N/A
N=943
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
Chemotherapy-induced Febrile Neutropenia
Bottom Line
View on ClinicalTrials.gov: NCT02178475 ↗Enrolled (actual)
943
Serious AEs
0.6%
Results posted
Jul 2018
Primary outcome: Primary: Percentage of Participants With Febrile Neutropenia — 3.3; 1.9; 0.4; 0.5 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 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Febrile Neutropenia |
3.3; 1.9; 0.4; 0.5; 0.5; 0.3 | — |
| SECONDARY Number of Participants Who Discontinued Pegfilgrastim Prophylaxis |
26; 4; 22 | — |
| SECONDARY Number of Participants Who Discontinued G-CSF Prophylaxis |
44; 9; 35 | — |
| SECONDARY Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis |
6; 20; 0; 15; 11; 15 | — |
| SECONDARY Characteristics of Participants Who Discontinued G-CSF Prophylaxis |
8; 36; 0; 36; 8; 26 | — |
| SECONDARY Number of Cycles With No Pegfilgrastim Prophylaxis |
56 | — |
| SECONDARY Number of Cycles With no G-CSF Prophylaxis |
105 | — |
| SECONDARY Reasons for Discontinuation of Pegfilgrastim Prophylaxis |
14; 1; 2; 6; 3 | — |
| SECONDARY Reasons for Discontinuation of G-CSF Prophylaxis |
9; 14; 3; 2; 3; 22 | — |
| SECONDARY Percentage of Participants Who Experienced Complications of Febrile Neutropenia |
6.8 | — |
| SECONDARY Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis |
2 | — |
| SECONDARY Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis |
2 | — |
| SECONDARY Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis |
3 | — |
| SECONDARY Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred |
2 | — |
| SECONDARY Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred |
3 | — |
| SECONDARY Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis |
22 | — |
| SECONDARY Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis |
72; 611; 546; 2; 1; 134 | — |
Summary
To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years old.
- Any stage NHL or breast cancer and received the first cycle of a new chemotherapy course.
- Received the first cycle of a permitted standard dose chemotherapy regimens with an estimated high (> 20%) FN risk according to published data or guidelines (dose modifications +/-10% in Cycle 1 are allowable).
- Initiated treatment in Cycle 1 with pegfilgrastim according to the pegfilgrastim summary of product characteristics. (SmPC). Enrolment must occur after the first pegfilgrastim dosing in Cycle 1 and before the second day of Cycle 2.
Exclusion Criteria
- Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the national competent authorities for any indication.
- Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated).
Data sourced from ClinicalTrials.gov (NCT02178475). 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.