Evaluation of risk factors predictive of nausea and vomiting with current standard-of-care antiemetic treatment: analysis of phase 3 trial of aprepitant in patients receiving adriamycin–cyclophosphamide-based chemotherapy
- 13 May 2010
- journal article
- research article
- Published by Springer Science and Business Media LLC in Supportive Care in Cancer
- Vol. 19 (6), 807-813
- https://doi.org/10.1007/s00520-010-0899-5
Abstract
A number of prognostic factors have been identified as risk factors for chemotherapy-induced emesis. This post-hoc analysis addressed whether: (1) these prognostic factors can identify a low-risk group for whom ondansetron plus dexamethasone alone provide a high level of protection (≥80% no emesis); (2) the NK1 receptor antagonist aprepitant improves antiemetic outcome regardless of emetic risk. Breast cancer patients in a phase III double-blind, placebo-controlled trial were randomized to antiemetic regimens including ondansetron and dexamethasone, or aprepitant, ondansetron, and dexamethasone. Multivariate logistic regression models were used to assess the impact on emesis (but not nausea) of the regimen with aprepitant, and previously reported risk factors, including age (P < 0.0001), older age (P = 0.006), ethanol use (P = 0.0048), and no history of morning sickness (P = 0.0007) were all significantly associated with reduced likelihood of emesis. The proportion of patients with one, two, or three risk factors who remained emesis free was significantly higher with the aprepitant-containing regimen than with the active control (70.2–82.8% vs. 38.6–66.4%, respectively). Aprepitant markedly improved control of emesis in patients with one or more risk factors. This analysis did not support using risk factors for modifying the antiemetic approach. A low-risk group with zero risk factors for whom aprepitant provided little benefit was of questionable clinical utility, since they comprised less than 3% of patients.This publication has 26 references indexed in Scilit:
- Evaluation of risk factors predictive of nausea and vomiting with current standard-of-care antiemetic treatment: analysis of two phase III trials of aprepitant in patients receiving cisplatin-based chemotherapySupportive Care in Cancer, 2009
- Chemotherapy-induced nausea and vomiting: ESMO Clinical Recommendations for prophylaxisAnnals of Oncology, 2008
- Quality Oncology Practice Initiative Registration Surpasses 250 Oncology Practices: Spring 2007 Data Collection Provides Data to Drive Practitioner-Led ImprovementJournal of Oncology Practice, 2007
- Costs of uncontrolled chemotherapy‐induced nausea and vomiting among working‐age cancer patients receiving highly or moderately emetogenic chemotherapyCancer, 2007
- Prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus ConferenceAnnals of Oncology, 2005
- Efficacy and tolerability of aprepitant for the prevention of chemotherapy‐induced nausea and emesis over multiple cycles of moderately emetogenic chemotherapyCancer, 2005
- ESMO Minimum Clinical Recommendations for prophylaxis of chemotherapy-induced nausea and vomiting (NV)Annals of Oncology, 2005
- Anticipatory nausea and vomitingSupportive Care in Cancer, 2004
- The Oral Neurokinin-1 Antagonist Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial in Patients Receiving High-Dose Cisplatin—The Aprepitant Protocol 052 Study GroupJournal of Clinical Oncology, 2003
- Effect of postchemotherapy nausea and vomiting on health-related quality of lifeSupportive Care in Cancer, 1997