A randomized open-label study of guideline-driven antiemetic therapy versus single agent antiemetic therapy in patients with advanced cancer and nausea not related to anticancer treatment

作者：Hardy Janet^*; Skerman Helen; Glare Paul; Philip Jennifer; Hudson Peter; Mitchell Geoffrey; Martin Peter; Spruyt Odette; Currow David; Yates Patsy

来源：BMC Cancer, 2018, 18(1): 510.

DOI：10.1186/s12885-018-4404-8

• Nausea
• Vomiting
• Palliative care
• Antiemetic
• Guidelines

Background: Nausea/vomiting (N/V) not related to anti-cancer treatment is common in patients with advanced cancer. The standard approach to management is to define a dominant cause, and treat with an antiemetic selected through pathophysiologic knowledge of emetic pathways. High rates of N/V control have been reported using both etiology-based guideline-driven antiemetic regimens and an empiric approach using single agents in uncontrolled studies. These different approaches had never been formally compared.
Methods: This randomized, prospective, open label, dose-escalating study used readily available antiemetics in accordance with etiology-based guidelines or single agent therapy with haloperidol. Participants had a baseline average nausea score of >= 3/10. Response was defined as a >= 2/10 point reduction on a numerical rating scale of average nausea score with a final score < 3/10 at 72 h.
Results: Nausea scores and distress from nausea improved over time in the majority of the 185 patients randomized. For those who completed each treatment day, a greater response rate was seen in the guideline arm than the single agent arm at 24 h (49% vs 32%; p = 0.02), but not at 48 or 72 h. Response rates at 72 h in the intention to treat analysis were 49 and 53% respectively, with no significant difference between arms (0.04; 95% CI: -0.11, 0.19; p = 0.59). Over 80% of all participants reported an improved global impression of change. There were few adverse events worse than baseline in either arm.
Conclusion: An etiology-based, guideline-directed approach to antiemetic therapy may offer more rapid benefit, but is no better than single agent treatment with haloperidol at 72 h.

• 出版日期2018-5-2