Infusion site adverse events in breast cancer patients receiving highly emetic chemotherapy with prophylactic anti-emetic treatment with aprepitant and fosaprepitant: A retrospective comparison

Abstract

Abstract. The incidences of infusion site adverse events in chemotherapy regimens, including anthracyclines with either fosaprepitant or aprepitant as the anti-emetic, were not highlighted in the randomized trial comparing aprepitant and fosaprepitant. The present retrospective analysis was performed in breast cancer patients receiving anthracycline-containing chemotherapy, a combination of epirubicin and cyclophosphamide with or without 5-fluorouracil as the adjuvant or neoadjuvant, at the outpatient infusion center of St. Marianna University Hospital (Kawasaki, Japan). Infusion site adverse events were retrospectively compared between the 3 months prior to and three months following switching from 3 day oral administration of aprepitant to intravenous infusion of fosaprepitant. A total of 62 patients were included in the aprepitant group and 38 in the fosaprepitant group. Of these patients, 26 (42%) in the aprepitant group and 36 patients (96%) in the fosaprepitant group experienced any grade of infusion site adverse events at least once (P<0.001). As an anti-emetic treatment for chemotherapy using anthracyclines, fosaprepitant may be associated with a higher risk of infusion site adverse events compared with aprepitant.

Phase IIIb Safety and Efficacy of Intravenous NEPA for Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients with Breast Cancer Receiving Initial and Repeat Cycles of Anthracycline and Cyclophosphamide (AC) Chemotherapy

“…In the large registration clinical trial in cancer patients receiving cisplatin, the incidence rate of infusion‐site AEs was 2.2% . However, in fosaprepitant postmarketing retrospective trials incidence rates ranged from 28% to 96% , with higher rates associated with increased speed of delivery , use of peripheral venous access , and AC‐based chemotherapy . Rolapitant IV and HTX‐019 were both approved in the U.S. based only on pharmacokinetic bioequivalence studies (to the oral formulations) in healthy volunteers .…”

“…Importantly, there were no injection‐site reactions related to IV NEPA over repeated cycles and no instance of anaphylaxis with either formulation of NEPA. This is particularly noteworthy as hypersensitivity reactions and anaphylaxis have been reported with IV fosaprepitant , HTX‐019 (IV aprepitant) , and IV rolapitant . Studies have shown a differential impact of fosaprepitant on infusion‐site adverse events (AEs), with patients receiving AC chemotherapy at higher risk compared with those receiving cisplatin‐based chemotherapy, possibly because of the potential for vascular endothelial damage with both fosaprepitant and anthracycline .…”

Aprepitant and fosaprepitant drug interactions: a systematic review

“…One prospective study and six retrospective studies evaluated the incidence of phlebitis when fosaprepitant and anthracycline chemotherapy were administered via the same peripheral vein. Two of these studies compared the incidence of this adverse event in patients receiving anthracycline vs. non‐anthracycline chemotherapy .…”

“…In these studies, the reported odds ratios of having phlebitis with fosaprepitant and anthracycline therapy vs. fosaprepitant and platinum chemotherapy were 12.95 (95% CI: 5.74 to 29.2) [55] and 8.1 (95% CI: 2.0 to 31.9) [56]. Other studies comparing phlebitis rates with/ without fosaprepitant also noted statistically significant increases in phlebitis with fosaprepitant compared to aprepitant [62,64,73].…”

“…Of these, interactions between fosaprepitant and anthracyclines and aprepitant and ifosfamide IV were the suspected cause. One prospective study [60] and six retrospective studies [55,56,61,62,64,73] evaluated the incidence of phlebitis when fosaprepitant and anthracycline chemotherapy were administered via the same peripheral vein. Two of these studies compared the incidence of this adverse event in patients receiving anthracycline vs. non-anthracycline chemotherapy [55,56].…”