Feasibility and safety of a reduced duration of therapy of colony-stimulating factor in a dose-dense regimen

Abstract

PurposeThe risk of febrile neutropenia (FN) in cancer patients receiving chemotherapy is mainly due to the type of chemotherapy regimen and the presence of specific risk factors in patients. The recent trend of using a dose-dense treatment schedule has enhanced the risk of FN. In the present prospective study, we evaluated the feasibility of a reduction of duration of therapy with colony-stimulating factor (G-CSF) in a dose-dense regimen.MethodsBetween June 2002 and December 2011, 107 patients with a new diagnosis of non-Hodgkin lymphoma (NHL) receiving dose-dense chemotherapy, every 14 days, were included in the study. The primary endpoint was defined as the completion of planned chemotherapy cycles as scheduled. Secondary endpoints were median number of administered G-CSF doses (vials), incidence of FN, hospitalization and toxicity.ResultsThe planned chemotherapy cycles (primary endpoint) were completed by 84.1 % of patients. The median number of G-CSF (lenograstim) doses administered for each patient was 24 (range 10–35), which corresponds to a median of five vials (range 0–10) for each cycle. Grades 3–4 toxicities, related to G-CSF administration, included neutropenia and thrombocytopenia (14.0 and 1.9 %, respectively). No grades 3–4 bone pain was detected. The incidence of FN and hospitalization was 9.3 % (10/107) and 4.5 % (5/107), respectively.ConclusionsReduced dosage of G-CSF allows dose-dense chemotherapy scheduling, limits exposure to G-CSF and also represents an opportunity for cost savings.

Efbemalenograstim alfa not inferior to pegfilgrastim in providing neutrophil support in women with breast cancer undergoing myelotoxic chemotherapy: results of a phase 2 randomized, multicenter, open-label trial

“…Most of the current cancer regimens are associated with a 10-20% risk of neutropenia and breast cancer patients treated with a dose-dense anthracycline/taxane-based regimen, such as TAC, have > 20% risk of developing febrile neutropenia [10]. To help mitigate this safety risk, prophylactic use of G-CSF is recommended when the risk of febrile neutropenia, determined by considering patient factors and the chemotherapy regimen, is estimated to be approximately 20% [11][12][13]. The neutrophil support provided by efbemalenograstim alfa, a once per cycle G-CSF, was evaluated in this study and was demonstrated to have an efficacy and safety profile similar to pegfilgrastim.…”