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Olanzapine Plus Triple Antiemetic Therapy for the Prevention of Carboplatin-Induced Nausea and Vomiting: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Aug 10; Vol. 42 (23), pp. 2780-2789. Date of Electronic Publication: 2024 Jun 04. - Publication Year :
- 2024
-
Abstract
- Purpose: We evaluated the efficacy and safety of antiemetic therapy with olanzapine, a neurokinin-1 receptor antagonist (RA), a 5-hydroxytryptamine-3 (5-HT <subscript>3</subscript> ) RA, and dexamethasone for preventing chemotherapy-induced nausea and vomiting in patients receiving carboplatin-containing chemotherapy.<br />Patients and Methods: Chemotherapy-naïve patients scheduled to receive carboplatin (AUC ≥5) were randomly assigned to receive either olanzapine 5 mg once daily (olanzapine group) or placebo (placebo group) in combination with aprepitant, a 5-HT <subscript>3</subscript> RA, and dexamethasone. The primary end point was the complete response (CR; no vomiting and no rescue therapy) rate in the overall phase (0-120 hours). Secondary end points included the proportion of patients free of nausea and safety.<br />Results: In total, 355 patients (78.6% male, median age 72 years, 100% thoracic cancer), including 175 and 180 patients in the olanzapine and placebo groups, respectively, were evaluated. The overall CR rate was 86.9% in the olanzapine group versus 80.6% in the placebo group. The intergroup difference in the overall CR rate was 6.3% (95% CI, -1.3 to 13.9). The proportions of patients free of chemotherapy-induced nausea in the overall (88.6% in the olanzapine group v 75.0% in the placebo group) and delayed (89.7% v 75.6%, respectively) phases were significantly higher in the olanzapine group than in the placebo group (both P < .001). Somnolence was observed in 43 (24.6%) and 41 (22.9%) patients in the olanzapine and placebo groups, respectively, and no events were grade ≥3 in severity.<br />Conclusion: The addition of olanzapine was not associated with a significant increase in the overall CR rate. Regarding the prevention of nausea, adding olanzapine provided better control in patients receiving carboplatin-containing chemotherapy, which needs further exploration.
- Subjects :
- Humans
Male
Female
Double-Blind Method
Aged
Middle Aged
Aged, 80 and over
Drug Therapy, Combination
Adult
Benzodiazepines adverse effects
Benzodiazepines administration & dosage
Benzodiazepines therapeutic use
Antineoplastic Agents adverse effects
Morpholines therapeutic use
Morpholines administration & dosage
Neoplasms drug therapy
Neurokinin-1 Receptor Antagonists therapeutic use
Neurokinin-1 Receptor Antagonists administration & dosage
Olanzapine therapeutic use
Olanzapine administration & dosage
Olanzapine adverse effects
Carboplatin adverse effects
Carboplatin administration & dosage
Nausea chemically induced
Nausea prevention & control
Antiemetics therapeutic use
Antiemetics administration & dosage
Vomiting chemically induced
Vomiting prevention & control
Dexamethasone therapeutic use
Dexamethasone administration & dosage
Aprepitant therapeutic use
Aprepitant administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 42
- Issue :
- 23
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 38833659
- Full Text :
- https://doi.org/10.1200/JCO.24.00278