The levels of evidence (I–IV) and strength of recommendations (A–C) are defined at the end of the "Major Recommendations" field.
Prophylactic and Adjunctive Use of Colony-Stimulating Factors (CSFs)
- Primary prophylaxis is not routinely recommended unless the expected incidence of febrile neutropenia is greater than 40% (level IIa, grade B).
- Secondary prophylaxis cannot be routinely justified because of a lack of available evidence but is indicated for tumours in which dose reduction/dose delay would compromise overall survival (level III, grade B).
- Adjunctive treatment is not recommended for patients with uncomplicated febrile neutropenia (level Ib, grade A) but should be considered in patients with the poor prognostic factors listed in the text (level IV, grade C).
Use of CSFs in Association With Chemotherapy
- Acute myeloid leukaemia (AML). The routine use of CSF is recommended after consolidation chemotherapy (level Ib, Grade A). CSF is recommended after induction if it is appropriate to reduce hospital stay or antibiotic usage.
- Acute lymphoblastic leukaemia (ALL). Granulocyte colony-stimulating factor (G-CSF) is indicated to reduce the severity of neutropenia following intensive phases of therapy (level Ib, grade A).
- Myelodysplastic syndromes (MDS). CSFs are indicted to reduce the severity of neutropenia in patients receiving intensive chemotherapy (level Ib, grade A). CSFs are also recommended on an intermittent basis for patients with neutropenia and infection (level IV, grade C), but continuous prophylactic use is not routinely justified.
- Aplastic anaemia. There is insufficient evidence to make any general recommendations and hence patients should be given CSFs only on an individual therapeutic trial basis (level IV, grade C).
- Bone marrow failure syndromes. G-CSF is recommended when improvement of neutrophil count is appropriate (level III, grade B).
- Malignant lymphomas. There is evidence to support the routine use of CSFs to reduce the incidence of infection, chemotherapy delay and hospitalization especially when the risk of febrile neutropenia exceeds 40% (level Ia, grade A). There is also emerging evidence of improved survival with G-CSF-supported dose intensification in elderly patients with high-grade non-Hodgkin's lymphoma (NHL) (level Ib, grade A). At present, this evidence is insufficient to justify a change in policy in all patients with lymphoma, but elderly patients may benefit from G-CSF support.
CSFs for Peripheral Blood Progenitor cell (PBPC) Mobilization
- CSFs are indicated for the mobilization of PBPCs.
CSFs After PBPC and Marrow Transplantation
- CSFs are indicated to accelerate reconstitution after allogeneic and autologous PBPC transplantation or bone marrow transplantation (BMT) (level Ib, grade A).
Definitions:
Statements of Evidence
Ia Evidence obtained from meta-analysis of randomized controlled trials.
Ib Evidence obtained from at least one randomized controlled trial.
IIa Evidence obtained from at least one well-designed controlled study without randomization.
IIb Evidence obtained from at least one other type of well-designed quasi-experimental study
III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies.
IV Evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities.
Grades of Recommendations
- Requires at least one randomized controlled trial as part of a body of literature of overall good quality and consistency addressing the specific recommendation. (Evidence levels Ia, Ib)
- Requires the availability of well-conducted clinical studies but no randomized clinical trials on the topic of recommendation. (Evidence levels IIa, IIb, III)
- Requires evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities. Indicates an absence of directly applicable clinical studies of good quality. (Evidence level IV)
