Abstract P2-11-01: Non interventional study with netupitant/ palonosetron (NEPA) as CINV prophylaxis in highly or moderately emetogenic chemotherapy
Authors: Schilling JP , Karthaus M , Klare P , Guth D , Ortner PA 
Published: March 2017

Background

Nausea and Vomiting due to cancer therapy is still a problem for patients and physicians and therefore an ongoing item of research in oncology. International antiemetic guidelines (ASCO, NCCN, MASCC/ESMO) have been published and new drugs are introduced into the market. The fixed oral combination of the NK1-receptor antagonist (RA) netupitant and the 5-HT3-RA palonosetron (NEPA) was recently approved in US and EU 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). The MASCC guidelines 2016 recommend a triple combination of 5-HT3- and NK1-RA and dexamethasone given on day 1 for patients receiving HEC, anthracycline / cyclophosphamide (AC)-containing chemotherapy as well as for carboplatin-based MEC for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Objectives

The primary endpoint of this non interventional study is the evaluation of quality of life in adult cancer patients receiving NEPA for CINV prevention in MEC or HEC. Secondary endpoints are efficacy and safety of NEPA.

Methods

This non-interventional study evaluates CINV prophylaxis with NEPA and QoL in 2500 cancer patients receiving single day or two day MEC or HEC in an ambulatory setting in German cancer hospitals and specialized cancer practices. NEPA is prescribed in accordance with the EU marketing authorization. Quality of life is recorded by FLIE questionnaires. Efficacy - measured as complete response (CR, no vomiting, no rescue medication) –as well as additional medication, safety and adverse events (AEs) are documented by an online questionnaire filled by the physician and a patient diary. 3 consecutive chemotherapy cycles are documented online using the ODM QuaSi documentation system. All specifications in the online documentation must be verifiable.

Results

700 patients from 175 centers (93 gynaecologic oncology, 79 medical oncology, 3 urologic oncology) are included to date. The majority of patients were women (88.7%). 71% of all patients had breast cancer. 92.6% had an ECOG performance status of 0-1. 77.6% received (neo)adjuvant chemotherapy. Most common chemotherapy regimens were AC-based regimens (53.9%), carboplatin-based regimens (15.9%) and cisplatin-based regimens (12%).

Efficacy data are available for 486 patients in cycle 1 and 350 patients over 3 cycles. During 3 consecutive chemotherapy cycles, 89% of patients had a CR on day 1 as recorded by patient diaries. In the delayed phase (days 2-5), 85% of patients had a CR. 93% recorded no vomiting during the entire 5 days at risk following chemotherapy and 69% reported no or only mild nausea. &gt; 90% of the medical staff rated the efficacy of the CINV-prophylaxis with NEPA as good or very good over 3 cycles.

Adverse events (AE), mostly constipation were rare and mild and only of grade 1 or 2. No serious AEs were observed.

Summary

NEPA is a safe and efficacious option for the prophylaxis of nausea and vomiting in highly and moderately emetogenic chemotherapy.

Citation Format: Schilling JP, Karthaus M, Klare P, Guth D, Ortner PA. Non interventional study with netupitant/ palonosetron (NEPA) as CINV prophylaxis in highly or moderately emetogenic chemotherapy [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-11-01.