Low-dose dexamethasone with fosaprepitant and palonosetron to prevent cisplatin-induced nausea and vomiting in head and neck cancer patients

Abstract

Objective: To determine if a lower dose of dexamethasone can be used in combination with fosaprepitant and palonosetron for cisplatin-induced nausea and vomiting in head and neck cancer patients, we conducted a single-center, two-arm, cross-over comparison study.

Methods: Patients were randomly assigned to either standard dose dexamethasone group: intravenous 9.9 mg on day 1 and 6.6 mg on days 2–4 or low-dose dexamethasone group: intravenous 3.3 mg on days 1–4 for the first course and crossed over to the other treatment for the second course. The primary endpoint was complete response (CR) in the overall period.

Results: Twenty-five patients were screened for the study and 22 were evaluable. Eleven patients were randomly assigned to the standard dose dexamethasone group and 12 patients to the low-dose dexamethasone group. The CR rate in the overall period was 86% in the standard dose group and 73% in the low-dose group, showing no significant difference (p = .61).

Conclusion: The efficacy of low-dose dexamethasone with fosaprepitant and palonosetron was not inferior to that of the standard dose dexamethasone in the highly emetogenic cisplatin-based treatment for head and neck cancer patients.

Chinese abstract

目的：为了确定是否可以将较低剂量的地塞米松与福斯帕辛特和帕洛诺司琼联合用于治疗头颈部癌症患者的顺铂诱导的恶心和呕吐, 我们进行了单中心、双组、交叉比较研究。

方法：患者被随机分配到标准剂量的地塞米松组（第1天静脉注射9.9 mg, 第2-4天静脉注射6.6 mg）, 或低剂量地塞米松组（第1个疗程在第1-4天静脉注射3.3 mg, 第二疗程用其它药治疗）。主要终结点是整个期间内的完全反应（CR）。

结果：为进行该研究, 对25名患者进行了筛选, 22名患者可接受评估。 11名患者被随机分配到标准剂量地塞米松组, 12名患者被分配到低剂量地塞米松组。标准剂量组的CR率为86％, 低剂量组为73％, 两者无显著差异（p = .61）。

结论：使用小剂量地塞米松结合福斯帕辛特和帕洛诺司琼治疗头颈部肿瘤患者的顺铂诱导的恶心呕吐的疗效与标准剂量地塞米松相比并不逊色。

Keywords:

• Head and neck cancer
• CINV
• dexamethasone
• HEC
• aprepitant
• fosaprepitant

Disclosure statement

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.