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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Febrile Neutropenia

• Study Type: Observational
• Enrollment (Actual): 943

Contacts and Locations

Study Locations

• Austria
  • Eggenburg, Austria, 3730
    • Research Site
  • Graz, Austria, 8036
    • Research Site
  • Leoben, Austria, 8700
    • Research Site
  • Schwarzach im Pongau, Austria, 5620
    • Research Site
  • Wien, Austria, 1090
    • Research Site
  • Wien, Austria, 1030
    • Research Site
• Belgium
  • Arlon, Belgium, 6700
    • Research Site
  • Liege, Belgium, 4000
    • Research Site
  • Liège, Belgium, 4000
    • Research Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Research Site
  • Sofia, Bulgaria, 1756
    • Research Site
• Czechia
  • Chomutov, Czechia, 430 12
    • Research Site
  • Horovice, Czechia, 268 31
    • Research Site
  • Novy Jicin, Czechia, 741 01
    • Research Site
  • Plzen, Czechia, 304 60
    • Research Site
  • Praha 10, Czechia, 100 34
    • Research Site
  • Praha 2, Czechia, 128 08
    • Research Site
• France
  • Aix en Provence, France, 13100
    • Research Site
  • Amiens, France, 80000
    • Research Site
  • Beuvry, France, 62660
    • Research Site
  • Marseille, France, 13009
    • Research Site
  • Marseille cedex 5, France, 13385
    • Research Site
  • Meaux Cedex, France, 77100
    • Research Site
  • Nancy, France, 54100
    • Research Site
  • Nimes cedex 09, France, 30029
    • Research Site
  • Orleans Cedex, France, 45067
    • Research Site
  • Perpignan, France, 66000
    • Research Site
  • Pierre Benite Cedex, France, 69495
    • Research Site
  • Périgueux cedex, France, 24004
    • Research Site
  • Saint Priest en Jarez Cedex, France, 42270
    • Research Site
  • Sarcelles, France, 95200
    • Research Site
  • Strasbourg, France, 67000
    • Research Site
• Germany
  • Bonn, Germany, 53111
    • Research Site
  • Dresden, Germany, 01307
    • Research Site
  • Fulda, Germany, 36043
    • Research Site
  • Hildesheim, Germany, 31134
    • Research Site
  • Kassel, Germany, 34119
    • Research Site
  • Stolberg, Germany, 52222
    • Research Site
  • Troisdorf, Germany, 53840
    • Research Site
  • Velbert, Germany, 42551
    • Research Site
  • Westerstede, Germany, 26655
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Athens, Greece, 11528
    • Research Site
  • Athens, Greece, 12462
    • Research Site
  • Chania, Greece, 73300
    • Research Site
  • Kalamata, Greece, 24100
    • Research Site
  • Larissa, Greece, 41110
    • Research Site
  • Nea Kifissia, Athens, Greece, 14564
    • Research Site
  • Papagou, Greece, 11526
    • Research Site
  • Piraeus, Greece, 18537
    • Research Site
  • Thessaloniki, Greece, 54622
    • Research Site
  • Thessaloniki, Greece, 54636
    • Research Site
  • Thessaloniki, Greece, 54645
    • Research Site
  • Thessaloniki, Greece, 55236
    • Research Site
• Poland
  • Bialystok, Poland, 15-027
    • Research Site
  • Gdynia, Poland, 81-519
    • Research Site
  • Koszalin, Poland, 75-581
    • Research Site
  • Krakow, Poland, 31-501
    • Research Site
  • Krakow, Poland, 31-531
    • Research Site
  • Poznan, Poland, 61-485
    • Research Site
  • Walbrzych, Poland, 58-309
    • Research Site
  • Warszawa, Poland, 02-781
    • Research Site
  • Warszawa, Poland, 02-097
    • Research Site
• Romania
  • Baia Mare, Romania, 430031
    • Research Site
  • Braila, Romania, 810325
    • Research Site
  • Bucharest, Romania, 022328
    • Research Site
  • Bucharest, Romania, 022338
    • Research Site
  • Bucharest, Romania, 030171
    • Research Site
  • Bucuresti, Romania, 010825
    • Research Site
  • Bucuresti, Romania, 031864
    • Research Site
  • Campina, Romania, 105600
    • Research Site
  • Cluj-Napoca, Romania, 400124
    • Research Site
  • Iasi, Romania, 700483
    • Research Site
  • Oradea, Romania, 410469
    • Research Site
  • Ploiesti, Romania, 100337
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Febrile Neutropenia	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Discontinued Pegfilgrastim Prophylaxis	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).	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Discontinued G-CSF Prophylaxis	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).	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Discontinued G-CSF Prophylaxis	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 were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No Pegfilgrastim Prophylaxis	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With no G-CSF Prophylaxis	A cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Reasons for Discontinuation of Pegfilgrastim Prophylaxis	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Reasons for Discontinuation of G-CSF Prophylaxis	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Percentage of Participants Who Experienced Complications of Febrile Neutropenia	Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis	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.	Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2014
• Primary Completion (Actual): October 28, 2016
• Study Completion (Actual): October 28, 2016

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): June 30, 2014

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Breast Cancer; NHL
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Wounds and Injuries; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Lymphoma; Body Temperature Changes; Heat Stress Disorders; Lymphoma, Non-Hodgkin; Neutropenia; Hyperthermia; Fever; Febrile Neutropenia; Chemotherapy-Induced Febrile Neutropenia
• Other Study ID Numbers: 20120214