Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study

Study Overview
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Brief Summary
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The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.

Detailed Description
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This is a longitudinal, observational, prospective, multicentre, cohort study, conducted in France among a representative sample of public and/or private hospital-based oncologists. Data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations: Baseline visit: prescription of Nivestim®. Follow-up visit: during the first cycle of chemotherapy after the first course of Nivestim®. Final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.

Official Title
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PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.

Conditions
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Chemotherapy-Induced Neutropenia

Intervention / Treatment
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* Biological: Nivestim®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour. Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis. Patients informed about the computer processing of their medical data and their right of access and correction. Exclusion Criteria: Patients with contraindication of use of Nivestim®. Patients with haematological malignancy including Myelodysplasia and Chronic myeloid leukemia treated or untreated. Patients participating or having participated in the previous month in a clinical trial. Patients refusing to participate in this study.

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 |
| --- | --- |
| Cancer patients treated with Nivestim®<br> | Biological: Nivestim®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim | The factors which determined the use of Nivestim among participants included participant's sex, young participant, elderly participant, past history of infection, comorbidities, life expectancy, past history of febrile neutropenia and severe neutropenia, occupational activity, family activity and other important criteria. Percentage of participants were categorized based upon the level of importance under different categories which included very important, important, relatively important, not important and not applicable. | Inclusion visit (Week 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Continued Chemotherapy | Chemotherapy is a type of cancer treatment that uses one or more anti-cancer drugs as a part of a standardize treatment regimen. Chemotherapy may be given with curative intent, or it may aim to prolong life or to reduce symptoms. | Follow-up visit (Week 3); End of study visit ( up to Week 19) | 
| Number of Participants Who Discontinued Chemotherapy |  | Follow-up visit (Week 3); End of study visit ( up to Week 19) | 
| Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit |  | Follow-up visit (Week 3) | 
| Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia | Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microliter (microL) in blood) and was classified as Grade 1 (mild) with an absolute neutrophil count (ANC) of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL. | Follow-up visit (Week 3) | 
| Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia | Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microliter (microL) in blood) and was classified as Grade 1 (mild) with an absolute neutrophil count (ANC) of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL. | Follow-up visit (Week 3) | 
| Number of Participants With Unplanned Discontinuation of Chemotherapy at the End of Study Visit | The reasons for unplanned discontinuation of chemotherapy included neutropenia, febrile neutropenia, other toxicity, development of resistance to treatment and other. Also, one participant could have more than one reason for unplanned discontinuation. | End of study visit (up to Week 19) | 
| Number of Participants With Change in Chemotherapy Protocol at End of Study Visit | Number of participants with change in chemotherapy protocol due to each conditions (neutropenia, febrile neutropenia, neutropenia/febrile neutropenia, other toxicity, neutropenia/other toxicity) has been reported in this outcome measure. | End of study visit (up to Week 19) | 
| Number of Participants With Neutropenia and Febrile Neutropenia | Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microL in blood) and was classified as Grade 1 (mild) with an ANC of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL. The incidence of neutropenia (between follow up and final visit) were described from the questionnaire completed by the investigator during the final visit. Febrile neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 degree celsius for >1 hour and ANC less than (<) 1.0 *10^9 neutrophils per liter. The incidence of febrile neutropenia were described from the questionnaire completed by the investigator during the follow-up and final visits. Only those categories which had atleast 1 abnormality have been reported in this outcome measure. | Follow-up visit (Week 3); End of study visit (up to Week 19) | 
| Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study | Change in the disease status of the participant was measured by the change in the count of neutrophils (NPs), platelets and leukocytes as reported in this outcome measure. | Inclusion visit (Week 1), End of study visit (up to Week 19) | 
| Change From Inclusion Visit in Disease Status as Measured by Participants Performance Status at End of Study | The Karnofsky performance scale was used for rating participant activities of daily living. The KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. The lower the Karnofsky score, the worse the survival for most serious illnesses. The score ranges included as 100 (Normal; no complaints), 90 (Able to carry on normal activity), 80 (Normal activity with effort), 70 (Cares for self; unable to carry on normal activity), 60 (Requires occasional assistance, but is able to care), 50 (Requires considerable assistance and frequent medical care), 40 (Disabled; requires special care), 30 (Severely disabled), 20 (Very sick; hospital admission necessary), 10 (Moribund; fatal processes progressing rapidly) and 0 (Dead). | Inclusion visit (Week 1); End of study visit (up to Week 19) | 
| Change From Inclusion Visit in Disease Status as Measured by Haemoglobin Level at End of Study Visit | Change in the disease status of the participant was measured by the change in the hemoglobin level as reported in this outcome measure. | Inclusion visit (Week 1), End of study visit (up to Week 19) | 
| Pain Experienced by Participant During Injection of Nivestim as Assessed by Pain at the Injection Site | Pain experienced by participant at the injection site was measured on a scale 0 to 10 (0 = no pain to 10 = maximum pain), where higher score indicates maximum pain. | End of study visit (up to Week 19) | 
| Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment | Participant's satisfaction after the chemotherapy treatment was assessed by the doctor and was categorized under the 4 categories as very satisfied, satisfied, not very satisfied and dissatisfied. | End of study visit (up to Week 19) | 
| Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary |  | End of study visit (up to Week 19) | 
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after Inclusion visit up to end of study visit (up to Week 19). AEs included both serious and non-serious adverse event. If a participant who reported an SAE also reported an AE that was not serious, that would count as 1 participant in the total number of participants reporting AEs. | Inclusion visit (Week 1) up to end of study visit (up to Week 19) |