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AGIHOHematology2026advanced

Evidence-based AGIHO guideline update on prophylaxis of infectious complications with granulocyte-stimulating factors (G-CSF) for the treatment of adult patients with cancer.

Published by Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO) · ESCMID criteria

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Summary

AI-generated

Febrile neutropenia (FN) is an important complication of cancer treatment. This updated evidence-based guideline provides recommendations for the prophylactic use of G-CSF to reduce the risk of FN in adult cancer patients, addressing changes in antineoplastic treatments such as immunotherapy over the past decade.

G-CSFgranulocyte-stimulating factorscancerprophylaxisinfectious complicationsAGIHODGHOhematology

Key Takeaways

  • 1
    Hodgkin lymphoma: BrECADD or BV+AVD are new standard immunochemotherapy protocols and should be complemented with G-CSF.
  • 2
    AML: G-CSF is safe in the treatment of AML and should be considered regarding the shortening of neutropenia and duration of hospitalization.
  • 3
    Treatment with T cell engager products: G-CSF administration in neutropenia after CAR T cell therapy and bispecific antibody treatment is safe.
  • 4
    Biosimilar G-CSF is at least non-inferior compared to originator G-CSF in terms of efficacy and survival and is a cost-effective alternative.
  • 5
    Efbemalenograstim alfa is at least non-inferior compared to pegfilgrastim or filgrastim in terms of efficacy.
  • 6
    G-CSF for primary prophylaxis can help to save antibiotics.

What's New in This Version

Updated the 2014 AGIHO guideline to provide a comprehensive analysis of literature since 2014, including new recommendations on the use of G-CSF in immunotherapy settings (CAR T cells and bispecific antibodies), new immunochemotherapy protocols (BrECADD, BV+AVD), and the use of biosimilars and efbemalenograstim alfa.

Key Recommendations

6. G-CSF in the treatment of non-Hodgkin lymphoma

  • rec-1

    It is recommended to administer G-CSF on days 2–4 after completing cytotoxic treatment rather than on the same day as chemotherapy to avoid an increase in febrile neutropenia.

    BEvidence: IIprophylaxis

7. G-CSF in the treatment of Hodgkin lymphoma

  • rec-2

    Primary G-CSF prophylaxis is not routinely recommended in patients with Hodgkin lymphoma undergoing ABVD 1st line treatment but might be a clinically valid supportive option in selected patients with advanced age or relevant comorbidities.

    CEvidence: IIuprophylaxis
  • rec-3

    Primary G-CSF prophylaxis is recommended for both younger and elderly patients receiving BV+AVD as first-line treatment for advanced (stage III/IV) HL.

    AEvidence: IIuprophylaxis
  • rec-4

    Prophylactic G-CSF should be given in all patients with HL undergoing escalated BEACOPP or BrECADD therapy.

    AEvidence: IIuprophylaxis

8. G-CSF in the treatment of acute leukemia

  • rec-5

    G-CSF shows effects on the reduction of neutropenia and a benefit regarding infections for patients undergoing medium-intensity consolidation with high-dose cytarabine (≥60 years) and should be considered to shorten hospitalization.

    BEvidence: IIuprophylaxis

9. Secondary application of G-CSF

  • rec-6

    Secondary application of G-CSF is recommended after a neutropenic complication in the previous cycle has occurred.

    BEvidence: IIIsecondary prophylaxis

10. G-CSF after CAR T cell therapy

  • rec-7

    We recommend the use of G-CSF in neutropenia after CAR-T cell treatment.

    BEvidence: IIItherapeutic

11. G-CSF after treatment with bispecific antibodies (BsAb)

  • rec-8

    G-CSF should not be administered during step-up dosing or during cytokine release syndrome (CRS).

    BEvidence: IIIcontraindication

12. Biosimilar G-CSF and efbemalenograstim alfa

  • rec-9

    Using biosimilar G-CSF for prophylaxis of infections in patients with cancer is recommended as it is cost-effective and at least non-inferior to originator G-CSF.

    AEvidence: Iprophylaxis

13. G-CSF as part of antibiotic stewardship programs

  • rec-10

    G-CSF should be preferred over antibiotics whenever reasonable for primary prophylaxis of FN/infections due to putative long term detrimental effects of antibiotics.

    AEvidence: Iprophylaxis

Scope & Objectives

Clinical Topic

Prophylaxis of infectious complications with G-CSF

Objectives

To provide evidence-based information for day-by-day clinical decision making in the care of adult patients with hematological and solid malignancies.

Target Patient Population

Adult patients with cancer

Target Providers

HematologistsOncologistsInfectious disease specialists

Patient Criteria & Setting

Therapeutic Area

Oncology

Guideline Scope

Prophylaxis

Special Populations

Elderly patients

Evidence Grading

System: ESCMID criteria

Evidence Levels

IEvidence from ≥ 1 properly designed RCT
IIEvidence from ≥ 1 well-designed clinical trial, without randomization; from cohort or case-controlled analytic studies; from multiple time series; or from dramatic results of uncontrolled experiments. Sub-categories include r (meta-analysis/systematic review of RCTs), t (transferred evidence), h (historical control), u (uncontrolled trial), a (published abstract).
IIIEvidence from opinions of respected authorities, based on clinical experience, descriptive case studies

Recommendation Strength

AAGIHO strongly supports a recommendation for use
BAGIHO moderately supports a recommendation for use
CAGIHO marginally supports a recommendation for use
DAGIHO supports a recommendation against use

Safety & Contraindications

Contraindications

  • During step-up dosing of bispecific antibodies
  • During cytokine release syndrome (CRS)

Authors & Contributors

Michael SandherrEnrico SchalkWerner J. HeinzPhilipp KöhlerStefan W. KrauseBlasius LissLea KauscheHartmut LinkSibylle C. MellinghoffMartin Schmidt-HieberNikolai SchuelperKarsten SpiekermannRosanne SpruteRuth Seggewiss-Bernhardt

Guideline Features

Based on systematic reviewMultidisciplinaryDrug interactions discussed

Learning Context

Difficulty

advanced

Learning Paths

Febrile NeutropeniaG-CSF ProphylaxisImmunotherapy ToxicityCAR-T TherapyBispecific AntibodiesBiosimilarsAntibiotic Stewardship