Risk Factors Associated with Chemotherapy-Induced Nausea and Vomiting Among Women with Breast Cancer Receiving Highly Emetogenic Chemotherapy: Individual Patient-Based Analysis of Three Prospective Antiemetic Trials

Abstract

Purpose

Although risk factors related to chemotherapy-induced nausea and vomiting (CINV) have been identified in previous studies, only a few studies have evaluated the risk factors associated with contemporary antiemetic prophylaxis, including olanzapine/aprepitant- or NEPA-containing regimens. This study aimed to identify the risk factors associated with CINV development in Chinese breast cancer patients receiving doxorubicin and cyclophosphamide chemotherapy.

Methods

Data from 304 patients enrolled in 3 previously reported prospective antiemetic studies were included. Multivariate logistic regression models were used to predict risk factors associated with CINV occurrence. Additionally, the likelihood of treatment failure in relation to the number of risk factors in individual patients was evaluated.

Results

Multivariate analysis of the entire study group revealed that obesity status (defined as body mass index/= 25.0 kg/m2) and the use of olanzapine/aprepitant- or NEPA-containing anti-emetic regimens were associated with a high likelihood, while a history of motion sickness was associated with a lower likelihood, complete response (CR), and “no nausea” in the overall phase. A history of vomiting during pregnancy was also associated with a lower likelihood of an overall CR. Patients with an increasing number of risk factors had a higher likelihood of treatment failure and shorter time to first vomiting. Those who did not achieve CR and “no nausea” in the first cycle were less likely to achieve these parameters in the subsequent cycle of chemotherapy.

Conclusion

The present study confirmed previously reported risk factors for CINV in Chinese breast cancer patients receiving doxorubicin and cyclophosphamide. Further optimization of CINV control is required for patients with identifiable risk factors; olanzapine/aprepitant- or NEPA- containing prophylaxis are the preferred contemporary anti-emetics regimens for Chinese breast cancer patients undergoing doxorubicin and cyclophosphamide chemotherapy.

Keywords:

• cytotoxic
• nausea and vomiting
• olanzapine
• aprepitant
• NEPA

Declaration

Part of the data in the manuscript has been presented in the 2023 St Gallen Breast Cancer Conference in Vienna, Austria on 17 March 2023.

Data Sharing Statement

All data relevant to the study are included in the article or uploaded as supplementary information. The data are available from the Comprehensive Cancer Trials Unit of the Department of Clinical Oncology, Chinese University of Hong Kong, but restrictions apply to the availability of these data. These data were used under permission for the current study, and so are not publicly available. Data are, however, available from the authors (W Yeo and F Mo) upon reasonable request. Data will be made available for 15 years from the start of the clinical trials.

Ethics Approval and Informed Consents

This study was approved by the regional ethics committee (the Joint Clinical Research Ethics Committee of Chinese University of Hong Kong and New Territories East Cluster of Hospital Authority, and the Kowloon West Cluster Research Ethics Committee of the Hong Kong Hospital Authority). Written informed consents were obtained from all study patients. The trials complied with the Declaration of Helsinki.

Acknowledgment

This study was supported by an education grant from Madam Diana Hon Fun Kong Donation for Cancer Research.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

Yeo has been involved in the CINV Network in Asia and has been a speaker of the CINV organized by Mundipharma. Mundipharma supported the study design of the NEPA, but had no role in the present analysis, data collection and analysis, decision to publish, or preparation of the manuscript. Molasiotis has received grants and has been a speaker for Helsinn. Madam Diana Hon Fun Kong Donation for Cancer Research had no role in the study design, data collection and analysis, decision to publish, or manuscript preparation. None of the other authors declare any conflict of interest. The statements presented in this paper are the sole responsibility of the authors.