Meeting
2019 Supportive Care in Oncology Symposium
Antiemetic efficacy of intravenous (IV) NEPA in patients with breast cancer (BC) receiving anthracycline/cyclophosphamide (AC) chemotherapy.
Authors
Lee S. Schwartzberg
West Cancer Center, Germantown, TN
Lee S. Schwartzberg, Matti S. Aapro
Organizations
West Cancer Center, Germantown, TN, Genolier Cancer Center, Clinique de Genolier, Genolier, Switzerland
Research Funding
Pharmaceutical/Biotech Company
Helsinn Healthcare.
Background: The complexity of administering multi-agent prophylactic antiemetic combinations required to prevent chemotherapy-induced nausea and vomiting (CINV) may contribute to poor guideline adherence seen in multiple studies. NEPA, a combination antiemetic of an NK1 receptor antagonist (RA) [netupitant (oral)/fosnetupitant (IV)] and 5-HT3RA, palonosetron, offers 5-day CINV prevention with a single dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients, thereby minimizing infusion-related toxicities that have been reported with other NK1RAs. This study previously reported the safety of IV NEPA in BC patients receiving repeat cycles of AC; there were no infusion-site or hypersensitivity reactions related to IV NEPA reported. The efficacy results of this study are the focus of this presentation. Methods: This was a Phase 3b, double-blind safety study in females with BC naïve to highly/moderately emetogenic chemotherapy. Patients were randomized 1:1 to receive a single 30-min infusion of IV NEPA or a single oral NEPA capsule on Day 1 prior to AC. Oral dexamethasone was also given to all patients before AC on Day 1 only. Complete response (CR: no emesis, no rescue) and no significant nausea (NSN: < 25mm on 100mm VAS scale) rates were calculated daily during the 5 days (0-120 h) post-AC in Cycle 1. No formal statistical comparison between groups was planned. Results: 402 total patients were included in the analysis. Most patients were white (93%) with ECOG status of 0 (75%); the mean age was 55 years. Comparable CR and NSN rates were seen for IV and oral NEPA during each of the 5 days post-AC.
Conclusions: As a simplified single-dose formulation, IV NEPA showed high response rates in BC patients receiving AC, with favorable safety as no treatment-related infusion-site/hypersensitivity reactions were reported.
|
| Complete Response | No Significant Nausea | ||
| % patients | IV NEPA (N = 200) | Oral NEPA (N = 202) | IV NEPA (N = 200) | Oral NEPA (N = 202) |
| Day 1 | 86.5 | 88.6 | 84.0 | 85.1 |
| Day 2 | 84.0 | 85.6 | 85.0 | 85.1 |
| Day 3 | 81.5 | 84.7 | 80.0 | 82.7 |
| Day 4 | 88.0 | 90.1 | 85.5 | 86.1 |
| Day 5 | 92.0 | 91.6 | 88.5 | 88.1 |
| Days 1-5 | 73.0 | 77.2 | 70.0 | 74.8 |
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Details
Session Type
Poster Session
Session Title
Poster Session B
Track
Mental Health and Psychological Well-being,Psychosocial and Spiritual/Cultural Assessment and Management,Models of Care,Patient Reported Outcomes and Patient Experience,Prevention, Assessment, and Management of Disease and Treatment-related Symptoms,Prognostication ,Survivorship and Late Effects of Cancer
Sub Track
Prevention, Assessment, and Management of Disease and Treatment-related Symptoms
Clinical Trial Registration Number
NCT03403712
Citation
J Clin Oncol 37, 2019 (suppl 31; abstr 115)
DOI
10.1200/JCO.2019.37.31_suppl.115
Abstract #
115
Poster Bd #
D4
Abstract Disclosures
Similar Abstracts
Abstract
2022 ASCO Annual Meeting
Efficacy of olanzapine, netupitant, and palonosetron in controlling nausea and vomiting associated with highly emetogenic chemotherapy in patients with breast cancer (OLNEPA).
First Author: Camilla Vieira de Reboucas
Abstract
2024 ASCO Annual Meeting
An open-label randomized trial comparing addition of olanzapine 5 mg versus olanzapine 10 mg as anti-emetic to standard anti-emetic regime for doxorubicin or epirubicin and cyclophosphamide in breast cancer.
First Author: Tilak Tvsvgk
Abstract
2019 ASCO Annual Meeting
Safety of intravenous (IV) NEPA and oral NEPA for prevention of CINV in patients (pts) with breast cancer (BC) receiving anthracycline/cyclophosphamide (AC) chemotherapy (CT).
First Author: Lee S. Schwartzberg
Abstract
2023 ASCO Annual Meeting
A phase III, double-blind, non-inferiority, randomized controlled trial of antiemetic prophylaxis for highly emetogenic chemotherapy without dexamethasone: CINV POD study.
First Author: Venkatraman Radhakrishnan