2094P - A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for highly emetogenic chemotherapy in breast cancer

Background

Dexamethasone is one of the key antiemetic agents and is widely used even now. However, dexamethasone has been associated with a number of adverse reactions even after short-term administration. Therefore, the development of steroid-free antiemetic regimen is an important issue to be considered. Thus, the purpose of this study was to investigate the efficacy and safety of palonosetron, aprepitant, and olanzapine in a multi-institutional phase II study.

Methods

Chemotherapy-naive patients scheduled to receive for highly emetogenic chemotherapy in breast cancer were enrolled and evaluated the occurrence of chemotherapy-induced nausea and vomiting during 120 hours after chemotherapy. The primary endpoint of the study was total control (TC) in the overall phase. Key secondary endpoint was complete response (CR), which was assessed in the acute, delayed, and overall phase, respectively. Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events.

Results

Eighty-nine patients were enrolled from 8 centers in Japan, of which 76 were evaluable for analyses. The percentage of patients achieved TC during the overall phase was 17.1% (95% confidence interval [CI] 0.094–0.275; p = 0.275). CR was achieved in 43.4% (95% CI 0.321–0.553; p = 0.726), 53.9% (95% CI 0.421–0.655), and 63.2% (95% CI 0.513–0.739) of patients during the overall, acute, and delayed phases, respectively

Conclusions

The primary endpoint was below the threshold and we could not find any benefit in the dexamethasone-free regimen. The CR rate was also examined as one of the secondary endpoints, with similar results. Although dexamethasone is considered to have side effect concerns, its effect on CINV cannot be ignored, suggesting that easy complete omission should be avoided.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

D. Tsuji: Financial Interests, Personal, Invited Speaker: Taiho Phamaceutical Co., Ltd., Kyowa Kirin Co., Ltd. K. koizumi: Financial Interests, Personal, Invited Speaker: Pfizer, Chugai Pharmaceutical. K. Suzuki: Financial Interests, Personal and Institutional, Invited Speaker: Taiho, Nipro. All other authors have declared no conflicts of interest.