2725 - Safety profile of oral netupitant/palonosetron in hematopoietic stem cell transplantation recipients.

Background

The oral, fixed-combination NEPA containing netupitant and palonosetron target crucial pathways involved in both acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients with highly emetogenic chemotherapy.Hematopoietic stem cell transplantation (HSCT) is associated with infectious complications, especially bloodstream infections (BSI). The risk factors associated with BSI include presence of indwelling vascular catheters. NEPA eliminates accessing intravenous catheters leading to a decreased risk of infection in HSCT recipients.There is a paucity of studies about the management of CINV during preparative regimens for HSCT. The aim of this study was to assess the safety of NEPA during and after HSCT conditioning.

Methods

Patients with chronic myeloid leukemia, multiple myeloma, myelodysplastic syndrome, and acute myeloid leukemia who received an allogeneic HSCT between 2017 and 2018 were retrospective studied. Conditioning regimen consisted of fludarabine and busulfan. Graft versus host disease prophylaxis was done with high-dose cyclophosphamide on days +3 to + 4 post-HSCT. Patients received a single capsule of NEPA prior to conditioning regimen and before cyclophosphamide, both with oral dexamethasone on days 1-3 . Safety was assessed by evaluation of adverse events and use of rescue medications (baclofen for hiccups and lactitol, macrogol and sennosides for constipation).

Results

Six patients were included: 4/6were male and median age was 50 years (IQR: 46-53 years). Two patients reported hiccups needing baclofen and 6 required rescue medications for constipation. Five out of six patients presented neutropenic enterocolitis on day +7, oral intake was stopped in 4 of them, total parenteral nutrition was started in 3 cases, 3 patients required extra antibiotic coverage, and 4 received analgesic therapy. All patients improved with conservative measures.

Conclusions

In this real-world observational study, the incidence of neutropenic enterocolitis was considerably higher than previous reports in HSCT recipients. It may be associated with NEPA administration but future studies will be needed to confirm this relationship.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Hospital Clínic Barcelona.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.