Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC ≥4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From India
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...
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American Society of Clinical Oncology
2025-04-01
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| Series: | JCO Global Oncology |
| Online Access: | https://ascopubs.org/doi/10.1200/GO.24.00166 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Sneh Bhargave |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-2fbfc7ee7d76401b9f2e0ef7e362dc77 |
| institution | DOAJ |
| issn | 2687-8941 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | American Society of Clinical Oncology |
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| series | JCO Global Oncology |
| spelling | doaj-art-2fbfc7ee7d76401b9f2e0ef7e362dc772025-08-20T03:17:58ZengAmerican Society of Clinical OncologyJCO Global Oncology2687-89412025-04-011110.1200/GO.24.00166Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC ≥4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From IndiaSneh Bhargave0Vinod Sharma1Babita Kataria2Atul Batra3Deepam Pushpam4Aparna Sharma5Raja Pramanik6Prabhat S. Malik7Ranjit. K. Sahoo8Sachin Khurana9Vishwajeet Singh10Sameer Bakhshi11Atul Sharma12Lalit Kumar13Akash Kumar14Department of Medical Oncology, IRCH, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Oncology, National Cancer Institute, AIIMS— Jhajjar Campus, All India Institute of Medical Sciences, Haryana, IndiaDepartment of Medical Oncology, National Cancer Institute, AIIMS— Jhajjar Campus, All India Institute of Medical Sciences, Haryana, IndiaDepartment of Medical Oncology, IRCH, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Oncology, IRCH, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Oncology, National Cancer Institute, AIIMS— Jhajjar Campus, All India Institute of Medical Sciences, Haryana, IndiaDepartment of Medical Oncology, IRCH, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Oncology, IRCH, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Oncology, IRCH, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Oncology, IRCH, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Geriatrics, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Oncology, IRCH, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Oncology, IRCH, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Oncology, IRCH, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Medical Oncology, National Cancer Institute, AIIMS— Jhajjar Campus, All India Institute of Medical Sciences, Haryana, IndiaPURPOSEPrevention 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.https://ascopubs.org/doi/10.1200/GO.24.00166 |
| spellingShingle | 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 Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC ≥4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From India JCO Global Oncology |
| title | Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC ≥4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From India |
| title_full | Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC ≥4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From India |
| title_fullStr | Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC ≥4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From India |
| title_full_unstemmed | Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC ≥4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From India |
| title_short | Olanzapine Versus NK1 Receptor Antagonist for Prevention of Carboplatin-Induced (AUC ≥4) Emesis: A Phase III, Double-Blind, Placebo-Controlled Randomized Trial From India |
| title_sort | olanzapine versus nk1 receptor antagonist for prevention of carboplatin induced auc ≥4 emesis a phase iii double blind placebo controlled randomized trial from india |
| url | https://ascopubs.org/doi/10.1200/GO.24.00166 |
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