Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents

Study Overview
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Brief Summary
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The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.

Official Title
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Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice

Conditions
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Solid Tumors, Malignant Hemopathy, Chemotherapy-induced Febrile Neutropenia (FN)

Intervention / Treatment
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* Biological: Nivestim®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients presenting with a solid tumor or a malignant hemopathy, Patients treated with or beginning treatment with neutropenia-inducing chemotherapy (regardless of the cycle), Patients in whom treatment with Nivestim® is instituted for the purpose of reducing the duration of the neutropenias and the incidence of the chemotherapy-induced febrile neutropenias Exclusion Criteria: Patients presenting with a chronic myeloproliferative syndrome, Patients presenting with a myelodysplastic syndrome, Patients showing hypersensitivity to any of the ingredients of Nivestim®, Patients not receiving chemotherapy, Patients who were already included in the study during a previous chemotherapy line

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 |
| --- | --- |
| Curative or prophylactic Nivestim® treatment for FN<br> | Biological: Nivestim®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy. | The safety will be assessed by the record of all treatment emergent adverse events and all data about hospitalization due to any febrile neutropenia or infection. | Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment with Nivestim® | Assess the efficacy of the treatment with Nivestim® by studying occurrence of febrile neutropenia, infection and the impact of these events on the chemotherapy treatment (cycle postponement, dose reduction) | Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months | 
| Characteristics of the patients treated with Nivestim® in real-life practice | Describe the characteristics of the patients treated with Nivestim® in real-life practice, | At Visit 1 | 
| Methods of treatment with Nivestim® | Describe the methods of treatment with Nivestim® depending on the indications (curative or prophylactic) in routine practice. | Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months | 
| Profiles of the physicians participating in the study | Describe the profiles of the physicians participating in the study | At visit 1 | 
| General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF) | Assess the general practice of these physicians with regard to prescription of G-CSF | At visit 1 |