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Should 5-Hydroxytryptamine-3 Receptor Antagonists Be Administered Beyond 24 Hours After Chemotherapy to Prevent Delayed Emesis? Systematic Re-Evaluation of Clinical Evidence and Drug Cost Implications

From the Department of Public Health Sciences and Epidemiology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI; and Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria

Address reprint requests to Hans-Georg Eichler, MD, MS, Department of Clinical Pharmacology, Medical University of Vienna, Allgemeines Krankenhaus, Währinger Gürtel 18-20, A-1090 Vienna, Austria; e-mail: Hans-Georg.Eichler{at}meduniwien.ac.at

PURPOSE: 5-Hydroxytryptamine-3 receptor antagonists (5-HT₃ antagonists) are effective for preventing acute chemotherapy-induced emesis but the benefits of continuing administration of these agents beyond 24 hours after chemotherapy (delayed emesis) remain unclear. The purpose of this study was to provide estimates of clinical efficacy and drug acquisition cost associated with administering 5-HT₃ antagonists beyond 24 hours, as monotherapy or as added to dexamethasone.

METHODS: This analysis is based on the Cancer Care Ontario Practice Guidelines Initiative meta-analysis of the efficacy of 5-HT₃ antagonists. Results from the clinical trials covered in that meta-analysis were reanalyzed to provide estimates of absolute risk reductions (ARR) and numbers needed to treat (NNT) for 5-HT₃ antagonists, as monotherapy or as adjunct treatment. Numbers of 5-HT₃ antagonist unit doses per successfully treated patient were also calculated.

RESULTS: Five studies (comprising 1,716 assessable patients) compared a 5-HT₃ antagonist with placebo; five studies (2,240 patients) compared a combination of a 5-HT₃ antagonist and dexamethasone with dexamethasone monotherapy. ARR for monotherapy was only 8.2% (95% CI, 3.0% to 13.4%). On average, 74 5-HT₃ antagonist doses must be administered to 12 patients (NNT, 12.2; 95% CI, 7.5 to 33.4) not receiving dexamethasone to protect one patient from delayed emesis. In those patients receiving dexamethasone as standard antiemetic treatment in the delayed phase, the addition of a 5-HT₃ antagonist did not significantly improve control of delayed emesis as compared with dexamethasone monotherapy (ARR, 2.6%; 95% CI, –0.6% to 5.8%).

CONCLUSION: Neither clinical evidence nor considerations of cost effectiveness justify using 5-HT₃ antagonists beyond 24 hours after chemotherapy for prevention of delayed emesis.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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