Dr.-von-Hauner'sches Kinderspital, Paediatric Haematology, Oncology and Stem Cell Transplantation, Ludwig-Maximilians-University München, 80337, Munich, Germany.
Department I - General Paediatrics, Haematology/Oncology, University Children's Hospital Tübingen, Hoppe-Seyler-Str. 1, 72076, Tübingen, Germany.
BMC Cancer. 2019 Nov 15;19(1):1118. doi: 10.1186/s12885-019-6252-6.
Chemotherapy-induced nausea and vomiting (CINV) belong among the most burdensome side effects in hemato-oncology. Mostly, a combination of ondansetron and dexamethasone is used as antiemetic prophylaxis in pediatric patients undergoing emetogenic chemotherapy. However, dexamethasone is prohibited in different pediatric chemotherapy protocols. Currently, data on the use of ondansetron with the new antiemetic agent fosaprepitant without dexamethasone is not available for pediatric patients.
In this non-interventional observation study, 79 pediatric patients with a median age of 8.0 years (range 0.5-17.9 years) who received a CINV prophylaxis regimen with either fosaprepitant (4 mg/kg; maximum 150 mg) and ondansetron (as 24-h continuous infusion) (n = 40; fosaprepitant group/FG) or ondansetron only (n = 39; control group/CG) during moderately or highly emetogenic chemotherapy were analyzed. The groups were analyzed and compared for frequency of vomiting, administered doses of on-demand antiemetic dimenhydrinate and adverse events during the acute (0-24 h after chemotherapy administration) and delayed (> 24 h-120 h) CINV phases.
A total of 112 and 116 chemotherapy blocks were analyzed in the fosaprepitant and the control group, respectively. The emetogenic potential of the administered chemotherapy did not significantly differ (p = 0.8812) between the two cohorts. In the acute CINV phase, the percentage of patients experiencing vomiting (n = 26 patients) and the vomiting events were significantly higher (p = 0.0005 and p < 0.0001, respectively) in the CG (n = 26 patients (66.7%); 88 events) compared with the FG (n = 10 patients (25.0%); 37 events). In the delayed CINV phase, the percentage of patients experiencing vomiting and the vomiting events were also significantly higher (p = 0.0017 and p < 0.0001, respectively) in the CG (n = 31 patients (79.5%); 164 events) compared with the FG (n = 17 patients (42.5%); 103 events). Additionally, significantly more dimenhydrinate doses were administered in the CG compared with the FG patients (n = 322/n = 198; p < 0.0001). The occurrence of adverse events did not significantly differ between the two groups (p > 0.05).
Fosaprepitant (4.0 mg/kg) in addition to ondansetron, without application of dexamethasone, was well tolerated, safe, effective and superior to ondansetron only as CINV prophylaxis in pediatric patients during moderately and highly emetogenic chemotherapy.
化疗引起的恶心和呕吐（CINV）是血液肿瘤学中最具负担性的副作用之一。儿科患者在接受致吐性化疗时，通常采用昂丹司琼联合地塞米松作为止吐预防。然而，地塞米松在不同的儿科化疗方案中被禁用。目前，尚无儿科患者使用昂丹司琼联合新型止吐药福沙匹坦，而不使用地塞米松的数据。
本非干预性观察研究纳入了 79 名接受化疗引起的恶心和呕吐（CINV）预防方案的儿科患者，中位年龄为 8.0 岁（范围 0.5-17.9 岁）。这些患者在中度或高度致吐性化疗期间接受了以下两种预防方案：福沙匹坦（4mg/kg；最大剂量 150mg）联合昂丹司琼（24 小时持续输注）（n=40；福沙匹坦组/FG）或仅接受昂丹司琼（n=39；对照组/CG）。对两组患者在急性（化疗后 0-24 小时）和迟发性（>24 小时-120 小时）CINV 期的呕吐频率、按需给予的昂丹司琼二甲硅油剂量以及不良事件进行分析。
福沙匹坦组和对照组分别分析了 112 个和 116 个化疗周期。两组接受的化疗药物致吐性无显著差异（p=0.8812）。在急性 CINV 期，CG 中出现呕吐的患者比例（n=26 例）和呕吐事件显著高于 FG（n=10 例）（p=0.0005 和 p<0.0001），CG（n=26 例（66.7%）；88 次事件）和 FG（n=10 例（25.0%）；37 次事件）。在迟发性 CINV 期，CG 中出现呕吐的患者比例（n=31 例）和呕吐事件也显著高于 FG（n=17 例）（p=0.0017 和 p<0.0001），CG（n=31 例（79.5%）；164 次事件）和 FG（n=17 例（42.5%）；103 次事件）。此外，CG 中给予昂丹司琼二甲硅油的剂量明显多于 FG（n=322/ n=198；p<0.0001）。两组患者不良事件的发生无显著差异（p>0.05）。
在中度和高度致吐性化疗期间，福沙匹坦（4.0mg/kg）联合昂丹司琼，不使用地塞米松，作为儿科患者的 CINV 预防药物，耐受性良好、安全、有效，优于单独使用昂丹司琼。
