Rebouças Camilla Vieira de, Alves Rafaela de Brito, Yamada Alayne Magalhães Trindade Domingues, Del Giglio Auro, Cruz Felipe José Silva Melo
Núcleo de Pesquisa e Ensino IBCC Oncologia, São Paulo, SP, Brazil.
Centro Universitário FMABC, São Paulo, SP, Brazil.
Einstein (Sao Paulo). 2025 May 12;23:eAO1124. doi: 10.31744/einstein_journal/2025AO1124. eCollection 2025.
A phase II study evaluated a corticosteroid-free regimen (olanzapine, netupitant, and palonosetron) for the treatment of chemotherapy-induced nausea and vomiting. The results showed control rates comparable to those of standard protocols, demonstrating its feasibility without dexamethasone. ■ Evaluation of a corticosteroid-free antiemetic regimen. ■ Primary endpoint: 46% nausea control. ■ Secondary endpoint: 68% emesis control. ■ Comparable to standard four-drug protocols.
Chemotherapy-induced nausea and vomiting are highly prevalent adverse events that can lead to poor treatment adherence and a decreased quality of life. To the best of our knowledge, the complete omission of dexamethasone from any regimen for preventing nausea and vomiting has not yet been evaluated. This study aimed to evaluate the efficacy of a three-drug protocol without corticosteroids for preventing nausea and vomiting.
This prospective, single-arm, phase II study was designed to evaluate the efficacy of olanzapine, netupitant, and palonosetron in controlling nausea and vomiting induced by emetogenic chemotherapy. Patients were assigned to receive olanzapine on days 1-5 and netupitant and palonosetron on day 1. No corticosteroids were administered. The primary endpoint was complete nausea control during the first 5 days after chemotherapy. Secondary endpoints included complete emesis control (no emesis and no use of rescue medication) and overall complete control (no emesis, no rescue medication, and no nausea).
The complete nausea control rate was 46% (95% confidence interval [95%CI] 0.32-0.59). The emesis control rate was 68% (95%CI= 0.55-0.80), and the overall control rate was 46% (95%CI= 0.32-0.59).
These findings suggest that omitting dexamethasone in highly emetogenic chemotherapy is feasible and results in nausea and vomiting control rates similar to those of the standard four-drug protocol. However, randomized controlled trials are required to confirm this hypothesis.
一项II期研究评估了一种不含皮质类固醇的方案（奥氮平、奈妥吡坦和帕洛诺司琼）用于治疗化疗引起的恶心和呕吐。结果显示其控制率与标准方案相当，证明了在不使用地塞米松的情况下该方案的可行性。
评估一种不含皮质类固醇的止吐方案。
主要终点：46%的恶心控制率。
次要终点：68%的呕吐控制率。
与标准四联药物方案相当。
化疗引起的恶心和呕吐是非常普遍的不良事件，可导致治疗依从性差和生活质量下降。据我们所知，尚未对任何预防恶心和呕吐的方案完全不使用地塞米松进行评估。本研究旨在评估一种不含皮质类固醇的三联药物方案预防恶心和呕吐的疗效。
这项前瞻性、单臂、II期研究旨在评估奥氮平、奈妥吡坦和帕洛诺司琼控制致吐性化疗引起的恶心和呕吐的疗效。患者在第1 - 5天接受奥氮平治疗，第1天接受奈妥吡坦和帕洛诺司琼治疗。不使用皮质类固醇。主要终点是化疗后前5天的完全恶心控制。次要终点包括完全呕吐控制（无呕吐且未使用解救药物）和总体完全控制（无呕吐、未使用解救药物且无恶心）。
完全恶心控制率为46%（95%置信区间[95%CI] 0.32 - 0.59）。呕吐控制率为68%（95%CI = 0.55 - 0.80），总体控制率为46%（95%CI = 0.32 - 0.59）。
这些发现表明，在高度致吐性化疗中省略地塞米松是可行的，且恶心和呕吐控制率与标准四联药物方案相似。然而，需要随机对照试验来证实这一假设。
