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Dexamethasone-sparing on days 2-4 with combined palonosetron, neurokinin-1 receptor antagonist, and olanzapine in cisplatin: a randomized phase III trial (SPARED Trial).
- Source :
-
British journal of cancer [Br J Cancer] 2024 Feb; Vol. 130 (2), pp. 224-232. Date of Electronic Publication: 2023 Nov 16. - Publication Year :
- 2024
-
Abstract
- Background: This study evaluated the non-inferiority of dexamethasone (DEX) on day 1, with sparing on days 2-4 in cisplatin-based chemotherapy.<br />Methods: Patients with malignant solid tumors who were treated with cisplatin (≥50 mg/m²) were randomly assigned (1:1) to receive either DEX on days 1-4 (Arm D4) or DEX on day 1 (Arm D1) plus palonosetron, NK-1 RA, and olanzapine (5 mg). The primary endpoint was complete response (CR) during the delayed (24-120 h) phase. The non-inferiority margin was set at -15%.<br />Results: A total of 281 patients were enrolled, 278 of whom were randomly assigned to Arm D4 (n = 139) or Arm D1 (n = 139). In 274 patients were included in the efficacy analysis, the rates of delayed CR in Arms D4 and D1 were 79.7% and 75.0%, respectively (risk difference -4.1%; 95% CI -14.1%-6.0%, P = 0.023). However, patients in Arm D1 had significantly lower total control rates during the delayed and overall phases, and more frequent nausea and appetite loss. There were no significant between-arm differences in the quality of life.<br />Conclusion: DEX-sparing is an alternative option for patients receiving cisplatin; however, this revised administration schedule should be applied on an individual basis after a comprehensive evaluation.<br />Clinical Trials Registry Number: UMIN000032269.<br /> (© 2023. The Author(s), under exclusive licence to Springer Nature Limited.)
- Subjects :
- Humans
Palonosetron therapeutic use
Cisplatin adverse effects
Neurokinin-1 Receptor Antagonists therapeutic use
Olanzapine therapeutic use
Dexamethasone adverse effects
Vomiting chemically induced
Quality of Life
Quinuclidines adverse effects
Antiemetics therapeutic use
Antineoplastic Agents adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1532-1827
- Volume :
- 130
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- British journal of cancer
- Publication Type :
- Academic Journal
- Accession number :
- 37973958
- Full Text :
- https://doi.org/10.1038/s41416-023-02493-7