K. Nakanishi , N. Sugimoto , Y. Kodera , H. Kawakami , A. Makiyama , H. Konishi , S. Morita , Y. Narita , K. Minashi , M. Imano , R. Inamoto , T. Nishina , T. Kawakami , M. Hagiwara , H. Kume , K. Yamaguchi , W. Hashimoto , K. Muro
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This secondary analysis investigated prognostic factors for real-world progression-free survival (rwPFS) and objective response rate (ORR) for T-DXd as third- or later-line treatment.</div></div><div><h3>Patients and methods</h3><div>Patients aged ≥20 years with histopathologically confirmed human epidermal growth factor receptor 2 (HER2)-positive unresectable advanced or recurrent gastric or gastroesophageal junction adenocarcinoma, who had worsened after chemotherapy, were included. Patients received T-DXd as third- or later-line therapy between September 2020 and September 2021. Univariate and multivariate analyses identified prognostic factors for rwPFS and ORR.</div></div><div><h3>Results</h3><div>Of the 307 patients, 75.6% were male and 69.1% were aged ≥65 years. The median duration of prior trastuzumab treatment was 6.5 months (range 0-81.5 months). Multivariate analysis showed HER2 immunohistochemistry (IHC) 3+ [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.49-0.86], intestinal type lesions (HR 0.59, 95% CI 0.43-0.79), modified Glasgow Prognostic Score (mGPS) 0 and 1 (HR 0.71, 95% CI 0.53-0.95), and longer duration of prior trastuzumab treatment (≥ median) (HR 0.75, 95% CI 0.58-0.97) as positive prognostic factors for rwPFS. Longer prior trastuzumab treatment was also a positive prognostic factor for ORR (odds ratio 2.02, 95% CI 1.13-3.63).</div></div><div><h3>Conclusions</h3><div>Patients with clinical benefits from prolonged trastuzumab treatment are likely to benefit from T-DXd. Similarly, HER2 IHC 3+, intestinal type lesions, and better mGPS (0 or 1) are associated with longer rwPFS. However, T-DXd should not be withheld even in patients without these factors, as a median PFS of 3.42 months was observed in those with the shortest prior trastuzumab exposure.</div></div>","PeriodicalId":100490,"journal":{"name":"ESMO Gastrointestinal Oncology","volume":"8 ","pages":"Article 100184"},"PeriodicalIF":0.0000,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Prognostic factors and treatment response in HER2-positive gastric cancer patients receiving trastuzumab deruxtecan: secondary analysis of the EN-DEAVOR study\",\"authors\":\"K. Nakanishi , N. Sugimoto , Y. Kodera , H. Kawakami , A. Makiyama , H. Konishi , S. Morita , Y. Narita , K. Minashi , M. Imano , R. Inamoto , T. Nishina , T. Kawakami , M. Hagiwara , H. Kume , K. Yamaguchi , W. Hashimoto , K. Muro\",\"doi\":\"10.1016/j.esmogo.2025.100184\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>EN-DEAVOR was a multi-institutional retrospective study evaluating the effectiveness and safety of trastuzumab deruxtecan (T-DXd) in gastric cancer patients. This secondary analysis investigated prognostic factors for real-world progression-free survival (rwPFS) and objective response rate (ORR) for T-DXd as third- or later-line treatment.</div></div><div><h3>Patients and methods</h3><div>Patients aged ≥20 years with histopathologically confirmed human epidermal growth factor receptor 2 (HER2)-positive unresectable advanced or recurrent gastric or gastroesophageal junction adenocarcinoma, who had worsened after chemotherapy, were included. Patients received T-DXd as third- or later-line therapy between September 2020 and September 2021. Univariate and multivariate analyses identified prognostic factors for rwPFS and ORR.</div></div><div><h3>Results</h3><div>Of the 307 patients, 75.6% were male and 69.1% were aged ≥65 years. The median duration of prior trastuzumab treatment was 6.5 months (range 0-81.5 months). Multivariate analysis showed HER2 immunohistochemistry (IHC) 3+ [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.49-0.86], intestinal type lesions (HR 0.59, 95% CI 0.43-0.79), modified Glasgow Prognostic Score (mGPS) 0 and 1 (HR 0.71, 95% CI 0.53-0.95), and longer duration of prior trastuzumab treatment (≥ median) (HR 0.75, 95% CI 0.58-0.97) as positive prognostic factors for rwPFS. Longer prior trastuzumab treatment was also a positive prognostic factor for ORR (odds ratio 2.02, 95% CI 1.13-3.63).</div></div><div><h3>Conclusions</h3><div>Patients with clinical benefits from prolonged trastuzumab treatment are likely to benefit from T-DXd. Similarly, HER2 IHC 3+, intestinal type lesions, and better mGPS (0 or 1) are associated with longer rwPFS. 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引用次数: 0
摘要
den - deavor是一项多机构回顾性研究，评估曲妥珠单抗德鲁德康（T-DXd）治疗胃癌患者的有效性和安全性。这项二级分析调查了T-DXd作为三线或后期治疗的真实无进展生存期（rwPFS）和客观缓解率（ORR）的预后因素。患者和方法纳入年龄≥20岁，经组织病理学证实为人表皮生长因子受体2 （HER2）阳性，不可切除的晚期或复发性胃或胃食管交界处腺癌，化疗后恶化的患者。患者在2020年9月至2021年9月期间接受T-DXd作为三线或后期治疗。单因素和多因素分析确定了rwPFS和ORR的预后因素。结果307例患者中，男性占75.6%，年龄≥65岁占69.1%。既往曲妥珠单抗治疗的中位持续时间为6.5个月（范围0-81.5个月）。多因素分析显示，HER2免疫组化（IHC） 3+[危险比（HR） 0.65, 95%可信区间（CI） 0.49-0.86]、肠道类型病变（HR 0.59, 95% CI 0.43-0.79）、改良格拉斯哥预后评分（mGPS） 0和1 （HR 0.71, 95% CI 0.53-0.95）、既往曲单抗治疗持续时间较长（≥中位数）（HR 0.75, 95% CI 0.58-0.97）是rwPFS的阳性预后因素。先前更长时间的曲妥珠单抗治疗也是ORR的一个积极预后因素（优势比2.02,95% CI 1.13-3.63）。结论长期曲妥珠单抗治疗有临床获益的患者可能从T-DXd中获益。同样，HER2 IHC 3+、肠型病变和较好的mGPS（0或1）与较长的rwPFS相关。然而，即使在没有这些因素的患者中，T-DXd也不应该被保留，因为在曲妥珠单抗暴露时间最短的患者中，观察到中位PFS为3.42个月。
Prognostic factors and treatment response in HER2-positive gastric cancer patients receiving trastuzumab deruxtecan: secondary analysis of the EN-DEAVOR study
Background
EN-DEAVOR was a multi-institutional retrospective study evaluating the effectiveness and safety of trastuzumab deruxtecan (T-DXd) in gastric cancer patients. This secondary analysis investigated prognostic factors for real-world progression-free survival (rwPFS) and objective response rate (ORR) for T-DXd as third- or later-line treatment.
Patients and methods
Patients aged ≥20 years with histopathologically confirmed human epidermal growth factor receptor 2 (HER2)-positive unresectable advanced or recurrent gastric or gastroesophageal junction adenocarcinoma, who had worsened after chemotherapy, were included. Patients received T-DXd as third- or later-line therapy between September 2020 and September 2021. Univariate and multivariate analyses identified prognostic factors for rwPFS and ORR.
Results
Of the 307 patients, 75.6% were male and 69.1% were aged ≥65 years. The median duration of prior trastuzumab treatment was 6.5 months (range 0-81.5 months). Multivariate analysis showed HER2 immunohistochemistry (IHC) 3+ [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.49-0.86], intestinal type lesions (HR 0.59, 95% CI 0.43-0.79), modified Glasgow Prognostic Score (mGPS) 0 and 1 (HR 0.71, 95% CI 0.53-0.95), and longer duration of prior trastuzumab treatment (≥ median) (HR 0.75, 95% CI 0.58-0.97) as positive prognostic factors for rwPFS. Longer prior trastuzumab treatment was also a positive prognostic factor for ORR (odds ratio 2.02, 95% CI 1.13-3.63).
Conclusions
Patients with clinical benefits from prolonged trastuzumab treatment are likely to benefit from T-DXd. Similarly, HER2 IHC 3+, intestinal type lesions, and better mGPS (0 or 1) are associated with longer rwPFS. However, T-DXd should not be withheld even in patients without these factors, as a median PFS of 3.42 months was observed in those with the shortest prior trastuzumab exposure.
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