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 Type
OBSERVATIONAL
Enrollment
943
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.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
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).
Time frame: 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).
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Research Site
Eggenburg, Austria
Research Site
Graz, Austria
Research Site
Leoben, Austria
Research Site
Schwarzach im Pongau, Austria
Research Site
Vienna, Austria
Research Site
Vienna, Austria
Research Site
Arlon, Belgium
Research Site
Liège, Belgium
Research Site
Pleven, Bulgaria
Research Site
Sofia, Bulgaria
...and 64 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.