Clinical trial NCT02178475: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Febrile Neutropenia
Keywords: NHL
Breast Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-06-30
Enrollment: 943
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with NHL or breast cancer who have initiated treatment with a permitted standard-dose chemotherapy regimen that has a high FN risk (\> 20%) per published studies or international guidelines, and who started pegfilgrastim in Cycle 1

Brief 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).

Primary outcomes:
measure: Percentage of Participants With Febrile Neutropenia
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Secondary outcomes:
measure: Number of Participants Who Discontinued Pegfilgrastim Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Number of Participants Who Discontinued G-CSF Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Characteristics of Participants Who Discontinued G-CSF Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Number of Cycles With No Pegfilgrastim Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Number of Cycles With no G-CSF Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Reasons for Discontinuation of Pegfilgrastim Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Reasons for Discontinuation of G-CSF Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Percentage of Participants Who Experienced Complications of Febrile Neutropenia
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
measure: Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis
timeFrame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Other outcomes:
Locations:
city: Eggenburg
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Schwarzach im Pongau
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Arlon
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Chomutov
country: Czechia
facility: Research Site
city: Horovice
country: Czechia
facility: Research Site
city: Novy Jicin
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha 10
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Aix en Provence
country: France
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Beuvry
country: France
facility: Research Site
city: Marseille cedex 5
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Meaux Cedex
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nimes cedex 09
country: France
facility: Research Site
city: Orleans Cedex
country: France
facility: Research Site
city: Perpignan
country: France
facility: Research Site
city: Pierre Benite Cedex
country: France
facility: Research Site
city: Périgueux cedex
country: France
facility: Research Site
city: Saint Priest en Jarez Cedex
country: France
facility: Research Site
city: Sarcelles
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Fulda
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Stolberg
country: Germany
facility: Research Site
city: Troisdorf
country: Germany
facility: Research Site
city: Velbert
country: Germany
facility: Research Site
city: Westerstede
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Chania
country: Greece
facility: Research Site
city: Kalamata
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Nea Kifissia, Athens
country: Greece
facility: Research Site
city: Papagou
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Koszalin
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Walbrzych
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
city: Braila
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Campina
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Mahtani RL, Belani R, Crawford J, Dale D, DeCosta L, Gawade PL, Huynh C, Lawrence T, Lewis S, MacLaughlin WW, Narang M, Rifkin R. A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis. Support Care Cancer. 2022 Jul;30(7):6135-6144. doi: 10.1007/s00520-022-07025-2. Epub 2022 Apr 14.