Abstract 2094P
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.
Resources from the same session
2116P - Preoperative body mass index, waist circumference, and mortality after major cancer surgery: A nationwide cohort study in South Korea
Presenter: Jiwon Yoon
Session: Poster session 06
2117P - Dietary patterns and clinical outcomes in patients with lung cancer: What needs to change
Presenter: Imanuely Borchardt
Session: Poster session 06
2118P - Refeeding syndrome: A prospective analysis in adults admitted to an oncology hospital
Presenter: Filipe Gonçalves
Session: Poster session 06
2119P - The prognostic impact of nutritional assessment and scores in advanced gastric cancer
Presenter: Sara Torresan
Session: Poster session 06
2120P - Nutritional deficiency post gastric cancer surgery
Presenter: Abay Makishev
Session: Poster session 06
2121P - Association between nutritional status and adverse events in gastrointestinal cancer patients undergoing outpatient chemotherapy in Japan
Presenter: Naoko Sato
Session: Poster session 06
2122P - Clinical significance of oncology patients’ nutritional status assessment
Presenter: Efthymios Kostaridis
Session: Poster session 06
2123P - Value of immuno-nutritional scores in the prognosis of hospitalised patients with lung cancer
Presenter: Jesús López
Session: Poster session 06
2124P - The impact of NUTRItional status at first medical oncology visit ON Clinical Outcomes: The NUTRIONCO study
Presenter: Maurizio Muscaritoli
Session: Poster session 06
2125P - Potential ROle of hypoVItaminosis D in patiENts with cancer treated with immune ChEckpoint inhibitors (PROVIDENCE): A prospective observational study
Presenter: Alessio Cortellini
Session: Poster session 06