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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chemotherapy-Induced Neutropenia
• Intervention / Treatment: Biological: Nivestim®

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1160

Contacts and Locations

Study Locations

• France
  • Aix En Provence, France, 13100
    • Clinique Rambot La Provençale Tour d'Aygosi
  • Aix En Provence, France, 13616
    • Centre Hospitalier du Pays d'Aix Service d'Hématologie - Oncologie
  • Angers, France, 49000
    • ICO Centre Paul Papin Service d'Oncologie Médicale
  • Angers Cedex 9, France, 49933
    • CHU - Hôtel-Dieu Service Hépato-Gastro-entérologie
  • Armentieres, France, 59280
    • CH d'Armentières Service Oncologie
  • Arras Cedex, France, 62000
    • Centre Marie Curie A l'attention de Laëtitia
  • Auxerre Cedex, France, 89011
    • Centre Hospitalier Service Oncologie
  • Bastia, France, 20200
    • Clinique du Dr Maymard Service d'Oncologie
  • Bastia Cedex, France, 20604
    • Hôpital de Falconaja Furiani Service d'Oncologie
  • Beaune, France, 21200
    • Centre Hospitalier Philippe le Bon Service de Medecine Interne - 3e Etage
  • Besancon Cedex, France, 25030
    • CHU - Hôpital Jean Minjoz Service Oncologie Médicale
  • Beziers Cedex, France, 34525
    • Centre Hospitalier Service Onco-Hématologie
  • Bobigny Cedex, France, 93009
    • Hôpital Avicenne Service Gastro-Entérologie
  • Bordeaux Cedex, France, BP 114 33030
    • Clinique Tivoli
  • Boulogne Sur Mer Cedex, France, 62321
    • Centre Hospitalier Service d'Oncologie
  • Bourg En Bresse, France, CS 90401 01012
    • CH de Fleyriat Service de Pneumologie
  • Bourg En Bresse, France, CS 90401 01012
    • CH de Fleyriat Service Onco-Hématologie
  • Brest, France, 29200
    • Clinique Pasteur Lanroze Service Oncologie
  • Brest Cedex, France, 29609
    • Hôpital Morvan - CHU Institut de Cancérologie et d'Hématologie
  • Brest Cedex 2, France, 29609
    • Hôpital Augustin Morvan Institut de Cancérologie et d'Hématologie
  • Bron Cedex, France, 69677
    • Hôpital Louis Pradel Service Pneumologie - Centre des Maladies Orphelines
  • Caen Cedex 5, France, 14076
    • Centre François Baclesse Oncologie Médicale. Pathologie Mammaire et Recherche Clinique
  • Carcassonne Cedex, France, 11010
    • Centre Hospitalier Service d'Oncologie
  • Carcassonne Cedex 9, France, 11890
    • Centre Hospitalier de Carcassonne Service d'Oncologie
  • Challes Les Eaux, France, 73190
    • Médipôle de Savoie
  • Challes Les Eaux, France, 73190
    • Medipole de Savoie Service Oncologie
  • Chalon Sur Saone Cedex, France, 71321
    • CH William Morey Service d'Oncologie Médicale
  • Cherbourg, France, 50100
    • CHP du Cotentin - Site de Cherbourg Service d'Oncologie
  • Cholet, France, 49325
    • Centre Hospitalier de Cholet Service d'Hépato-Gastro-Entérologie
  • Cholet Cedex, France, 49325
    • Centre Hospitalier de Cholet Service d' Oncologie Médicale
  • Colmar Cedex, France, 68024
    • Centre hospitalier Louis Pasteur Service de Pneumologie
  • Colmar Cedex, France, 68024
    • Hôpital Louis Pasteur Service de Pneumologie - Médecine F
  • Compiegne, France, 60204
    • Centre de Radiothérapie GIE CROM
  • Dijon Cedex, France, BP 77908 21079
    • CHU de Dijon - Hôpital du Bocage Service Hépato-Gastro-Entérologie
  • Draguignan, France, BP 249 83007
    • Centre Hospitalier de la Dracénie Service d'Oncologie
  • Draguignan, France, BP 249 83300
    • Centre Hospitalier de la Dracénie Service d'Oncologie
  • Epinal Cedex, France, 88021
    • Centre Hospitalier Emile Durkheim Service Oncologie
  • Evreux Cedex, France, 27025
    • Clinique Chirurgicale Pasteur Service Oncologie Médicale
  • Frejus, France, 83608
    • CHI Fréjus Saint Raphaël Service d'Oncologie Médicale
  • GAP, France, 05007
    • CHI des Alpes du sud Site de Gap Muret Hôpital de Jour - Oncologie
  • Gonesse Cedex, France, BP 30071 95503
    • Centre Hospitalier Service d'Oncologie
  • Le Mans, France, 72000
    • Centre Hospitalier Service Onco-Hématologie
  • Levallois Perret, France, 92300
    • Centre de radiothérapie Hartmann
  • Levallois Perret, France, 92300
    • Institut Franco Britannique Service Oncologie Médicale
  • Levallois Perret Cedex, France, 92309
    • Clinique Hartman Service de Radiothérapie
  • Levallois Perret Cedex, France, 92309
    • Clinique Hartmann Service Oncologie
  • Levallois Perret Cedex, France, CS 90004 92309
    • Centre de radiothérapie Hartmann
  • Lille Cedex, France, 59037
    • CHRU Lille - Hôpital Huriez Unité d'Oncologie Médicale
  • Limoges, France, 87042
    • CHU Dupuytren Limoges Service d'Oncologie
  • Lons le Saunier Cedex, France, 39000
    • Centre Hospitalier Service de Médecine 2 - Hôpital de jour
  • Lyon, France, 69008
    • Centre Léon Bérard Service d'Oncologie Médicale
  • Lyon, France, 69008
    • Hôpital Privé Jean Mermoz Service d'Oncologie Médicale
  • Lyon Cedez 07, France, 69365
    • CH Saint-Joseph et Saint-Luc Service de Gastro-Entérologie
  • Marseille, France, 13009
    • Centre Hospitalier Privé Clairval Service de Cancérologie
  • Marseille Cedex 20, France, 13915
    • Hôpital Nord Service d'Oncologie Multidisciplinaires et Innovations Thérapeutiques
  • Metz Cedex 03, France, 57072
    • Clinique Claude Bernard Service de Chimiothérapie
  • Metz Cedex 03, France, BP 45050 57072
    • Clinique Claude Bernard Service Chimiothérapie
  • Mont de Marsan Cedex, France, 40024
    • Centre Hospitalier Layne Service d'Oncologie
  • Montbeliard, France, 25200
    • Centre Hospitalier de Belfort-Montbéliard Site du Mittan-Oncologie et radiothérapie
  • Montpellier, France, 34000
    • Clinique Clementville Service d'Oncologie
  • Montpellier Cedex 5, France, 34295
    • CHU Montpellier - Hôpital Arnaud de Villeneuve Service de Cancérologie
  • Mulhouse Cedex, France, 68070
    • Centre Hospitalier Emile Muller
  • Mulhouse Cedex, France, 68070
    • CH de Mulhouse - Hôpital Emile Muller Hôpital de Jour - Oncologie
  • Nancy, France, 54100
    • Polyclinique de Gentilly Service Oncologie Médicale
  • Nantes, France, 44093
    • CHU de Nantes - Hôpital Laënnec Service d'Oncologie Médicale
  • Nantes Cedex 1, France, 44093
    • CHU - Hôpital Hôtel Dieu Unité de Gastroentérologie
  • Narbonne, France, 11108
    • Centre Hospitalier de Narbonne Oncologie / Hématologie
  • Neuilly Sur Seine, France, 92200
    • Hôpital Américain
  • Paris, France, 75014
    • Institut Mutualiste Montsouris Service Oncologie Médicale
  • Paris, France, 75015
    • Clinique Alleray Labrouste Service d'Oncologie Médicale
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou Service d'Oncologie Médicale
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou Service Oncologie Médicale - 4e étage (ascenseur B)
  • Paris Cedex 18, France, 75877
    • Hôpital Bichat Claude Bernard Service Hépato-Gastroentérologie et Cancérologie Digestive
  • Paris Cedex 20, France, 75970
    • Hôpital Tenon Service d'oncologie médicale
  • Perpignan, France, 66046
    • Centre Hospitalier Service d'Oncologie
  • Perpignan, France, BP 4052 66046
    • Centre Hospitalier Service de Pneumologie
  • Pringy Cedex, France, 74370
    • Centre Hospitalier Annecy Genevois Service Pneumologie
  • Pringy Cedex, France, METZ TESSY 74374
    • Centre Hospitalier de la region d'Annecy Pole Medecine
  • Quimper Cedex, France, 29107
    • CH de Cornouaille Service d'Oncologie Médicale
  • Reims Cedex, France, 51726
    • Institut Jean Godinot
  • Rouen, France, 76100
    • Clinique de l'Europe Unité d'Oncologie
  • Saint Avold Cedex, France, 57502
    • Hôpital de Saint-Avold Service Oncologie II
  • Saint Gregoire, France, 35760
    • Centre Hospitalier Privé Saint Grégoire Service d'Oncologie - Radiothérapie
  • Saint Gregoire, France, 35760
    • Centre Hospitalier Privé Saint-Grégoire Service d'Oncologie - Radiothérapie
  • Saint-dizier, France, 52100
    • Clinique François 1er
  • Soyaux, France, 16800
    • Centre Clinical Service d'Oncologie-Radiothérapie
  • Strasbourg Cedex, France, 67085
    • Centre de Radiothérapie SCP Strasbourg Oncologie Libérale
  • Thionville, France, 57312
    • Hôpital Bel Air Service Pneumologie
  • Thionville Cedex, France, BP 60327 57126
    • Hôpital de Thionville Service Oncologie Médicale
  • Toulouse, France, 31059
    • Hôpital Rangueil Service d'Oncologie Médicale Digestive et Gynécologique
  • Toulouse Cedex 3, France, BP 27617 31076
    • Clinique Pasteur
  • Tours Cedex 9, France, 37044
    • Hôpital Bretonneau Service d'Oncologie Médicale

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: Non-Probability Sample

Study Population

Patients with solid tumour treated with cytotoxic chemotherapy and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) is initiated

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer patients treated with Nivestim®	Biological: Nivestim®

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in Different Profiles Receiving Treatment With Nivestim	Classification of participants into three different profiles were established by level of importance of the determining factors for the use of Nivestim and was categorized as profile 1= not applicable, profile 2= relatively unimportant and profile 3 = not important. A multiple correspondence analysis was conducted on the whole analysis population in order to identify possible different patient profiles. None of these profiles could have been associated to a type of chemotherapy (adjuvant or metastatic).	End of study visit (up to Week 19)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Hospira, now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): October 18, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 22, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): June 28, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia
• Other Study ID Numbers: VISTA; C1121007 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.