Department of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Hoppe-Seyler-Str. 1, 72076, Tübingen, Germany.
Department of Hematology and Oncology, Olgahospital Stuttgart, Kriegsbergstrasse 60, 70174, Stuttgart, Germany.
J Cancer Res Clin Oncol. 2020 Apr;146(4):1089-1100. doi: 10.1007/s00432-020-03143-8. Epub 2020 Feb 13.
Chemotherapy-induced nausea and vomiting (CINV) is a severe and distressing complication during allogeneic hematopoietic stem cell transplantation (alloHSCT). The antiemetic fosaprepitant has shown favorable results in pediatric and adult patients receiving chemotherapy. Data on fosaprepitant in children and adolescents undergoing alloHSCT are missing.
In this non-interventional observation study, 120 children and adolescents with a median age of 11.8 years undergoing alloHSCT after a moderately or highly emetogenic conditioning (MEC or HEC) were analyzed. They received an antiemetic prophylaxis with granisetron (2 × 40 µg/kg d) with or without fosaprepitant (4 mg/kg; single dose, max. 1 × 150 mg/kg BW), and were analyzed in the control (CG; n = 60) or fosaprepitant group (FG; n = 60). The efficacy and safety of the two antiemetic prophylaxis regimens were analyzed and compared with respect to the acute (0-24 h) and the delayed (> 24-120 h) CINV phase and > 120-240 h after MEC or HEC administration.
During MEC, significantly more patients in the CG experienced vomiting during the first 0-24 h (58.6 vs. 25.0%; p = 0.0156) and during > 24-120 h (93.1% vs. 57.1%; p = 0.0020), compared with the FG. Likewise, significantly more vomiting events (269 vs. 136; p < 0.0001) were registered in the CG. During HEC, significantly more patients in the CG experienced vomiting during the first 0-24 h (32.3 vs. 9.4%; p = 0.0319) compared with the FG. Significantly more vomiting events (241 vs. 99; p < 0.0001) were registered in the CG. Laboratory and clinical adverse events were not significantly different between the two groups (p > 0.05).
Antiemetic prophylaxis with fosaprepitant and granisetron was well tolerated, safe, and effective in pediatric patients undergoing alloHSCT. However, larger prospective trials are necessary to evaluate these findings.
化疗引起的恶心和呕吐（CINV）是异基因造血干细胞移植（alloHSCT）期间一种严重且令人痛苦的并发症。抗恶心药福沙匹坦在接受化疗的儿科和成年患者中已显示出良好的效果。在接受 alloHSCT 的儿童和青少年中，尚无关于福沙匹坦的数据。
在这项非介入性观察研究中，分析了 120 名年龄中位数为 11.8 岁的接受中度或高度致吐性预处理（MEC 或 HEC）的儿童和青少年。他们接受了格拉司琼（2×40μg/kg/d）的止吐预防治疗，联合或不联合福沙匹坦（4mg/kg；单剂量，最大 1×150mg/kg BW），并在对照组（CG；n=60）或福沙匹坦组（FG；n=60）中进行分析。分析比较了两种止吐预防方案的疗效和安全性，主要针对急性（0-24 小时）和迟发性（>24-120 小时）CINV 期以及 MEC 或 HEC 给药后>120-240 小时。
在 MEC 中，CG 中在第 0-24 小时（58.6%比 25.0%；p=0.0156）和>24-120 小时（93.1%比 57.1%；p=0.0020）期间经历呕吐的患者明显更多，与 FG 相比。同样，CG 中记录到的呕吐事件（269 比 136；p<0.0001）也明显更多。在 HEC 中，CG 中在第 0-24 小时（32.3%比 9.4%；p=0.0319）期间经历呕吐的患者明显更多，与 FG 相比。CG 中记录到的呕吐事件（241 比 99；p<0.0001）也明显更多。两组的实验室和临床不良事件无显著差异（p>0.05）。
福沙匹坦联合格拉司琼的止吐预防在接受 alloHSCT 的儿科患者中耐受性良好、安全且有效。然而，需要更大的前瞻性试验来评估这些发现。
