Efficacy and safety of 5\u2009mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials

Senri Yamamoto,Yoh Hayasaki,Masakazu Abe,Hisao Imai,Ken-Ichirou Morishige,Yukiyoshi Fujita,Kazuto Nakamura,Hitoshi Kawazoe,Ryuji Uozumi,Hirotoshi Iihara,Takafumi Suda,Akio Suzuki,Naoki Inui,Chiemi Hirose,Masato Karayama,Yasushi Ohno,Kazuki Tanaka

doi:10.1186/s12885-021-08572-3

Abstract

BackgroundThe efficacy of olanzapine as an antiemetic agent in cancer chemotherapy has been demonstrated. However, few high-quality reports are available on the evaluation of olanzapine’s efficacy and safety at a low dose of 5 mg among patients treated with carboplatin regimens. Therefore, in this study, we investigated the efficacy and safety of 5 mg olanzapine for managing nausea and vomiting in cancer patients receiving carboplatin regimens and identified patient-related risk factors for carboplatin regimen-induced nausea and vomiting treated with 5 mg olanzapine.MethodsData were pooled for 140 patients from three multicenter, prospective, single-arm, open-label phase II studies evaluating the efficacy and safety of olanzapine for managing nausea and vomiting induced by carboplatin-based chemotherapy. Multivariable logistic regression analyses were performed to determine the patient-related risk factors.ResultsRegarding the endpoints of carboplatin regimen-induced nausea and vomiting control, the complete response, complete control, and total control rates during the overall study period were 87.9, 86.4, and 72.9%, respectively. No treatment-related adverse events of grade 3 or higher were observed. The multivariable logistic regression models revealed that only younger age was significantly associated with an increased risk of non-total control. Surprisingly, there was no significant difference in CINV control between the patients treated with or without neurokinin-1 receptor antagonist.ConclusionsThe findings suggest that antiemetic regimens containing low-dose (5 mg) olanzapine could be effective and safe for patients receiving carboplatin-based chemotherapy.

Highlights

The efficacy of olanzapine as an antiemetic agent in cancer chemotherapy has been demonstrated
The findings suggest that antiemetic regimens containing low-dose (5 mg) olanzapine could be effective and safe for patients receiving carboplatin-based chemotherapy
CBDCA with a target area under the curve [Area under the curve (AUC)] ≥ 4 mg/mL/min is classified as a moderateemetic-risk chemotherapy (MEC) or high-emetic-risk chemotherapy (HEC) [4,5,6,7]

Summary

Introduction

The efficacy of olanzapine as an antiemetic agent in cancer chemotherapy has been demonstrated. In this study, we investigated the efficacy and safety of 5 mg olanzapine for managing nausea and vomiting in cancer patients receiving carboplatin regimens and identified patient-related risk factors for carboplatin regimen-induced nausea and vomiting treated with 5 mg olanzapine. Chemotherapy-induced nausea and vomiting (CINV) is the most distressing side effect of cancer chemotherapy [1, 2]. It can have a strong negative impact on patients’ quality of life (QOL) [3]. In female patients or patients with gynecologic cancer receiving CBDCA, the CR rate was approximately 62% [16, 17] Given this context, further efforts are warranted to control CBDCA-induced nausea and vomiting in female and younger patients to improve their QOL

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