Quality of Life and Patient Reported Outcome (PRO) in Patients Receiving High and Moderate Emetogenic Chemotherapy (Ctx) - Results of a German Non-Interventional Study with NEPA - a Netupitant/Palonosetron Fixed Dose Combination

Introduction: NEPA is a fixed dose combination of the NK1-receptor antagonist (RA) netupitant and the 5-HT3-RA palonosetron and approved for prevention of chemotherapy-induced nausea and vomiting (CINV) in pts receiving cisplatin-based highly emetogenic (HEC) or moderately emetogenic Ctx (MEC). Data from one of the pivotal studies demonstrates the safety and efficacy of NEPA in antrazyklin (A)-cyclophosphamid based Ctx, a regime recently reclassified as HEC. Both drugs are frequently used in regimens for hematology pts. A German non-interventional study investigated NEPA's efficacy and impact on quality of life in adult cancer pts by patient-related outcomes (PRO) and physicians' personal assessment under real life conditions. Primary objective was the evaluation of quality of life (QoL) in adults receiving NEPA for CINV prevention. Secondary endpoints were efficacy and safety of NEPA.

Methods: Open label, non-interventional, prospective, national, multicenter study that evaluates CINV prevention and patients' QoL with NEPA in pts receiving either HEC or MEC on up to 2 consecutive Ctx days for at least consecutive 3 cycles. QoL was evaluated by the validated FLIE questionnaires at the end of each Ctx cycle. Efficacy was documented by the treating physicians and via patient diaries for 3 Ctx cycles within 24 hours after and additional 4 days after chemotherapy. Safety, additional medication and physicians' overall satisfaction was reported via eCRF.

Results: Between June 2015 and May 2017 a total of 1959 pts were enrolled with 1883 pts being eligible. 1846 pts were included in the efficacy analysis in the 1^st, 1711 pts in the 2^nd and 1600 pts in the 3^rd cycle. Median age was 57 (range of 28-89). 55% received anthracyclin-based and 31% platinum based Ctx. Efficacy, evaluated by physicians' personal assessment on a 4-point scale, was rated very good or good for 1656 (89.7%), 1540 (90.0%) and 1469 (91.8%) patients in cycle 1, 2 and 3, respectively. At this stage, PRO with complete response was analyzed based on 293 completed diaries. Here, 83.9% reported no emesis and no rescue medication in the acute phase (0-24h post chemotherapy), while 78.5% and 74.0% reported complete response in the delayed (>24-120h post chemotherapy) and overall phase (0-120h post chemotherapy). A high percentage of patients did not suffer from any emesis (94%, 94% and 90% in the acute, delayed and overall phase, respectively). Over 90% of pts reported no impact on daily QoL due to vomiting in all 3 cycles with HEC or MEC.

Conclusions: NEPA proved to be highly effective for prevention of CINV. Patient reported outcome was rated very good or good in more than 90% of patients in all three reported Ctx cycles in the acute as the delayed phase of highly and moderately emetogenic Ctx including platinum or anthracyclin based therapy. The physicians evaluation was concordant to PRO.