapy in which no pegfilgrastim prophylaxis was administered, but another G-CSF was administered.
Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles. Data includes both temporary and permanent pegfilgrastim discontinuation.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=26 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Male
|
6 participants
|
|
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Female
|
20 participants
|
|
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Race: Black
|
0 participants
|
|
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Race: White
|
15 participants
|
|
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Race: Missing
|
11 participants
|
|
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Age < 65 years
|
15 participants
|
|
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Age ≥ 65 years
|
11 participants
|
|
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Age ≥ 75 years
|
1 participants
|
|
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Tumor type: NHL
|
15 participants
|
|
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
Tumor type: Breast cancer
|
11 participants
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.
Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Data includes both temporary and permanent discontinuation of G-CSF prophylaxis.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=44 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Male
|
8 participants
|
|
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Female
|
36 participants
|
|
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Race: Black
|
0 participants
|
|
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Race: White
|
36 participants
|
|
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Race: Missing
|
8 participants
|
|
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Age < 65 years
|
26 participants
|
|
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Age ≥ 65 years
|
18 participants
|
|
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Age ≥ 75 years
|
2 participants
|
|
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Tumor type: NHL
|
13 participants
|
|
Characteristics of Participants Who Discontinued G-CSF Prophylaxis
Tumor type: Breast cancer
|
31 participants
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: All cycles of chemotherapy for participants in the primary analysis set
A cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=5049 cycles
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Number of Cycles With No Pegfilgrastim Prophylaxis
|
56 cycles
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: All cycles of chemotherapy for participants in the primary analysis set
A cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=5049 cycles
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Number of Cycles With no G-CSF Prophylaxis
|
105 cycles
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Participants who received at least 1 cycle of chemotherapy in which no pegfilgrastim prophylaxis was administered, but another G-CSF was administered.
Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles. Data includes both temporary and permanent pegfilgrastim discontinuation.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=26 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Reasons for Discontinuation of Pegfilgrastim Prophylaxis
Daily G-CSF preferred to once-per-cycle G-CSF
|
14 Participants
|
|
Reasons for Discontinuation of Pegfilgrastim Prophylaxis
Cost
|
1 Participants
|
|
Reasons for Discontinuation of Pegfilgrastim Prophylaxis
Following protocol of hospital or country/region
|
2 Participants
|
|
Reasons for Discontinuation of Pegfilgrastim Prophylaxis
Adverse reaction to G-CSF
|
6 Participants
|
|
Reasons for Discontinuation of Pegfilgrastim Prophylaxis
Other
|
3 Participants
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.
Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Data includes both temporary and permanent discontinuation of G-CSF prophylaxis. Participants may have more than 1 discontinuation reason.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=44 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Reasons for Discontinuation of G-CSF Prophylaxis
Chemotherapy dose intensity reduced
|
9 participants
|
|
Reasons for Discontinuation of G-CSF Prophylaxis
Patient no longer considered at high risk of FN
|
14 participants
|
|
Reasons for Discontinuation of G-CSF Prophylaxis
Cost
|
3 participants
|
|
Reasons for Discontinuation of G-CSF Prophylaxis
Following protocol of hospital or country/region
|
2 participants
|
|
Reasons for Discontinuation of G-CSF Prophylaxis
Adverse reaction to G-CSF
|
3 participants
|
|
Reasons for Discontinuation of G-CSF Prophylaxis
Other
|
22 participants
|
|
Reasons for Discontinuation of G-CSF Prophylaxis
Missing
|
2 participants
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: primary analysis set
Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=844 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Percentage of Participants Who Experienced Complications of Febrile Neutropenia
|
6.8 percentage of participants
Interval 5.2 to 8.7
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: All FN events observed for participants in the primary analysis set
The number of febrile neutropenia events that occurred during a cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=31 febrile neutropenia events
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis
|
2 febrile neutropenia events
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.
The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=44 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis
|
2 participants
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered
The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced complications of febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=44 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis
|
3 participants
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Cycles of chemotherapy for participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered.
The number of chemotherapy cycles during which an event of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=105 cycles
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred
|
2 cycles
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Cycles of chemotherapy for participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered, in which no G-CSF prophylaxis was administered.
The number of chemotherapy cycles during which complications of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=105 cycles
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred
|
3 cycles
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Primary analysis set
The number of participants who received pegfilgrastim prophylaxis from cycle 1 until a cycle when other G-CSF prophylaxis was administered, and this G-CSF or a different G-CSF agent (not pegfilgrastim) was received as prophylaxis at each remaining cycle of the chemotherapy course.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=844 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis
|
22 participants
|
SECONDARY outcome
Timeframe: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.Population: Participants who received pegfilgrastim across all cycles, administered 1- 3 days after the end of cytotoxic chemotherapy in each cycle.
On-schedule pegfilgrastim primary prophylaxis was defined as participants who received pegfilgrastim in cycle 1 and continued to receive pegfilgrastim across all cycles, administered 1-3 days after the end of cytotoxic chemotherapy in each cycle.
Outcome measures
| Measure |
Chemotherapy + Pegfilgrastim
n=683 Participants
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Male
|
72 participants
|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Female
|
611 participants
|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Race: White
|
546 participants
|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Race: Black or African American
|
2 participants
|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Race: Other
|
1 participants
|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Race: Missing
|
134 participants
|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Age < 65 years
|
464 participants
|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Age ≥ 65 years
|
219 participants
|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Age ≥ 75 years
|
38 participants
|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Tumor type: NHL
|
112 participants
|
|
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
Tumor type: Breast cancer
|
571 participants
|
Adverse Events
Chemotherapy + Pegfilgrastim
Serious adverse events
| Measure |
Chemotherapy + Pegfilgrastim
n=844 participants at risk
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.36%
3/844 • Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
In this observational study only adverse events deemed to be related to study drug (adverse drug reactions; ADRs) were collected. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.24%
2/844 • Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
In this observational study only adverse events deemed to be related to study drug (adverse drug reactions; ADRs) were collected. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
1/844 • Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
In this observational study only adverse events deemed to be related to study drug (adverse drug reactions; ADRs) were collected. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Chemotherapy + Pegfilgrastim
n=844 participants at risk
Patients with non-Hodgkin's lymphoma or breast cancer being treated with a permitted standard-dose chemotherapy regimen with a high FN risk (\> 20%) and who had pegfilgrastim prophylaxis initiated in the first cycle of chemotherapy.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
11/844 • Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
In this observational study only adverse events deemed to be related to study drug (adverse drug reactions; ADRs) were collected. Other Adverse Events summarizes the non-serious occurrences of ADRs that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER