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

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

Abstract

© 2018 The Author(s). 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. Clinical trial registration: Australian New Zealand Clinical.

Citation

Hardy, J., Skerman, H., Glare, P., Philip, J., Hudson, P., Mitchell, G., …Yates, P. (2018). 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. BMC Cancer, 18(1), Article 510. https://doi.org/10.1186/s12885-018-4404-8

• Journal Article Type: Article
• Acceptance Date: Apr 18, 2018
• Online Publication Date: May 2, 2018
• Publication Date: 2018-12
• Deposit Date: Jun 3, 2020
• Publicly Available Date: Jun 8, 2020
• Journal: BMC Cancer
• Print ISSN: 1471-2407
• Electronic ISSN: 1471-2407
• Publisher: BioMed Central
• Peer Reviewed: Peer Reviewed
• Volume: 18
• Issue: 1
• Article Number: 510
• DOI: https://doi.org/10.1186/s12885-018-4404-8
• Keywords: Genetics; Cancer Research; Oncology
• Public URL: https://hull-repository.worktribe.com/output/3515253
• Publisher URL: https://bmccancer.biomedcentral.com/articles/10.1186/s12885-018-4404-8#article-info
• Additional Information: Received: 1 December 2017; Accepted: 18 April 2018; First Online: 2 May 2018; : The study was approved by Human Research Ethics Committees at all sites: Alfred Hospital Ethics Committee (Victoria lead), Hunter New England Human Research Ethics Committee (NSW lead), Mater Health Services Human Research Ethics Committee, Southern Adelaide Clinical Research Ethics Committee, St. Vincent’s Health & Aged Care, Queensland University of Technology. All participants signed an approved Patient Information and Consent Form.; : All authors report the NHMRC Grant Funding. JH declares participation in medical advisory boards of MundiPharma Pty Ltd. and Menarini Ltd. Australia. OS declares advisory board consulting fees for Teva Pharmaceutical.; : Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.