1672P - Single-dose NEPA versus 3-day aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with risk factors receiving moderately emetogenic chemotherapy (MEC)

Background

In this first head-to-head neurokinin (NK) 1 receptor antagonist (RA) comparative study in patients receiving anthracycline cyclophosphamide (AC) and non-AC MEC, a single dose of NEPA (fixed combination NK₁RA, netupitant, and 5-HT₃RA, palonosetron) was non-inferior to a 3-day aprepitant (APR) regimen in preventing CINV. The overall (0-120 h) complete response (CR; no emesis, no rescue) rates were 65% NEPA vs 54% APR. While chemotherapy emetogenicity may be the primary consideration when choosing antiemetics, it is established that patient factors also play a role in determining emetic risk. For patients receiving non-AC MEC, antiemetic guidelines recommend an NK₁RA regimen for those receiving carboplatin or those with additional patient-related risk factors. In this post-hoc analysis, we evaluated the subgroup of patients receiving non-AC MEC who had ≥1 patient-related emetic risk factor.

Methods

This subgroup was from a pragmatic, multicenter, randomized, prospective study. Oral NEPA was administered as a single dose on day 1, while APR was given on days 1-3 + ondansetron on day 1; all patients were to receive dexamethasone on days 1-4. Chemotherapy-naïve patients included were those receiving non-AC MEC and either female, male <60 years, male ≥60 years who received carboplatin, or male ≥60 years with anxiety. CR rates were compared between groups during the acute (0-24 h), delayed (25-120 h) and overall (0-120 h) phases.

Results

Of all patients (n = 211) in the non-AC MEC subgroup, 181 (86%) were included in this risk factor subset. Significantly higher CR rates were seen for NEPA during both the acute and overall phases. Table: 1672P

Conclusions

A single dose of NEPA, administered on day 1 only, was shown to be more effective that a 3-day APR regimen in preventing CINV following non-AC MEC in patients with emetic risk factors.

Clinical trial identification

NCT03831633.

Editorial acknowledgement

Editorial and medical writing assistance was provided by Jennifer Vanden Burgt, an independent Medical Affairs consultant, Minneapolis, MN and funded by Helsinn Healthcare SA, Lugano, Switzerland.

Legal entity responsible for the study

VIFOR France provided the funding for this study. Capionis, Bordeaux, France was the contract research organization who managed the study.

Funding

VIFOR France.

Disclosure

L. Zelek: Financial Interests, Personal, Advisory Board: VIFOR; Financial Interests, Personal, Other, Personal fees: Novartis; Financial Interests, Personal, Other, Personal fees: Roche; Financial Interests, Personal, Other, Personal fees: Lilly; Financial Interests, Personal, Other, Personal fees: Sandoz; Financial Interests, Personal, Other, Personal fees: Pfizer. P. Debourdeau: Financial Interests, Personal, Other, Personal fees: Bayer; Financial Interests, Personal, Other, Personal fees: Leo Pharma. J.P. Wagner: Financial Interests, Personal, Research Grant: MSD. C. Lefeuvre-Plesse: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Other, Travel/accommodations: Roche; Financial Interests, Personal, Other, Travel/accommodations: Novartis; Financial Interests, Personal, Other, Travel/accommodations: Pfizer; Financial Interests, Personal, Other, Travel/accommodations: Pierre Fabre. J. Bachet: Financial Interests, Personal, Other, Personal fees: Amgen; Financial Interests, Personal, Other, Personal fees: AstraZeneca; Financial Interests, Personal, Other, Personal fees : Bayer; Financial Interests, Personal, Other, Personal fees: Merck Serono; Financial Interests, Personal, Other, Personal fees: Pierre Fabre; Financial Interests, Personal, Other, Personal fees: Sanofi; Financial Interests, Personal, Other, Personal fees: Servier; Financial Interests, Personal, Other, Personal fees: Roche. H. Simon: Financial Interests, Personal, Advisory Board: VIFOR; Financial Interests, Personal, Other, Personal fees: Roche; Financial Interests, Personal, Other, Personal fees: Mundipharma; Financial Interests, Personal, Other, Personal fees: Mylan; Financial Interests, Personal, Other, Personal fees: Lilly; Financial Interests, Personal, Other, Personal fees: Sandoz; Non-Financial Interests, Personal, Other: AstraZeneca; Non-Financial Interests, Personal, Other: Lilly. D. Mayeur: Financial Interests, Personal, Advisory Board: VIFOR; Financial Interests, Personal, Other, Personal fees: Leo Pharma; Financial Interests, Personal, Other, Personal fees: Roche; Financial Interests, Personal, Other, Personal fees: Novartis; Financial Interests, Personal, Other, Personal fees: Pfizer; Financial Interests, Personal, Invited Speaker, Personal fees: Astellas. N. Jovenin: Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Tesaro; Financial Interests, Personal, Advisory Board: Vifor France; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: Leo Pharma; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Vifor France; Financial Interests, Personal, Research Grant: Teva; Financial Interests, Personal, Research Grant: Amgen; Financial Interests, Personal, Research Grant: BMS; Financial Interests, Personal, Research Grant: Pfizer; Financial Interests, Personal, Research Grant: Roche; Financial Interests, Personal, Research Grant: Sandoz; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Kiowa Kerin; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Other, Honoraria: Arrows; Financial Interests, Personal, Other, Honoraria: Ethylpharm; Financial Interests, Personal, Other, Honoraria: Norgine; Financial Interests, Personal, Other, Honoraria: Pierre Fabre. F. Scotté: Financial Interests, Personal, Advisory Board: VIFOR; Financial Interests, Personal, Advisory Board: Helsinn Healthcare SA; Financial Interests, Personal, Advisory Board: Tesaro; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Other, Personal fees: Roche; Financial Interests, Personal, Other, Personal fees: Amgen; Financial Interests, Personal, Other, Personal fees: Pfizer; Financial Interests, Personal, Other, Personal fees: Leo Pharma; Financial Interests, Personal, Other, Personal fees: Mylan; Financial Interests, Personal, Other, Personal fees: Mundi Pharma. All other authors have declared no conflicts of interest.