Abstract PS13-35: Evaluation of age as a risk factor for CINV in breast cancer patients: Post-hoc analysis of the German real-world AkyPRO study
Authors: Schilling Joerg , Busch Steffi , Hollaender Martin , Kaltenecker Gabriele , Müller Eberhard , Resch Thomas , Till Angelika , Karthaus Meinholf 
Published: February 2021

Abstract
Background: The primary objective of the prospective, non-interventional study (NIS) AkyPRO was the evaluation of quality of life (QoL) in adult cancer patients (pts) receiving NEPA as antiemetic prophylaxis. Secondary endpoints were efficacy and safety of NEPA. NEPA is administered as an oral fixed dose combination of 300 mg of the neurokinin-1-receptor antagonist - (NK1RA) netupitant and 0,5 mg of the 5-hydroxytryptamin-3-receptor antagonist (5-HT3RA) palonosetron once per chemotherapy cycle as primary prophylaxis for chemotherapy-induced nausea and vomiting (CINV) associated with moderately (MEC) or highly (HEC) emetogenic chemotherapy. In modern antiemetic guidelines, anthracycline/ cyclophosphamide (AC) - containing chemotherapy (AC-CT) is classified as HEC requiring triple antiemetic prophylaxis with a 5-HT3RA, a NK1RA and dexamethasone. Pts with breast cancer (BC) have additional risk factors for nausea and vomiting, like female sex and younger age, thus representing a high-risk group for CINV. Here, we present a post-hoc analysis of quality of life data and effectiveness of NEPA in the subgroup of BC pts in two age groups ≥ and &lt; 60 years (y), who were treated with AC-CT in the AkyPRO NIS. Methods: The AkyPRO NIS has been conducted to evaluate quality of life and effectiveness of antiemetic prophylaxis with NEPA in cancer pts with various cancer entities receiving single day or two day MEC or HEC in a real life situation. Quality of life (QoL) was recorded by FLIE questionnaires. Effectiveness of NEPA as indicated by complete response (CR: no vomiting, no rescue medication), additional medication, and adverse events were recorded in patient diaries over three consecutive chemotherapy cycles. Patients and physicians documented overall antiemetic control on a 4-point scale (very good, good, satisfactory, poor). Results: In total, the AkyPro NIS enrolled 2,427 pts. 1,428 pts (65.7 %) had breast cancer. In this post hoc analysis 1,197 BC pts receiving AC-CT (83 % of all BC pts) were evaluated. 782 pts (65%) were &lt;60y, 415 (35%) ≥ 60y old. Most pts received AC-CT in the adjuvant or neoadjuvant setting. Pts ≥ 60y reported a higher CR rate in the overall phase over 3 cycles (c1 88%, c2 90%, c3 88%) than pts &lt;60y (c1 78%, c2, 78%, c77%). Pts ≥ 60y also experienced moderate or severe nausea less frequently, with the non-significant nausea (NSN) rate being 67, 67, 70% c1-c3 in these pts vs. 57, 59, 58% in c1-c3 in younger pts. QoL data confirmed this observation. Older pts reported more often to have no impact on daily life (NIDL) due to nausea (58-62% in c1-c3) than younger pts (50-54% in c1-c3). Comparison of patients’ and physicians’ perception of antiemetic treatment effectiveness revealed that in both groups the majority estimated the effectiveness of antiemetic prophylaxis with NEPA high and comparably well and good or very good.
Conclusion: This real-life study confirmed the effectiveness of NEPA in preventing CINV in the subgroup of BC pts receiving AC-chemotherapy. Pts ≥ 60y experienced less CINV compared to pts &lt;60y, confirming that younger age represents a risk factor for CINV and indicating that the choice of an adequate antiemetic prophylaxis is crucial in this group of pts.
Citation Format: Joerg Schilling, Steffi Busch, Martin Hollaender, Gabriele Kaltenecker, Eberhard Müller, Thomas Resch, Angelika Till, Meinholf Karthaus. Evaluation of age as a risk factor for CINV in breast cancer patients: Post-hoc analysis of the German real-world AkyPRO study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS13-35.