West Cancer Center, Memphis, Tennessee.
Staedt. Klinikum Neuperlach and Harlaching, Munich, Germany.
Cancer Med. 2019 May;8(5):2064-2073. doi: 10.1002/cam4.2091. Epub 2019 Apr 9.
To assess the efficacy of oral NEPA (netupitant-palonosetron 300/0.50 mg) over multiple chemotherapy cycles.
Two randomized phase III studies evaluated a single dose of oral NEPA given on day 1 in chemotherapy-naive patients receiving anthracycline-cyclophosphamide (AC)-based (Study 1) or highly (HEC)/moderately (MEC) emetogenic chemotherapy (safety Study 2). Oral NEPA was compared with oral palonosetron 0.50 mg (Study 1) or oral aprepitant 125 mg day 1, 80 mg days 2-3/palonosetron 0.50 mg (Study 2; no formal statistical comparisons). Oral dexamethasone was administered in all treatment groups. Complete response (CR; no emesis/no rescue medication), no emesis, and no significant nausea (NSN) rates during acute (0-24 h) and delayed (>24-120 h) phases of chemotherapy cycles 1-4 in each study were evaluated.
In Study 1, 1450 patients received 5969 chemotherapy cycles; in Study 2, 412 patients received 1961 chemotherapy cycles. In each study, ≥75% of patients completed 4 or more cycles. In Study 1, oral NEPA was superior to palonosetron in preventing chemotherapy-induced nausea and vomiting (CINV) in the acute and delayed phases of cycle 1, with higher rates of CR (all P < 0.05), no emesis (all P < 0.05), and NSN (delayed phase P < 0.05 cycles 1, 2, and 4) reported across 4 cycles. In Study 2, oral NEPA had numerically higher CR and NSN rates in the acute and delayed phases than aprepitant-palonosetron in MEC/HEC patients.
Oral NEPA was highly effective in preventing both acute and delayed CINV over multiple chemotherapy cycles of HEC, AC, and MEC regimens.
Study 1, NCT01339260; Study 2, NCT01376297.
评估口服 NEPA（奈妥吡坦-帕洛诺司琼 300/0.50 毫克）在多个化疗周期中的疗效。
两项随机 III 期研究评估了在接受蒽环类环磷酰胺（AC）为基础（研究 1）或高度（HEC）/中度（MEC）致吐性化疗（安全性研究 2）的化疗初治患者中，给予单次口服 NEPA 剂量的疗效。口服 NEPA 与口服帕洛诺司琼 0.50 毫克（研究 1）或口服阿瑞匹坦 125 毫克第 1 天、80 毫克第 2-3 天/帕洛诺司琼 0.50 毫克（研究 2；无正式的统计学比较）进行比较。所有治疗组均给予口服地塞米松。评估每个研究中第 1-4 个化疗周期的急性（0-24 小时）和迟发性（>24-120 小时）阶段的完全缓解（无呕吐/无解救药物，CR）、无呕吐和无显著恶心（NSN）率。
在研究 1 中，1450 名患者接受了 5969 个化疗周期；在研究 2 中，412 名患者接受了 1961 个化疗周期。在每个研究中，≥75%的患者完成了 4 个或更多周期。在研究 1 中，与帕洛诺司琼相比，口服 NEPA 在预防第 1 个周期的急性和迟发性化疗引起的恶心和呕吐（CINV）方面更具优势，CR 率更高（均 P<0.05），无呕吐（均 P<0.05），以及在第 4 个周期中迟发性恶心（NSN）（第 1、2 和 4 个周期 P<0.05）。在研究 2 中，与阿瑞匹坦-帕洛诺司琼相比，MEC/HEC 患者中，口服 NEPA 在急性和迟发性阶段的 CR 和 NSN 率均具有更高的数值。
口服 NEPA 在 HEC、AC 和 MEC 方案的多个化疗周期中均能有效预防急性和迟发性 CINV。
研究 1，NCT01339260；研究 2，NCT01376297。
