Effectiveness of NEPA, an oral fixed-dose combination of netupitant and palonosetron in the prevention of chemotherapy induce nausea (CIN): A post-hoc analysis.

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e24140 Background: Despite widespread use of antiemetics, chemotherapy-induced nausea is still reported by upto 70% of adult patients receiving moderately emetogenic chemotherapy(MEC) or highly emetogenic chemotherapy (HEC) agents. Control of nausea remains an important, unmet need among cancer patients. The current evidence suggests that, overall, no significant nausea is reported by upto 75% of the patients with the aprepitant based regimens. Here, we present a post-hoc analysis of an observational study on NEPA (NEtupitant 300mg and PAlonosetron 0.50 mg) in preventing nausea in patients receiving HEC/MEC in a real-world setting in India. Methods: An open-label, single-arm, prospective study among chemonaive patients was conducted across six centers from April 2019 to December 2021 after approval from each institutional ethics committee (CTRI/2020/02/023586). A post-hoc analysis was carried out to assess the effectiveness of NEPA in preventing CIN in patients. The parameters assessed included severity of nausea using a visual analogue scale (VAS) [No significant nausea (includes no/mild nausea) < 2.5cm on VAS scale, moderate nausea 2.5cm to 7.5cm, Severe nausea 7.5cm to 10cm], complete control (no nausea and complete response) and safety. Results: Of the 354 patients, 289 (81.64%) received the HEC regimen, and the remaining 65 (18.36%) received the MEC regimen. Anthracycline-Cyclophosphamide (36.16%) and FOLFOX (6.21%) were the most common HEC and MEC regimens, respectively. In the overall, acute, and delayed phases, no significant nausea was reported in 89.83%., 93.22% and 92.65% of the patients, respectively. Moderate and severe nausea was reported in 5.65%, and 1.13% of patients in the acute phase, 5.65%, and 1.69% in the delayed phase, and 8.19%, and 1.98% in the overall phase respectively. Among, those on HEC and MEC regimen, no significant nausea was reported in 93.42 % and 89.23 % respectively during the overall phase (Table 1). Complete control was achieved in 77.40% of patients in the overall phase, 82.77% in the acute phase, and 85.03% in the delayed phase. Adverse events were reported in 10 (3.4%) patients, with leg pain being the most common 3(0.8%). Conclusions: NEPA was found to be effective and well tolerated in preventing nausea in patients receiving HEC/MEC regimens, with almost 90% of patients reporting no significant nausea in real world Indian setting. Clinical trial information: CTRI/2020/02/023586 .[Table: see text]