Abstract 1947
Background
NEPA is the first and only fixed oral combination of a long-acting NK1receptor antagonist (RA), netupitant, and a pharmacologically distinct 5-HT3RA, palonosetron. NEPA is approved for prevention of chemotherapy (ctx)-induced nausea and vomiting (CINV) in patients (pts) receiving cisplatin-based highly emetogenic ctx (HEC) or moderately emetogenic ctx (MEC). Here we present patient-reported outcomes (PRO) of patients (pts) receiving NEPA as an antiemetic prophylaxis during platin-based chemotherapy in a prospective non-interventional study. This group of patients presents a population at high risk for CINV.
Methods
The ongoing prospective AkyPRO study was designed to evaluate quality of life (QoL) in 2500 pts receiving NEPA for CINV prevention in single or two-day MEC or HEC over 3 cycles. The primary endpoint QoL was recorded by FLIE questionnaires. Secondary endpoints were efficacy, reported by pts and physicians on a 4-point scale; antiemetic rescue medication, and safety.
Results
In this interims analysis 595 pts receiving platin-based ctx were evaluated. PRO data show that ctx-induced vomiting can be controlled very efficiently in the majority of platin-receiving pts. Between 80-90% of pts reported no impact on daily life due to vomiting and between 84-90% of pts had a complete response (no vomiting, no rescue medication) in the 3 analysed cycles, independently of which type of platin-ctx they received. Furthermore, the majority of pts (74%, 81% and 68%, respectively) reported no or mild nausea in the cisplatin-, carboplatin- and oxaliplatin-subgroup in cycle 1. However, even mild nausea seems to have a strong impact on daily life with 40% of pts receiving cisplatin- or carboplatin-based chemotherapy and 46% of oxaliplatin-receiving pts reporting an impact on daily life due to nausea in cycle 1.
Conclusions
NEPA was proven highly effective in controlling both vomiting and nausea over three cycles of ctx independent of the type of platin administered. Despite the reported MEC classification of oxaliplatin in contrast to the HEC classification of cis- and carboplatin, nausea was more difficult to control in oxaliplatin-receiving patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Riemser Pharma.
Funding
Riemser Pharma.
Disclosure
M. Karthaus: Advisory / Consultancy: Helsinn; Advisory / Consultancy: Riemser. J. Schilling: Advisory / Consultancy: Riemser. All other authors have declared no conflicts of interest.
Resources from the same session
2935 - Correlation of progression free survival-2 and overall survival in solid tumors
Presenter: Paul Mainwaring
Session: Poster Display session 1
Resources:
Abstract
2273 - High performance of serial tumor biopsies in first in human (FIH) phase I trials.
Presenter: Jun Sato
Session: Poster Display session 1
Resources:
Abstract
5933 - Response rates and lesion-level progression patterns of solid tumor patients in an academic phase 1 program: implications for tumor heterogeneity
Presenter: Christopher Chen
Session: Poster Display session 1
Resources:
Abstract
3569 - Clinical Benefit and Response Rate in Early Phase Clinical Trials: First Report from a Single-Institution Study
Presenter: Antonio Marra
Session: Poster Display session 1
Resources:
Abstract
4139 - Patient (pt) selection for immunotherapeutic early-phase clinical trials (ieCTs): a single Phase I Unit experience
Presenter: Matteo Simonelli
Session: Poster Display session 1
Resources:
Abstract
4451 - Improving patient selection for immuno-oncology phase 1 trials: an external validation of five prognostic scores at Claudius Regaud Institute of Toulouse, Oncopôle (IUCT-O).
Presenter: Ghassan Al Darazi
Session: Poster Display session 1
Resources:
Abstract
1696 - Demonstrating the Changing Trends in Phase 1 Clinical Trials
Presenter: Christina Guo
Session: Poster Display session 1
Resources:
Abstract
3202 - Participation of Women in phase 1 oncology clinical trials
Presenter: Laura Vidal
Session: Poster Display session 1
Resources:
Abstract
4518 - Predictors for early trial discontinuation of patients with cancer participating in phase I clinical trials
Presenter: Joeri Douma
Session: Poster Display session 1
Resources:
Abstract
4368 - Safety of Tumor Treating Fields delivery to the torso: Meta analysis from TTFields clinical trials
Presenter: Federica Grosso
Session: Poster Display session 1
Resources:
Abstract