Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy.
Medical Oncology Unit, Santa Chiara Hospital, Trento, Italy.
Support Care Cancer. 2019 Sep;27(9):3593-3597. doi: 10.1007/s00520-019-4645-3. Epub 2019 Feb 14.
Chemotherapy-induced nausea and vomiting (CINV) is one of the most feared and disturbing adverse events of cancer treatment associated with decreased adherence to effective chemotherapy regimens. For high-risk soft tissue sarcoma patients, receiving multiple-day chemotherapy (MD-CT), antiemetic guidelines recommend a combination of an NK receptor antagonist (NK-RA), a 5-HT receptor antagonist (5HT-RA), and dexamethasone on each day of the antineoplastic treatment. NEPA is the first oral fixed-dose combination of a highly selective NK-RA, netupitant, and second-generation 5HT-RA, palonosetron. So far, no data has been published in literature about the efficacy of a single dose of NEPA in MD-CT.
We performed a prospective, non-comparative study to assess the efficacy of one shot of NEPA plus dexamethasone in sarcoma patients receiving MD-CT. The primary efficacy endpoint was a complete response (CR: no emesis, no rescue medication) during the overall phase (0-120 h) in cycle 1. The main secondary endpoints were CR during the overall phase of cycles 2 and 3.
The primary endpoint was reached in 88.9% of patients. Cycles 2 and 3 overall CR rates were 88.9% and 82.4%, respectively. The antiemetic regimen was well tolerated.
This pilot study showed the benefit of one shot of NEPA to prevent CINV in sarcoma patients receiving MD-chemotherapy.
化疗引起的恶心和呕吐(CINV)是癌症治疗中最令人恐惧和困扰的不良反应之一,与有效化疗方案的依从性降低有关。对于接受多日化疗(MD-CT)的高危软组织肉瘤患者,抗恶心指南建议在抗肿瘤治疗的每一天使用神经激肽-1 受体拮抗剂(NK-RA)、5-羟色胺受体拮抗剂(5HT-RA)和地塞米松的组合。NEPA 是首个高选择性 NK-RA 奈妥吡坦和第二代 5HT-RA 帕洛诺司琼的口服固定剂量复方制剂。到目前为止,文献中尚无关于 NEPA 在 MD-CT 中单剂疗效的数据。
我们进行了一项前瞻性、非对照研究,以评估 NEPA 加地塞米松单次给药在接受 MD-CT 的肉瘤患者中的疗效。主要疗效终点是第 1 周期的整个阶段(0-120 小时)完全缓解(CR:无恶心,无解救药物)。主要次要终点是第 2 和第 3 周期的整个阶段的 CR。
主要终点在 88.9%的患者中达到。第 2 和第 3 周期的总体 CR 率分别为 88.9%和 82.4%。抗恶心方案耐受良好。
这项初步研究表明,在接受 MD-化疗的肉瘤患者中,单次使用 NEPA 预防 CINV 是有益的。