P046 (0052) NO CLINICAL SIGNALS OF DRUG – DRUG INTERACTION OF NEPA (NETUPITANT + PALONOSETRON) IN CHL PATIENTS RECEIVING ABVD REGIMEN

A SINGLE-CENTER REAL LIFE EXPERIENCE

doi: 10.1097/01.HS9.0000547895.96114.44
Survivorship and Patients Perspective
Free

Vittorio Ruggero Zilioli, Periana Minga, Lara Crucitti, Erika Meli, Chiara Rusconi, Roberto Cairoli

Division of Hematology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy

Background: In the setting of cHL, ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) is the most widely used first line chemotherapeutic treatment and it is well known that this regimen is associated with a high emetic risk (HEC). Netupitant (NETU) is the NK1-RA (neurokinin receptor antagonist) component of NEPA, the first antiemetic drug available as oral fixed combination: NETU (300 mg) + palonosetron (PALO 0.5 mg). Both ABVD drugs and NETU are metabolized by cytochrome P-450 isoform 3A4 (CYP3A4), but respect to other NK1-receptor antagonist available, NETU has demonstrated to have no clinical relevant interaction with chemotherapy drugs like etoposide, cyclophosphamide and docetaxel. However, no data are currently available about the safety profile of NETU in the setting of ABVD treatment; for that reason we started the use of this drug as salvage therapy after PALO failure.

Methods: We retrospectively analyzed the cHL patients (pts) treated with ABVD at our Center from September 2016 to January 2018. We used PALO + dexamethasone as first-line anti-CINV prophylaxis, while NEPA was introduced as salvage drug for those pts with inadequately controlled CINV. The primary endpoint of the study was safety of NEPA in ABVD treated pts, while CINV control (no nausea or vomiting) was the secondary endpoint. NEPA-related safety data have been compared to the same data collected at the moment of the last previous PALO-containing regimen.

Results: Among the 32 pts treated with ABVD during the study period, 13 (41%) received NEPA due to PALO failure of CINV control. Globally 53 NEPA administrations were delivered during subsequent cycles. The observed adverse events are listed in Table 1.

With regard to the secondary endpoint, anticipatory, acute and delayed CINV were detected in 15%, 77%, 77%, of PALO pts and 15%, 46% and 15% of NEPA pts, respectively.

Conclusion: In cHL ABVD treated pts who experienced nausea and/or vomiting after failure of PALO + dexamethasone antiemetic prophylaxis, NEPA has demonstrated to be effective in CINV control. NETU did not show drug-drug interaction with ABVD chemotherapy agents, and NEPA administration was globally well tolerated with mild and transient adverse events. These data would suggest the use of NEPA as primary anti-CINV prophylaxis in previously untreated cHL pts.

Figure

Figure

Copyright © 2018 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the European Hematology Association.