Abstract P6-11-05: NEPA for CINV prevention in highly or moderately emetogenic chemotherapy – interim results of a German non-interventional study on quality of life and efficacy
Authors: J Schilling, P Klare, V Heilmann, P Wülfing, M Karthaus
Journal: Cancer Research (2018)

Abstract Background Inadequately controlled chemotherapy-induced nausea and vomiting (CINV) has a significant impact on the quality of life and daily functioning of cancer patients. Despite international antiemetic guidelines (ASCO, NCCN, MASCC/ESMO), CINV remains a problem for patients, especially in the delayed phase after chemotherapy application. International guidelines recommend a triple combination of 5-HT3- and NK1-receptor antagonist (RA) and dexamethasone given on day 1 for patients receiving HEC including anthracycline / cyclophosphamide (AC)-containing chemotherapy. The MASCC/ESMO guidelines recommend the triple regimen on day 1 also for patients receiving carboplatin-based MEC. NEPA, a fixed dose combination of the NK1-RA netupitant and the 5-HT3-RA palonosetron, has been approved for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in cancer patients receiving cisplatin-based highly emetogenic (HEC) or moderately emetogenic chemotherapy (MEC). Objectives The primary objective of this prospective, non-interventional study is the evaluation of quality of life (QoL) in adult cancer patients receiving NEPA for CINV prevention in MEC or HEC. Secondary endpoints are efficacy and safety of NEPA. Methods The study is planned to enroll 2,500 cancer patients receiving single or two day MEC or HEC in German oncology centers. NEPA is prescribed in accordance with the marketing authorization. QoL is recorded in FLIE questionnaires. Efficacy, determined as complete response (CR, no vomiting, no rescue medication), additional medication, and adverse events are recorded in patient diaries and e-CRF. Three consecutive chemotherapy cycles must be documented. Results At the cut-off date 31 May 2017, 1,959 patients had been included. 86.3% of patients were female, with a median age of 57 years. 94.1% of patients had an ECOG Performance Status of 0 or 1. 67.4% of patients had breast cancer. 47% of patients received adjuvant, 31.7% received neoadjuvant chemotherapy. At the cut-off date 31.05.2017, efficacy, assessed by physicians on a 4 point scale, was rated very good or good for 1,656 (89.7%), 1,540 (90.0%) and 1,469 (91.8%) patients in cycle 1, 2 and 3, respectively. The overall efficacy assessments of physicians and patients were very similar with approximately 90 % of good or very good efficacy of NEPA. Quality of life data as analyzed by 24 March 2017: Less than 10% of patients experienced reduced quality of life, with 90.8%, 92.1% and 90.8% reporting no impact on daily life due to vomiting for HEC in cycle 1, 2 and 3 and 92.1%, 91.7% and 93.6% for MEC. Nausea was harder to control. 64.0%-65.2% of the patients receiving HEC reporting no impact on daily life by nausea and 61.1% - 65.0% of the patients receiving MEC. Conclusions NEPA was very effective in the CINV-prevention in patients receiving HEC or MEC, with more than 90% of patients reporting no impact on daily life by vomiting. The study is ongoing. Citation Format: Schilling J, Klare P, Heilmann V, Wülfing P, Karthaus M. NEPA for CINV prevention in highly or moderately emetogenic chemotherapy – interim results of a German non-interventional study on quality of life and efficacy [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-05.