Literature DB >> 25761321

Safety and efficacy of granulocyte colony-stimulating factor biosimilars in engraftment after autologous stem cell transplantation for haematological malignancies: a 4-year, single institute experience with different conditioning regimens.

Simona Bassi1, Elisa M Stroppa2, Carlo F Moroni1, Maria C Arbasi3, Elena Trabacchi1, Anna Di Franco3, Antonio Lazzaro1, Patrizia Bernuzzi1, Mauro Moretto3, Annalisa Arcari1, Costanza Bosi1, Alessandra Riva4, Luigi Cavanna2, Daniele Vallisa1.   

Abstract

BACKGROUND: Filgrastim biosimilars have recently been introduced into clinical practice. To date biosimilars have demonstrated comparable efficacy and safety as the originator in chemotherapy-induced neutropenia. Published experience in engraftment after autologous stem cell transplantation (ASCT) is limited and concerns relatively few patients.
MATERIALS AND METHODS: With the aim of assessing the efficacy and the safety of filgrastim biosimilars in post-ASCT bone marrow recovery, we conducted a single institution, retrospective study in 56 lymphoma and myeloma patients who received filgrastim biosimilars (Tevagrastim(®) and Zarzio(®)) at standard doses from day 5. We compared our results with recently published data on the originator. A cost analysis of each biosimilar was performed.
RESULTS: Neutrophil counts recovered in 55 patients. The median number of filgrastim biosimilar vials injected was seven per patient. The median time to neutrophil and platelet recovery was 10 and 12 days, respectively. Twenty-six patients had febrile neutropenia, in half of whom the agent involved was identified. In the cost analysis, the use of Tevagrastim(®) and Zarzio(®) was associated with cost reductions of 56% and of 86%, respectively. DISCUSSION: Despite differences in CD34+ cell counts and time of starting filgrastim, our results in terms of time to engraftment and median number of vials injected are similar to published data. Comparing our results by single conditioning regimen to recent literature data, the time to engraftment and duration of hospitalisation were equivalent. Significant differences were observed in the incidence of febrile neutropenia, perhaps due to different preventive and prophylactic protocols for infections. Although prospective studies should be performed to confirm our results, filgrastim biosimilars were found to be effective and safe in engraftment after ASCT.

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Year:  2015        PMID: 25761321      PMCID: PMC4614302          DOI: 10.2450/2015.0198-14

Source DB:  PubMed          Journal:  Blood Transfus        ISSN: 1723-2007            Impact factor:   3.443


  15 in total

1.  Experience (1 year) of G-CSF biosimilars in PBSCT for lymphoma and myeloma patients.

Authors:  J-C Ianotto; A Tempescul; X Yan; P Delepine; R Le Calloch; E Hardy; J-R Eveillard; N Mugnier; C Berthou; G Guillerm
Journal:  Bone Marrow Transplant       Date:  2011-09-26       Impact factor: 5.483

2.  Peripheral blood stem cell mobilization and engraftment after autologous stem cell transplantation with biosimilar rhG-CSF.

Authors:  Péter Reményi; László Gopcsa; Imelda Marton; Marienn Réti; Gábor Mikala; Mónika Pető; Anikó Barta; Arpád Bátai; Zita Farkas; Zita Borbényi; Zoltán Csukly; Imre Bodó; János Fábián; Agnes Király; Lilla Lengyel; Klára Piukovics; Eva Torbágyi; Tamás Masszi
Journal:  Adv Ther       Date:  2014-04-01       Impact factor: 3.845

Review 3.  EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours.

Authors:  M S Aapro; D A Cameron; R Pettengell; J Bohlius; J Crawford; M Ellis; N Kearney; G H Lyman; V C Tjan-Heijnen; J Walewski; D C Weber; C Zielinski
Journal:  Eur J Cancer       Date:  2006-06-05       Impact factor: 9.162

4.  2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline.

Authors:  Thomas J Smith; James Khatcheressian; Gary H Lyman; Howard Ozer; James O Armitage; Lodovico Balducci; Charles L Bennett; Scott B Cantor; Jeffrey Crawford; Scott J Cross; George Demetri; Christopher E Desch; Philip A Pizzo; Charles A Schiffer; Lee Schwartzberg; Mark R Somerfield; George Somlo; James C Wade; James L Wade; Rodger J Winn; Antoinette J Wozniak; Antonio C Wolff
Journal:  J Clin Oncol       Date:  2006-05-08       Impact factor: 44.544

5.  Physicochemical and biologic comparability of a biosimilar granulocyte colony-stimulating factor with its reference product.

Authors:  Fritz Sörgel; Helmut Lerch; Thomas Lauber
Journal:  BioDrugs       Date:  2010-12-01       Impact factor: 5.807

6.  Comparison of 1-day vs 2-day dosing of high-dose melphalan followed by autologous hematopoietic cell transplantation in patients with multiple myeloma.

Authors:  S R Parmar; R Bookout; J F Shapiro; R Tombleson; J Perkins; J Kim; B Yue; M Tomblyn; M Alsina; T Nishihori
Journal:  Bone Marrow Transplant       Date:  2014-03-24       Impact factor: 5.483

7.  Incidence of febrile neutropenia and myelotoxicity of chemotherapy: a meta-analysis of biosimilar G-CSF studies in breast cancer, lung cancer, and non-Hodgkin's lymphoma.

Authors:  Andreas Engert; Auro del Giglio; Peter Bias; Heinz Lubenau; Ulrich Gatzemeier; David Heigener
Journal:  Onkologie       Date:  2009-09-14

Review 8.  Biosimilar agents in oncology/haematology: from approval to practice.

Authors:  Dietger Niederwieser; Stephan Schmitz
Journal:  Eur J Haematol       Date:  2011-01-25       Impact factor: 2.997

Review 9.  Presently available biosimilars in hematology-oncology: G-CSF.

Authors:  Pere Gascon
Journal:  Target Oncol       Date:  2012-01-19       Impact factor: 4.493

Review 10.  Biosimilar G-CSF based mobilization of peripheral blood hematopoietic stem cells for autologous and allogeneic stem cell transplantation.

Authors:  Michael Schmitt; Amy Publicover; Kim H Orchard; Matthias Görlach; Lei Wang; Anita Schmitt; Jiju Mani; Panagiotis Tsirigotis; Reeba Kuriakose; Arnon Nagler
Journal:  Theranostics       Date:  2014-01-23       Impact factor: 11.556

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  7 in total

1.  Cost efficiency and effectiveness of biosimilar filgrastim in autologous transplant.

Authors:  Luisa Giaccone; Lucia Brunello; Jaime Suarez Londono; Matilde Scaldaferri; Marco Cerrano; Valter Redoglia; Paola Omedè; Giuseppe Lia; Massimo Massaia; Dario Ferrero; Federica Cavallo; Sara Bringhen; Sarah Leone; Francesco Cattel; Tiziana Francisci; Valter Tassi; Andrea Evangelista; Mario Boccadoro; Benedetto Bruno
Journal:  Bone Marrow Transplant       Date:  2021-11-30       Impact factor: 5.483

2.  Drug use evaluation of opioid analgesics in pain management among patients with hematopoietic stem cell transplantation.

Authors:  Hyun Jin Oh; So Yeon Hong; Young Mi Jeong; Kyung Suk Choi; Eunsook Lee; Euni Lee; Yu Jung Kim; Soo-Mee Bang
Journal:  Blood Res       Date:  2020-09-30

Review 3.  Italian consensus conference for the outpatient autologous stem cell transplantation management in multiple myeloma.

Authors:  M Martino; R M Lemoli; C Girmenia; L Castagna; B Bruno; F Cavallo; M Offidani; I Scortechini; M Montanari; G Milone; L Postacchini; A Olivieri
Journal:  Bone Marrow Transplant       Date:  2016-04-04       Impact factor: 5.483

4.  Evaluation of a biosimilar granulocyte colony-stimulating factor (filgrastim XM02) for peripheral blood stem cell mobilization and transplantation: a single center experience in Japan.

Authors:  Hideaki Yoshimura; Masaaki Hotta; Takahisa Nakanishi; Shinya Fujita; Aya Nakaya; Atsushi Satake; Tomoki Ito; Kazuyoshi Ishii; Shosaku Nomura
Journal:  J Blood Med       Date:  2017-01-24

5.  Clonal hematopoiesis of indeterminate potential and its impact on patient trajectories after stem cell transplantation.

Authors:  Derek S Park; Afua A Akuffo; David E Muench; H Leighton Grimes; Pearlie K Epling-Burnette; Philip K Maini; Alexander R A Anderson; Michael B Bonsall
Journal:  PLoS Comput Biol       Date:  2019-04-26       Impact factor: 4.475

6.  Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation Mobilization.

Authors:  Sadik Husian; Preethi Jeyaraman; S K Gupta; Reeta Rai; Sangeeta Pathak; Nitin Dayal; Rahul Naithani
Journal:  South Asian J Cancer       Date:  2021-09-04

7.  Efficacy and Safety of Nivestim Versus Neupogen for Mobilization of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation.

Authors:  Cindy Chew; Hong Yen Ng
Journal:  Sci Rep       Date:  2019-12-27       Impact factor: 4.379

  7 in total

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