A randomised phase II study of the efficacy, safety and cost-effectiveness of pegfilgrastim and filgrastim after autologous stem cell transplant for lymphoma and myeloma (PALM study)

Sebban, Catherine; Lefranc, Anne; Perrier, Lionel; Moreau, Philippe; Espinouse, Daniel; Schmidt, Aline; Kammoun, L.; Ghesquières, Hervé; Ferlay, Céline; Bay, Jacques‐Olivier; Lissandre, Séverine; Pérol, David; Michallet, Mauricette; Quittet, Philippe

doi:10.1016/j.ejca.2011.12.016

Cited by 29 publications

(28 citation statements)

References 30 publications

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“…No differences were found for other post-transplant outcomes such as need for transfusion, infection rate, transplant-related mortality, and length of hospital stay [5],[22]. Interestingly, the analysis of costs in 2 randomized trials, one single-centre, double-blind, placebo-controlled, and one multicenter, open-label, showed that the use of pegfilgrastim was less expensive than filgrastim [22],[23]. Pegfilgrastim is still off-label for pediatric patients despite several authors having documented its efficacy and safety for prophylaxis of febrile neutropenia post-chemotherapy and as the mobilizing agent for peripheral blood stem cell collection [6]–[10],[12]–[15],[34].…”

Section: Discussionmentioning

confidence: 99%

A Randomized, Non-Inferiority Study Comparing Efficacy and Safety of a Single Dose of Pegfilgrastim versus Daily Filgrastim in Pediatric Patients after Autologous Peripheral Blood Stem Cell Transplant

et al. 2013

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PurposeTo assess the non-inferiority of pegfilgrastim versus filgrastim in speeding the recovery of polymorphonuclear cells (PMN) in pediatric patients who underwent autologous peripheral blood stem cell transplant (PBSCT).MethodsThe sample size of this randomized, multicenter, phase III study, was calculated assuming that a single dose of pegfilgrastim of 100 ug/kg was not inferior to 9 doses of filgrastim of 5 ug/kg/day. Randomization was performed by a computer-generated list and stored by sequentially numbered sealed envelopes.ResultsSixty-one patients, with a median age of 11.5 years, were recruited: 29 in the filgrastim arm and 32 in the pegfilgrastim arm. Twenty percent were affected by lymphoma/leukaemia and eighty percent by solid tumors. The mean time to PMN engraftment was 10.48 days (standard deviation [SD] 1.57) and 10.44 days (SD 2.44) in the filgrastim and pegfilgrastim arms, respectively. Having fixed a non-inferiority margin Delta of 3, the primary endpoint of non-inferiority was reached. No differences were observed for other secondary endpoints: platelet engraftment, mean time to platelet recovery (28 days vs. 33 days), fever of unknown origin (79% vs. 78%), proven infection (34% vs. 28%), mucositis (76% vs. 59%). After a median follow-up of 2.3 years (95% C.I.: 1.5, 3.3), 20 deaths were observed due to disease progression.ConclusionsWe conclude that pegfilgrastim was not inferior to daily filgrastim in pediatric patients who underwent PBSCT.EU Clinical Trial Register Number 2007-001430-14

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Section: Discussionmentioning

confidence: 99%

A Randomized, Non-Inferiority Study Comparing Efficacy and Safety of a Single Dose of Pegfilgrastim versus Daily Filgrastim in Pediatric Patients after Autologous Peripheral Blood Stem Cell Transplant

et al. 2013

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“…ema.europa.eu/ema/). However, these molecules are not employed to boost tumor-targeting immune responses, but rather as immunoreconstituting (G-CSF, GM-CSF) [36][37][38][39][40][41][42][43] or oncotoxic (TNF) factors. [44][45][46][47][48][49][50][51][52][53][54][55] Importantly, cytokines can cause relatively severe adverse effects (especially upon systemic administration), which de facto reflect their robust immunostimulatory activity and/or their biological pleiotropism.…”

Section: Introductionmentioning

confidence: 99%

Trial Watch—Immunostimulation with cytokines in cancer therapy

Vacchelli¹,

Aranda

Bloy³

et al. 2015

OncoImmunology

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During the past decade, great efforts have been dedicated to the development of clinically relevant interventions that would trigger potent (and hence potentially curative) anticancer immune responses. Indeed, developing neoplasms normally establish local and systemic immunosuppressive networks that inhibit tumor-targeting immune effector cells, be them natural or elicited by (immuno)therapy. One possible approach to boost anticancer immunity consists in the (generally systemic) administration of recombinant immunostimulatory cytokines. In a limited number of oncological indications, immunostimulatory cytokines mediate clinical activity as standalone immunotherapeutic interventions. Most often, however, immunostimulatory cytokines are employed as immunological adjuvants, i.e., to unleash the immunogenic potential of other immunotherapeutic agents, like tumor-targeting vaccines and checkpoint blockers. Here, we discuss recent preclinical and clinical advances in the use of some cytokines as immunostimulatory agents in oncological indications.

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“…En países europeos se han realizado estudios de costo-eficacia de estimuladores de colonias de granulocitos como filgrastim biocomparable y pegfilgrastim 17 . La profilaxis o tratamiento de la NF con el biocomparable ha sido rentable en todos los escenarios posibles de tratamiento en relación con filgrastim y pegfilgrastim [18][19][20][21][22][23][24][25][26][27][28][29][30] . Se han realizado pocos estudios clínicos pediátricos para validar la seguridad y efectividad del pegfilgrastim en niños.…”

Section: Introductionunclassified

Estudio de costo-beneficio del tratamiento profiláctico de la neutropenia febril con pegfilgrastim versus filgrastim en pacientes pediátricos con tumores sólidos

Facundo¹,

Escamilla²,

Romero³

et al. 2022

GAMO

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32-36Resumen Antecedentes: La neutropenia febril (NF) es una de las principales complicaciones de los pacientes oncológicos, que incrementa exponencialmente los costos del tratamiento. El pegfilgrastim es la forma pegilada del filgrastim y podría disminuir la severidad y duración de la NF, así como los costos. Objetivo: Analizar el costo-beneficio del tratamiento profiláctico de la NF con pegfilgrastim versus filgrastim en pacientes pediátricos con tumores sólidos. Métodos: Se realizó un estudio de costo-beneficio en el cual se analizaron los expedientes clínicos completos de pacientes pediátricos con tumores sólidos y NF que recibieron tratamiento profiláctico con pegfilgrastim versus filgrastim. Se consideraron las variables clí-nico-demográficas, los eventos de NF y los días de estancia hospitalaria, así como las complicaciones y el costo global relacionados, con búsqueda de diferencias mediante t de Student y χ 2 . Resultados: Se incluyeron 26 pacientes con un total de 106 cursos de quimioterapia. A 14 (53.8%) pacientes se les administró filgrastim y 12 (46.1%) recibieron pegfilgrastim. El 57.6% eran del género masculino. El promedio de días de estancia hospitalaria y el costo fueron significativamente mayores en el grupo de filgrastim que en el de pegfilgrastim (p < 0.001). Conclusión: El uso del pegfilgrastim disminuyó el número de eventos de neutropenia y fiebre, los días de estancia hospitalaria y los costos hasta en un 30%. (creativecommons.org/ licenses/by-nc-nd/4.0/). *E-mail para correspondencia: oncouaem2009@hotmail.com (N.A. López-Facundo) ARTÍCULO ORIGINAL Estudio de costo-beneficio del tratamiento profiláctico de la neutropenia febril con pegfilgrastim versus filgrastim en pacientes pediátricos con tumores sólidos

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A randomised phase II study of the efficacy, safety and cost-effectiveness of pegfilgrastim and filgrastim after autologous stem cell transplant for lymphoma and myeloma (PALM study)

Cited by 29 publications

References 30 publications

A Randomized, Non-Inferiority Study Comparing Efficacy and Safety of a Single Dose of Pegfilgrastim versus Daily Filgrastim in Pediatric Patients after Autologous Peripheral Blood Stem Cell Transplant

A Randomized, Non-Inferiority Study Comparing Efficacy and Safety of a Single Dose of Pegfilgrastim versus Daily Filgrastim in Pediatric Patients after Autologous Peripheral Blood Stem Cell Transplant

Trial Watch—Immunostimulation with cytokines in cancer therapy

Estudio de costo-beneficio del tratamiento profiláctico de la neutropenia febril con pegfilgrastim versus filgrastim en pacientes pediátricos con tumores sólidos

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