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Olanzapine for the prevention of chemotherapy-induced nausea and vomiting.
Open accessAbstract
BACKGROUND: We examined the efficacy of olanzapine for the prevention of nausea and vomiting in patients receiving highly emetogenic chemotherapy. METHODS: In a randomized, double-blind, phase 3 trial, we compared olanzapine with placebo, in combination with dexamethasone, aprepitant or fosaprepitant, and a 5-hydroxytryptamine type 3-receptor antagonist, in patients with no previous chemotherapy who were receiving cisplatin (≥70 mg per square meter of body-surface area) or cyclophosphamide-doxorubicin. The doses of the three concomitant drugs administered before and after chemotherapy were similar in the two groups. The two groups received either 10 mg of olanzapine orally or matching placebo daily on days 1 through 4. Nausea prevention was the primary end point; a complete response (no emesis and no use of rescue medication) was a secondary end point. RESULTS: In the analysis, we included 380 patients who could be evaluated (192 assigned to olanzapine, and 188 to placebo). The proportion of patients with no chemotherapy-induced nausea was significantly greater with olanzapine than with placebo in the first 24 hours after chemotherapy (74% vs. 45%, P=0.002), the period from 25 to 120 hours after chemotherapy (42% vs. 25%, P=0.002), and the overall 120-hour period (37% vs. 22%, P=0.002). The complete-response rate was also significantly increased with olanzapine during the three periods: 86% versus 65% (P<0.001), 67% versus 52% (P=0.007), and 64% versus 41% (P<0.001), respectively. Although there were no grade 5 toxic effects, some patients receiving olanzapine had increased sedation (severe in 5%) on day 2. CONCLUSIONS: Olanzapine, as compared with placebo, significantly improved nausea prevention, as well as the complete-response rate, among previously untreated patients who were receiving highly emetogenic chemotherapy. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02116530.).
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“With olanzapine being associated with undesired sedation in some situations, 15 it is interesting to note that there was decreased sedation and improved fatigue in the olanzapine arm.”
From Olanzapine for the Treatment of Advanced Cancer–Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial (2020) · cites this paper as [15]
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Metadata
- Authors
- Navari, R. M., Qin, R., Ruddy, K. J., Liu, H., Powell, S. F., Bajaj, M., Dietrich, L., Biggs, D., Lafky, J. M., & Loprinzi, C. L.
- Affiliations
- Mayo Clinic (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-07-14
- Volume
- 375
- Issue
- 2
- Pages
- 134-142
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5344450
- OpenAlex
- W2460792208
- Semantic Scholar
- e1dd1b394f61bd93ef976725f95376ef359b5a7d
- Cited by
- 452
- References
- 57
- Citations by year
- 2026: 28 · 2025: 46 · 2024: 56 · 2023: 43 · 2022: 36 · 2021: 39 · 2020: 54 · 2019: 34 · 2018: 54 · 2017: 52 · 2016: 9
- FWCI
- 55.02
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Purdue University Indianapolis (Indiana University) (submittedVersion)
- Funders
- National Institutes of Health
- National Cancer Institute (UG1CA189823, UG1CA189825, UG1CA189830, U10CA180790, U10CA180867, CA035269, U10CA035269, P50CA108961, UG1CA189956, UG1CA189819, P30CA012197, P30CA015083)
- National Center for Research Resources (M01RR000585, M01RR007122, M01RR000034)
- Topics
- Health Sciences › Medicine › Surgery › Nausea and vomiting management
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Chemotherapy-induced organ toxicity mitigation
- Keywords
- olanzapine, chemotherapy-induced nausea and vomiting, antiemetic prophylaxis, highly emetogenic chemotherapy, cisplatin, dexamethasone, aprepitant, fosaprepitant, 5-HT3 receptor antagonists, sedation, complete response
- MeSH terms
- Olanzapine, Aprepitant, Adult, Aged, Aged, 80 and over, Antiemetics, Antineoplastic Agents, Benzodiazepines, Dexamethasone, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Morpholines, Nausea, Vomiting, Intention to Treat Analysis
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