A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naive, Unresectable HER2-Positive Salivary Gland Cancer

This phase II trial tests whether ado-trastuzumab emtansine works to shrink tumors in patients with HER2-positive salivary gland cancer that has come back (recurrent), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab in treating patients with salivary gland cancer.

开始日期2022-09-30

申办/合作机构

NRG Oncology

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JPRN-UMIN000046620 / Recruiting

HERCEPTIN for intravenous infusion 60 and 150. General drug use-results survey - Advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection - - HERCEPTIN for intravenous infusion 60 and 150. General drug use-results survey - Advanced or recurrent HER2-positive salivary gland cancer not amenable to curative resection -

开始日期2022-02-01

申办/合作机构

Chugai Pharmaceutical Co., Ltd.

NCT04620187 / Recruiting临床2期IIT

A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas

This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.

开始日期2020-12-24

申办/合作机构

Dana-Farber Cancer Institute, Inc.

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100 项与 HER2阳性唾液腺癌相关的临床结果

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100 项与 HER2阳性唾液腺癌相关的转化医学

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0 项与 HER2阳性唾液腺癌相关的专利（医药）

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项与 HER2阳性唾液腺癌相关的文献（医药）

2022-05-01·BMJ Case Reports

Role of ado-trastuzumab emtansine (T-DM1) in HER2 positive salivary gland tumour with brain metastasis

Article

作者: Koyyala, Venkata Pradeep Babu ; Chougule, Snehal ; Dhamne, Nilesh ; Pawar, Suraj

Malignant neoplasms of salivary gland neoplasms are rare and often involve the parotid gland. The primary treatment of these malignancies is surgery with or without adjuvant therapy. Chemotherapy or systemic therapy is indicated in recurrent or metastatic disease where surgery or radiotherapy is not possible. Salivary gland carcinomas, which are human epidermal growth factor receptor 2 (HER2) positive, show an aggressive behaviour with a poor prognosis. Targeting the HER2 pathway with drugs designed to block this pathway is an interesting novel therapy to treat salivary gland carcinomas. We report a case of a patient with HER 2-overexpressing parotid gland adenocarcinoma with brain metastasis, who was managed with ado-trastuzumab emtansine (T-DM1): a monoclonal antibody-cytotoxic drug conjugate that combines trastuzumab with the microtubule inhibitor, emtansine. The patient showed excellent response to the therapy. This case highlights the role of systemic chemotherapy with T-DM1 in HER2 positive salivary gland tumours that could be considered a part of the treatment regimen.

2022-02-01·Journal of the National Comprehensive Cancer Network2区 · 医学

Metastatic Parotid Gland Carcinoma With ERBB2 Amplification With Complete Response to Fam‐Trastuzumab Deruxtecan

2区 · 医学

Article

作者: Shukla, Navika D. ; Chiang, Ryan S. ; Colevas, Alexander D.

HER2 mutations have been shown to be targetable in select cases of salivary gland cancers with overexpression or amplification of the HER2 oncogene. Fam-trastuzumab deruxtecan, a novel antibody–drug conjugate that combines trastuzumab with a topoisomerase I inhibitor, has recently demonstrated efficacy as a third-line agent in HER2-overexpressing breast cancer after trastuzumab failure. These promising results in breast cancer suggest a potential paradigm for use in other tumors with known HER2 alterations, including salivary gland cancer. This report describes a 67-year-old man with HER2-positive metastatic parotid gland carcinoma who experienced disease progression after parotidectomy with adjuvant cisplatin-based chemoradiation, neratinib, and ado-trastuzumab emtansine. After disease progression on the latter HER2-directed therapy, his malignancy demonstrated complete response to fam-trastuzumab deruxtecan, which has been sustained for the past 7 months. Fam-trastuzumab deruxtecan appears to be a well-tolerated therapeutic option in patients with HER2-positive salivary gland carcinoma, with activity demonstrated after progression on ado-trastuzumab emtansine and HER2-directed kinase inhibition. Further studies should be conducted to explore the use of this agent in HER2-positive salivary gland cancers.

2020-07-01·The Oncologist2区 · 医学

The Benefits of Adjuvant Trastuzumab for HER-2-Positive Salivary Gland Cancers

2区 · 医学

Article

作者: Lorch, Jochen H. ; Jo, Vickie Y. ; Tishler, Roy B. ; Goguen, Laura A. ; Schoenfeld, Jonathan D. ; Bae, Ji Eun ; Hanna, Glenn J. ; Haddad, Robert I. ; Margalit, Danielle N. ; Annino, Donald J. ; Chau, Nicole G.

AbstractBackgroundAlthough high-grade salivary gland cancers (SGCs) often express androgen receptor (AR) and/or HER-2/neu, therapeutically targeting these receptors in SGC remains investigational. We investigated the prevalence of receptor expression and the benefit of adjuvant HER-2 directed therapy in the high-risk postoperative setting and explored the clinical utility of sequentially targeting these receptors in the setting of advanced disease.Materials and MethodsWe clinically annotated 95 patients with SGC (excluding adenoid cystic carcinoma) treated at our institution from 2002 to 2019 and recorded AR, HER-2/neu status, and tumor genomic profiling results when available. Clinicopathologic information was then integrated with outcomes.ResultsOf 95 patients, most had high-risk histologies, with salivary duct carcinoma (SDC) as the most frequent diagnosis (43, 45%). Thirty-five (37%) experienced recurrence (51% SDC). HER-2/neu was positive (1–3+) by immunostaining in 34 of 52 (65%) evaluable cases. There was no difference in survival based on HER-2/neu or AR expression. Nine of 17 (53%) patients with HER-2+ SDC received adjuvant chemoradiation with trastuzumab. Median disease-free survival (DFS) and overall survival (OS) were longer among patients with HER-2/neu 3+ staining tumors who received adjuvant trastuzumab versus those who did not (DFS, 117 vs. 9 months; p = .02; OS, 74 vs. 43 months; p = .02), with no difference among other HER-2/neu subgroups (0–2+). Two of nine (22%) patients treated with adjuvant trastuzumab demonstrated recurrence, both with low HER-2/neu staining intensity (1+). Longer time to recurrence (hazard ratio, 0.94; p = .01) predicted improved outcomes. Both androgen deprivation and HER-2-directed therapies had clinical benefit beyond the first-line metastatic setting, with partial response observed beyond second-line use.ConclusionAlthough prospective data are lacking, the use of adjuvant trastuzumab in high-risk patients with SGC appears beneficial, particularly among patients with tumors exhibiting HER-2/neu 3+ immunostaining.Implications for PracticeResults of this study showed an improved disease-free and overall survival in patients treated with adjuvant trastuzumab for high-risk salivary gland cancers with strong HER-2/neu staining intensity. Following recurrence or metastatic spread, sequential HER-2, and androgen-directed therapies may benefit certain patients with salivary gland cancer.