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Randomized Controlled Trial
. 2020 Apr:50:30-38.
doi: 10.1016/j.breast.2020.01.005. Epub 2020 Jan 14.

A randomized study of olanzapine-containing versus standard antiemetic regimens for the prevention of chemotherapy-induced nausea and vomiting in Chinese breast cancer patients

Winnie Yeo  1 , Thomas Kh Lau  2 , Leung Li  2 , Kwai Tung Lai  2 , Elizabeth Pang  2 , Maggie Cheung  2 , Vicky Tc Chan  2 , Ashley Wong  2 , Winnie Mt Soo  2 , Vanessa Ty Yeung  2 , Teresa Tse  2 , Daisy Cm Lam  2 , Eva Wm Yeung  2 , Kim Pk Ng  2 , Nelson Ls Tang  3 , Macy Tong  2 , Joyce Js Suen  2 , Frankie Kf Mo  2
Affiliations
Randomized Controlled Trial

A randomized study of olanzapine-containing versus standard antiemetic regimens for the prevention of chemotherapy-induced nausea and vomiting in Chinese breast cancer patients

Winnie Yeo et al. Breast. 2020 Apr.

Abstract

Objectives: Chemotherapy-induced nausea and vomiting (CINV) are distressing symptoms. This randomized study evaluated the antiemetic efficacies of standard antiemetic regimen with/without olanzapine.

Patients and methods: Eligible patients were chemotherapy-naive Chinese breast cancer patients who were planned for (neo)adjuvant doxorubicin/cyclophosphamide. Antiemetic regimen for all studied population included aprepitant, ondansetron and dexamethasone; patients were randomized to Olanzapine (with olanzapine) or Standard arms (without olanzapine). Patients filled in self-reported diaries and completed visual analogue scales for nausea, as well as Functional Living Index-Emesis questionnaires. Blood profiles including fasting glucose and lipids were monitored.

Results: 120 patients were randomized. In Cycle 1 doxorubicin/cyclophosphamide, the Olanzapine arm had significantly higher rates of "Complete Response" than the Standard arm: 65.0% vs 38.3% in the overall period (p = 0.0035), 70.0% vs 51.7% in the acute period (p = 0.0397) and 92.9% vs 74.2% in the delayed period (p = 0.0254). Olanzapine arm also had significantly higher rates of "No significant nausea" and "No nausea" during all 3 time-frames and better QOL. Similar findings were also revealed throughout multiple cycles. Pre-study abnormalities in glucose and lipids occurred in 39.7% and 34.2% of the studied population respectively; there were no differences in these parameters between the two arms at end-of-study assessment.

Conclusion: The addition of olanzapine to standard aprepitant-based antiemetic regimen provides clinically meaningful improvement in controlling CINV. This was associated with a positive impact on QOL and tolerable toxicity profiles among Chinese breast cancer patients receiving doxorubicin/cyclophosphamide chemotherapy. Further studies on metabolic profiles of breast cancer patients are warranted.

Keywords: Aprepitant; Asians; Cyclophosphamide; Dexamethasone; Doxorubicin; Ondansetron; Prospective.

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Conflict of interest statement

Declaration of competing interest WY reports consultancy/advisory roles and receipt of personal fees for Novartis, Pfizer, AstraZeneca, Eli Lilly, Roche, Mundipharma and Amgen.

Figures

Fig. 1
Fig. 1
Time to first vomiting episode during Cycle 1 of AC. X-axis – Time (hours) ranged from 0 to 120 h; Y-axis – Probability of First Vomiting in Cycle 1.
See this image and copyright information in PMC

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