Background

Chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) are common complications of chemotherapy that can lead to hospitalisation or chemotherapy disturbance. Standard of care is guideline-recommended prophylaxis with granulocyte colony-stimulating factors (GCSF) based on the regimen myelotoxicity and patient risk factors.

Methods

MONITOR-GCSF is a real-world European study of 1447 cancer patients (pts) receiving CIN/FN prophylaxis with biosimilar filgrastim; 77.2% had solid tumours and 22.8% haematological malignancies. We analysed prophylaxis patterns and CIN/FN outcomes in these cohorts and performed multi-level modelling of predictors of outcomes at the patient and cycle level.

Results

Differences in GCSF prophylaxis patterns were observed between cohorts. The solid tumour cohort vs the haematology cohort included significantly more over-prophylacted pts (29.7% vs 13.7%) and fewer correctly-prophylacted pts (54.0% vs 65.3%) (P = 0.009 for trend). Of note, 16.3% with solid tumours and 21.0% of haematology pts were under-prophylacted. In 60% of solid tumour pts, GCSF was initiated within the recommended time window vs 42% of haematology pts. Cycle-level analyses revealed higher rates of CIN (all grades) and FN in the haematology cohort, but no differences in hospitalisation or chemotherapy disturbance. No differences in patient-level outcomes (“ever” during the study) were found, except for FN (9.1% in haematological patients vs. 5.0% with solid tumours). Across patient- and cycle-level analyses, predictors of poor outcomes common to both cohorts included concomitant antibiotic prophylaxis, Eastern Cooperative Oncology Group performance status > =2 at any time, and CIN of any grade in a prior cycle. A GCSF Initiation Score of 1, indicating biosimilar filgrastim initiation within the 24–72 h window, was a common strong predictor of better outcomes.

Conclusions

Our analyses illustrate the importance of assuring adequate GCSF support in both haematology and solid tumour pts to prevent CIN/FN and related hospitalisations and chemotherapy disturbances.

Clinical trial identification

N/A

Legal entity responsible for the study

Sandoz Biopharmaceuticals

Funding

Sandoz Biopharmaceuticals

Disclosure

M. Aapro: Amgen (honoraria, speakers bureau, expert testimony), Helsinn Healthcare (advisory role, speakers bureau, research funding), Hospira (advisory role, speakers bureau, research funding), Teva (advisory role, speakers bureau), Merck KGaA (advisory role), Merck (advisory role), Sandoz (advisory role, speakers bureau, research funding), Pierre Fabre Medicament (advisory role, speakers bureau, research funding), Vifor Pharma (advisory role, speakers bureau), Tesaro (advisory role, speakers bureau), Novartis (speakers bureau, research funding), Roche (speakers bureau), Johnson & Johnson (speakers bureau). C. Bokemeyer: Hexal AG (personal fees). M. Boccadoro: Celgene (personal fees), Novartis (personal fees), Amgen (personal fees), Sanofi (personal fees). P. Gascón: Sandoz (speakers bureau). K. Denhaerynck: Matrix45 (employment). Matrix45 has been under contract for scientific consulting services to GCSF manufacturers including Hospira, Hexal/Sandoz and Therapeutic Proteins International. By company policy, employees cannot hold equity in sponsor organizations and cannot receive direct personal benefits, financial or other, from sponsor organizations. A. Krendyukov: Hexal AG (employment).

I. Abraham, K. Macdonald: Matrix45 (employment). Matrix45 is under contract with study Sponsor, Hexal/Sandoz, for scientific support services including study design, statistical analysis and manuscript preparation for the MONITOR-GCSF study. Matrix45 has been under contract for scientific consulting services to other GCSF manufacturers including Hospira. By company policy, employees cannot hold equity in sponsor organizations and cannot receive direct personal benefits, financial or other, from sponsor organizations. Matrix45 provides similar services to other biopharmaceutical companies without exclusivity constraints. H. Ludwig: Celgene (speaker’s honoraria), Takeda (research funding, speaker’s honoraria), Amgen (honoraria for advisory boards and speakers board).