Febrile neutropenia prophylaxis with prolonged G-CSF in elderly cancer patients: Analysis from the EMPREREAL study.

Abstract

e13773 Background: Guidelines consider age ≥ 65 years a key factor in recommending primary prophylaxis with granulocyte colony-stimulating factors (G-CSFs) for patients receiving chemotherapy regimens with an intermediate risk (10-20%) of febrile neutropenia (FN). There is limited evidence on neutropenia outcomes in elderly patients receiving prolonged G-CSF. We report a prespecified analysis of elderly patients from the EMPEREAL study assessing chemotherapy-induced neutropenia (CIN) of any grade, FN, and dose-limiting neutropenia (DLN). Methods: EMPEREAL is an observational prospective cohort study of 2384 cancer patients receiving chemotherapy (CT) and primary FN prophylaxis with prolonged G-CSF empegfilgrtastim. Patients were followed up for up to five cycles of CT. Number and proportion of patients with FN, CIN of grade 4, grade 3-4, grade 1-4 and DLN in the elderly cohort are presented. Results: The EMPEREAL study included 634 patients (26.6%) aged ≥65 years. Their mean age was 69 years, 65/634 (10.3%) were aged ≥75 years, 2/634 (0.3%) were aged ≥85 years. 468/634 (73.8%) were females. Primary sites for the malignancies included breast cancer (51.4%), digestive cancer (24.0%), lung cancer (8.5%). Most patients (93.8%) had ECOG 0–1. One-third of the patients (31.2%) had received previous systemic therapy. About half (52.5%) pts had a regimens with 10–20% FN risk and 38,5% pts had a regimens with ≥20% risk, Included dose-dense regimens in 12,4 %. 598/634 (94.3%) had at least one risk factors for FN additional to age (median number of additional risk factors was 2): advanced stage (22.9%), female gender (73.8%), Hb < 12 g/dL (26.0%), previous radiation therapy (8.2%), renal or liver failure or heart disease (48.6%), malnutrition (4.4%), history of febrile neutropenia (3.0%). There were no data on neutropenia available for 57/634 (9.0%) patients. FN, CIN of any grade and DLN were registered in 0/577 (0%), 61/577 (15.1%) and 6/577 (1.6%), respectively (Table 1). Conclusions: These results support the effectiveness of primary prophylaxis with empegfilgrastim in routine practice for elderly patients. Clinical outcomes at the patient level. FN 0 (0.0%) CIN grade 4 6 (1.6%) CIN grade 3-4 7 (1.8%) CIN grade 1 through 4 61 (15.1%) DLN 6 (1.6%)