Prophylaxis of chemotherapy-induced neutropenia with lipegfilgrastim in patients with breast cancer: results from an interim analysis of the non-interventional study NADIR

Abstract

Introduction: Platinum‐based chemotherapy regimens are the standard treatment for patients with lung cancer. Neutropenia is one of the most serious hematological and major dose‐limiting toxicities that can comprise treatment outcomes. Guidelines recommend prophylactic granulocyte colony‐stimulating factor (G‐CSF) use for patients (pts) at high risk for febrile neutropenia (FN). Lipegfilgrastim (LIP) is a glyco‐pegylated G‐CSF approved to reduce the duration of neutropenia and the incidence of FN. Here we report on results from an interim analysis of the non‐interventional study NADIR in pts with lung cancer. Methods: The prospective multicenter non‐interventional study NADIR is conducted in 270 outpatient centers and hospitals across Germany, aiming to collect data on prophylactic LIP use in 2500 pts with different tumor entities under antineoplastic treatment in routine clinical practice. The objective of the study is to assess the effectiveness of LIP by determining the incidence of neutropenia grade 3/4 and FN. Results: At the time of data cut‐off (3/2016), 2422 pts were enrolled by 198 sites. 1556 pts were evaluable, thereof 172 pts with lung cancer (NSCLC: 73; SCLC: 94). Mean age was 65.1 years for lung cancer pts, 56.4% of pts were male. At inclusion 68.0% of pts had an ECOG of 0 or 1 (14.5% missing data). In 79.1% of pts chemotherapy was applied in a palliative setting. 78.5% of pts were treated with platinum‐based combination chemotherapy. 589 of 636 documented chemotherapy cycles (92.6%) were supported by LIP. Neutropenia grade 3/4 occurred in 33.1% of pts, one patient developed FN. Dose reductions were reported in 73 of 636 cycles (11.4%), in 10 cases due to chemotherapy‐induced neutropenia. For 12.2% of pts LIP‐related adverse events were reported. The most frequent LIP‐related adverse event reported was leucocytosis (3.5%). LIP‐related serious adverse events were reported for 1.7% of pts. Conclusions: In pts with lung cancer treated with a platinum‐based combination regimen LIP was effective and well tolerated. The incidence of neutropenia grade 3/4 and FN was low and comparable to literature. FN only occurred in < 1% of pts.