Febrile neutropenia (FN) and pegfilgrastim prophylaxis in breast cancer and non-Hodgkin’s lymphoma patients receiving high (> 20%) FN-risk chemotherapy: results from a prospective observational study

• Published in: Supportive care in cancer 2019-04, Vol.27 (4), p.1449-1457
• Main Authors: Salmon, Jean Paul, Smakal, Martin, Karanikiotis, Charisios, Wojtukiewicz, Marek Z., Omnes, Yohann, DeCosta, Lucy, Wetten, Sally, O’Kelly, James
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - epidemiology; Breast Neoplasms - pathology; Chemoprevention - methods; Chemotherapy; Chemotherapy-Induced Febrile Neutropenia - epidemiology; Chemotherapy-Induced Febrile Neutropenia - prevention & control; Clinical medicine; Dose-Response Relationship, Drug; Female; Filgrastim - therapeutic use; Granulocyte Colony-Stimulating Factor - therapeutic use; Humans; Incidence; Lymphoma; Lymphoma, Non-Hodgkin - drug therapy; Lymphoma, Non-Hodgkin - epidemiology; Lymphoma, Non-Hodgkin - pathology; Male; Medicine; Medicine & Public Health; Middle Aged; Neutropenia; Nursing; Nursing Research; Observational studies; Oncology; Original Article; Pain Medicine; Polyethylene Glycols - therapeutic use; Rehabilitation Medicine; Risk Factors
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-018-4473-x

Purpose Prophylaxis for febrile neutropenia (FN) is recommended for the duration of myelosuppressive chemotherapy in high-risk patients; yet, granulocyte-colony-stimulating factor (G-CSF) discontinuation occurs frequently in clinical practice. The objective of this study was to investigate the incidence of FN in real-world settings and the extent and impact of early pegfilgrastim discontinuation. Methods This prospective, observational study enrolled patients with any-stage non-Hodgkin’s lymphoma (NHL) or breast cancer initiating a new chemotherapy course with a high (> 20%) FN risk, with pegfilgrastim in cycle 1. During routine clinical visits, data were collected on FN events, discontinuation of pegfilgrastim (defined as administration of G-CSF other than pegfilgrastim for ≥ 1 cycle) and all G-CSF (and reasons), neutropenic complications and adverse drug reactions (ADRs). Results Overall, 943 patients were enrolled; 844 met the eligibility criteria (full analysis set) and 814 (86%) completed the study. Twenty-eight patients (3%) had 31 FN events (NHL, n  = 17; breast cancer, n  = 11). Twenty-six patients (3%) discontinued pegfilgrastim. Forty-four patients (5%) discontinued G-CSF. The most common reason for pegfilgrastim discontinuation was physician preference for daily G-CSF ( n  = 14 [2%]), and for discontinuation of all G-CSFs was reduced FN risk ( n  = 14 [2%]). Patients who continued G-CSF prophylaxis were less likely to experience neutropenic complications (odds ratio [95% confidence interval]: 0.26 [0.09–0.80]). Suspected ADRs to pegfilgrastim occurred in 43 patients (5%) and serious ADRs in 5 (1%). Conclusions FN rates were consistent with previous reports with pegfilgrastim in clinical practice. No new ADRs were observed. G-CSF discontinuation was uncommon but appeared to increase the likelihood of neutropenic complications.