A Randomized, Double Blind, Placebo-Controlled Study Evaluating Efficacy of Combination Olanzapine, Ondansetron and Dexamethasone for Prevention of...

Date 24 November 2018
Event ESMO Asia 2018 Congress
Session Poster display - Cocktail
Topics Supportive Measures
Complications/Toxicities of Treatment
Presenter WIPADA Nipondhkit
Citation Annals of Oncology (2018) 29 (suppl_9): ix129-ix138. 10.1093/annonc/mdy444
Authors W. Nipondhkit
  • Medical Oncology, Udonthanee Cancer Hospital, 41330 - Udon Thani/TH

Abstract

Background

Most of Thai cancer patients receiving high emetogenic chemotherapy cannot access to neurokinin-1 receptor antagonists or palonosetron for chemotherapy-induced nausea and vomiting (CINV) prevention. We evaluated efficacy of olanzapine with real-life practice antiemetic drugs for CINV prevention from doxorubicin plus cyclophosphamide (AC) regimen in early stage breast cancer patients.

Methods

A randomized, double-blind, placebo-controlled trial. The intervention group received olanzapine 10 mg orally and the control group received matching placebo daily on day 1,2,3,4. All patients received ondansetron 8 mg and dexamethasone 20 mg intravenously before chemotherapy administration then dexamethasone 10 mg orally from day 2,3,4. The primary end point was no nausea rate in the early period (0-24 hours). The secondary end points were no nausea rate in the delayed (24-120 hours) and overall (0-120 hours) periods and complete response (no vomiting and no use of rescue drug). Outcomes were assessed by self-reported records.

Results

Total 39 patients were randomized in 1:1 ratio to receive olanzapine (20 patients) and matching placebo (19 patients). There were significantly greater proportions of patients without nausea in the olanzapine group (50%) than the placebo group (10.5%) in the early period (P = 0.008). In the overall period, there were 30.0% and 0% of patients without nausea in the olanzapine and the placebo groups, respectively (P = 0.009). In the early period, there was significantly more complete response rate in the olanzapine group (75.0%) than the placebo group (36.8%) (P = 0.016). Overall treatment-related adverse events were not different, except somnolence was more common in the olanzapine group.

Conclusions

Olanzapine 10 mg combined with ondansetron and dexamethasone was more effective than placebo for CINV prevention from AC regimen in early stage breast cancer patients. The short duration of olanzapine was safe and well tolerated.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

Rajavithi Hospital Ethical Review Board. (Research number 60086).

Funding

Rajavithi Hospital.

Disclosure

The author has declared no conflicts of interest.