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Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC ≥4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From India
Sneh Bhargave, Vinod Sharma, Babita Kataria, Atul Batra, Deepam Pushpam, Aparna Sharma, Raja Pramanik, Prabhat S. Malik, Ranjit. K. Sahoo, Sachin Khurana, Vishwajeet Singh, Sameer Bakhshi, Atul Sharma, Lalit Kumar, Akash Kumar
JCO Global Oncology, Iss 11 (2025)
Sparad:
| Titel | Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC ≥4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From India |
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| Författarna | Sneh Bhargave, Vinod Sharma, Babita Kataria, Atul Batra, Deepam Pushpam, Aparna Sharma, Raja Pramanik, Prabhat S. Malik, Ranjit. K. Sahoo, Sachin Khurana, Vishwajeet Singh, Sameer Bakhshi, Atul Sharma, Lalit Kumar, Akash Kumar |
| Utgivningsår |
2025
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| Källa |
JCO Global Oncology, Iss 11 (2025)
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| Beskrivning |
PURPOSEPrevention of chemotherapy-induced nausea and vomiting with currently recommended NK1 receptor antagonist–based triplet during carboplatin (AUC ≥4) chemotherapy appears inadequate. A comparative study between olanzapine and NK1 receptor antagonist–based combination is lacking.METHODSThis was a single-center, phase III, prospective randomized, double-blind, placebo-controlled superiority study comparing olanzapine (olanzapine, ondansetron, dexamethasone [OOD]-experimental arm) with fosaprepitant (fosaprepitant, ondansetron, dexamethasone [FOD]-standard arm) in combination with ondansetron and dexamethasone among chemotherapy-naïve patients (age ≥18 years) receiving carboplatin (AUC ≥4) during the first cycle of single-day chemotherapy. The OOD arm received olanzapine 5 mg per oral once daily (day 1-4), ondansetron 8 mg with dexametahsone 12 mg intravenous (IV) once daily (20 mg with paclitaxel; day 1), and matching placebo for fosaprepitant (day 1). The FOD arm received fosaprepitant 150 mg IV once daily, with the combination (day 1) and matching placebo for olanzapine (days 1-4). The primary outcome was no nausea during the overall period (0-120 hours).RESULTSBetween April 2021 and August 2022, a total of 195 patients were evaluable. The proportion of patients without nausea (0 as per Edmonton Symptom Assessment System scale) in OOD versus FOD arms was 44.1% versus 34.4% (P = .19) in the overall period (0-120 hours). Complete response rates and total control rates were also similar in both arms. One patient had grade 3 sedation in the olanzapine arm.CONCLUSIONOlanzapine, in comparison with NK1 antagonist, is not superior for nausea control during carboplatin-induced emesis. It may act as an effective oral alternative for prevention.
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| Dokumenttyp |
article
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| Språk |
English
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| Information om utgivare |
American Society of Clinical Oncology, 2025.
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| Ämnestermer | |
