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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chemotherapy-induced Febrile Neutropenia

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy + Pegfilgrastim<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, Breast Cancer