Quality of life, effectiveness and patient reported outcomes of antiemetic prophylaxis with NEPA within the German NIS AkyPRO: post-hoc analysis of patients receiving carboplatin-based chemotherapy
Schilling J.1, Lorenz R.2, Rezek D.3, Bauer L.4, Hornung D.5, Sattler D.6, Ackermann S.7, Karthaus M.8
1'Gemeinschaftspraxis Dr. med. Schilling, Dr. med. Till, Dr. med. Kohn', Berlin, Deutschland, 2Gynäkologisch Onkologische Gemeinschaftspraxis, Braunschweig, Deutschland, 3Brustkrebszentrum am Marien-Hospital Wesel, Wesel, Deutschland, 4GRN-Klinik Weinheim, Gynäkologie, Weinheim, Deutschland, 5Vidia Diakonissenkrankenhaus Karlsruhe, Frauenklinik, Karlsruhe, Deutschland, 6Gynäkologie Arabella, Praxis für Gynäkologische Onkologie und Chirurgie, München, Deutschland, 7Klinikum Darmstadt, Frauenklinik, Darmstadt, Deutschland, 8Hämatologie und Onkologie, Klinikum Neuperlach, München, Deutschland
Purpose: Carboplatin is classified as moderate emetogenic, but shows a higher incidence of chemotherapy (CT)- induced nausea and vomiting (CINV). We present a post-hoc analysis of effectiveness, quality of life (QoL) and patient reported outcomes (PRO) of CINV prevention with NEPA, the fixed antiemetic combination of the NK1-receptor-antagonist (RA) netupitant and the 5-HT3-RA palonosetron NEPA for carboplatin-CT in the German non-interventional study AkyPRO.
Methods: The AkyPRO study was designed to evaluate impact on quality of life (QoL) due to vomiting or nausea in 2500 pts receiving NEPA for CINV prevention. QoL was measured by Functional Living Index-Emesis (FLIE) questionnaires. Effectiveness was reported in patient diaries. Complete response (CR) was defined as no emesis and no rescue medication (RM) in the five to six days post-chemotherapy. Non-significant nausea (NSN) was no or mild nausea. Adverse events (AEs) were reported on d1-21 of each cycle.
Results: 413 pts receiving carboplatin were included in the post-hoc analysis of this subgroup. Median age 58 years, 87% female. Tumor types: ovarian 37%, breast 31%, lung 13%, cervical 3% other 17%. 81/87% of patients reported no impact on daily life due to vomiting. CR rates were high with no vomiting rates of 98/99% and no nausea rates of 95/97%. Patients and physicians rated effectiveness similar and very good or good.
Summary and Conclusion: NEPA was highly effective in the prevention of CINV and maintenance of QoL in carboplatin-CT in this real-world study. Vomiting and Nausea were well controlled.