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Patient-reported outcome data during real-world use of NEPA for prevention of chemotherapy-induced nausea and vomiting in high-risk platin-receiving patients - A prospective multicenter trial

Date

28 Sep 2019

Session

Poster Display session 1

Presenters

Meinolf Karthaus

Citation

Annals of Oncology (2019) 30 (suppl_5): v718-v746. 10.1093/annonc/mdz265

Authors

M. Karthaus1, V. Heilmann2, M. Klausmann3, G. Kaltenecker4, B. Whitlock5, J. Schilling6

Author affiliations

  • 1 Hematology And Oncology, Klinikum Neuperlach-Staedtisches Klinikum Muenchen, 81737 - Munich/DE
  • 2 Günzburg, Praxis, Günzburg/DE
  • 3 Aschaffenburg, Studienzentrum, Aschaffenburg/DE
  • 4 Gynäkologie, Städtisches Klinikum, Karlsruhe/DE
  • 5 Onkologie, Ontologische Tagesklinik, Balingen/DE
  • 6 Berlin, Praxisklinik, Berlin/DE
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Resources

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.

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