Abstract 1853P
Background
Oxaliplatin (Ox) is associated with Ctx induced nausea and vomiting (CINV), in particular delayed nausea. There is limited data from randomized trials and a lack of QoL for Ox based Ctx. NEPA, an oral fixed dose combination of netupitant 300 mg and palonosetron 0,5 mg has been approved for the prevention of acute and delayed Ctx-induced nausea and vomiting (CINV) in pts receiving highly (HEC) or moderately emetogenic Ctx (MEC). The primary objective of the prospective, non-interventional study (NIS) AkyPRO was the evaluation of QoL in adults receiving NEPA as primary prophylaxis for CINV associated with MEC or HEC. Here, we present an analysis of QoL, patient reported outcomes and effectiveness in the subgroup of pts receiving NEPA during Ox-Ctx.
Methods
The prospective NIS enrolled in total 2.429 pts. In this post-hoc analysis we evaluated pts receiving 3 consecutive cycles of Ox-Ctx. Primary endpoint was no impact of vomiting or nausea on daily life (NIDL), documented by Functional Living Index–Emesis (FLIE) questionnaires. Effectiveness was reported in pts diaries. Complete response (CR) was defined as no emesis and no rescue medication. Non-significant nausea (NSN) was no or mild nausea. Pts and physicians documented overall antiemetic effectiveness on a 4-point scale. Adverse events (AEs) were reported on d1–21 of each cycle.
Results
167 pts with Ox-CT were evaluable. Pts demographics: Med age 69 years; 38% female, 94% ECOG 0-1, 54% received Ox-Ctx in the palliative setting. Tumor entities were colon 38%, stomach 21%, pancreatic 17%, rectum 15%, others 10%. Overall, 82% of pts reported that vomiting had NIDL during cycle 1, this high rate was maintained in subsequent cycles. Nausea was more difficult to control than vomiting with two-thirds of the pts reporting NIDL due to nausea. CR was high, with over 84%, while over 69% of pts reported NSN all 3 cycles. Comparison of pts’ and physicians’ perception of antiemetic effectiveness was comparable. NEPA was well tolerated. Low-grade constipation (3 %) and diarrhea (3.6%) were the most frequent treatment-related AEs.
Conclusions
NEPA was highly effective in the prevention of CINV during Ox-Ctx in this real world study and QoL was maintained.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Riemser Pharma.
Disclosure
M. Karthaus: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Riemser. J. Schilling: Honoraria (self), Travel/Accommodation/Expenses: Riemser. All other authors have declared no conflicts of interest.