N/A
N=1,347
A Study of Neutropenia and Anemia Management in Patients With Solid Tumors Receiving Myelotoxic Chemotherapy
Breast Cancer · Non-Small Cell Lung Cancer · Ovarian Cancer · Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00883181 ↗Enrolled (actual)
1,347
Serious AEs
0.1%
Results posted
Apr 2016
Primary outcome: Primary: Percentage of Participants With Febrile Neutropenia (FN) — 8; 8; 15; 9 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Febrile Neutropenia (FN) |
8; 8; 15; 9; 11; 9 | — |
| PRIMARY Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia |
4; 3; 5; 1; 0; 1 | — |
| PRIMARY Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia |
0; 0; 21; 9; 9; 9 | — |
| PRIMARY Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia |
0; 20; 9; 6; 17; 7 | — |
| PRIMARY Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia |
0; 36; 40; 14; 33; 16 | — |
| PRIMARY Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia |
27; 13; 15; 20; 22; 21 | — |
| PRIMARY Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia |
0; 0; 17; 0; 14 | — |
| PRIMARY Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia |
25; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia |
0; 0; 0 | — |
| PRIMARY Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia |
44; 13; 13; 12; 25; 14 | — |
| PRIMARY Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia |
100 | — |
| SECONDARY Number of Participants Who Received G-CSF During Cycles 1 to 8 |
24; 22; 33; 360; 32; 393 | — |
| SECONDARY Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim |
1.00; 1.00; 1.01; 1.00; 1.01; 1.00 | — |
| SECONDARY Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF |
3.67; 3.95; 4.95; 4.77; 5.85; 4.88 | — |
| SECONDARY Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim |
1.00; 1.00; 1.04; 1.02; 1.00; 1.02 | — |
| SECONDARY Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF |
3.66; 4.28; 4.04; 4.74; 3.50; 4.58 | — |
| SECONDARY Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim |
1.40; 1.00; 1.00 | — |
| SECONDARY Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF |
3.11; 4.45; 2.83; 2.95; 2.38; 2.84 | — |
| SECONDARY Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 |
48; 46; 52; 29; 47; 31 | — |
| SECONDARY Percentage of Cycles With Chemotherapy Dose Delays |
20; 24; 24; 7; 17; 8 | — |
| SECONDARY Percentage of Participants With Chemotherapy Dose Reductions |
34; 25; 22; 16; 29; 17 | — |
| SECONDARY Percentage of Cycles With Chemotherapy Dose Reductions |
16; 13; 12; 6; 16; 7 | — |
| SECONDARY Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 |
1; 6; 6; 12; 3; 15 | — |
| SECONDARY Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 |
4; 4; 3; 15; 6; 21 | — |
| SECONDARY Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8 |
23; 46; 53; 198; 20; 218 | — |
| SECONDARY Number of Participants With Unplanned Hospitalizations |
26; 52; 41; 107; 18; 125 | — |
| SECONDARY Investigator Assessed Clinical Response at End of Treatment |
49; 8; 17; 218; 4; 222 | — |
| SECONDARY Number of Participants With Hematological Toxicities |
19; 7; 9; 45; 5; 50 | — |
| SECONDARY Time to Disease Progression |
12.4; 6.5; 6.8; NA; 11.8; NA | — |
| SECONDARY Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs) |
5.3 | — |
| SECONDARY Reason for Treatment With Erythropoiesis-stimulating Agents |
134; 10; 3; 3 | — |
| SECONDARY Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment |
19; 95; 29; 4 | — |
| SECONDARY Number of Clinical Visits in Cycles 1-8 by ESA Use |
3.1; 2.8; 3.9; NA | — |
| SECONDARY Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment |
11 | — |
| SECONDARY Change in Hemoglobin During ESA Treatment Phase |
0.38 | — |
| SECONDARY Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response |
45 | — |
| SECONDARY Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment |
58 | — |
| SECONDARY Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment |
85 | — |
| SECONDARY Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment |
66 | — |
| SECONDARY Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment |
35 | — |
| SECONDARY Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment |
84 | — |
| SECONDARY Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment |
30 | — |
| SECONDARY Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment |
15 | — |
| SECONDARY Number of Participants With Systemic Transfusions in Cycles 1 to 8 |
20; 23; 26; 25; 4; 29 | — |
| SECONDARY Number of Transfusions Per Participant in Cycles 1 to 8 |
137; 201; 111; 713; 86; 800 | — |
Summary
The primary objective was to describe the incidence of febrile neutropenia based on granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no usage) in patients receiving myelotoxic chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Subjects greater than or equal to 18 years old with breast, ovarian or lung cancer receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy.
- These subjects must have an Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 European Organisation for Research and Treatment of Cancer (EORTC) G-CSF Guidelines
Exclusion Criteria
- Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study).
Data sourced from ClinicalTrials.gov (NCT00883181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.