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

Chemotherapy-Induced Neutropenia Clinical Trial

— VISTA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02454530
• Other study ID #: VISTA
• Secondary ID: C1121007
• Status: Terminated
• Start date: September 2014
• Est. completion date: January 2017

Study information

• Verified date: March 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1160
• Est. completion date: January 2017
• Est. primary completion date: October 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-Induced Neutropenia
• Neutropenia

Intervention

Biological:
• Nivestim®

Locations

Country	Name	City	State
France	Centre Hospitalier du Pays d'Aix Service d'Hématologie - Oncologie	Aix En Provence
France	Clinique Rambot La Provençale Tour d'Aygosi	Aix En Provence
France	ICO Centre Paul Papin Service d'Oncologie Médicale	Angers
France	CHU - Hôtel-Dieu Service Hépato-Gastro-entérologie	Angers Cedex 9
France	CH d'Armentières Service Oncologie	Armentieres
France	Centre Marie Curie A l'attention de Laëtitia	Arras Cedex
France	Centre Hospitalier Service Oncologie	Auxerre Cedex
France	Clinique du Dr Maymard Service d'Oncologie	Bastia
France	Hôpital de Falconaja Furiani Service d'Oncologie	Bastia Cedex
France	Centre Hospitalier Philippe le Bon Service de Medecine Interne - 3e Etage	Beaune
France	CHU - Hôpital Jean Minjoz Service Oncologie Médicale	Besancon Cedex
France	Centre Hospitalier Service Onco-Hématologie	Beziers Cedex
France	Hôpital Avicenne Service Gastro-Entérologie	Bobigny Cedex
France	Clinique Tivoli	Bordeaux Cedex
France	Centre Hospitalier Service d'Oncologie	Boulogne Sur Mer Cedex
France	CH de Fleyriat Service de Pneumologie	Bourg En Bresse
France	CH de Fleyriat Service Onco-Hématologie	Bourg En Bresse
France	Clinique Pasteur Lanroze Service Oncologie	Brest
France	Hôpital Morvan - CHU Institut de Cancérologie et d'Hématologie	Brest Cedex
France	Hôpital Augustin Morvan Institut de Cancérologie et d'Hématologie	Brest Cedex 2
France	Hôpital Louis Pradel Service Pneumologie - Centre des Maladies Orphelines	Bron Cedex
France	Centre François Baclesse Oncologie Médicale. Pathologie Mammaire et Recherche Clinique	Caen Cedex 5
France	Centre Hospitalier Service d'Oncologie	Carcassonne Cedex
France	Centre Hospitalier de Carcassonne Service d'Oncologie	Carcassonne Cedex 9
France	Médipole de Savoie	Challes Les Eaux
France	Medipole de Savoie Service Oncologie	Challes Les Eaux
France	CH William Morey Service d'Oncologie Médicale	Chalon Sur Saone Cedex
France	CHP du Cotentin - Site de Cherbourg Service d'Oncologie	Cherbourg
France	Centre Hospitalier de Cholet Service d'Hepato-Gastro-Enterologie	Cholet
France	Centre Hospitalier de Cholet Service d' Oncologie Médicale	Cholet Cedex
France	Centre hospitalier Louis Pasteur Service de Pneumologie	Colmar Cedex
France	Hôpital Louis Pasteur Service de Pneumologie - Médecine F	Colmar Cedex
France	Centre de Radiothérapie GIE CROM	Compiegne
France	CHU de Dijon - Hôpital du Bocage Service Hépato-Gastro-Entérologie	Dijon Cedex
France	Centre Hospitalier de la Dracénie Service d'Oncologie	Draguignan
France	Centre Hospitalier de la Dracénie Service d'Oncologie	Draguignan
France	Centre Hospitalier Emile Durkheim Service Oncologie	Epinal Cedex
France	Clinique Chirurgicale Pasteur Service Oncologie Médicale	Evreux Cedex
France	CHI Fréjus Saint Raphaël Service d'Oncologie Médicale	Frejus
France	CHI des Alpes du sud Site de Gap Muret Hôpital de Jour - Oncologie	GAP
France	Centre Hospitalier Service d'Oncologie	Gonesse Cedex
France	Centre Hospitalier Service Onco-Hématologie	Le Mans
France	Centre de Radiothérapie Hartmann	Levallois Perret
France	Institut Franco Britannique Service Oncologie Médicale	Levallois Perret
France	Centre de Radiothérapie Hartmann	Levallois Perret Cedex
France	Clinique Hartman Service de Radiothérapie	Levallois Perret Cedex
France	Clinique Hartmann Service Oncologie	Levallois Perret Cedex
France	CHRU Lille - Hôpital Huriez Unité d'Oncologie Médicale	Lille Cedex
France	CHU Dupuytren Limoges Service d'Oncologie	Limoges
France	Centre Hospitalier Service de Médecine 2 - Hôpital de jour	Lons le Saunier Cedex
France	Centre Léon Bérard Service d'Oncologie Médicale	Lyon
France	Hôpital Privé Jean Mermoz Service d'Oncologie Médicale	Lyon
France	CH Saint-Joseph et Saint-Luc Service de Gastro-Entérologie	Lyon Cedez 07
France	Centre Hospitalier Privé Clairval Service de Cancérologie	Marseille
France	Hôpital Nord Service d'Oncologie Multidisciplinaires et Innovations Thérapeutiques	Marseille Cedex 20
France	Clinique Claude Bernard Service Chimiothérapie	Metz Cedex 03
France	Clinique Claude Bernard Service de Chimiothérapie	Metz Cedex 03
France	Centre Hospitalier Layne Service d'Oncologie	Mont de Marsan Cedex
France	Centre Hospitalier de Belfort-Montbéliard Site du Mittan-Oncologie et radiothérapie	Montbeliard
France	Clinique Clementville Service d'Oncologie	Montpellier
France	CHU Montpellier - Hôpital Arnaud de Villeneuve Service de Cancérologie	Montpellier Cedex 5
France	Centre Hospitalier Emile Muller	Mulhouse Cedex
France	CH de Mulhouse - Hôpital Emile Muller Hôpital de Jour - Oncologie	Mulhouse Cedex
France	Polyclinique de Gentilly Service Oncologie Médicale	Nancy
France	CHU de Nantes - Hôpital Laënnec Service d'Oncologie Médicale	Nantes
France	CHU - Hôpital Hôtel Dieu Unité de Gastroentérologie	Nantes Cedex 1
France	Centre Hospitalier de Narbonne Oncologie / Hématologie	Narbonne
France	Hôpital Américain	Neuilly Sur Seine
France	Clinique Alleray Labrouste Service d'Oncologie Médicale	Paris
France	Hôpital Européen Georges Pompidou Service d'Oncologie Médicale	Paris
France	Hôpital Européen Georges Pompidou Service Oncologie Médicale - 4e étage (ascenseur B)	Paris
France	Institut Mutualiste Montsouris Service Oncologie Médicale	Paris
France	Hôpital Bichat Claude Bernard Service Hépato-Gastroentérologie et Cancérologie Digestive	Paris Cedex 18
France	Hôpital Tenon Service d'oncologie médicale	Paris Cedex 20
France	Centre Hospitalier Service d'Oncologie	Perpignan
France	Centre Hospitalier Service de Pneumologie	Perpignan
France	Centre Hospitalier Annecy Genevois Service Pneumologie	Pringy Cedex
France	Centre Hospitalier de la region d'Annecy Pole Medecine	Pringy Cedex
France	CH de Cornouaille Service d'Oncologie Médicale	Quimper Cedex
France	Institut Jean Godinot	Reims Cedex
France	Clinique de l'Europe Unité d'Oncologie	Rouen
France	Hôpital de Saint-Avold Service Oncologie II	Saint Avold Cedex
France	Centre Hospitalier Privé Saint Grégoire Service d'Oncologie - Radiothérapie	Saint Gregoire
France	Centre Hospitalier Privé Saint-Grégoire Service d'Oncologie - Radiothérapie	Saint Gregoire
France	Clinique François 1er	Saint-dizier
France	Centre Clinical Service d'Oncologie-Radiothérapie	Soyaux
France	Centre de Radiothérapie SCP Strasbourg Oncologie Libérale	Strasbourg Cedex
France	Hôpital Bel Air Service Pneumologie	Thionville
France	Hôpital de Thionville Service Oncologie Médicale	Thionville Cedex
France	Hôpital Rangueil Service d'Oncologie Médicale Digestive et Gynécologique	Toulouse
France	Clinique Pasteur	Toulouse Cedex 3
France	Hôpital Bretonneau Service d'Oncologie Médicale	Tours Cedex 9

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)
Secondary	Number of Participants Who Discontinued Chemotherapy		Follow-up visit (Week 3); End of study visit ( up to Week 19)
Secondary	Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit		Follow-up visit (Week 3)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary		End of study visit (up to Week 19)
Secondary	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)