TY - JOUR
T1 - Low-Dose Olanzapine Plus Granisetron and Dexamethasone for Carboplatin-Induced Nausea and Vomiting in Patients with Thoracic Malignancies
T2 - A Prospective Multicenter Phase II Trial
AU - Sakai, Chizuru
AU - Shimokawa, Mototsugu
AU - Iihara, Hirotoshi
AU - Fujita, Yukiyoshi
AU - Ikemura, Shinnosuke
AU - Hirose, Chiemi
AU - Kotake, Mie
AU - Funaguchi, Norihiko
AU - Gomyo, Takenobu
AU - Imai, Hisao
AU - Hakamata, Jun
AU - Kaito, Daizo
AU - Minato, Koichi
AU - Arai, Takahiro
AU - Kawazoe, Hitoshi
AU - Suzuki, Akio
AU - Ohno, Yasushi
AU - Okura, Hiroyuki
N1 - Funding Information:
We express our gratitude to all the patients and their families for participating in this study. We thank the members of the independent data monitoring committee: Prof. Shigehira Saji (Fukushima Medical University), Dr. Toru Mukohara (National Cancer Center Hospital East), Dr. Hideki Hayashi (Gifu Pharmaceutical University); and the independent alliance data center: Mami Matsumaru (Gifu University Hospital). We are very grateful to Yukari Ohtsuka (Gifu University Hospital) for the assistance in this study. We would like to thank Editage (www.editage.com) for English language editing and reviewing. This study was self-funded by the Department of Cardiology and Respiratory Medicine, Gifu University Graduate School of Medicine. This trial protocol was presented at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology Annual Meeting 2018, Vienna, Austria, June 28–30, 2018. The protocol has been published as the following: Iihara H, Shimokawa M, Gomyo T et al. Clinical trial protocol of doublet therapy and olanzapine for carboplatin-induced nausea and vomiting in patients with thoracic cancer: a multicenter phase II trial. BMJ Open 2019;9:e028056.
Publisher Copyright:
© 2021 The Authors. The Oncologist published by Wiley Periodicals LLC on behalf of AlphaMed Press.
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - Carboplatin
KW - Nausea
KW - Olanzapine
KW - Thoracic malignancies
KW - Vomiting
UR - http://www.scopus.com/inward/record.url?scp=85104513608&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85104513608&partnerID=8YFLogxK
U2 - 10.1002/onco.13772
DO - 10.1002/onco.13772
M3 - Article
C2 - 33811782
AN - SCOPUS:85104513608
SN - 1083-7159
VL - 26
SP - e1066-e1072
JO - Oncologist
JF - Oncologist
IS - 6
ER -
