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Background The oral fixed dose combination of netupitant and palonosetron NEPA 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). The primary objective of the prospective, non-interventional study (NIS) AkyPRO is the evaluation of quality of life in adults receiving MEC or HEC and NEPA for CINV prevention. Secondary endpoints are efficacy and safety of NEPA. Here we present an interim analysis of NEPA efficacy in the subgroup of breast cancer patients, who represent the largest subgroup (66%) of enrolled patients. Since September 2015, 2427 patients have been enrolled, of whom 986 are breast cancer patients. Methods The NIS has been designed to evaluate NEPA in 2,500 cancer patients receiving single day or two day MEC or HEC. QoL is recorded by FLIE questionnaires. Efficacy (complete response (CR, no vomiting, no rescue medication)), additional medication, and adverse events are recorded in patient diaries over three consecutive chemotherapy cycles. Additionally, physicians report their efficacy assessments of NEPA online, using an eCRF. Results At the cut-off date November 11, 2017, 2427 patients had been enrolled in the study. For the interim analysis 986 breast cancer patients were evaluated who had been fully documented in the eCRF at the cut-off date. 95% had an ECOG performance status of 0 or 1. 51% received adjuvant, 44% neoadjuvant, and 5% palliative chemotherapy. 80% of patients received HEC, mostly (79%) anthracycline/cyclophosphamide (AC) combinations. Of the women receiving MEC, the majority were treated with carboplatin-based regimens (9%). 7% of patients received other MEC regimens. 81.4-82.8 % of patients reported CR in cycles 1-3 and more than 93% of patients reported no emesis during the 3 treatment cycles covered in the patient diaries. No significant nausea was reported by 62.7-64.2% of patients. Physicians rated the efficacy of the antiemetic prophylaxis with NEPA using the 4 categories very good, good, satisfactory, and poor. In cycles 1 and 2, more than 89% of physicians rated the efficacy of NEPA very good or good. In cycle 3, 90.6% rated it very good or good. In addition to reporting CR, nausea and emesis episodes in their patient diaries, patients used the same 4 categories to assess the efficacy of NEPA at the end of each treatment cycle. Efficacy assessments of physicians and patients were very similar, with 87% of patients choosing very good or good in cycle 1 compared to 89% of physicians. NEPA was well tolerated. Low-grade constipation (14.9%) and insomnia (8.3%) were the most frequent treatment-related adverse event. Conclusion In this real life study, NEPA was effective in the prevention of CINV in the subgroup of breast cancer patients receiving HEC or MEC. The efficacy assessments by patients and physicians were comparable, with approximately 90% good or very good efficacy for 3 consecutive cycles. More than 93% of patients reported no emesis and more than 81% reported CR during the 5 days post-chemotherapy during all 3 cycles. The study is ongoing. Citation Format: Schilling J, Hielscher C, Hanusch C, Kurbacher C, Busch S, Karthaus M. Efficacy of NEPA as antiemetic prophylaxis in breast cancer patients receiving highly or moderately emetogenic chemotherapy – Interim results of a German prospective, non-interventional study [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-11-10.

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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.

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