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There are limited data concerning the use of biosimilars of filgrastim in autologous stem cell transplantation (ASCT). This study aimed to evaluate G-CSF efficiency and safety (based on haemograms, transfusion needs and complications) of two biosimilars (Zarzio and Ratiograstim®) compared to those of Neupogen® for our patients who underwent ASCT.
Since 2008, Investigator collected data of all patients who underwent ASCT to treat lymphoma or myeloma.
All the patients signed an institutional informed consent form before the harvest of peripheric stem cells (PROMISE program). Patients received Neupogen® (Amgen-SA) between April 2008 and February 2010, and the next group of patients was treated with Ratiograstim® (Ratiopharm GmbH) until May 2012. The last group of patients received Zarzio® (Sandoz GmbH) until November 2014.
Investigator studied the impact of the Zarzio® use on biological parameters of the bone marrow recovery, transfusion needs and infectious complications. These parameters were then compared to those of the previous patients which were treated with the two other drugs.
The patients were recruited in the University Hospital of Brest. They were consecutive patients, treated by ASCT for their high risk lymphoma and myeloma but without selection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of patients treated with Zarxio | All consecutive patients, treated for lymphoma or myeloma, which underwent autologous stem cell transplantation in the University Hospital of Brest. All these patients were treated with biosimilars of Filgrastim: Zarzio®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgrastim Prefilled Syringe [Zarzio®] | Drug | Daily subcutaneous injection of Zarxio post ASCT, from day 5 until bone marrow recovery (neutrophils >1 giga/l) |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to bone marrow recovery | timing in days from the day of ASCT until the day when neutrophils >1 giga/l | daily evaluation, around 8 days normally |
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Inclusion Criteria:
Exclusion Criteria:
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All patients treated by ASCT in the case of DLBCL or Hodgkin disease or multiple myeloma
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| Name | Affiliation | Role |
|---|---|---|
| IANOTTO Jean-Christophe, MD, PhD | Hématologie Clinique-Institut de Cancéro-Hématologie | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28278727 | Result | Nicol C, Henry C, Couturier MA, Delepine P, Tripogney C, Buors C, Guillerm G, Berthou C, Tempescul A, Ianotto JC. Biosimilars of filgrastim in autologous stem cell transplantation: certain differences for myeloma patients only. Leuk Lymphoma. 2017 Sep;58(9):1-3. doi: 10.1080/10428194.2017.1285025. Epub 2017 Feb 7. No abstract available. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |