Low-Dose Olanzapine Plus Granisetron and Dexamethasone for Carboplatin-Induced Nausea and Vomiting in Patients with Thoracic Malignancies: A Prospective Multicenter Phase II Trial

The oncologist

article

Chizuru Sakai¹  Hisao Imai²  Jun Hakamata⁴  Daizo Kaito¹  Koichi Minato²  Takahiro Arai⁵  Hitoshi Kawazoe⁶  Akio Suzuki⁷  Yasushi Ohno¹  Hiroyuki Okura¹  Mototsugu Shimokawa⁹  Hirotoshi Iihara⁷  Yukiyoshi Fujita⁵  Shinnosuke Ikemura^1,11  Chiemi Hirose⁷  Mie Kotake²  Norihiko Funaguchi^1,13  Takenobu Gomyo¹ 

[1] Department of Cardiology and Respiratory Medicine, Gifu University Graduate School of Medicine;Division of Respiratory Medicine, Gunma Prefectural Cancer Center;Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University;Department of Pharmacy, Keio University Hospital;Division of Pharmacy, Gunma Prefectural Cancer Center;Division of Pharmaceutical Care Sciences, Center for Social Pharmacy and Pharmaceutical Care Sciences, Keio University Faculty of Pharmacy;Department of Pharmacy, Gifu University Hospital;Laboratory of Pharmacy Practice and Social Science, Gifu Pharmaceutical University;Department of Biostatistics, Yamaguchi University Graduate School of Medicine;Cancer Biostatistics Laboratory, Clinical Research Institute, National Hospital Organization Kyushu Cancer Center;Division of Pulmonary Medicine, Department of Medicine, Keio University, School of Medicine;Keio Cancer Center, Keio University, School of Medicine;Department of Respirology, Asahi University Hospital

关键词: Thoracic malignancies;    Olanzapine;    Carboplatin;    Nausea;    Vomiting;   

DOI  :  10.1002/onco.13772

学科分类：地质学

来源: AlphaMed Press Incorporated

【 摘 要 】

Background Olanzapine is an inexpensive and durable agent for the treatment of chemotherapy-induced nausea and vomiting and is also superior to neurokinin-1 receptor antagonists in the control of nausea. This study aimed to investigate the efficacy and safety of a low dose of 5 mg olanzapine plus granisetron and dexamethasone for treatment of carboplatin (CBDCA)-induced nausea and vomiting in patients with thoracic malignancies. Materials and Methods We conducted a prospective, open-label, single-arm, multicenter, phase II trial in four centers in Japan. Registered patients were scheduled to receive area under the curve (AUC) ≥5 mg/mL per minute of CBDCA and had never received moderately to highly emetogenic chemotherapy. Patients received olanzapine 5 mg/day orally after supper for 4 days, in combination with granisetron and dexamethasone. Primary endpoint was complete response (CR; no emesis and no use of rescue medication) rate during the overall phase (0–120 hours). Results Between February 2018 and June 2020, 51 patients were enrolled, and 50 patients were evaluated. The CR rates in the overall (0–120 hours), acute (0–24 hours), and delayed phases (24–120 hours) were 94.0%, 100%, and 94.0%, respectively. No grade 3 or higher adverse effects of olanzapine were observed. Conclusion Prophylactic antiemetic therapy with a low dose of 5 mg olanzapine plus granisetron and dexamethasone showed durable efficacy with an acceptable safety profile. This three-drug combination appears to be a reasonable treatment approach in patients with thoracic malignancies receiving an AUC ≥5 mg/mL per minute of CBDCA-based regimen. Clinical trial identification number : UMIN000031267. Implications for Practice The results of this phase II trial indicated that the prophylactic administration of low-dose of 5 mg olanzapine combined with granisetron and dexamethasone has promising activity with acceptable safety profile in patients with thoracic malignancy receiving high-dose carboplatin chemotherapy.

【 授权许可】

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