Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio®) initiated “same-day” (< 24 h), “per-guidelines” (24–72 h), and “late” (> 72 h): findings from the MONITOR-GCSF study

Heinz Ludwig, Pere Gascón, Carsten Bokemeyer, Matti Aapro, Mario Boccadoro, Kris Denhaerynck, Andriy Krendyukov, Karen MacDonald, Ivo L Abraham

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Purpose: Granulocyte colony-stimulating factors (G-CSFs) are indicated for prophylaxis or management of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Guidelines recommend G-CSF 24–72 h following chemotherapy; however, some evidence suggests that G-CSF initiated < 24 h may benefit some patients. Methods: MONITOR-GCSF was a prospective, observational, multicenter, pan-European study of 1447 chemotherapy-treated patients receiving daily biosimilar (standard) filgrastim (Zarzio®/Zarxio®, filgrastim-sndz, Hexal AG, Sandoz Inc.). In this analysis, cycles were classified as same-day, per-guidelines, or late if G-CSF support was initiated < 24 h, 24–72 h, and > 72 h after chemotherapy. Outcomes included occurrence of CIN of any grade (CIN1/4), grade 3 or 4 (CIN3/4), grade 4 (CIN4), or FN: CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance. Results: A total of 5930 chemotherapy cycles from 1423 evaluable patients from MONITOR-GCSF had data for day of G-CSF initiation: 795 cycles (13.4%) classified as same-day, 3320 (56.0%) as per-guidelines, and 1815 (30.6%) as late. Groups did not differ as to CIN1/4 and FN episodes, or CIN/FN-related hospitalizations or chemotherapy disturbances. Patients in the same-day and per-guidelines groups had statistically similar odds of not experiencing any outcomes of interest in any given cycle. Patients in the late group had worse odds of experiencing CIN1/4, CIN3/4, and CIN4 episodes in any given cycle. Proportions of patients reporting clinical events of interest were generally similar. Conclusions: This real-world evidence indicates that CIN/FN prophylaxis initiated with biosimilar filgrastim within 24–72 h post-chemotherapy is effective and safe. Filgrastim administration on the day of chemotherapy may be appropriate in some patients.

Original languageEnglish (US)
JournalSupportive Care in Cancer
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Biosimilar Pharmaceuticals
Chemotherapy-Induced Febrile Neutropenia
Drug Therapy
Febrile Neutropenia
Neutropenia
Granulocyte Colony-Stimulating Factor
Guidelines
Filgrastim
Hospitalization

Keywords

  • Biosimilar
  • Chemotherapy-induced neutropenia
  • Febrile neutropenia
  • Filgrastim
  • Granulocyte colony-stimulating factors

ASJC Scopus subject areas

  • Oncology

Cite this

Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio®) initiated “same-day” (< 24 h), “per-guidelines” (24–72 h), and “late” (> 72 h) : findings from the MONITOR-GCSF study. / Ludwig, Heinz; Gascón, Pere; Bokemeyer, Carsten; Aapro, Matti; Boccadoro, Mario; Denhaerynck, Kris; Krendyukov, Andriy; MacDonald, Karen; Abraham, Ivo L.

In: Supportive Care in Cancer, 01.01.2018.

Research output: Contribution to journalArticle

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title = "Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio{\circledR}) initiated “same-day” (< 24 h), “per-guidelines” (24–72 h), and “late” (> 72 h): findings from the MONITOR-GCSF study",
abstract = "Purpose: Granulocyte colony-stimulating factors (G-CSFs) are indicated for prophylaxis or management of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Guidelines recommend G-CSF 24–72 h following chemotherapy; however, some evidence suggests that G-CSF initiated < 24 h may benefit some patients. Methods: MONITOR-GCSF was a prospective, observational, multicenter, pan-European study of 1447 chemotherapy-treated patients receiving daily biosimilar (standard) filgrastim (Zarzio{\circledR}/Zarxio{\circledR}, filgrastim-sndz, Hexal AG, Sandoz Inc.). In this analysis, cycles were classified as same-day, per-guidelines, or late if G-CSF support was initiated < 24 h, 24–72 h, and > 72 h after chemotherapy. Outcomes included occurrence of CIN of any grade (CIN1/4), grade 3 or 4 (CIN3/4), grade 4 (CIN4), or FN: CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance. Results: A total of 5930 chemotherapy cycles from 1423 evaluable patients from MONITOR-GCSF had data for day of G-CSF initiation: 795 cycles (13.4{\%}) classified as same-day, 3320 (56.0{\%}) as per-guidelines, and 1815 (30.6{\%}) as late. Groups did not differ as to CIN1/4 and FN episodes, or CIN/FN-related hospitalizations or chemotherapy disturbances. Patients in the same-day and per-guidelines groups had statistically similar odds of not experiencing any outcomes of interest in any given cycle. Patients in the late group had worse odds of experiencing CIN1/4, CIN3/4, and CIN4 episodes in any given cycle. Proportions of patients reporting clinical events of interest were generally similar. Conclusions: This real-world evidence indicates that CIN/FN prophylaxis initiated with biosimilar filgrastim within 24–72 h post-chemotherapy is effective and safe. Filgrastim administration on the day of chemotherapy may be appropriate in some patients.",
keywords = "Biosimilar, Chemotherapy-induced neutropenia, Febrile neutropenia, Filgrastim, Granulocyte colony-stimulating factors",
author = "Heinz Ludwig and Pere Gasc{\'o}n and Carsten Bokemeyer and Matti Aapro and Mario Boccadoro and Kris Denhaerynck and Andriy Krendyukov and Karen MacDonald and Abraham, {Ivo L}",
year = "2018",
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day = "1",
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language = "English (US)",
journal = "Supportive Care in Cancer",
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T1 - Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio®) initiated “same-day” (< 24 h), “per-guidelines” (24–72 h), and “late” (> 72 h)

T2 - findings from the MONITOR-GCSF study

AU - Ludwig, Heinz

AU - Gascón, Pere

AU - Bokemeyer, Carsten

AU - Aapro, Matti

AU - Boccadoro, Mario

AU - Denhaerynck, Kris

AU - Krendyukov, Andriy

AU - MacDonald, Karen

AU - Abraham, Ivo L

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Purpose: Granulocyte colony-stimulating factors (G-CSFs) are indicated for prophylaxis or management of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Guidelines recommend G-CSF 24–72 h following chemotherapy; however, some evidence suggests that G-CSF initiated < 24 h may benefit some patients. Methods: MONITOR-GCSF was a prospective, observational, multicenter, pan-European study of 1447 chemotherapy-treated patients receiving daily biosimilar (standard) filgrastim (Zarzio®/Zarxio®, filgrastim-sndz, Hexal AG, Sandoz Inc.). In this analysis, cycles were classified as same-day, per-guidelines, or late if G-CSF support was initiated < 24 h, 24–72 h, and > 72 h after chemotherapy. Outcomes included occurrence of CIN of any grade (CIN1/4), grade 3 or 4 (CIN3/4), grade 4 (CIN4), or FN: CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance. Results: A total of 5930 chemotherapy cycles from 1423 evaluable patients from MONITOR-GCSF had data for day of G-CSF initiation: 795 cycles (13.4%) classified as same-day, 3320 (56.0%) as per-guidelines, and 1815 (30.6%) as late. Groups did not differ as to CIN1/4 and FN episodes, or CIN/FN-related hospitalizations or chemotherapy disturbances. Patients in the same-day and per-guidelines groups had statistically similar odds of not experiencing any outcomes of interest in any given cycle. Patients in the late group had worse odds of experiencing CIN1/4, CIN3/4, and CIN4 episodes in any given cycle. Proportions of patients reporting clinical events of interest were generally similar. Conclusions: This real-world evidence indicates that CIN/FN prophylaxis initiated with biosimilar filgrastim within 24–72 h post-chemotherapy is effective and safe. Filgrastim administration on the day of chemotherapy may be appropriate in some patients.

AB - Purpose: Granulocyte colony-stimulating factors (G-CSFs) are indicated for prophylaxis or management of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Guidelines recommend G-CSF 24–72 h following chemotherapy; however, some evidence suggests that G-CSF initiated < 24 h may benefit some patients. Methods: MONITOR-GCSF was a prospective, observational, multicenter, pan-European study of 1447 chemotherapy-treated patients receiving daily biosimilar (standard) filgrastim (Zarzio®/Zarxio®, filgrastim-sndz, Hexal AG, Sandoz Inc.). In this analysis, cycles were classified as same-day, per-guidelines, or late if G-CSF support was initiated < 24 h, 24–72 h, and > 72 h after chemotherapy. Outcomes included occurrence of CIN of any grade (CIN1/4), grade 3 or 4 (CIN3/4), grade 4 (CIN4), or FN: CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance. Results: A total of 5930 chemotherapy cycles from 1423 evaluable patients from MONITOR-GCSF had data for day of G-CSF initiation: 795 cycles (13.4%) classified as same-day, 3320 (56.0%) as per-guidelines, and 1815 (30.6%) as late. Groups did not differ as to CIN1/4 and FN episodes, or CIN/FN-related hospitalizations or chemotherapy disturbances. Patients in the same-day and per-guidelines groups had statistically similar odds of not experiencing any outcomes of interest in any given cycle. Patients in the late group had worse odds of experiencing CIN1/4, CIN3/4, and CIN4 episodes in any given cycle. Proportions of patients reporting clinical events of interest were generally similar. Conclusions: This real-world evidence indicates that CIN/FN prophylaxis initiated with biosimilar filgrastim within 24–72 h post-chemotherapy is effective and safe. Filgrastim administration on the day of chemotherapy may be appropriate in some patients.

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KW - Febrile neutropenia

KW - Filgrastim

KW - Granulocyte colony-stimulating factors

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