Abstract 454P
Background
T-DXd is approved as 2L or later treatment for HER2-positive gastric cancer in several countries and is considered emetogenic. Nausea and vomiting affect significantly patient quality of life, leading to poor compliance with further treatment. Therefore, we sought to identify the optimal combination of antiemetic prophylaxis with T-DXd.
Methods
This study was a multicenter, randomized, open-label, non-comparative, Ph2 study to investigate optimal antiemetic prophylaxis for Japanese patients (pts) with gastric cancer treated with T-DXd. The pts were randomized to a doublet regimen (DxR, dexamethasone and palonosetron) or a triplet regimen (TxR, aprepitant in addition to doublet regimen) at a ratio of 1:1; stratified by gender, gastrectomy status, and study site. T-DXd admiration was started at 6.4 mg/kg and the antiemetic prophylaxis was administered from day 1 up to day 5. The primary endpoint was antiemetic complete response (CR, defined no emetic event and no rescue drug) rate to assess control emesis based on patient reported outcomes for 21 days. CR rate in acute phase (0-24hr) and delayed phase (2-21d) were evaluated as a secondary endpoint. With 29 pts per arm, the primary analysis considered a regimen promising if either arm had ≥18 CRs.
Results
A total of 58 pts were eligible for this analysis. Three pts were discontinued follow-up (2 pts in DxR, 1 pt in TxR). Both antiemetic CR rate for 21 days (overall) and CR rate in delayed phase were 41.4% (12/29) for DxR and 37.9% (11/29) for TxR. The antiemetic CR rate in acute phase was 86.2% (25/29) in both regimens. The median first emetic event occurred at 3 day in both regimens.
Conclusions
Both antiemetic prophylaxis regimens did not meet the prespecified antiemetic CR rate. This study, which used patient reported outcome to assess emetic events, has resulted in a higher rate of emetic events compare to monitoring by physicians reported in previous studies. Given the study design and small sample size, further research may help to fully characterize nausea and vomiting with T-DXd in gastric cancer pts.
Clinical trial identification
jRCTs031200336.
Editorial acknowledgement
Legal entity responsible for the study
Yokohama City University Hospital, Epidemiological and Clinical Research Information Network (ECRIN), and Daiichi Sankyo Co., Ltd.
Funding
Daiichi Sankyo Co., Ltd.
Disclosure
K. Oba: Financial Interests, Personal, Invited Speaker: Chugai, Daiichi Sankyo; Financial Interests, Personal, Other, IDMC member: Eisai, Ono pharmaceutical co, Janssen. K. Nishikawa: Financial Interests, Personal, Invited Speaker, Lecture fee: Bristol Myers Squibb, Daiichi Sankyo, EA Pharma, Eli Lilly, MSD, Ono, Taiho, Yakult. H. Maeda: Financial Interests, Personal, Invited Speaker: Tsumura Co; Financial Interests, Personal, Writing Engagement: Igaku-shoin; Non-Financial Interests, Personal, Other, journal editor: Annals of cancer research and therapy; Non-Financial Interests, Personal, Other, research advisory: Japanese foundation of multidisciplinary cancer treatment; Non-Financial Interests, Personal, Other, editorial board: Japanase society of human cells. A. Makiyama: Financial Interests, Personal, Invited Speaker: Eli Lilly, Taiho, Ono, Daiichi Sankyo, Bristol Myers Squibb. T. Oshima: Financial Interests, Personal, Invited Speaker: Taiho, Astellas; Financial Interests, Personal, Writing Engagement: Astellas; Financial Interests, Personal, Other, research grant: Taiho, Kyowa Kirin, Chugai, Nihon kayaku. A. Katayama: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo; Financial Interests, Personal, Stocks/Shares: Daiichi Sankyo. K. Shiosakai: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo Co., Ltd. All other authors have declared no conflicts of interest.
Resources from the same session
5P - Clinicopathologic features and genomic profiling of occult breast cancer
Presenter: Liansha Tang
Session: Poster Display
Resources:
Abstract
6P - Tumor cell-released autophagosomes (TRAPs) promote lung metastasis through inducing PD-L1 high expression of pulmonary vascular endothelial cells (PVECs) in breast cancer
Presenter: Xuru Wang
Session: Poster Display
Resources:
Abstract
7P - Tumor cell-released autophagosomes (TRAPs) promote breast cancer lung metastasis by modulating neutrophil extracellular traps formation
Presenter: Xiaohe Zhou
Session: Poster Display
Resources:
Abstract
9P - Clinicopathological features and prognosis of mucinous breast cancer: A retrospective analysis of 358 patients in Vietnam
Presenter: Hoai Hoang
Session: Poster Display
Resources:
Abstract
10P - Comparison of 28-gene and 70-gene panel in risk-prediction of Chinese women with early-stage HR-positive and HER2-negative breast cancer
Presenter: Lei Lei
Session: Poster Display
Resources:
Abstract
11P - Multimodal analysis of methylation and fragmentomic profiles in plasma cell-free DNA for differentiation of benign and malignant breast tumors
Presenter: Hanh Nguyen
Session: Poster Display
Resources:
Abstract
12P - Plasma cell-free mRNA profiles enable early detection of breast cancer
Presenter: Chi Nguyen
Session: Poster Display
Resources:
Abstract
13P - Relationship of distress and quality of life with gut microbiome composition in newly diagnosed breast cancer patients: A prospective, observational study
Presenter: Chi-Chan Lee
Session: Poster Display
Resources:
Abstract
14P - Classification of molecular subtypes of breast cancer in whole-slide histopathological images using a novel deep learning algorithm
Presenter: Hyung Suk Kim
Session: Poster Display
Resources:
Abstract
15P - The regulation of pregnenolone in breast cancer
Presenter: Hyeon-Gu Kang
Session: Poster Display
Resources:
Abstract