{"title":"一项多中心随机开放标签2期研究，研究曲妥珠单抗德鲁德替康治疗晚期/复发性胃癌患者的最佳止吐疗法：EN-hance研究。","authors":"Toru Aoyama, Akira Ooki, Koji Oba, Kazuhiro Nishikawa, Ryohei Kawabata, Michitaka Honda, Hiromichi Maeda, Mitsuro Kanda, Keiji Sugiyama, Akitaka Makiyama, Kenki Segami, Masazumi Takahashi, Yoshiaki Shindo, Tsutomu Namikawa, Takashi Oshima, Aya Katayama, Kazuhito Shiosakai, Junichi Sakamoto","doi":"10.1007/s10147-025-02748-8","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Trastuzumab deruxtecan (T-DXd) has been approved for the treatment of human epidermal growth factor receptor-2 (HER2)-positive gastric cancer and other indications in several countries and is considered moderately or highly emetogenic. The management of nausea and vomiting associated with T-DXd treatment has not been fully evaluated and the effectiveness of conventional prophylaxis remains unknown.</p><p><strong>Methods: </strong>This open-label, randomized, multicenter, phase 2 study aimed to investigate the optimal antiemetic therapy for Japanese patients with gastric cancer undergoing T-DXd treatment. Patients were randomized to a doublet regimen group (dexamethasone and palonosetron) or triplet regimen group (aprepitant, dexamethasone, and palonosetron) at a ratio of one to one, stratified by sex, gastrectomy status, and study institution. Both antiemetic treatments were administered from day 1 before T-DXd administration, and emetic events and nausea were observed for 21 days. The primary endpoint was the antiemetic complete response (CR) rate to assess control for emetic events based on voluntary patient-reported outcomes (PROs) during cycle 1 (1-21 days).</p><p><strong>Results: </strong>Of the 60 enrolled patients, 58 were eligible for inclusion in this analysis (29 patients in each regimen group). The overall CR rates for the doublet and triplet regimens were 41.4% (12/29 patients) and 37.9% (11/29 patients), respectively, and neither regimen met the pre-specified threshold (> 18/29 patients). The CR rate in the acute phase (0-24 h) was 86.2% (25/29 patients) for both regimens, and the CR rates in the delayed phase (2-21 days) were 41.4% (12/29 patients) and 37.9% (11/29 patients) for the doublet and triplet regimens, respectively.</p><p><strong>Conclusions: </strong>Given that the primary endpoint was not met, further research is needed to better characterize nausea and vomiting with T-DXd to tailor an anti-emetic regimen that suits the needs of the patients.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1162-1173"},"PeriodicalIF":2.8000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12122603/pdf/","citationCount":"0","resultStr":"{\"title\":\"A multicenter randomized open-label phase 2 study investigating optimal antiemetic therapy for patients with advanced/recurrent gastric cancer treated with trastuzumab deruxtecan: the EN-hance study.\",\"authors\":\"Toru Aoyama, Akira Ooki, Koji Oba, Kazuhiro Nishikawa, Ryohei Kawabata, Michitaka Honda, Hiromichi Maeda, Mitsuro Kanda, Keiji Sugiyama, Akitaka Makiyama, Kenki Segami, Masazumi Takahashi, Yoshiaki Shindo, Tsutomu Namikawa, Takashi Oshima, Aya Katayama, Kazuhito Shiosakai, Junichi Sakamoto\",\"doi\":\"10.1007/s10147-025-02748-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Trastuzumab deruxtecan (T-DXd) has been approved for the treatment of human epidermal growth factor receptor-2 (HER2)-positive gastric cancer and other indications in several countries and is considered moderately or highly emetogenic. The management of nausea and vomiting associated with T-DXd treatment has not been fully evaluated and the effectiveness of conventional prophylaxis remains unknown.</p><p><strong>Methods: </strong>This open-label, randomized, multicenter, phase 2 study aimed to investigate the optimal antiemetic therapy for Japanese patients with gastric cancer undergoing T-DXd treatment. Patients were randomized to a doublet regimen group (dexamethasone and palonosetron) or triplet regimen group (aprepitant, dexamethasone, and palonosetron) at a ratio of one to one, stratified by sex, gastrectomy status, and study institution. Both antiemetic treatments were administered from day 1 before T-DXd administration, and emetic events and nausea were observed for 21 days. The primary endpoint was the antiemetic complete response (CR) rate to assess control for emetic events based on voluntary patient-reported outcomes (PROs) during cycle 1 (1-21 days).</p><p><strong>Results: </strong>Of the 60 enrolled patients, 58 were eligible for inclusion in this analysis (29 patients in each regimen group). The overall CR rates for the doublet and triplet regimens were 41.4% (12/29 patients) and 37.9% (11/29 patients), respectively, and neither regimen met the pre-specified threshold (> 18/29 patients). The CR rate in the acute phase (0-24 h) was 86.2% (25/29 patients) for both regimens, and the CR rates in the delayed phase (2-21 days) were 41.4% (12/29 patients) and 37.9% (11/29 patients) for the doublet and triplet regimens, respectively.</p><p><strong>Conclusions: </strong>Given that the primary endpoint was not met, further research is needed to better characterize nausea and vomiting with T-DXd to tailor an anti-emetic regimen that suits the needs of the patients.</p>\",\"PeriodicalId\":13869,\"journal\":{\"name\":\"International Journal of Clinical Oncology\",\"volume\":\" \",\"pages\":\"1162-1173\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12122603/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10147-025-02748-8\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/4/28 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10147-025-02748-8","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/28 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
A multicenter randomized open-label phase 2 study investigating optimal antiemetic therapy for patients with advanced/recurrent gastric cancer treated with trastuzumab deruxtecan: the EN-hance study.
Background: Trastuzumab deruxtecan (T-DXd) has been approved for the treatment of human epidermal growth factor receptor-2 (HER2)-positive gastric cancer and other indications in several countries and is considered moderately or highly emetogenic. The management of nausea and vomiting associated with T-DXd treatment has not been fully evaluated and the effectiveness of conventional prophylaxis remains unknown.
Methods: This open-label, randomized, multicenter, phase 2 study aimed to investigate the optimal antiemetic therapy for Japanese patients with gastric cancer undergoing T-DXd treatment. Patients were randomized to a doublet regimen group (dexamethasone and palonosetron) or triplet regimen group (aprepitant, dexamethasone, and palonosetron) at a ratio of one to one, stratified by sex, gastrectomy status, and study institution. Both antiemetic treatments were administered from day 1 before T-DXd administration, and emetic events and nausea were observed for 21 days. The primary endpoint was the antiemetic complete response (CR) rate to assess control for emetic events based on voluntary patient-reported outcomes (PROs) during cycle 1 (1-21 days).
Results: Of the 60 enrolled patients, 58 were eligible for inclusion in this analysis (29 patients in each regimen group). The overall CR rates for the doublet and triplet regimens were 41.4% (12/29 patients) and 37.9% (11/29 patients), respectively, and neither regimen met the pre-specified threshold (> 18/29 patients). The CR rate in the acute phase (0-24 h) was 86.2% (25/29 patients) for both regimens, and the CR rates in the delayed phase (2-21 days) were 41.4% (12/29 patients) and 37.9% (11/29 patients) for the doublet and triplet regimens, respectively.
Conclusions: Given that the primary endpoint was not met, further research is needed to better characterize nausea and vomiting with T-DXd to tailor an anti-emetic regimen that suits the needs of the patients.
期刊介绍：
The International Journal of Clinical Oncology (IJCO) welcomes original research papers on all aspects of clinical oncology that report the results of novel and timely investigations. Reports on clinical trials are encouraged. Experimental studies will also be accepted if they have obvious relevance to clinical oncology. Membership in the Japan Society of Clinical Oncology is not a prerequisite for submission to the journal. Papers are received on the understanding that: their contents have not been published in whole or in part elsewhere; that they are subject to peer review by at least two referees and the Editors, and to editorial revision of the language and contents; and that the Editors are responsible for their acceptance, rejection, and order of publication.
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